Atec KODIAK User manual

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KODIAKTM SPINAL FIXATION SYSTEM
INSTRUCTIONS FOR USE
GENERAL INFORMATION:
The Kodiak Spinal Fixation System is intended for posterior, non-cervical, spinal fixation as an adjunct to fusion
for the treatment of degenerative disease, deformity, and trauma indications.
The Kodiak Spinal Fixation System consists of a variety of shapes and sizes of rods, screws, hooks, connectors,
and cross connectors that provide temporary internal fixation and stabilization during bone graft healing and/or
fusion mass development. The screws, hooks, connectors, and cross connectors are manufactured from surgical
grade titanium alloy (Ti-6Al-4V ELI). The rods are available in commercially pure titanium, titanium alloy, and
cobalt chrome (CP Ti Grade 4, Ti-6Al-4V ELI, and Co-28Cr-6Mo).
If additional levels of fixation are required, the Kodiak Spinal Fixation System rods may be used in conjunction
with Alphatec Spine’s Solanas®Posterior System, which may connect to the Avalon®Occipital Plate System. The
Kodiak Cross Connectors accept various rod diameters, and are appropriate for use with Alphatec Spine’s 5.5
mm diameter rod-based systems, including the Arsenal Spinal Fixation System and the Zodiac®Spinal Fixation
System.
INDICATIONS FOR USE:
The Kodiak Spinal Fixation System is intended for posterior, non-cervical fixation in skeletally mature patients as
an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic
origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e.,
fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor;
pseudarthrosis; and/or failed previous fusion.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Kodiak Spinal Fixation
System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis,
kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis.
Additionally, the Kodiak Spinal Fixation System is intended to treat pediatric patients diagnosed with the following
conditions: spondylolisthesis / spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or
failed previous fusion. Pediatric pedicle screw fixation is limited to a posterior approach.
The Kodiak Spinal Fixation System is intended to be used with autograft and/or allograft.
CONTRAINDICATIONS:
The system is contraindicated for:
1. Use in the cervical spine
2. Use with bone cement
3. Patients with allergy to titanium or cobalt chrome
4. Patients with osteopenia, bone absorption, bone and/or joint disease, deficient soft tissue at the wound site
or probable metal and/or coating intolerance
5. Patients with infection, inflammation, fever, tumors, elevated white blood count, obesity, pregnancy, mental
illness, and/or other medical conditions, which would prohibit beneficial surgical outcome
6. Patients resistant to following postoperative restrictions on movement especially in athletic and occupational
activities
7. Spinal surgery cases that do not require bone grafting and/or spinal fusion
8. Reuse or multiple uses

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WARNINGS:
1. The implants and instruments of the system are provided non-sterile and must be cleaned and sterilized prior
to use. Refer to the CLEANING and STERILIZATION sections.
2. The safetyand effectiveness of thisdevicehasnotbeen established foruse as partofa growing rod construct.
This device is only intended to be used when definitive fusion is being performed at all instrumented levels.
3. The system implants are used only to provide temporary internal fixation during the bone fusion process with
the assistance of a bone graft. A successful result may not be achieved in every instance of use with these
devices. Without solid bone fusion, these devices cannot be expected to support the spine indefinitely and
may fail due to bone-metal interface, rod failure or bone failure.
4. The implants are designed and intended as temporary fixation devices. The devices should be removed after
complete healing has occurred. Devices which are not removed after serving their intended purpose may
bend, dislocate, or break and/or cause corrosion, localized tissue reaction, pain, infection, and/or bone loss
due to stress shielding. Complete postoperative management to maintain the desired result should also follow
implant removal surgery.
5. The product implants are single use devices. Do not reuse. While an implant may appear undamaged, it may
have small defectsor internal stresspatterns that could lead to fatigue failure. Inaddition, the removed implant
has not been designed or validated for the decontamination of microorganisms. Reuse of this product could
lead to cross-infection and/or material degradation as a result of the decontamination process.
6. The instruments in the Kodiak Spinal Fixation System are reusable surgical devices except for the Fascial
Blades, Single Step Stylets, and Guidewires used with the Kodiak Spinal Fixation System, which are single
use only. Single-use instruments are disposable devices, designed for single use and should not be re-used
or re-processed. Reprocessing of single-use instruments may lead to instrument damage and possible
improper function.
7. Do not comingle titanium and stainless steel components within the same construct.
8. 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 segment, degenerative spondylolisthesis with objective
evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed
previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are
unknown.
9. Based on the fatigue test results, the physician/surgeon should consider the levels of implantation, patient
weight, patient activity level and patient conditions, which may impact the performance of the system when
using this device. Use of these systems is significantly affected by the surgeon’s proper patient selection,
preoperative planning, proper surgical technique, proper selection and placement of implants.
10.Risks identified with the use of these devices, which may require additional surgery, include device component
failure, loss of fixation/stabilization, non-union, vertebral fracture, neurological injury, vascular or visceral
injury.
11.Risk factors that may affect successful surgical outcomes include: alcohol abuse, obesity, patients with poor
bone, muscle and/or nerve quality. Patients who use tobacco or nicotine products should be advised of the
consequences that an increased incidence of non-union has been reported with patients who use tobacco or
nicotine products.
12.The benefit of spinal fusions utilizing any pedicle screw fixation system has not been adequately established
in patients with stable spines. Without solid bone fusion, these devices cannot be expected to support the
spine indefinitely and may fail due to bone-metal interface, rod failure or bone failure.
13.The final operative procedure with the system must include tightening of the set screws in order to maintain
construct integrity using the appropriate instrument(s), e.g., Torque Handle. Failure to tighten the Set Screws
using the recommended instrument(s) could compromise the mechanical stability of the construct. Each
locking mechanism must be rechecked for tightness before closing the soft tissues as noted in the
Intraoperative Management section.

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14.The implants and instruments of Alphatec Spine product lines should not be used with any other company’s
spinal systems.
15.To prevent Guidewire breakage, do not use a kinked or bent Guidewire.
16.Guidewire advancement should be monitored using fluoroscopic imaging. Failure to do so may cause the
Guidewire or part of it to advance through the bone and into a location that may cause damage to underlying
structures.
17. During Single Step Stylet usage, Stylet advancement should be monitored using fluoroscopic imaging.
PRECAUTIONS:
1. 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.
2. Device components should be received and accepted only in packages that have not been damaged.
Damaged implants and damaged or worn instruments should not be used. Components must be carefully
handled and stored in a manner that prevents scratches, damage, and corrosion.
3. The physician/surgeon should consider the levels of implantation, patient weight, patient activity level, other
patient conditions, etc. which may have an impact on the performance of the system.
MRI SAFETY INFORMATION:
The Kodiak Spinal Fixation System has not been evaluated for safety and compatibility in the magnetic resonance
(MR) environment. It has not been tested for heating, migration, or image artifact in the MR environment. The
safety of the Kodiak Spinal Fixation System in the MR environment is unknown. Scanning a patient who has this
device may result in patient injury.
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, disassembly, bending, dislocation, and/or breakage of device components
2. Physiological reaction to implant devices due to foreign body intolerance including inflammation, local tissue
reaction, seroma, and possible tumor formation
3. In the case of insufficient soft tissue at and around the wound site to cover devices, skin impingement and
possible protrusion through the skin
4. Loss of desired spinal curvature, spinal correction, and/or a gain or loss in height
5. Infection and/or hemorrhaging
6. Bone graft, vertebral body and/or sacral fracture, and/or discontinued growth of fused bone at, above and/or
below the surgery level
7. Non-union and/or pseudarthrosis
8. Neurological disorder, pain and/or abnormal sensations
9. Revision surgery
10.Death

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PREOPERATIVE MANAGEMENT:
1. Only patients meeting the criteria listed in the indications for use section should be selected.
2. Surgeons should have a complete understanding of the surgical technique, system indications,
contraindications, warnings and precautions, safety information, as well as functions and limitations of the
implants and instruments.
3. Careful preoperative planning should include construct strategy, pre-assembly of component parts (if
required), and verification of required inventory for the case.
INTRAOPERATIVE MANAGEMENT:
1. To prevent possible nerve damage and associated disorders, extreme caution should be taken to avoid the
spinal cord and nerve roots at all times.
2. Rods should be contoured in only one direction, one time. Avoid notching, scratching or reverse bending of
the devices because these alterations will produce defects in the surface finish and internal stresses which
may become the focal point for eventual breakage of the implant.
3. If it is mandatory to cut the rods to a more specific length, rod cutting should be done at a distance from the
operative range, and such that a non-sharp edge remains on the rod.
4. Bone graft must be placed in the area to be fused and graft material must extend from the upper to the lower
vertebrae being fused.
5. Final tightening of Set Screws: All Set Screws must be tightened using the appropriate instruments (e.g.,
Torque Handle, Final Driver, and Counter Torque) as indicated in the Surgical Technique Guide.
6. During Guidewire placement, it is recommended to frequently use alternate imaging planes. Ideally, an A-P,
lateral, and oblique view should be taken at all criticalsteps during the procedure to confirm proper positioning
and alignment, and to prevent kinking or breakage of the devices.
POSTOPERATIVE MANAGEMENT:
Postoperative management by the surgeon, including instruction and warning and compliance by the patient, of
the following is essential:
1. Patient should be informed and compliant with the purpose and limitations of the implant devices.
2. The surgeon should instruct the patient regarding amount and time frame after surgery of any weight bearing
activity. The increased risk of bending, dislocation, and/or breakage of the implant devices, as well as an
undesired surgical result are consequences of any type of early or excessive weight bearing, vibratory motion,
fall, jolts or other movements preventing proper healing and/or fusion development.
3. Implant devices should be revised or removed if bent, dislocated, or broken.
4. Immobilization should be considered in order to prevent bending, dislocation, or breakage of the implant
device in the case of delayed, mal-union, or non-union of bone. Immobilization should continue until a
complete bone fusion mass has developed and been confirmed.
5. Postoperative patients should be instructed not to use tobacco or nicotine products, consume alcohol, or use
non-steroidal anti-inflammatory drugs and aspirin, as determined by the surgeon. Complete postoperative
management to maintain the desired result should also follow implant surgery.
6. The implants are designed and intended as temporary fixation devices. The devices should be removed after
complete healing has occurred. Devices which are not removed after serving their intended purpose may
bend, dislocate, or break and/or cause corrosion, localized tissue reaction, pain, infection, and/or bone loss
due to stress shielding. Complete postoperative management to maintain the desired result should also follow
implant removal surgery.
REPROCESSING OF REUSABLE INSTRUMENTS
General Information for all Instruments:
•Point-of-Use Processing: To facilitate cleaning, instruments should be cleaned initially directly after use in

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order to facilitate more effective subsequent cleaning steps. Place instruments in a tray and cover with a wet
towel to prevent drying.
•The cleaning process is the first step in effectively reprocessing reusable instruments. Adequate sterilization
depends on thoroughness of cleaning.
•The cleaning and sterilization processes in this IFU have been validated and demonstrate that soil and
contaminants have been removed leaving the devices effectively free of viable microorgansims.
•It is recommended that all new relevant clinical practice guidelines be followed as per the CDC guidance,
“Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008.”
•It is recommended to rinse the device components with water that meets specifications for AAMI TIR34
“Water for the reprocessing of medical devices, 2014” for example, DI/RO water.
Instrument Preparation:
•Cleaning, inspection, lubrication, and sterilization must be performed by hospital personnel trained in the
general procedures involving contaminant removal.
•Instruments must be cleaned prior to lubrication and sterilization.
•All instrument hinged, rotating, and articulating parts must be lubricated prior to sterilization with a water
soluble and sterilizable lubricant intended for surgical instruments (Hinge-Free®for example).
Cleaning Instructions for all Instruments:
•Instruments must be cleaned prior to sterilization. Cleaning, maintenance and mechanical inspection must
be performed by hospital personnel trained in the general procedures involving contaminant removal.
•Disconnect all handles/knobs prior to cleaning.
•Complex instruments, such as those with, cannulas, hinges, retractable features, mated surfaces, and
textured surface finishes, require special attention during cleaning. Brush tight tolerance areas with an
appropriately sized brush and flush using a water jet or syringe where debris could become trapped.
•Ensure all moving parts of instruments are cleaned at both extents of travel.
•Handle all products with care. Mishandling may lead to damage and possible improper functioning.
•Clean the instruments, trays and inserts using only recommended cleaning solutions. Use of caustic solutions
(caustic soda) will damage the instruments.
•Visually inspect each instrument for deterioration such as corrosion and worn components; ensure that the
laser markings are legible and verify that all actuating parts move freely. Visual inspection must be performed
at each cleaning to determine if an instrument is acceptable for use. If an instrument is not acceptable for
use, return to the manufacturer.
Cleaning of Instruments, Containers, and Trays:
•All solutions for cleaning must be prepared per the manufacturer’s instructions.
•Instruments provided in a set must be removed from the set for cleaning. Instrument trays, containers, and
lids must be thoroughly cleaned separately until visually clean.
•Ensure instruments are in the fully extended, open position throughout cleaning. Disconnect Quick Connect
handles from the shafted instruments prior to cleaning.
•Pay special attention during cleaning to complex instruments, such as those with cannulas, hinges,
retractable features, mated surfaces, and textured surface finishes.
•Use of water with high mineral content should be avoided.
Visually inspect the instrument after each cleaning step to ensure the instrument is clean. If not clean,
repeat the step until clean.

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Manual Cleaning Steps for Instruments
Step 1
Rinse devices in ambient temperature tap water to remove visible soil.
Step 2
Prepare enzymatic solution, such as Prolystica®2X Concentrate Enzymatic Presoak & Cleaner or
equivalent, per manufacturer’s recommendations and submerge device in enzyme solution. Actuate
the device while it is submerged and soak for a minimum of 10 minutes.
Step 3
Actuate and scrub the device using an appropriately sized soft bristled brush, such as a Spectrum
Surgical code #M-16 or 45-542 (or equivalent), to brush the lumen for a minimum of 2 minutes. If
needed, actuate at several locations to access all surfaces. Use of a syringe (minimum of 50 ml) or
water jet is recommended for the hard to reach
areas and repeat 3 times.
Step 4
Rinse devices in DI/RO water for a minimum of 1 minute.
Step 5
Prepare cleaning solution, such as Prolystica®2X Concentrate Alkaline Detergent, per manufacturer’s
recommendations and submerge and actuate devices in cleaning solution and sonicate for a minimum
of 10 minutes.
Step 6
Thoroughly rinse devices with DI/RO water to remove all detergent residues.
Step 7
Dry devices with a clean, lint free cloth or filtered compressed air.
Automatic Washer Cleaning Steps for Instruments
Step 1
Complex instruments, such as those with cannulations, lumens, hinges, retractable features, mated
surfaces, and textured surface finishes, require special attention during cleaning. Brush tight tolerance
areas with an appropriately sized brush and flush using a water jet or syringe with ambient temperature
tap water where debris could become trapped. Place them into the Washer/Disinfector and process
through a standard surgical instrument cycle.
Step 2
Prewash with cold tap water for 2 minutes.
Step 3
Enzyme wash using cleaner such as Prolystica®2X Concentrate Enzymatic Presoak & Cleaner or
equivalent, per manufacturer’s recommendations, hot tap water, 1
minute.
Step 4
Detergent wash using detergent such as Prolystica®2X Concentrate Alkaline Detergent, per
manufacturer’s recommendations, hot tap water (66°C/150°F), 2 minutes.
Step 5
Rinse 2 times, hot tap water, 15 seconds.
Step 6
Purified water rinse (66°C/150°F), 10 seconds.
Step 7
Hot air dry (115°C/239°F) for at least 10 minutes.
INSPECTION:
•Inspect each instrument, container, and tray to ensure that all visible contamination has been removed. If
contamination is noted, repeat the cleaning/disinfection process.
•Check the action of moving parts (e.g., hinges, box-locks, connectors, sliding parts, etc.) to ensure smooth
operation throughout the intended range of motion.
•Check instruments with long slender features (particularly rotating instruments) for distortion.

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•Drill bits, reamers, rasps and other cutting instruments should be inspected after processing with alkaline
detergents.
•Inspect instruments for any other damage, wear, and/or corrosion.
STERILIZATION and RESTERILIZATION (for all Instruments and Implants):
•All implants and instruments are provided non-sterile and must be steam sterilized prior to use in the trays
provided, using the validated cycle parameters in Tables 1 and 2.
•Alphatec products have been validated to achieve sterility using FDA cleared sterilization accessories
(sterilization wraps, container and filters).
•Instrument sets have been validated in standard configurations. No additional items should be added to
the set for sterilization.
Sterilization Parameters
System
Cycle Type
Temperature
Minimum Exposure
Time
Minimum Drying Time
Cool Down Time
Kodiak Spinal
Fixation System
Sets
Pre-vacuum
270°F
(132°C)
4 minutes
45 minutes
15 minutes
Sterilization Notes:
•The cycle conditions in the tables above were validated to achieve a SAL of 10-6.
•These parameters are consistent with the appropriate version of ANSI/AAMI ST79 “Comprehensive guide to
steam sterilization and sterility assurance in health care facilities.”
UDI Construction
To compile a unique device identifier (UDI) for reusable, reprocessed devices, the device identifier (GTIN) may
be ascertained by searching for the part number in the FDA GUDID at https://accessgudid.nlm.nih.gov/. The
production identifier(s) (e.g., lot number, serial number) may be found directly marked on the device.
COMPLAINT HANDLING/REPORTING:
All product complaints relating to safety, efficacy or performance of the product should be reported immediately
to Alphatec Spine by telephone, fax, e-mail, or letter, per contact information below. All complaints should be
accompanied by name, part number, and lot numbers. The person formulating the complaint should provide their
name, address, and as many details as possible. You may contact Customer Service directly at:
customerservi[email protected].
Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.
For a listing of Symbols and Explanations, see atecspine.com/eifu

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ALPHATEC SPINE, INC
1950 Camino Vida Roble
Carlsbad, CA 92008 USA
[phone]
[phone]
www.atecspine.com