Hydralok Polyaxial Screw System Operative

HydraLok
®
Operative Technique
Polyaxial Pedicle
Screw System
Table of Contents
Introduction.............................................................................................1
OPERATIVE TECHNIQUE OVERVIEW...........................................................2
DETAILED OPERATIVE TECHNIQUE.............................................................4
LOCATE AND PREPARE THE PEDICLE...................................................4
PROBE THE PEDICLE..............................................................................4
ENSURE THE INTEGRITY OF THE PEDICLE WALL................................4
GUIDE PIN INSERTION (OPTIONAL).....................................................4
TAPPING (OPTIONAL)............................................................................5
LOAD POLYAXIAL SCREW.....................................................................5
REDUCTION SCREWS............................................................................6
ROD SELECTION.....................................................................................6
ROD BENDER..........................................................................................6
ROD PLACEMENT AND TIGHTENING...................................................6
ROD REDUCTION...................................................................................6
DEROTATION, COMPRESSION AND DISTRACTION (OPTIONAL)......7
Counter TORQUE AND FINAL TIGHTENING......................................7
CROSS CONNECTOR PLACEMENT......................................................7
iMPLANT Listing.........................................................................................8
instrument listing.................................................................................9
Indications for Use...............................................................................13
Introduction
HydraLok® Polyaxial Pedicle Screw System is a 6.0mm top-loading system that
includes screws, rods and connectors that may be used in the thoracic, lumbar and
sacral spine. HydraLok offers a complete range of titanium color-coded pedicle screws
from 5.0mm to 8.0mm and 35mm to 55mm lengths. The 360-degree head rotation and
45-degree screw angulation allow for easy rod placement with minimal contouring.
The system also features self-tapping screws that are designed to save valuable time
in the operating room.
1
OPERATIVE TECHNIQUE OVERVIEW
1
3
2
Establish Pedicle Entry Point
Ensure Integrity of Pedicle Wall
Probe the Pedicle
4
4a
Mark the Pedicle
5
6
Tap the Pedicle
Load Pedicle Screw
2
8
7
Place Rod and Tighten
Insert Polyaxial Screw
9
10
Derotate Rod
Compression/Distraction
and Final Tightening
11
12
Apply Cross Connectors
Final Tightening of Cross Connectors
3
DETAILED OPERATIVE TECHNIQUE
LOCATE AND PREPARE THE PEDICLE
Identify the pedicle and the entry hole location.
The pedicle is typically located at the intersection
of the superior articulate facet and the midline of
the transverse process. Create an entry hole for the
pedicle screw by using the Bone Awl to puncture
the cortex. With the Bone Awl, penetrate the cortex
by using a downward twisting force (Figure 1).
Figure 1
Establish Pedicle
Entry Point
PROBE THE PEDICLE
The Straight or Curved Pedicle Probe is used to
create the screw path through the pedicle and
into the vertebral body. Both of these instruments
include depth markings at the tip of the instrument
(Figure 2).
ENSURE THE INTEGRITY OF THE PEDICLE WALL
After the pedicle has been cannulated, the pedicle
may now be sounded. Using the Straight Tester,
verify the integrity of the interior pedicle walls by
palpating the cephalad edge, the medial wall and
the inferior edge as well as the deepest portion of
the opening (Figure 3).
Figure 2
Probe the Pedicle
GUIDE PIN INSERTION (OPTIONAL)
Guide Pins are available and may be inserted to
confirm the pedicle location under visualization if
desired (Figure 4, 4a).
Figure 3
Ensure Integrity of
Pedicle Wall
Figure 4
Mark the Pedicle
Figure 4a
Mark the Pedicle
4
Figure 5
Tap the Pedicle
TAPPING (OPTIONAL)
All Polyaxial Screws are self-tapping. If pretapping
is desired, Taps are available in various sizes
that correspond to the diameters of the Polyaxial
Screws. The Tap that is used must match the size
of the Polyaxial Screw that is desired. The Taps
are downsized approximately .5mm to provide an
interface for the Screw. Attach the appropriately
sized Tap to the Straight or Ratcheting T-Handle and
proceed to tap the Screw entry hole by rotating the
handle clockwise. The Depth Gauge may be used to
determine Screw length (Figure 5).
Figure 6
Load Pedicle Screw
LOAD POLYAXIAL SCREW
After determining the appropriate Screw length,
attach the Reversible Polyaxial Screwdriver into the
inner hexalobe of the Screw and lock it by rotating
the central locking wheel clockwise.
Note: It is important to note that there are two
configurations for the Reversible Polyaxial
Screwdriver. Use the small Reversible Drive Shaft
for 5, 6 and 7mm screws and the Large Reversible
Drive Shaft for the 7.5 and 8.0 Screws (Figure 6).
INSERT POLYAXIAL SCREW
The Polyaxial Screws may now be inserted into
pedicle to the pre-determined depth. Turn the
Reversible Polyaxial Screwdriver clockwise to
insert the Screw (Figure 7). Once the Screw is fully
inserted, disengage the Screw from the Reversible
Polyaxial Screwdriver by turning the central locking
wheel counterclockwise. Repeat the steps for all
remaining Pedicle Screws.
Figure 7
Insert Polyaxial Screw into
Vertebral Body
5
REDUCTION SCREWS
If necessary, Reduction Polyaxial Screws are also
available and can be inserted using the Reversible
Reduction Polyaxial Screwdriver corresponding
to the desired screw size. The small Reversible
Polyaxial Screwdriver is inserted into the Screw
tulip and tightened by rotating the central locking
wheel clockwise.
ROD SELECTION
After the Polyaxial Screws have been placed, the
desired length of the rod should be selected. The
Curved Rods are in pre-cut lengths ranging from
40mm to 110mm. The Straight Rods are available
in pre-cut lengths ranging from 120mm to 480mm.
Figure 8
Place Rod and Tighten
ROD BENDER
The French Rod Bender is primarily used for
curving or bending Straight Rods. If needed, it can
also be used to increase or decrease the lordosis in
the Curved Rod.
The degree of lordosis can be varied by adjusting
the center button. A small, medium or large radius
may be selected by pulling out the large center
knob while rotating the knob as desired. The Rod
should seat fully into the tulip of the Pedicle Screw.
Note: In Situ Benders may also be used to bend the
Rod once it is placed within the construct.
ROD PLACEMENT AND TIGHTENING
After the Rod has been contoured as desired, it
is then placed into the Polyaxial Screw housing
with the Curved or Straight Rod Holder (Figure 8).
The Polyaxial Screw allows up to 45 degrees of
angulation.
Once the Rod has been placed, load a set
screw onto the Twist Tip Set Screwdriver and
provisionally tighten each screw.
Figure 9
Derotate Rod
ROD REDUCTION
To assist with the reduction of the Rod into the
Screw, several instruments are available.
1. The Rod Pusher helps to persuade the Rod
into the Screw head, without capturing the
Screw head.
2. The Pistol Grip Rod Persuader is inserted
over the Rod and Screw, and the Ratcheting
Handle allows the Rod to be slowly reduced.
3. The Cylinder Style Rod Persuader is used
to fully capture the Polyaxial Screw head in
place, while the Ratcheting Handles reduce
the Rod.
After the Rod is fully reduced into the Screw head,
it can be provisionally tightened using the Set
Screw Starter as described above.
6
Figure 10
Compression/Distraction
and Final Tightening
DEROTATION, COMPRESSION AND DISTRACTION
(OPTIONAL)
After all of the Set Screws have been provisionally
inserted into the Screw housing, the De-rotator
may be used to rotate the contoured Rod into the
desired position (Figure 9). While the Rod is held
in place with the De-rotator, the Set Screws are
tightened using the Set Screwdriver attached to the
T-Handle Torque Limiting Driver.
The Compressor or Distractor can also be used
to apply final compression or distraction to the
construct. Once the desired compression or
distraction is accomplished, the Set Screws can be
tightened using the Set Screwdriver attached to the
T-Handle Torque Limiting Driver (Figure 10).
Counter TORQUE AND FINAL TIGHTENING
After any desired derotation, compression
and distraction have been performed; the Set
Screwdriver should be attached to the T-Handle
Torque Limiting Driver and inserted through the
Counter Torque for final tightening of the Set
Screws (Figure 10). The Set Screw should be
rotated clockwise until the arrows on the torque
indicator are aligned with one another, indicating
the necessary torque has been applied.
Figure 11
Apply Cross Connector
CROSS CONNECTOR PLACEMENT
A Cross Connector may now be used if desired.
Cross Connectors are available in sizes ranging
from 30 to 40mm in 5mm increments and in 40 to
70mm in 10mm increments.
The Cross Connector is attached to the longitudinal
rods either by hand or by using the Cross Connector
Nut Starter. The Crosslink Nut Starter snaps around
the arm of the Cross Connector underneath the
connector nut (Figure 11). This leaves the nut and
rod clamp portion of the Connector free to rotate
for proper positioning over the construct.
Figure 12
Final Tightening of
Cross Connector
The Connector is pushed down until the rod clamp
mechanism clicks onto the rod. Once positioned
onto both rods, the Cross Connector Torque
Limiting Wrench is connected to the Nut Driver
and inserted through the Cross Connector Counter
Torque to tighten all the nuts. The Torque Limiting
Wrench should be rotated clockwise until the
Handle clicks indicating that the necessary torque
has been applied (Figure 12).
7
iMPLANT Listing
Catalog Number
Part Description
Cross Connectors
28220
28221
28222
28223
28224
Cross Connector, 30mm-35mm
Cross Connector, 35mm-40mm
Cross Connector, 40mm-50mm
Cross Connector, 50mm-60mm
Cross Connector, 60mm-70mm
Curved Rods
28239-040
28239-050
28239-060
28239-070
28239-080
28239-090
28239-100
28239-110
Straight Rods
28240-120
28240-200
28240-480
Set Screws
28301
28202
Curved Rod, 6.0mm x 40mm
Curved Rod, 6.0mm x 50mm
Curved Rod, 6.0mm x 60mm
Curved Rod, 6.0mm x 70mm
Curved Rod, 6.0mm x 80mm
Curved Rod, 6.0mm x 90mm
Curved Rod, 6.0mm x 100mm
Curved Rod, 6.0mm x 110mm
Straight Rod, 6.0mm x 120mm
Straight Rod, 6.0mm x 200mm
Straight Rod, 6.0mm x 480mm
Set Screws, 5.0mm, 6.0mm and 7.0mm
Set Screws, 7.5mm and 8.0mm
Reduction Screws
PS60040R
PS60045R
PS60050R
PS70040R
PS70045R
PS70050R
Reduction Polyaxial Screw, 6.0mm x 40mm
Reduction Polyaxial Screw, 6.0mm x 45mm
Reduction Polyaxial Screw, 6.0mm x 50mm
Reduction Polyaxial Screw, 7.0mm x 30mm
Reduction Polyaxial Screw, 7.0mm x 45mm
Reduction Polyaxial Screw, 7.0mm x 50mm
8
Catalog Number
Part Description
Polyaxial Screws
PS50035
PS50040
PS50045
PS50050
PS60035
PS60040
PS60045
PS60050
PS60055
PS70035
PS70040
PS70045
PS70050
PS70055
PS75035
PS75040
PS75045
PS75050
PS75055
PS80035
PS80040
PS80045
PS80050
PS80055
Polyaxial Screw, 5.0mm x 35mm
Polyaxial Screw, 5.0mm x 40mm
Polyaxial Screw, 5.0mm x 45mm
Polyaxial Screw, 5.0mm x 50mm
Polyaxial Screw, 6.0mm x 35mm
Polyaxial Screw, 6.0mm x 40mm
Polyaxial Screw, 6.0mm x 45mm
Polyaxial Screw, 6.0mm x 50mm
Polyaxial Screw, 6.0mm x 55mm
Polyaxial Screw, 7.0mm x 35mm
Polyaxial Screw, 7.0mm x 40mm
Polyaxial Screw, 7.0mm x 45mm
Polyaxial Screw, 7.0mm x 50mm
Polyaxial Screw, 7.0mm x 55mm
Polyaxial Screw, 7.5mm x 35mm
Polyaxial Screw, 7.5mm x 40mm
Polyaxial Screw, 7.5mm x 45mm
Polyaxial Screw, 7.5mm x 50mm
Polyaxial Screw, 7.5mm x 55mm
Polyaxial Screw, 8.0mm x 35mm
Polyaxial Screw, 8.0mm x 40mm
Polyaxial Screw, 8.0mm x 45mm
Polyaxial Screw, 8.0mm x 50mm
Polyaxial Screw, 8.0mm x 55mm
instrument listing
27152
Straight Probe
27190
Curved Probe
28254
Straight Tester
28255
Guide Pin Driver
28256
Guide Pin
28257
Guide Pin, Grooved
28258
Depth Gauge
9
HYDRALOK instrument Listing
Catalog Number
Part Description
28260
Hydralok 5.0mm Tap
28261
HydraLok 6.0mm Tap
28262
HydraLok 7.0mm Tap
28263
HydraLok 7.5mm Tap
28264
HydraLok 8.0mm Tap
28265
2.5mm Hex Driver
28266
4.0mm Hex Driver
28269
Straight Rod Holder
28271
Rod Pusher
28272
Curved Rod Holder
28273
De-rotator
28274
French Rod Bender
28275
Distractor
28276
Compressor
10
Catalog Number
Part Description
28277
Modular Straight Handle
28278
Modular T-Handle
28279
Ratchet T-Handle
28280
Polyaxial Driver Assay
28281-1
28281-2
Small Driver, 5.0-7.0mm screws
Large Driver, 7.5mm and 8.0mm screws
28282
T-Handle and Torque Limiting Driver
28285
Counter Torque Head Positioner
28287
28288
In Situ Bender, Left
In Situ Bender, Right
05-059-00-0000
Counter Torque, Cross Connector
05-059-02-0000
Cross Connector Nut Driver
05-059-03-0000
Cross Connector Torque Limiting Driver Handle
05-059-10-0000
Curved Probe
05-059-41-0000
Small Polyaxial Driver Assembly
11
Catalog Number
Part Description
05-059-42-0000
Bone Awl
05-059-44-0000
Large Polyaxial Pedicle Screw Driver
05-059-45-0000
Cross connector Nut Starter
05-059-46-0000
Crosslink Nut Driver
05-059-47-0000
Persuader, Pistol Grip
05-059-48-0000
Persuader, Cylinder Style
05-059-49-0000
Yoke Manipulator
05-059-50-0000
Tap Breaker, Reduction Screw
05-059-04-0005
HydraLok Implant Tray #1
05-059-04-0006
HydraLok 5.0mm Pedicle Screw Caddy
05-059-04-0007
HydraLok 6.0mm Pedicle Screw Caddy
05-059-04-0008
HydraLok 7.0mm Pedicle Screw Caddy
05-059-04-0009
HydraLok 7.5mm Pedicle Screw Caddy
12
05-059-04-0010
HydraLok 8.0mm Pedicle Screw Caddy
05-059-04-0016
HydraLok Implant Tray #2
05-059-04-0017
HydraLok Reduction
Pedicle Screw Caddy
05-059-04-0018
HydraLok Set Screw Caddy
05-059-04-0019
HydraLok 6.0mm
Cross Connector Caddy
10-121-00-0001
Double Height Outer Cast
10-301-05-0001
Outer Case Lid
Indications for Use
GENERAL DESCRIPTION
In addition, when used as a pedicle screw fixation system, the
HydraLok System is intended for skeletally mature patients with severe
spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra, who are receiving
fusion by autogenous bone graft only having the device attached to the
lumbar and sacral spine (L3 and below), who are having the device removed
after the development of a solid fusion.
The HydraLok® System is a top-loading spinal fixation system including
screws, rods, and connectors for fixation to the thoracic, lumbar and sacral
spine. Various sizes of the implants are provided. The components are
manufactured from titanium alloy (Ti-6AI-4V ELI as described by ASTM
F136). The HydraLok System components are provided clean and non-sterile.
The products must be steam sterilized by the hospital prior to use.
CONTRAINDICATIONS
INDICATIONS FOR USE
Contraindications for the HydraLok System are similar to those of other
systems of similar design, and include, but are not limited to:
The HydraLok System is intended to provide immobilization and stabilization
of spinal segments as an adjunct to fusion in the treatment of the following
acute and chronic instabilities or deformities of the thoracic, lumbar and
sacral spine including degenerative spondylolisthesis with objective
evidence of neurological impairment, fracture, dislocation, scoliosis,
kypohsis, spinal tumor and failed previous fusion (pseudoarthrosis).
• A
ctive infectious process in the patient, particularly in or adjacent to the
spine or spinal structures
• Morbid obesity
13
(continued on back)
Indications for Use (cont.)
• Pregnancy
• G
rossly distorted anatomy (e.g., congenital abnormalities) and bone
abnormalities (e.g., bone absorption, osteopenia, or osteoporosis)
preventing safe screw fixation
• A
ny medical or surgical condition which would preclude the potential
benefit of spinal implant surgery
• Suspected or documented metal allergy or intolerance
WARNINGS AND PRECAUTIONS
The HydraLok System should only be implanted 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. In addition, based on the fatigue test
results, the surgeon should consider the levels of implantation, patient
weight, patient activity level, and other patient conditions (e.g., smoking,
occupation), which may impact on the performance of the system.
Due to the presence of implants, interference with roentgenographic, CT,
and/or MR imaging will result.
The HydraLok System has not been evaluated for safety and compatibility
in the MR environment. The HydraLok System has not been tested for
heating or migration in the MR environment.
Preoperative
A successful result is not achieved in every surgical case, especially in spinal
surgery where many extenuating circumstances may compromise results.
Preoperative planning and operating procedures, including knowledge of
surgical techniques, proper reduction, and proper selection and placement
of the implant are critical considerations in achieving a successful result.
Only patients that meet the criteria described in the indications should
be selected. Patient conditions and/or predispositions such as those
mentioned in the contraindications should be avoided.
The safety and effectiveness of pedicle screw spinal 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 conditions are unknown.
Care should be used in the handling and storage of the implant components.
The implants should not be scratched or otherwise damaged. Implants and
instruments should be protected during storage, especially from corrosive
environments.
The type of construct to be assembled for the case should be determined
prior to beginning the surgery. An adequate inventory of sizes should be
available at the time of surgery, including sizes larger and smaller than
those expected to be used.
assemble the devices to verify that all parts and necessary instruments are
present before the surgery begins.
All components and instruments must be cleaned and sterilized prior
to use. Additional sterile components should be available in case of
unexpected need.
Intraoperative
The surgeon should follow established practices and specific instructions
for implant of the system.
Contouring or bending of a screw may reduce its fatigue strength and
cause failure under load. If screws are bent or damaged during insertion or
adjustment, they may not be implanted and must be replaced. Rods should
only be contoured with the proper contouring instruments. Incorrectly
contoured rods or rods which have been repeatedly or excessively
contoured should not be implanted.
Bone grafts must be placed in the area to be fused.
Some degree of corrosion occurs on all implanted metal and alloys. Mixing
of dissimilar metals can accelerate the corrosion process. Stainless steel
and titanium implants must NOT be used together in building a construct.
Different manufacturers use different materials, varying tolerances and
design configurations. Components of the HydraLok System must not be
used with components from any other system or manufacturer.
Postoperative
The physician's post-operative directions and warnings to the patient and
the corresponding patient compliance are extremely important.
Detailed instructions on the use and limitations of the device should be
given to the patient. The patient should be instructed to limit and restrict
physical activities, especially lifting and twisting motions and any type of
sport participation. Patients should be advised of their inability to bend at
the point of spinal fusion and taught to compensate for this permanent
restriction in body motion. The patient should be advised not to smoke or
consume alcohol during the bone graft healing process.
If a non-union develops or the components loosen, bend, and/or break,
the device(s) should be revised and/or removed immediately before
serious injury occurs. Failure to immobilize a delayed or nonunion of
bone will result in excessive and repeated stresses on the implant. By
the mechanism of fatigue these stresses can cause eventual bending,
loosening or breakage of the device(s).
Any decision to remove the implants should take into consideration the risk
to the patient of additional surgeries, as well as the difficulty of removal.
Any retrieved devices should be treated in such a manner that reuse in
another surgical procedure is not possible. As with all orthopedic implants,
none of the HydraLok System components should be reused under any
circumstances.
Since mechanical parts are involved, the surgeon should be familiar with
the various components before using the equipment and should personally
Exactech is proud to have offices and distributors around the globe.
For more information about Exactech products available in your country, please visit www.exac.com
For additional device information, refer to the Exactech Spine–Instructions for Use for a device description, indications, contraindications, precautions and warnings. • For
further product information, please contact Customer Service, Exactech, Inc., 2320 NW 66th Court, Gainesville, Florida 32653-1630, USA. (352) 377-1140, (800) 392-2832 or FAX
(352) 378-2617.
The products discussed herein may be available under different trademarks in different countries. All copyrights, and pending and registered trademarks, are property of Exactech,
Inc. • This material is intended for the sole use and benefit of the Exactech sales force and physicians. It should not be redistributed, duplicated or disclosed without the express
written consent of Exactech, Inc. ©2011 Exactech, Inc.
352-377-1140
1-800-EXACTECH
www.exac.com
716-02-31 Rev. A
HyrdraLok Op. Tech. 0711
*+$716-02-310*