Phoenix ® Operative Technique

Transcription

OPERATIVE TECHNIQUE
PHOENIX®
MINIMALLY INVASIVE
SPINAL FIXATION SYSTEM
TA BL E O F CON T E N T S
Pre-Operative Planning
• Patient Positioning
• Pedicle Identification and Incision Planning
Operative Technique
• Incision and Guide Wire Insertion
• Pedicle Preparation and Tissue Dilation
• Multi-Axial Screw Placement • Rod Insertion
• Set Screw Insertion and Rod Reduction
•Compression/Distraction
• Final Tightening
• Tab Removal
• Removal Procedure
Part Numbers
Implant Inserter Assembly
and Disassembly
Indications for Use
The surgical technique shown is for illustrative purposes
only. The technique(s) actually employed in each case will
always depend upon the medical judgment of the surgeon
exercised before and during surgery as to the best mode
of treatment for each patient. Please see Instructions
for Use for the complete list of indications, warnings,
precautions, and other important medical information.
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1
2
4
4
5
8
10
12
14
15
15
16
18
20
PRE-OPERATIVE PLANNING
Fig. 1
1. PATIENT POSITIONING
Position the patient in the prone position. A/P
and lateral fluoroscopy should be used to provide
proper imaging. (Fig. 1)
1
2
Fig. 2a
Fig. 2b
2. P
EDICLE IDENTIFICATION AND
INCISION PLANNING
Attain an A/P fluoro with spinous process aligned and
end plates parallel to each other. (Fig. 2a)
Verify the lateral edge of the pedicle ovals are close to
the lateral edge of the vertebral body. (Fig. 2b) The
top of the ovals for both pedicles should be parallel
and equidistant from the end plate. (Fig. 2c)
Fig. 2c
Incision for Mini on both sides
using TLIF
Incision for Mini on both sides
using PLIF
Incision placement will depend on the surgical
approach and minimally invasive technique used
to place the rod. The four figures provide common
options when performing a single level fusion.
Incision for Mini on left side and
percutaneous on right using TLIF
Incision for Mini on left side using
TLIF and percutaneous on right
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4
OPERATIVE TECHNIQUE
Fig. 3a
Fig. 3b
Fig. 3c
3. INCISION AND GUIDE WIRE INSERTION
Locate and make the first incision as defined in the
incision planning step. The incision is approximately
14mm in length to match the diameter of the Phoenix
Screw Body. (Fig. 3a)
Insert the Pedicle Targeting Needle into the pedicle
entry point and advance under AP fluoro to ensure
that the Pedicle Targeting Needle is not medial to the
medial border of the pedicle prior to the entrance into
the vertebral body. Multiple Pedicle Targeting Needles
can be placed in succession prior to switching to lateral
fluoro to check superior/inferior angulation. (Fig. 3b)
Remove the inner stylet of the pedicle targeting needle.
Insert the Guide Wire (20-0123, 20-0124) through the
Pedicle Targeting Needle and place the Guide Wire into
the mid portion of the vertebral body on the lateral
view. (Fig. 3c)
OPERATIVE TECHNIQUE
Fig. 4a
4. P
EDICLE PREPARATION: TISSUE
DILATION AND PEDICLE TAPPING
Assembly of Dilator/Awl/Tap Instrument
Choose the appropriate diameter Tap, 4.5, 5.5, 6.5
or 7.5mm (20-0145, 20-0155, 20-0165, 20-0175)
based on surgeon preference and bone quality.
Each Tap has a color band on the proximal end that
corresponds the Tap diameter to the same color of
the Screw. Assemble the T-Handle (52-1011) or a
Straight Handle (52-1013) onto Tap. Next, assemble
the Tap Sleeve Dilator (20-0275) onto the Tap until
it lines up with the zero mark on the Tap. Advance
the Tap Dilator until it engages the first groove on
the Tap, this is your starting position for insertion
into the incision. The Dilator will be retained in this
position until the Release Button is depressed. A
visual inspection is recommended to confirm the
awl portion of the Tap thread is protruding through
the tip of the Tap sleeve. (Fig. 4a)
NOTE: If pedicle screw monitoring is to be
performed, there is a non-conductive dilator
(20-0218) that should be placed over Dilator/Awl/
Tap instrument prior to use.
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6
OPERATIVE TECHNIQUE
Fig. 4d
Fig. 4b
Fig. 4c
4. P
EDICLE PREPARATION: TISSUE DILATION
AND PEDICLE TAPPING CONT.
Tissue Dilation
Place Tap with assembled Dilator over the Guide Wire
(Fig. 4b) and advance through the tissue using a
twisting motion. (Fig. 4c) Once the Tap engages the
bone, push the Release Button to allow the Tap Sleeve
Dilator to move freely so the Awl and tapping can occur.
(Fig. 4d)
The Tap Sleeve Dilator has measurements to indicate the
appropriate length of Phoenix Screw Bodies to be used.
(Fig. 4e) Generally, the Short is used for the thoracic
region and Standard and Long are used in the lumbar
region based on patient size. Sometimes a longer size
may be preferred in a longer construct to reach the
anterolisthesed segment of a spondylolisthesis.
Skin Surface Level
It is ideal to have approximately 50% of the reduction
head visible above the surface of the skin as indicated
in the figure. (Fig. 4e)
A Non-Conductive Dilator (20-0218) can be placed on
the Tap Sleeve Dilator if stimulation of the Tap is desired.
Fig. 4e
OPERATIVE TECHNIQUE
Fig. 4g
Fig. 4f
Awl
The instrument has a sharp tip design functioning as
a Bone Awl to perforate the pedicle bone so tapping
can occur. Use a clockwise twisting motion to break
through the cortex. (Fig. 4f)
Tapping
Continue a clockwise motion for tapping the bone
while maintaining a straight trajectory to avoid bending
the tap. (Fig. 4g) Use periodic fluoroscopy to check on
depth and proper alignment. When the Tap is at the
desired depth, the screw length is measured by reading
the scale on the Tap. (Fig. 4h) The Dilator must be
in contact with the pedicle bone surface to achieve
accurate measurement.
Remove the Tap Assembly leaving Guide Wire and
Dilator (non-conductive) if desired behind.
Fig. 4h
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OPERATIVE TECHNIQUE
E
C
B
D
A
Fig. 5a
Fig. 5b
5. MULTI-AXIAL SCREW PLACEMENT
Implant Selection
There are two Phoenix Body styles to accommodate
different rod passing techniques. (Fig. 5a) The closed
(magenta) Phoenix Bodies are only used at the end
of a construct and are optional based on surgeon
preference. The closed style can also be used to
guide the Rod into place for mini-open techniques.
The open (green) Phoenix Bodies are used in multi-level
constructs and can also be used at the end of
constructs based on surgeon preference.
See Step 4 – The Dilator has measurements to
indicate the appropriate length of Phoenix Bodies
to be used. Generally, the Short is used for thoracic
region and Standard and Tall are used for lumbar
based on patient size.
Sometimes a longer size may be preferred in a longer
construct to reach the anterolisthesed segment of
a spondylolisthesis.
It is ideal to have approximately 50% of the reduction
head visible above the surface of the skin.
(Fig. 4e and 5b)
Phoenix
Screw Body
Styles
Short
Dimension
A
Height of
Saddle
Dimension
B
From Top
of Saddle
to Bottom
of Tab
Dimension
C
Height of
Tab
Dimension
D
Overall
Phoenix
Length
Dimension
E
Diameter
16mm 70mm 18mm104mm14mm
Standard
16mm 90mm 18mm124mm14mm
Tall
16mm 120mm18mm154mm14mm
Fig. 5b chart
OPERATIVE TECHNIQUE
Knob
Fig. 5c
Fig. 5d
Fig. 5e
Screw Driver Assembly
Attach the appropriate modular Phoenix Screw Body
onto the desired Firebird® Modular Screw. Confirm
a secure connection by pulling on the Screw.
Insert the Screwdriver (20-0200) with either the
Straight Handle (52-1013) or the T-Handle (52-1011)
into Phoenix Screw Body and engage the tip of the
Screwdriver with square of the Modular Screw.
(Fig. 5c) Rotate the knob on a Screwdriver in a
clockwise direction to assemble the Head of the Screw
onto the Screwdriver Tip. (Fig. 5d) Confirm the Screw
is solidly attached to the Screwdriver and do not
overtighten.
Using the Screwdriver, drive the Multi-Axial Screw
of appropriate length over the Guide Wire into the
prepared Pedicle. Remove the Guide Wire after the
Screw enters the vertebral body. (Fig. 5e) Periodically
check with fluoro to ensure proper Screw placement
based on surgeon preference. Over-insertion of Screw
may limit poly-axial motion of the Reduction Head.
Once the Screw is seated to the appropriate level, turn
the Knob in a counter-clockwise direction and remove
the Screwdriver. (Fig. 5d)
NOTE: If for any reason the Phoenix Screw needs to
be adjusted after the Screwdriver is removed, there is
modular Multi-Axial Adjustment Screw Driver (20-0201)
that mates with the Straight Handle (52-1013) to easily
advance or withdraw the Screw.
Place the remaining Screws using the same techniqueby
repeating Steps 3 to 5.
NOTE: Preparation of disc space may occur before or
after Screw placement based on surgeon preference.
NOTE: Optional sterile packed HA coated bone
screws are available upon request.
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OPERATIVE TECHNIQUE
Fig. 6a
Fig. 6c
Fig. 6b
6. ROD INSERTION – ROD LENGTH
Determination
Rod Inserter Assembly
The Rod Sizing Tool (20-0205) is inserted into the most
proximal and distal Phoenix Screw Body and the reading
is taken from the markings on the scale. (Fig. 6a) This is
a direct measurement and no additional numeric addition
is necessary to determine proper length. Example: if the
measurement tool reads 100mm, then select a 100mm
Lordotic or Straight Hex Rod. Both ends of the Caliper
must be inserted until they contact the screw head to
ensure an accurate measurement. This technique works
up to a maximum of 150mm. The option exists to cut
and bend Rods as required.
Align the Hex end of the Rod with the Hex mating
features of the Rod Holder (20-0214). Attach rod to
holder to allow for insertion while maintaining the
desired curvature of the rod. Firmly push the Hex into
the Rod Inserter until it is fully seated. (Fig. 6b) Rotate
the knob on the Inserter in a clockwise motion to draw
the Rod upwards until the front surface of the tip
aligns and is engaged in the undercut feature of the
Rod. (Fig. 6c) This will prevent the Rod from becoming
disengaged during insertion.
WARNING: Excessive or repeated bending of rods may
reduce strength and result in construct failure.
OPERATIVE TECHNIQUE
Fig. 6d
11
Fig. 6g
Fig. 6e
Fig. 6f
Option: Creating a Tunnel for Rod
Percutaneous Rod Passing
The Tissue Dissector (20-0283) may be used to create
a tunnel for passing the Rod into position. The distal
tip of the Tissue Dissector is passed through the end
of the construct with the hook facing up away
from the spine. (Fig. 6d) Advance the instrument
through each Phoenix Screw Saddle until it passes
to the opposite end of the construct. Slowly pull the
instrument back which will dissect the tissue with
distal hook of the instrument.
This technique requires use of the open body for
the end of the construct where the Rod is to be
introduced. Align the openings of the Phoenix Bodies
by hand to facilitate easy passing of the Rod. A Body
Alignment Tool (20-0212) is available to align the
openings if tissue or bone prevents positioning by
hand. The leading tapered end of the Rod is passed
through the open channel in the Phoenix Screw Body
until it passes below the fascia and into the Screw
Head. The Rod Inserter handle will be almost parallel to
the patient during this phase of Rod passage. (Fig. 6e)
When distal tip of Rod enters the Screw Head, begin
to rotate the Rod Inserter handle which will push the
Rod through to the adjacent levels. Once the Rod is
seated, the Rod Inserter handle will be approximately
perpendicular to the patient. (Fig. 6f)
Excessive forces should not be required to pass the
Rod through the tissue. If Rod passage is difficult,
remove the Rod Inserter and utilize the tissue dissector
(Fig. 6d). The Rod Pusher (20-0210) can be inserted
down the Phoenix Screw Body to seat the Rod into
position. (Fig. 6g)
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OPERATIVE TECHNIQUE
Fig. 6h
Fig. 7a
ALTERNATIVE - HOOK ROD INSERTER
Hook Rod Inserter (70-3208) can be used in mini-open
procedures by attaching the hook to the rod, and
dropping down between Phoenix Bodies. (Fig. 6h)
Fig. 7b
7. S
ET SCREW INSERTION AND
ROD REDUCTION
The Rod is brought into correct position and is
stabilized with Rod Holder. The Set Screws are
assembled onto the Set Screw Holders (20-0250,
20-0260) and held in place by depressing the button
on the top of the handle. The Set Screws are inserted
into each Phoenix Screw Body and are used to seat
the Rod into the Impant Saddle. The Set Screw is fully
seated when the Set Screw Holder’s corresponding
laser mark (Short, Standard, Tall) reaches the top of
the Screw Body. (Fig. 7a)
The instrument set contains two long Set Screw
Holders and one short Set Screw Holder. The two
different lengths of Inserters allow for simultaneous
tightening of the Set Screws in tight working spaces as
shown in figure. The round handle design eliminates
the issues with the interference of using T-Handles
side-by-side. A/P and lateral fluoroscopic views can be
used to ensure proper Rod positioning and the extent
of reduction. (Fig. 7b) There are two Round Handles
(20-0211) that can be placed on the existing set screw
handle, if a larger grip surface is desired. They can
also be used to provide greater force when reducing a
spondylolisthesis.
OPERATIVE TECHNIQUE
Fig. 7c
Fig. 7d
7b. A
LTERNATIVE STEP FOR TREATMENT
OF SPONDYLOLISTHESIS: SET SCREW
INSERTION AND ROD REDUCTION
The built-in reduction capability is also useful for
reducing a spondylolisthesis by first provisionally
tightening one Set Screw followed by tightening
of the anterolisthesed segment to establish
deformity correction.
Fully seat the set screws in the Phoenix Screw
Bodies on either side of the vertebrae with the
spondylolisthesis. Then insert the Set Screw on the
vertebrae with spondylolisthesis. (Fig. 7c)
Advancing the Screw provides the reduction force
to align the vertebrae. Make sure the black lines on
the set screw holder shaft indicate the set screw is
fully seated. (Fig. 7d) There are two Round Handles
(20-0211) that can be placed on the existing set
screw handle, if a larger grip surface is desired.
They can also be used to provide greater force
when reducing a spondylolisthesis.
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OPERATIVE TECHNIQUE
Compression
Fig. 8a
Distraction
Fig. 8b
8. COMPRESSION/DISTRACTION
Compression
Distraction
Slide the Torque Wrench Cannulas (20-0226)
over each Phoenix Screw Body to which you are
going to apply compression forces. Application of
compression forces without use of the cannulas in not
recommended. The slot in the end of the Cannula is
aligned and engages the rod. Slide the Alignment Tool
(70-3221) over the top of the cannulas and draw the
cannulas together with either upward or downward
force on the handle of the alignment tool. Alternative
method – The compression/distraction fixture
(20-0220) can be used in place of the alignment tool
(70-3221). Adjust the fixture to the desired width and
lock the adjustment nut on the fixture.
Slide the Torque Wrench Cannulas (20-0226)
over each Phoenix Screw Body to which you are
going to apply distraction forces. Application of
distraction forces without use of the cannulas is not
recommended. The slot in the end of the Cannula is
aligned and engages the rod. Slide the compression/
distraction fixture (20-0220) over the top of the
cannulas. Adjust the fixture to the desired width and
lock the adjustment nut on the fixture. Assemble the
distraction tips (left 70-3220 & right 70-3222) on
distraction instrument (70-3219) and attach to the
holes in the cannulas closest to the level of the skin.
Distract the Cannulas to the desired level and proceed
to final tightening of set screws. (Fig. 8b)
Attach the compression instrument (70-3218) to
the holes in the cannulas closest to the level of the
skin. Compress the Cannulas to the desired level and
proceed to final tightening of Set Screws. (Fig. 8a)
OPERATIVE TECHNIQUE
Fig. 9
Fig. 10a
Fig. 10b
9. FINAL TIGHTENING
10. TAB REMOVAL
The Torque Wrench Cannula slides over the Phoenix
Screw Body and has two distal openings to engage
the Rod. The Counter Torque Wrench Handle (20-0225)
slides over the hex end of the Cannula. The Torque
T-Handle (52-1512) attached to the Set Screw Driver
(52-1061) is passed down the Phoenix Screw Body and
mates with the Set Screw. ALTERNATIVE – When the
use of compression or Distraction is not desired, then
a one piece Counter Torque Wrench (20-0224) can
be used in place of the modular instruments. Turn the
Torque T-Handle (55-1068) clockwise to tighten the Set
Screw to 100 in/lbs. The handle will reach its maximum
torque and release at 100 in/lbs. (Fig. 9)
Position the three claws on the small end of the
Implant Tab Removal Tool (20-0280) below one of
the small tabs on the Phoenix Screw Body and use an
upward motion to engage the claws of the tool onto
the tab. Rotate the handle downward causing the small
end to rotate up and the small tab will break free of
the Phoenix Screw Body. Perform the same steps on
the opposite side. (Fig. 10a) The small tabs can be
discarded or recycled.
Slide the large opening of the Implant Tab Removal tool
over the large tab on one side of the Phoenix Screw.
Move the handle away from the midline and then
back to midline until the large tab dissociates from
the Phoenix Screw Head. Perform the same steps on
the remaining tab. (Fig. 10b) The larger tabs can be
discarded or recycled.
11. REMOVAL PROCEDURE
Removal of implants should be performed as outlined
in the Firebird Spinal Fixation Operative Technique.
15
16
PART NUMBERS
PHOENIX IMPLANT CASE, 20-0017
Part Numbers
Part #
Description
Part Numbers
Qty
Phoenix Implant Case
Implant Case (Empty)
20-0111
1
Phoenix Bodies
Phoenix™ Open Body, Short
20-2070
Phoenix™ Open Body, Standard
20-2090
Phoenix™ Open Body, Tall
20-2120
Phoenix™ Closed Body, Short
20-3070
Phoenix™ Closed Body, Standard
20-3090
Phoenix™ Closed Body, Tall
20-3120
18
18
18
*
*
*
Firebird Set Screws
Set Screw
44-2001
30
Firebird Cannulated Modular Screw/Self Tapping
4.5mm / 20mm
77-8420
4.5mm / 25mm
77-8425
4.5mm / 30mm
77-8430
4.5mm / 35mm
77-8435
4.5mm / 40mm
77-8440
4.5mm / 45mm
77-8445
4.5mm / 50mm
77-8450
4.5mm / 55mm
77-8455
5.5mm / 35mm
77-8535
5.5mm / 40mm
77-8540
5.5mm / 45mm
77-8545
5.5mm / 50mm
77-8550
5.5mm / 55mm
77-8555
6.5mm / 35mm
77-8635
6.5mm / 40mm
77-8640
6.5mm / 45mm
77-8645
6.5mm / 50mm
77-8650
6.5mm / 55mm
77-8655
7.5mm / 40mm
77-8740
7.5mm / 45mm
77-8745
7.5mm / 50mm
77-8750
7.5mm / 55mm
77-8755
8.5mm / 40mm
77-8840
8.5mm / 45mm
77-8845
*
*
*
*
*
*
*
*
6
8
8
6
4
4
10
12
10
4
4
6
6
4
2
2
* By Request Only, Not Standard in Set
Part #
Description
Qty
Firebird Lordotic Rods with Hex
Pre-Lordosed Rod w/hex and taper, 35mm
20-4035
20-4040
20-4045
20-4050
20-4055
20-4060
20-4065
20-4070
20-4075
20-4080
20-4090
20-4100
20-4110
20-4120
20-4130
20-4140
20-4150
4
4
4
4
4
4
4
4
4
4
4
4
4
4
4
4
4
Phoenix Straight Rods with Hex
Straight Rod w/hex and taper, 40mm
20-5040
20-5050
20-5060
20-5070
20-5080
20-5090
20-5100
20-5110
20-5120
20-5140
20-5160
20-5180
20-5200
Straight Rod w/hex, 450mm
20-5450
2
2
2
2
2
2
2
2
2
2
2
2
2
2
PART NUMBERS
PHOENIX INSTRUMENT CASE 1, 20-0015
PHOENIX INSTRUMENT CASE 2, 20-0016
INSTRUMENTS
INSTRUMENTS
Part #
20-0101
20-0123
20-0124
20-0145
20-0155
20-0165
20-0175
20-0200
20-0201
20-0205
20-0210
20-0211
20-0212
20-0214
20-0218
20-0224
20-0250
20-0251
20-0260
20-0261
20-0275
20-0280
20-0283
52-1011
52-1013
52-1061
70-3208
Description
Instrument Case 1 (Empty)
Guide Wire Nitinol, 21 inch - Blunt (1.57mm Dia)
Guide Wire Nitinol, 21 inch - Sharp (1.57mm Dia)
4.5mm Tap
5.5mm Tap
6.5mm Tap
7.5mm Tap
Screw Driver
Modular Multi-axial Adjustment Screw Driver
Rod Sizing Tool
Rod Pusher
Round Set Screw Inserter Handle
Body Alignment Instrument
Rod Holder/Inserter
Non-Conductive Dilator
Counter Torque Wrench
Set Screw Holder Long
Set Screw Holder Long Insert
Set Screw Holder Short
Set Screw Holder Short Insert
Tap Sleeve Dilator
Implant Tab Removal Tool
Tissue Dissector
Cannulated Firebird T-handle
Straight Ratcheting Handle, Small
Set Screw Driver (adapter)
Proview Rod Inserter
* By Request Only, Not Standard in Set
Qty
1
10
10
*
1
1
1
2
1
1
1
2
1
1
2
1
2
2
1
1
2
1
1
2
2
2
1
Part #
20-0120
20-0220
20-0225
20-0226
52-1512
70-3218
70-3219
70-3220
70-3221
70-3222
Description
Instrument Case 2 (Empty)
Compression/Distraction Fixture
Counter Torque Wrench Handle
Counter Torque Cannula
Torque T-Handle
Parallel Compressor
Parallel Distractor
Distractor Tip Left
Alignment Tool
Distractor Tip Right
17
Qty
1
1
1
2
1
1
1
1
1
1
OTHER INSTRUMENTS
Part #
21-5000
21-5011
Description
Bone Marrow Aspiration Needle Kit, 8 gauge
Bone Marrow Aspiration Needle Kit, 11 gauge
Qty
1
1
18
IMPLANT INSERTER ASSEMBLY/DISSASEMBLY INSTRUCTIONS
Instructions for Assembly/Disassembly of the Multi-Axial Screw Driver (20-0200)
There are three parts to the Multi-Axial Screw Driver: 1) Inner Shaft, 2) Screwdriver Shaft, and 3) Extender Shaft..
1
2
3
The Multi-Axial Screw Driver requires disassembly prior to
cleaning using the following steps.
(Fig. 1)
Assembly/Inspection of the Multi-Axial Screw Driver (20-0200)
a.Insert inner shaft completely into screwdriver shaft. Large end of inner shaft should be on the same side as the threaded tip of screwdriver shaft. not, reverse inner shaft insertion. (Fig. 1 & 2)
If
(Fig. 2)
b.While holding inner shaft and screwdriver shaft in place, align D-cut on inner shaft with D-shaped hole on extender shaft. (Fig. 3)
c.With slotted knob on the extender shaft pulled back (away from threads), slide extender shaft and inner shaft together until it clicks. (Fig. 4 & 5)
d.Push slotted knob on extender shaft forward and turn until threads are fully engaged. (Fig. 6)
(Fig. 3)
e.After assembly, ensure that turning extender shaft smoothly rotates inner shaft within the screwdriver. (Fig. 7)
f. If inner shaft does not rotate smoothly or extender shaft knob will not fully seat,
disassemble instrument and check for debris.
g.If debris is found, repeat cleaning and attempt assembly.
Disassembly of the Multi-Axial Screw Driver (20-0200)
(Fig. 4)
a.Turn slotted knob at back of screwdriver until knob completely unthreads. (Fig. 5)
b.Slide slotted knob back to the stop on extender shaft. (Fig. 4)
c.Remove extender shaft from inner shaft by pulling axially until extender shaft is free. (Fig. 3)
d.Pull inner shaft out of screwdriver shaft. (Fig. 1)
(Fig. 5)
Once disassembly is complete there will be three parts to the Multi-Axial Screw Driver. Note: To avoid components falling, it is suggested to hold the assembly horizontal and/or perform the assembly over a table.
(Fig. 6)
(Fig. 7)
IMPLANT INSERTER ASSEMBLY/DISSASEMBLY INSTRUCTIONS
Instructions for Assembly/Disassembly of the Mono-Axial Screw Driver (20-0300)
There are three parts to the Mono-Axial Screw Driver: 1) Drive Adapter, 2) Sleeve Assembly, and 3) Handle Adapter.
1
2
The Mono-Axial Screw Driver requires disassembly prior to
cleaning using the following steps..
3
(Fig. 1)
Assembly/Inspection of the Mono-Axial Screw Driver (20-0300)
a.Insert drive adapter completely into sleeve assembly. Large end of drive
adapter should be on the opposite side of the knob of the sleeve assembly. If
not, reverse drive adapter insertion. (Fig. 1 & 2)
(Fig. 2)
b.While holding drive adapter in place, align D-cut on drive adapter with
D-shaped hole on handle adapter. (Fig. 3 & 4)
c.With knob on the handle adapter loosened (away from threads), slide handle
adapter and drive adapter together until it clicks. (Fig. 5)
d.Push knob on handle adapter forward and turn until threads are fully
engaged. (Fig. 6 & 7)
e.After assembly, ensure that turning handle adapter smoothly rotates drive
adapter within the screw driver.
(Fig. 3)
f. If drive adapter does not rotate smoothly or handle adapter knob will not fully
seat, disassemble instrument and check for debris.
g.If debris is found, repeat cleaning and attempt assembly.
Disassembly of the Multi-Axial Screw Driver (20-0300)
(Fig. 4)
a.Turn knob on handle adapter until knob completely unthreads. (Fig. 5)
b.Remove handle adapter from drive adapter by pulling axially until handle
adapter is free. (Fig. 3)
c.Pull drive adapter out of sleeve assembly. (Fig. 1)
Once disassembly is complete there will be three parts to the Mono-Axial Screw
Driver. Note: To avoid components falling, it is suggested to hold the assembly
horizontal and/or perform the assembly over a table.
(Fig. 5)
(Fig. 6)
(Fig. 7)
19
20
INDICATIONS FOR USE
Description: The Firebird Spinal Fixation System and Phoenix MIS Spinal Fixation System are temporary, multiple component systems comprised of a variety of non-sterile
and sterile, single use components, made of titanium alloy or cobalt chrome alloy, that allow the surgeon to build a spinal implant construct. The systems are attached to the
vertebral body and illium by means of screw or hook fixation to the non-cervical spine. The Firebird Spinal Fixation System and Phoenix MIS Spinal Fixation System consist of
an assortment of rods, multi-axial and mono-axial pedicle screws, set screws, lateral offsets, bone screws, screw bodies, hooks, iliac connectors and STERILE packed HA Coated
bone screws. A subset of the Firebird Spinal Fixation System and Phoenix MIS Spinal Fixation System components may be used in pediatric patients. These components consist
of a variety of screws ranging in diameters from 4.0mm to 7.5mm and lengths ranging from 25mm to 60mm. The Firebird Spinal Fixation System and Phoenix MIS Spinal
Fixation System implants are not compatible with components or metal from any other manufacturer’s system.
Indications for Use: The Firebird Spinal Fixation System and Phoenix MIS Spinal Fixation System are intended for posterior, non-cervical pedicle, and non-pedicle fixation
(T1-S2/Ilium). Pedicle screw fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion using autograft or allograft. The device is indicated
for all of the following indications:
a) degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)
b) spondylolisthesis,
c) trauma (i.e., fracture or dislocation),
d) spinal stenosis,
e) deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
f) tumor,
g) pseudoarthrosis, and
h) failed previous fusion
When used for fixation to the ilium, the offset connectors of the Firebird Spinal Fixation System must be used in conjunction with pedicle screws planced at the S1 or S2
spinal level.
The Phoenix MIS Spinal Fixation System when used with the Firebird Spinal Fixation System is indicated to provide the surgeon with a minimally invasive approach for posterior
spinal surgery.
The Firebird Spinal Fixation System and Phoenix MIS Spinal Fixation System components are used with certain components of the Orthofix Spinal Fixation System, including
rods, rod connectors and cross-connectors.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Firebird Spinal Fixation System implants are indicated as an adjunct to fusion to treat
adolescent idiopathic scoliosis. The Firebird Spinal Fixation System for pediatric use is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is
limited to a posterior approach.
Contraindications include, but are not limited to:
1. Morbid obesity
2. Mental Illness
3. Alcoholism or drug abuse
4. Pregnancy
5. Metal sensitivity/allergies
6. Severe osteopenia
7. Patients unwilling or unable to follow post-operative care instructions
8. Use of the Firebird offset connectors for fixation to the ilium is contraindicated when the sacrum is absent or insufficient for implantation of pedicle screws at the S1 or
S2 spinal level.
9. Any circumstances not listed under the heading indications.
Potential Adverse Events:
All of the possible adverse events associated with spinal fusion surgery without instrumentation are possible. With instrumentation, a listing of possible adverse events includes,
but is not limited to:
1. Inability to use pedicle screw fixation due to anatomic limitations (pedicle dimensions, distorted anatomy)
2. Pedicle screw mal positioning, with or without neurological or vascular injury
3. Proximal or distal junctional kyphosis
4. Pancreatitis
5. Pedicle screw fixation, such as screw or rod bending, breakage, or loosening, may also occur in pediatric patients, and pediatric patients, and pediatric patients may be at
increased risk for device-related injury because of their smaller stature.
6. Device component fracture
7. Loss of fixation
8. Non-union
9. Fracture of the vertebra
10. Neurological injury
11. Vascular or visceral injury
12. Early or late loosening of any or all of the components
13. Disassembly and/or bending of any or all components
14 Foreign body (allergic) reaction to implants, debris, corrosion products, graft material, including metallosis, straining, tumor formation, and/or auto-immune disease
15. Pressure on the skin from component parts in patients with inadequate tissue coverage over the implant possibly causing skin penetration, irritation, and/or pain
16. Post-operative change in spinal curvature, loss of correction, height, and/or reduction
17. Infection
18. Pain, discomfort, or abnormal sensations due to the presence of the device
19. Hemorrhage
20. Cessation of any potential growth of the operated portion of the spine
21. Death
Note: Potential risks identified with the use of the device system may require additional surgery.
INDICATIONS FOR USE
Warnings and Precautions:
1. The safety and effectiveness of this device has not been established for use as part of a growing rod construct. This device is only intended to be used when definitive
fusion is being performed at all instrumented levels.
2. The use of pedicle screw fixation in the pediatric population may present additional risks when patients are of smaller stature and skeletally immature. Pediatric patients
may have smaller spinal structures (pedicle diameter or length) that may preclude the use of pedicle screws or increase the risk of pedicle screw mal positioning and
neurological or vascular injury. Patients who are not skeletally mature undergoing spinal fusion procedures may have reduced longitudinal spinal growth, or may be at
risk for rotational spinal deformities (the “crankshaft phenomenon”) due to continued differential growth of the anterior spine.
3. The implantation of pedicle screw spinal systems in pediatric patients should be performed only by experienced spinal surgeons with specific training in the use of this
pedicle screw spinal system in pediatric patients because this is a technically demanding procedure presenting a risk of serious injury to the patient.
4. Preoperative and operating procedures, including knowledge of surgical techniques, good reduction, and proper selection of placement of the implants are important
considerations in the successful utilization of the system in pediatric patients.
5. The selection of proper size, shape and design of the implant for each patient is crucial to the safe use of this device in pediatric patients.
6. The safety and effectiveness of pedicle screw systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion
with instrumentation. These conditions are: significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis
(grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal
tumor, and failed previous fusion (pseudoarthrosis). The safety and effectiveness of these devices for any other condition are unknown.
7. Benefit of spinal fusions utilizing any pedicle screw fixation system has not been adequately established in patients with stable spines.
8. Potential risks identified with the use of this device system, which may require additional surgery, include: device component fracture, loss of fixation, non-union, fracture
of the vertebra, neurological injury, and vascular or visceral injury.
9. Single use only
10. Non-sterile; the screws, hooks, rods, dominos, lateral offsets, spacers, staples, washers, locking nuts, cross connectors, and instruments are sold non-sterile, and
therefore must be sterilized before use.
11. To facilitate fusion, a sufficient quantity of autologous bone or other appropriate material should be used.
12. Failure to achieve arthrodesis will result in eventual loosening and failure of the device construct.
13. Excessive torque applied to the screws may strip the threads in the bone.
14. DO NOT REUSE IMPLANTS. Discard used, damaged, or otherwise suspect implants.
15. The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal
system because this is a technically demanding procedure presenting a risk of serious injury to the patient.
16. Based on fatigue testing results, the physician/surgeon should consider the levels of implantation, patient weight, patient activity level, other patient conditions, etc.
which may impact on the performance of the system.
17. Mixing of dissimilar metals can accelerate the corrosion process. Do not use the titanium alloy or cobalt chrome alloy components of this system with implants of other
material composition or components from different manufacturers unless specifically stated.
18. The Firebird Spinal Fixation System and Phoenix MIS Spinal Fixation System have not been evaluated for safety and compatibility in the MR environment, nor have the
Firebird Spinal Fixation System or the Phoenix MIS Spinal Fixation System been tested for heating or migration in the MR environment.
19. Reuse of the devices labeled as single-use could result in injury or re-operation due to breakage or infection. Do not attempt to re-sterilize single-use implants that
come in contact with body fluids.
20. When using the offset connectors to connect the Firebird spinal construct to the ilium, pedicle screws must be used at the S1 or S2 level of the spine. Do not use the
offset connectors to connect the ilium without this intermediate screw fixation.
21. The safety, efficacy and performance of the system have been established for conditions in which the system is used as intended and when used as identified in the
Indications for Use. Performance of the system has not been evaluated for use that is contrary to the Intended Use, Indications for Use or for use that in contraindicated.
Failure to use the system as indicated could detrimentally affect the performance of its components.
22. Other adverse effects related to pedicle screw fixation, such as screw or rod bending, breakage, or loosening, may also occur in pediatric patients. Pediatric patients
may be at increased risk for device-related injury because of their smaller stature.
23. The correct handling of the implant is extremely important. Implants should not be excessively or repeatedly bent, notched or scratched. These operations can produce
defects in surface finish and internal stress concentrations, which may become the focal point for eventual failure of the device.
21
Distributed by:
Manufactured by:
Orthofix
3451 Plano Parkway
Lewisville, Texas 75056-9453 USA
214-937-2000
0086
1.888.298.5700
www.orthofix.com
XR-1601 © Orthofix Holdings, Inc. 03/2016
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. Proper
surgical procedure is the responsibility of the medical professional. Operative techniques are furnished
as an informative guideline. Each surgeon must evaluate the appropriateness of a technique based
on his or her personal medical credentials and experience. Please refer to the “Instructions for Use”
supplied with the product for full information on indications for use, contraindications, warnings,
precautions, adverse reactions information and sterilization.

Phoenix ® Operative Technique

Transcription

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