NOVEL® TL

NOVEL TL
®
Spinal Spacer System
SURGICAL TECHNIQUE GUIDE
Novel-TL is cleared for use as an Interbody device.
ST-83104_NOVEL_TL.indd 1
10/15/2009 5:13:51 PM
SURGICAL TECHNIQUE GUIDE
2
ST-83104_NOVEL_TL.indd 2
10/15/2009 5:13:53 PM
Preface
As a next step in the evolution of spinal fixation, Alphatec Spine introduces the
NOVEL-TL Spinal Spacer System.
The NOVEL-TL applies the best of Alphatec Spine innovation and design to a
proven understanding of established, traditional spinal fusion techniques and
principles, producing optimal and reproducible results.
The system is simple and versatile in its application incorporating:
Bullet nose for ease of insertion
·· Bi-Convex shape for maximum end−plate contact
·· Low-profile pedicle screw distraction
·· Consistent 10mm width
·· Bullet shaped distractors and shavers
Contents
Preface....................................................................................................... 3
Surgical Technique................................................................................4-11
Instruments.........................................................................................12-13
Product Information.................................................................................. 14
3
ST-83104_NOVEL_TL.indd 3
10/15/2009 5:13:54 PM
PLATE FEATURES
Position Patient
Place the patient in the prone position.
A midline-open, mini-open, or minimally
invasive approach may be utilized.
The inferior and superior facet, pars
interarticularis, transverse process, and
lamina on the side of implantation should
be easily identified for this technique.
Modular Table System with Jackson Spinal Frame manufactured by MIZUHO OSI, Union City, California
Distraction
Option 1:
Screw to Screw Distractor
Place Screw to Screw Distractor
onto implanted pedicle screws. Insert
provisionally tightened Set Screws for
optimal distraction. Apply distraction on
the pedicle screws using the Screw to
Screw Distractor.
Option 2:
Lamina Distractor
Apply distraction on the base of the
spinous processes using a Lamina
Distractor before implantation of pedicle
screws and rods.
4
ST-83104_NOVEL_TL.indd 4
10/15/2009 5:14:04 PM
Create Transforaminal Window
Resect the inferior facet of the cephalad
vertebra with an Osteotome or high speed
burr. Excise the superior facet of the
caudal vertebra to the pedicle optimizing
entry point to the disc space. Care should
be taken to prevent penetration of the
pedicle cortex if using a high speed burr.
Note:
A Kerrison Rongeur or drill may be used
to carry out additional resection.
TIP
The local bone may be saved, decorticated and used
as bone graft material.
5
ST-83104_NOVEL_TL.indd 5
10/15/2009 5:14:19 PM
SURGICAL TECHNIQUE GUIDE
Perform Discectomy
Place Nerve Root Retractor to protect the
exiting nerves, and create an annulotomy
with a scalpel.
Enter the disc and perform a discectomy
using Pituitary Rongeurs, Curettes, and
Intradiscal Shavers.
Insert Shavers until the cutting edge is
completely within the disc space. Rotate
the Shavers to detach disc and endplate
cartilage. Remove any loose material from
the disc space with Pituitary Rongeurs.
Note:
Shavers are ideally shaped for maximum
contact, and available in 1mm increments
from 3-15mm.
6
ST-83104_NOVEL_TL.indd 6
10/15/2009 5:14:32 PM
Prepare Endplate
Roughen endplates to bleeding
cancellous bone with either a Straight or
Curved Rasp.
Straight
Note:
Two different rasps are available
for endplate preparation
Angled
7
ST-83104_NOVEL_TL.indd 7
10/15/2009 5:14:37 PM
SURGICAL TECHNIQUE GUIDE
Determine Implant Size
Insert a Implant Trial to confirm the
correct disc height.
Use AP and lateral fluoroscopy to confirm
position of the Trial.
Novel TL Dimensions (in millimeters)
Included in set
Optional
Footprint (width & depth)
Peek
Small
(22x10)
Med
(24x10)
Large
(28x10)
7
8
X Large
(30x10)
Note:
If Implant Trial becomes lodged in disc
space, then connect Slap Hammer to
Trial Handle and dislodge.
9
Height
10
11
12
13
14
15
16
17
Each spacer offered in 0˚ and 5˚ lordosis
8
ST-83104_NOVEL_TL.indd 8
10/15/2009 5:14:45 PM
Place Graft Material
Patient
Use the Bone Graft Funnel to place
bone grafting material sequentially in the
anterior and contralateral portions of the
disc space.
Implant
Use the Implant Graft Packing Block to
fill bone grafting material in the implant’s
central chamber.
TIP
Use bone grafting material: autogenous bone graft for interbody, or
allograft for vertebral body replacement
9
ST-83104_NOVEL_TL.indd 9
10/15/2009 5:14:46 PM
SURGICAL TECHNIQUE GUIDE
Insert Implant
0˚
0˚
30˚
Select the appropriate sized implant.
Load implant on either Straight or Curved
Inserter. Place implant into proper
position and disengage.
0˚
30˚
10
ST-83104_NOVEL_TL.indd 10
10/15/2009 5:14:50 PM
Verify Implant Position
Confirm implant position with AP and
lateral fluoroscopy.
Use either the Straight or Curved Tamp to
manipulate the implant into final position.
Pack additional bone grafting material
posteriorly.
Remove the distraction device, and
create lordosis by compressing on the
posterior Pedicle Screw construct.
Note:
Lateral view of spacer in perfect alignment
showing radiographic markers: beads
and wire.
Lateral View
Isometric View
TIP
The Implant Retriever may be used to reposition implant.
11
ST-83104_NOVEL_TL.indd 11
10/15/2009 5:14:53 PM
INSTRUMENTS
Shaver Disc, 3mm - 20mm
6mm
Screw to Screw Distractor
14mm
Rasp Endplate - Straight
Slap, Hammer
Tamp - Angle
Tamp - Straight
Rasp Endplate - Curved
Left
Right
12
ST-83104_NOVEL_TL.indd 12
10/15/2009 5:15:01 PM
Inserter 30 Degrees
Inserter - Straight
Handle Large with Soft Grip,
Non-Ratcheting Quick Connecting
Handle Medium with Soft Grip,
Non-Ratcheting Quick Connecting
T-Handle with Soft Grip, Non-Ratcheting Quick Connecting
Retriever, Implant
13
ST-83104_NOVEL_TL.indd 13
10/15/2009 5:15:08 PM
PRODUCT INFORMATION
IMPLANT PACKAGING INSERT
NOVEL® SPINAL SPACER SYSTEM
GENERAL INFORMATION:
The Novel Spinal Spacer System is an intervertebral body fusion device
that can also be used as a vertebral replacement device. It is a spinal
fixation system consisting of five cylindrical shapes (footprints) of varying
lengths, widths and heights to accommodate individual patient pathology. System implants are manufactured of surgical grade titanium alloy (ASTM
F-136) or polyetheretherkeytone, PEEK (ASTM F-2026). A radiographic
marker made of titanium (ASTM F-136) or tantalum (ASTM F-560) facilitates
visualization. The NOVEL Spinal System must be used with a supplemental
spinal fixation system. Specifically, the Novel Spinal Spacer System should
be used with the Alphatec Zodiac® Polyaxial System.
WARNINGS AND PRECAUTIONS:
1.
The Novel Spinal Spacer System is an implant device used only
to provide internal fixation during the bone fusion process with
the assistance of a bone graft (allogenous for vertebral body
replacement, autogenous for interbody fusion). A successful result
may not be achieved in every instance of use with this device. This
fact is especially true in spinal surgery where other patient conditions
may compromise the results.
2. The benefit of spinal fusions utilizing any vertebral body replacement
or intervertebral body fusion system has not been adequately
established in patients with stable spines.
3. Based on the fatigue testing results, the physician/surgeon should
consider the levels of implantation, patient weight, patient activity
level, compliance of the patient, and other patient conditions which
may have an impact on the performance and results of this system.
4. Potential risks identified with the use of this device, which may require
additional surgery, include device fracture, loss of fixation, non-union,
fracture of the vertebra, neurological injury and vascular or visceral
injury.
5. Patients who smoke should be advised of the consequences of the
fact that an increased incidence of non-union has been reported with
patients who smoke.
6. Other significant risks to spinal surgery include alcohol abuse, obesity,
and/or patients with poor bone, muscle and/or nerve quality.
7. This device is not intended to be the sole means of spinal support. The Novel Spinal System must be used with additional anterior and or
posterior instrumentation to augment stability.
8. Use of this product without a bone graft may not be successful. No
spinal implant can withstand body loads without the support of bone. In this event, bending loosening, disassembly, and or breakage of the
device may eventually occur.
9. The implants and instruments are provided non-sterile and must
be cleaned and sterilized before use. Validated Sterilization cycle
parameters are noted in the STERILIZATION/RESTERILIZATION
section of INS-010.
10. Preoperative and operating procedures, including knowledge of
surgical techniques, proper selection and placement of the implant,
and good reduction are important considerations in the success of
surgery.
11. Installation and positional adjustment of implants must only be done
with special equipment and instruments specific to these devices. They must not be used with other instrumentation unless specifically
recommended by Alphatec Spine Inc., because the combination with
other instrumentation may be incompatible.
12. Never reuse an internal fixation device under any circumstances. A
device that appears undamaged may have small defects or internal
stress patterns that may lead to early breakage.
13. The selection of the proper size, shape and design of the implant for
each patient is crucial to the success of the procedure. Metal implants
are subject to repeated stresses in use, and their strength is limited by
the need to adapt the design to the size and shape of human bones. Unless great care is taken in patient selection, proper placement of
the implant, and postoperative management to minimize stresses on
the implant, such stresses may cause metal fatigue and consequent
breakage, bending, or loosening of the device before the healing
process is complete, which may result in further injury or the need to
remove the device prematurely.
INDICATIONS:
The Novel Spinal Spacer System is indicated for use as a vertebral body
replacement device in the thoracolumbar spine (T1 to L5) for partial or total
replacement of a collapsed, damaged or unstable vertebral body due to
tumor or trauma (i.e., fracture). The Novel Spinal Spacer System is intended
for use with supplemental spinal fixation systems. Specifically, the Novel
Spinal Spacer System should be used with the Alphatec Zodiac Polyaxial
Spinal System or the Mirage Top Tightening Spinal System. Additionally,
The Novel Spinal Spacer System is intended for use with allogenous bone
graft.
The NOVEL Spinal Spacer System is indicated for use as an Intervertebral
Body Fusion Device as either one level or two contiguous levels in the
lumbar spine, from L2 to S1, for the treatment of degenerative disc
disease (DDD) with up to grade 1 spondylolisthesis. DDD is defined as
discogenic back pain with degeneration of the disc confirmed by patient
history and radiographic studies. These patients should have had six
months of non-operative treatment. The Novel Spinal Spacer System is to
be used with a supplemental fixation system and autogenous bone graft. CONTRAINDICATIONS:
The Novel Spinal Spacer System is contraindicated for:
1. Use in the cervical spine.
2. Patients with osteopenia, bone absorption, bone and/or joint disease,
deficient soft tissue at the wound site or probable metal and/or coating
intolerance.
3. Patients with infection, inflammation, fever, tumors, elevated white
blood count, obesity, pregnancy, mental illness and other medical
conditions, which would prohibit beneficial surgical outcome.
4. Spinal surgery cases that do not require bone grafting and/or spinal
fusion.
5. Patients resistant to following post-operative restrictions on movement
especially in athletic and occupational activities.
6. Use with components from other systems.
7. Reuse, or multiple use.
POSSIBLE ADVERSE EFFECTS:
The following complications and adverse reactions have been shown
to occur with the use of similar spinal instrumentation. These effects
and any other known by the surgeon must be discussed with the patient
preoperatively.
1. Initial or delayed loosening, bending, dislocation and/or breakage of
device components.
2. Physiological reaction to implant devices due to foreign body
intolerance including inflammation, local tissue reaction, and possible
tumor formation.
3. Loss of desired spinal curvature, spinal correction and/or a gain or
loss in height.
4.
Infection and/or hemorrhaging.
5. Bone graft, vertebral body and/or sacral fracture, and/or discontinued
growth of fused bone at, above and/or below the surgery level.
6. Non-union and/or pseudoarthrosis.
Neurological disorder, pain and/or abnormal sensations caused by
7.
improper placement of the device, and/or instruments.
8.
Scar tissue formation possibly causing neurological and/or vascular
compromise.
9.
Bone loss and/or decrease in density due to stress shielding.
10. Subsidence of the device into the vertebral body.
11. Revision surgery.
12. Death.
14
ST-83104_NOVEL_TL.indd 14
10/15/2009 5:15:09 PM
PRODUCT INFORMATION
CLEANING:
All implants and instruments must be free of packaging material and biocontaminants prior to sterilization. Cleaning, maintenance and mechanical
inspection must be performed by hospital personnel trained in the general
procedures involving contaminant removal. For complex devices, such as
those with, cannulas, hinges, retractable features, mated surfaces, and
textured surface finishes, require special attention during cleaning. Manual
pre-cleaning of such device features is required before automated cleaning
processing.
Assure devices are in the fully extended, open position throughout cleaning.
Certain instruments may require dismantling before cleaning.
Handle all products with care. Mishandling may lead to damage and
possible improper functioning of the device.
Manual Cleaning Steps for Instruments
Step 1
Rinse devices in deionized (DI) or reverse osmosis (RO)
water to remove excess soil.
Step 2
Submerge device in enzyme solution and allow to soak
for 5 minutes.
Step 3
Scrub device using a soft bristled brush until all visible
soil has been removed. Use of a syringe or water jet is
recommended for hard to reach areas.
Step 4
Rinse devices in lukewarm tap water for a minimum of 1
minute.
Step 5
Submerge devices in cleaning solution such as
CritiKlenz® and sonicate for a minimum of 10 minutes
Step 6
Thoroughly rinse devices with RO/DI water to remove all
detergent residues.
Step 7
Dry devices with a clean soft cloth.
Automatic Washer Cleaning
Step 1
Rinse devices in deionized (DI) or reverse osmosis (RO)
water to remove excess soil.
Step 2
Submerge device in enzyme solution and allow to soak
for 5 minutes.
Step 3
Rinse devices in lukewarm tap water to remove detergent
residuals.
Step 4
Place devices in fully extended open position into washer
and process through a standard washer/disinfector
instrument cycle.
Automatic Washer/Disinfector Cycle Steps
Step 1
Pre Wash, cold tap water, 2 minutes.
Step 2
Enzyme wash, hot tap water, 1 minute.
Step 3
Detergent wash, Hot tap water (66°C/150°F), 2 minutes.
Step 4
Rinse 2x, hot tap water, 15 seconds.
Step 5
Thermal Rinse, Hot tap water (80-93°C/176-200°F), 2
minutes.
Step 6
Purified Water rinse, Hot tap water (66°C/150°F), 10
seconds.
Step 7
Hot Air Dry, (116°C/240°F), 7- 30 minutes.
Caution: Federal law (USA) restricts these devices to sale by or on the
order of a physician.
Emergo Europe
Molenstaat 15
2513 BH The Hague
The Netherlands
Tel: (31) (0) 70 345-8570
15
ST-83104_NOVEL_TL.indd 15
10/15/2009 5:15:10 PM
Corporate Headquarters
For more
5818 El Camino Real
Carlsbad, California 92008
information, visit
alphatecspine.com
Physician Services
Toll Free: 800.922.1356
Local: 760.431.9286
Fax: 800.431.1624
or contact
Physician Services
at 800 922 1356
www.alphatecspine.com
5818 El Camino Real, Carlsbad, CA 92008
NOVEL, Zodiac and the Alphatec Spine logo are trademarks of Alphatec Spine, Inc. © 2009 Alphatec Spine, Inc. All rights reserved.
LIT-83104 Rev. G 10/09
ST-83104_NOVEL_TL.indd 16
10/15/2009 5:15:11 PM