ChoiceSpine Stealth User manual

CS.Stealth.IFU Rev 08 12/17
Stealth™Cervical Spacer System
Instruction for Use
Implants
General Description:
The STEALTH™ Cervical Spacer System consists of intervertebral body fusion
devices (“interbody spacers”) comprised of polyetheretherketone (PEEK-OPTIMA®
polymer, Invibio®) with tantalum markers (ASTM F2026 and ASTM F560,
respectively). The spacers have a basic oval shape that coincides with the shape of
vertebral bodies, a hollow center for placement of bone graft, and angled ridges,
or “teeth,” on both the superior and inferior surfaces for resisting migration. They
are available in an assortment of heights and in multiple angles of lordosis to
accommodate different anatomic requirements.
Indications for Use:
The STEALTH Cervical Spacer System is intended for anterior cervical spine
intervertebral body fusion at one level from the C2-C3 disc space to the C7-T1 disc
for the treatment of degenerative disc disease (DDD) in skeletally mature patients
who have had six (6) weeks of non-operative treatment. DDD is defined as neck
pain of discogenic origin with degeneration of the disc confirmed by history and
radiographic studies. The device system is to be used with supplemental fixation
and with autograft to facilitate fusion.
Contraindications:
Contraindications for the STEALTH Cervical Spacer System are similar to those of
other systems of similar design, and include, but are not limited to:
1. Active infectious process in the patient, particularly in or adjacent to the
spine or spinal structures
2. Conditions, such as morbid obesity, which may put excessive stress on the
bone and implants
3. Severe osteopenia or osteoporosis may prevent adequate fixation
4. Suspected or documented metal allergy
5. Use of these implants is relatively contraindicated in patients whose
activity, mental capacity, mental illness, alcohol or drug abuse, occupation
or life-style may interfere with their ability to follow post-operative
instructions
6. Pregnancy
Warnings:
1. Mixing of dissimilar metals can accelerate the corrosion process. Stainless
steel and titanium implants must NOT be used together in building a
construct.
2. A satisfactory outcome is enhanced by the selection of the appropriate
device size and angle.
3. The Stealth Cervical Spacer System has not been evaluated for safety and
compatibility in the MR environment. It has not been tested for heating
and migration in the MR environment.
Precautions:
1. The STEALTH Cervical Spacer System should be implanted only by surgeons
who are fully experienced in the use of such implants and the required
specialized spinal surgery techniques as this is a technically demanding
procedure.
2. The spacers should not be reused even if they appear in a perfect state. Any
spacer that has been used, twisted, bent, implanted and then removed,
even if it appears intact, must be discarded.
3. The STEALTH Cervical Spacer System is used to augment the development
of a spinal fusion by providing temporary stabilization.
The device (spacer) is not intended to be the sole means of spinal support.
Supplemental internal fixation must be used. Bone grafting must be part of
the spinal fusion procedure. If fusion is delayed or does not occur, material
fatigue may cause breakage of the implant. Damage to the implant during
surgery (i.e., scratches, notches) and loads from weight bearing and activity
will affect the implant’s longevity.
4. Refrain from handling the STEALTH Cervical Spacers as much as possible
before implantation, and always handle it with the utmost care. STEALTH
Cervical Spacers (in their original packaging) must be stored with care in a
clean and dry place away from radiation or extreme temperatures. Should
these requirements not be followed, reduced mechanical properties may
occur which could lead to implant failure in some cases.
Preoperative:
1. Preoperative instructions to the patient are essential. The patient should be
made aware of the limitations of the device and the potential adverse
effects of the surgery.
2. Only patients that meet the criteria described in the indications should be
selected.
3. Patient conditions and/or predispositions such as those mentioned in the
contraindications should be avoided.
4. 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.
Intraoperative:
1. The surgeon must be fully conversant with all aspects of the surgical
technique.
2. Proper function of the surgical instruments specific to the STEALTH Cervical
Spacer System should be verified prior to every surgical procedure.
3. The appropriate type and size of implant for the patient and the positioning
of the implant are important.
Postoperative:
1. Patients must be informed of the precautions to be taken in their everyday
life to enhance a maximum implant service life.
2. Regular post-operative follow-up is recommended to detect early signs of
implant failure and consider necessary action.
Potential Complications and Adverse Effects:
Potential complications and adverse effects for this system are similar to those of
other spinal instrumentation systems, and include, but are not limited to:
1. Early or late loosening of the components
2. Disassembly, bending or breakage of any or all of the components
3. Foreign body (allergic) reaction to the implants
4. Infection
5. Loss of neurological function, including paralysis, spinal cord impingement or
damage
6. Dural tears, CSF leak or fistula or meningitis
7. Bone graft donor complications, including pain, fracture or wound healing
problems
8. Vascular damage resulting in excessive bleeding and malpositioned devices
adjacent to large vessels could cause vessel erosion and catastrophic bleeding.
9. Loss or impairment of bowel, sexual, and/or bladder function and other types
of urological compromise
10. Possible local or systemic adverse reactions from potential long-term
degradation of the polymer or mechanical grinding causing wear debris
11. Bone loss due to resorption or stress shielding
12. Pseudoarthrosis
13. Death
Additional surgery may be necessary to correct some of these potential adverse
effects.
Choice Spine
400 Erin Drive
Knoxville, TN 37919

CS.Stealth.IFU Rev 08 12/17
How Supplied:
The STEALTH™ Cervical Spacer System devices are provided non-sterile
and must be sterilized prior to use. Implants are intended for single use only.
Instruments can be reprocessed using the recommended cleaning
instructions.
Cleaning and Decontamination:
All instruments and implants must first be cleaned using methods
recommended in this document or established hospital methods before
sterilization and introduction into a sterile surgical field.
Additionally, all instruments that have been previously taken into a
sterile surgical field must first be decontaminated and cleaned using
methods recommended in this document or established hospital
methods before sterilization and reintroduction into a sterile surgical
field. Cleaning and decontamination can include the use of neutral
cleaners followed by a deionized water rinse.
Note: Certain cleaning solutions such as those containing formalin,
glutaraldehyde, bleach and/or alkaline cleaners may damage some
devices, particularly instruments; these solutions should not be used.
These devices are packaged in a convenience caddy/case, all devices must
be removed from the case and inspected and cleaned via one of the
appropriate methods below.
Recommended Cleaning:
The terms “Steris 444”, “Enzol®” and “Prolystica®” are tradenames of
ultrasonic equipment and detergents utilized in the recommended cleaning
instructions. Any ultrasonic washer or equivalent ultrasonic detergent can be
utilized when used in accordance to the manufacturer’s instructions and
labeling.
Automated Cleaning:
1. Rinse instrument(s) under cool running tap water (< 35 °C) to remove
gross soil. Use a sterile syringe to flush water through & around cracks,
crevices, & hard to reach areas.
2. Use a soft bristle brush as needed to remove soil, paying close
attention to threads, crevices, & hard to reach areas.
3. Transfer instrument(s) into a STERIS 444 washer with the following
parameters. Incline the instrument(s) to assist in drainage. Motor
speed: High.
Phase
Time (min)
Temperature
Detergent
Pre-Wash 1
1:00
Cold tap water
N/A
Enzyme
Wash
1:00
Hot tap water
Enzol® at 1oz per
1 gal water
Wash 1
2:00
60°C
Prolystica®
2x Conc. Neutral
at 1/8 oz per 1 gal
water
Rinse 1
1:00
Hot tap water
N/A
Drying
7:00
115°C
N/A
4. Remove instruments and inspect for soil, repeat cleaning if necessary
Mechanical Cleaning (Ultrasonic):
1. Rinse instrument(s) under cool running tap water (< 35 °C) to remove
gross soil. Use a sterile syringe to flush water through & around cracks,
crevices, & hard to reach areas.
2. Prepare Enzol® solution of one (1) ounce per one (1) gallon of warm tap
water (< 55 °C).
3. Fully immerse instrument(s) in the detergent for at least one (1)
minute.
4. Use a soft bristle brush as needed to remove soil, paying close
attention to threads, crevices, & hard to reach areas.
5. Use a sterile syringe to flush detergent through & around cracks,
crevices, & hard to reach areas.
6. Remove instrument(s) from detergent & rinse with cool tap water (<
35°C) for at least one (1) minute.
7. Prepare the ultrasonic cleaner with an Enzo® solution of one (1) ounce per
one (1) gallon of warm tap water (< 55°C).
8. Load instrument(s) into the cleaner & sonicate for ten (10) minutes.
9. Remove instrument(s) from cleaner & thoroughly rinse using reverse
osmosis/deionized (RO/DI) water for at least one (1) minute.
10. Dry instrument(s) using a clean, soft towel & filtered, pressurized air
(20 psi).
11. Visually inspect for soil. Repeat if necessary.
Manual Cleaning:
1. Rinse instrument(s) under cool running tap water (< 35 °C) to remove
gross soil. Use a sterile syringe to flush water through & around cracks,
crevices, & hard to reach areas.
2. Prepare Enzol® solution of one (1) ounce per one (1) gallon of warm tap
water (< 55 °C).
3. Fully immerse instrument(s) in the detergent for at least one (1) minute.
4. Use a soft bristle brush as needed to remove soil, paying close attention
to threads, crevices, & hard to reach areas.
5. Use a sterile syringe to flush detergent through & around cracks,
crevices, & hard to reach areas.
6. Remove instrument(s) from detergent & thoroughly rinse with reverse
osmosis/deionized (RO/DI) water for at least one (1) minute. Use a sterile
syringe to aid in rinsing.
7. Dry instrument(s) using a clean, soft cloth & filtered, pressurized air
(20 psi).
8. Visually inspect for soil. Repeat if necessary.
Care and Handling:
•All products should be treated with care. Improper use and handling may
lead to damage and possible improper functioning of the device.
•Refer to ASTM standard F1744-96, “Standard Guide for Care and Handling
of Stainless Steel Surgical Instruments” for additional information.
•Before use, instruments should be visually inspected, and function should
be tested to ensure instruments are functioning properly. If instruments
are discolored, have loose screws/pins, are out of alignment, cracked,
show excessive wear, or have other irregularities, DO NOT use.
•Lubricate instruments to protect instruments during sterilization and
storage. This should be done with a water soluble, preserved lubricant
after each cleaning. The lubricant should contain a chemical preservative
to prevent bacterial growth and be made with distilled water. Excess
lubricant should be wiped off prior to storage and sterilization.
Inspection:
The implants should be inspected after processing, prior to sterilization. Any
implant with damage, corrosion, discoloration, scratches, residue, or debris
should be discarded.
Sterilization:
The STEALTH™ Cervical Spacer System instruments are provided non-sterile and
must be sterilized prior to use. All packaging materials must be removed prior
to sterilization. Instruments are recommended to be steam sterilized by the
hospital using the following process parameters (Alternative methods or
cycles may be used, but should be validated according to hospital practices
and procedures).
Steam Sterilizer Type: Pre-Vacuum
Temperature: 132°C
Duration: 4 minutes
Drying Time: 40 minutes
This steam sterilization cycle is not considered by the FDA to be a standard
sterilization cycle. It is the end user’s responsibility to use only sterilizers and
accessories (such as sterilization wraps or pouches, chemical or biological
indicators, and sterilization cassettes) that have been cleared by the FDA for
the sterilization cycle specifications (time and temperature).

CS.Stealth.IFU Rev 08 12/17
Alternative sterilization methods or cycles may be used, but should be
validated according to hospital practices and procedures. The use of an FDA
cleared wrap is recommended to ensure devices remain sterile prior to
implantation.
Single Use Only
Never reuse an implant. Any implant that has been twisted, bent, or implanted,
then removed, even if it appears intact, must be discarded. These devices are
provided as single use only.
Storage and Handling:
Implants should be stored in the implant sterilization case in clean, dry, well-
ventilated conditions away from floors, ceilings, and outside walls.
Store and transport sterile implants in such a way as to maintain sterility and
functional integrity.
Do not use implants if the sterilization wrap is opened, damaged or wet.
Implants should remain covered until needed to avoid contamination. Only
those to be implanted should be handled.
Limitations and Restrictions:
Repeated sterilization according to these instructions has a minimal effect on
Choice Spine devices. Sterilization equipment varies in performance
characteristics and must be validated accordingly. The sterilizing facility is
responsible for the routine validation and monitoring of all equipment,
materials and personnel used in their facility to ensure the desired results are
achieved. These instructions have been validated as being capable of
sterilizing these Choice Spine implants and instruments. Any deviations from
these procedures must be evaluated for efficacy by the sterilizing facility.
Patient Education
It is essential to provide preoperative instructions to the patient. S/he should be
made aware of the potential risks of the surgery and the implant limitations. The
patient should be instructed to limit postoperative activity, as this will reduce the
risk of bent, broken or loose implant components. The patient must be made
aware that implant components may bend, break, or loosen even though
restrictions in activity are followed.
Device Retrieval Efforts:
Should it become necessary to remove any or all of the STEALTHTM Cervical
Spacer System components, please call Choice Spine at the number below to
receive instructions regarding data collection, including histopathological,
mechanical, and adverse event information.
Surgical Technique Guide:
The STEALTHTM Cervical Spacer System Surgical Technique Guide is available by
contacting Choice Spine Customer Service.
Caution:
Federal law (USA) restricts this device to sale by or on the order of a physician
Information:
See www.choicespine.com/patents.html for patent information.
For product complaints please contact:
Choice Spine, LP
Quality/Regulatory Department
400 Erin Drive
Knoxville, TN 37919
Phone: [phone]; Fax: [phone]
For additional Product information please contact:
Choice Spine, LP
Customer Service Department
400 Erin Drive
Knoxville, TN 37919
Phone: [phone]; Fax: [phone]
[e-mail]
Symbol Legend:
Symbol
Definition
Do not reuse
Caution, consult instructions for use for
warnings and precautions
Consult instructions for use
Do not use if package is damaged
Lot number
Reference number
Serial Number
Sterilized by irradiation
Use by
Manufacturer
Date of Manufacture
Federal law (USA) restricts this device to
sale by or on the order of a physician
Non-Sterile
European Medical Devices
Authorized representative in the
European Community