ORTHOFIX CETRA Anterior Cervical Plate System Instruction Manual

INSTRUCTIONS FOR USE
Important Information
Please Read Prior to Use

Description

The Cetra Anterior Cervical Plate System is comprised of an assortment of non- sterile, single-use, titanium alloy (Ti6Al4V ELI per ASTM F136) plates and screws that allow a surgeon to build a temporary anterior cervical implant construct. The plate is attached to the anterior aspect of the vertebral body, by means of screws, to the cervical spine. The system includes the necessary instrumentation to assist in the surgical implantation of the devices.

Indications for Use

The Cetra Anterior Cervical Plate System is a temporary implant intended for anterior fixation to the cervical spine from C2 to C7 and indicated for:

1. Degenerative disc disease (defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies).
2. Spondylolisthesis.
3. Fracture.
4. Spinal stenosis.
5. Deformities (i.e., scoliosis, kyphosis, and/or lordosis).
6. Tumor.
7. Pseudoarthrosis.
8. Revision of previous surgery.

Contraindications

The Cetra Anterior Cervical Plate System is contraindicated in patients with a systemic infection, with a local inflammation at the bone site, or with rapidly progressive joint disease or bone absorption syndromes such as Paget’s disease, osteopenia, osteoporosis, or osteomyelitis. Do not use this system in patients with known or suspected metal allergies. Use of the system is also contraindicated in patients with any other medical, surgical or psychological condition that would preclude potential benefits of internal fixation surgery such as the presence of tumors, congenital abnormalities, elevation of sedimentation rate unexplained by another disease, elevation of white blood cells or a marked shift in white blood cell differential count.

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. Early or late loosening of any or all of the components.
2. Disassembly, bending, and/or breakage of any or all of the components.
3. Foreign body (allergic) reaction to implants, debris, corrosion products, graft material including metallosis, straining, tumor formation, and/or auto-immune disease.
4. Pressure on the skin from component parts in patients with inadequate tissue coverage over the implant possibly causing skin penetration, irritation, and/or pain.
5. Post-operative change in spinal curvature, loss of correction, height, and/or reduction.
6. Infection.
7. Vertebral body fracture at, above, or below the level of surgery.
8. Loss of neurological function, including paralysis (complete or incomplete).
9. Non-union delayed union.
10. Pain, discomfort, or abnormal sensations due to the presence of the device.
11. Hemorrhage.
12. Cessation of any potential growth of the operated portion of the spine.
13. Death.
14. Dysphagia

Note: As with any major surgical procedure, there are risks involved in orthopedic surgery. Infrequent operative and postoperative complications known to occur are: early or late infection, which may result in the need for additional surgeries, damage to blood vessels, spinal cord or peripheral nerves, pulmonary emboli, loss of sensory and/or motor function, impotence, permanent pain and/or deformity. Rarely, some complications may be fatal.

Warnings and Precautions:

1. The Cetra Anterior Cervical Plate System is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical spine.

2. To optimize bony union, perform an anterior microdiscectomy or corpectomy as indicated.

3. To facilitate fusion, a sufficient quantity of autograft or allograft material should be used.

4. Always orient the plate along the midline of the spine.

5. Excessive torque applied to the screws when seating the plate may strip the threads in the bone.

6. Failure to place screws within the intended angle range may result in plate locking mechanism fracture or screw back-out past the plate locking
   mechanism.

7. Failure to achieve arthrodesis will result in eventual loosening and failure of the device construct.

8. Single-use only. Reuse of devices labeled as single-use (e.g. implants, drills, tacks, trial rods) could result in injury or re-operation due to breakage or infection.

9. All implants are intended for SINGLE USE ONLY. Any used implant should be discarded. Even though the device may appear undamaged, it may have small defects and internal stress patterns that may lead to fatigue failure.

10. The health care provider must thoroughly clean the instruments prior to steam sterilization.

11. Do not combine implants of dissimilar metals, as it may result in galvanic corrosion.

12. The selection of the proper size, shape, and design of the implant for each patient is crucial to the safe use of this device in pediatric patients.

13. 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.

14. The implantation of anterior cervical plate systems should be performed only by experienced spinal surgeons with specific training in the use of anterior cervical plate systems because this is a technically demanding procedure presenting a risk of serious injury to the patient.

15. 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 the performance of the system.

16. 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.

17. 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 the eventual failure of the device.

MRI SAFETY INFORMATION

Non-clinical testing and electromagnetic/thermal simulations were performed to evaluate the entire family of implants from the Orthofix Plate Systems. An implant from the Plate System is MR Conditional. A patient with an implant or implants from the Plate System may be safely scanned under the following conditions. Failure to follow these conditions may result in injury to the patient.

MR CONDITIONAL

of continuous RF exposure.
MR IMAGE ARTIFACT| THE PRESENCE OF THIS IMPLANT PRODUCES AN IMAGING ARTIFACT APPROXIMATELY 4 MM FROM THIS DEVICE. THEREFORE, CAREFULLY SELECT PULSE SEQUENCE PARAMETERS TO MINIMIZE ARTIFACTS IF THE IMPLANT IS LOCATED IN THE AREA OF INTEREST.

Cleaning

Cetra Anterior Cervical Plate System instruments and implants are provided clean but not sterile.
Once an implant comes in contact with any human tissue or bodily fluid it should not be resterilized or used. Please discard all contaminated implants.
All instruments must be thoroughly cleaned after each use. Cleaning may be done using validated hospital methods or following the validated cleaning processes described below.
None of the instruments in the system require disassembly prior to cleaning.
From Point of Use:
Whenever possible, do not allow blood, debris, or body fluids to dry on instruments. For best results and to prolong the life of the surgical instrument reprocess immediately after use.

1. Remove excess body fluids and tissue from instruments with a disposable, non-shedding wipe. Place instruments in a basin of purified water or in a tray covered with damp towels. Do not allow saline, blood, body fluids, tissue, bone fragments, or other organic debris to dry on instruments prior to cleaning.
2. For optimal results, instruments should be cleaned within 30 minutes of use or after removal from the solution to minimize the potential for drying prior to cleaning.
3. Used instruments must be transported to the central supply in closed or covered containers to prevent unnecessary contamination risk.

Note: Soaking in proteolytic enzymatic detergents or other pre-cleaning solutions facilitates cleaning, especially in instruments with complex features and hard-to-reach areas (e.g. cannulated and tubular designs, etc.). These enzymatic detergents as well as enzymatic foam sprays break down protein matter and prevent blood and protein-based materials from drying on instruments. The manufacturer’s instructions for the preparation and use of these solutions should be explicitly followed.

Preparation for Cleaning

1. All instruments with moving parts (e.g., knobs, triggers, hinges) should be placed in the open position to allow access of the cleaning fluid to areas that are difficult to clean.
2. Soak the instruments for a minimum of 10 minutes in purified water prior to the manual or automated cleaning process.
3. Use a soft cloth or a soft plastic bristle brush to remove any visible soil from the instruments prior to manual or automated cleaning. Use a soft plastic bristle brush or a pipe cleaner to remove soil from any inner lumens. You can also use a syringe (if appropriate) for hard-to-reach areas.
4. Enzymatic detergent should be used for manual and automated cleaning. All enzymatic detergents should be prepared at the use dilution and temperature recommended by the manufacturer. Softened tap water may be used to prepare the enzymatic detergents. Use of recommended temperatures is important for the optimal performance of the enzymatic detergent.

Manual Cleaning

1. Completely submerge instruments in an enzymatic detergent and allow to soak for 20 minutes. Use a soft-bristled, nylon brush to gently scrub the device until all visible soil has been removed. Particular attention must be given to crevices, lumens, mated surfaces, connectors, and other hard-to-clean areas. Lumens should be cleaned with a long, narrow, soft-bristled brush (i.e. pipe cleaner brush).
2. Remove the instruments from the enzymatic detergent and rinse in tap water for a minimum of 3 minutes. Thoroughly and aggressively flush lumens, holes, and other difficult-to-reach areas.
3. Place prepared cleaning solution in a sonication unit. Completely submerge the device in the cleaning solution and sonicate for 10 minutes.
4. Rinse the instrument in purified water for at least 3 minutes or until there is no sign of blood or soil on the device or in the rinse stream. Thoroughly and aggressively flush lumens, holes, and other difficult-to-reach areas.
5. Repeat the sonication and rinse the steps above.
6. Remove excess moisture from the instrument with a clean, absorbent, and non-shedding wipe.
7. Inspect the instruments for visible soil. 8. If visible soil is noted, repeat the steps listed above.

Automated Cleaning

1. Completely submerge the instruments in an enzymatic detergent and allow them to soak and sonicate for 10 minutes each. Use soft nylon bristled brush to gently scrub the device until all visible soil has been removed. Particular attention must be given to crevices, lumens, mated surfaces, connectors, and other hard-to-clean areas. Lumens should be cleaned with a long, narrow, soft nylon bristled brush (i.e. pipe cleaner). The use of a syringe or water jet will improve the flushing of difficult-to-reach areas and closely mated surfaces.
2. Remove instruments from the cleaning solution and rinse in purified water for a minimum of 1 minute. Thoroughly and aggressively flush lumens, blind holes, and other difficult-to-reach areas.
3. Place instruments in a suitable washer/disinfector basket and process through a standard instrument washer/disinfector cleaning cycle
4. Orient instruments into the automated washer’s carriers as recommended by the washer manufacturer.
5. The following minimum parameters are essential for thorough cleaning. a. 2-minute prewash with cold tap water b. 1-minute prewash with hot tap water c. 2 minutes detergent wash with hot tap water (64-66°C/146-150°F) d. 1-minute hot tap water rinse e. 2-minute thermal rinse with purified water (80-93°C/176-200°F) f. 1 minute purified water rinse (64-66°C/146-150°F) g. 7 to 30 minutes hot air dry (116°C/240°F)
6. Inspect the instruments for visible soil.
7. If visible soil is noted, repeat the above-listed steps until no visible soil is noted.

Note: Certain cleaning solutions such as those containing caustic soda, formalin, glutaraldehyde, bleach, and/or other alkaline cleaners may damage instruments. These solutions should not be used.
Note: Visually inspect instruments after cleaning and prior to each use. Discard or return to Orthofix any instruments that are broken, discolored, corroded, have cracked components, pits, or gouges, or are otherwise found defective. Do not use defective instruments.
Torque Limiting Instrument Use:

• Never use torque-limiting drivers in the counter-clockwise (CCW) direction to loosen a fastener
• Only use torque limiting handle as intended per the operative technique
• Never impact on torque limiting handles or use as an impacting device on other devices
• Never use a torque limiting handle as a prying tool

Torque Limiting Instrument Maintenance :

• If a torque-limiting handle has been dropped, impacted or used incorrectly, return to Orthofix.
• Torque-limiting handles require maintenance at a minimum, every three years or per your service agreement. Please return your torque-limiting handles to Orthofix for required maintenance.

Instrument End of Life Determination:

Do not reuse Single Use instruments. Visually inspect the reusable instruments to determine if the instrument has reached the end of life. Orthofix reusable instruments have reached the End of Life when:

1. Instruments show signs of damage such as binding, bending, breakage, overt signs of wear, and/or any other conditions which may impact the devices safe and effective use.
2. Instruments intended for cutting the bone and/or tissue (e.g. tap, rasp, curette, rongeur) – when any of the cutting surfaces show signs of wear such as nicks, abrasions or otherwise dulled cutting surfaces.
3. Instruments that interface with other devices (e.g. implants, instruments, handles) – when the mating feature binds, fail to attach, or fails to hold the device securely. The instrument function should be verified prior to each use.
4. Do not use instruments that reached the End of Life. Discard End of Life instruments per your hospital procedure or return them to Orthofix for disposal.

Sterilization:

Sterilization in Orthofix Cases with Blue Wrap:
The Cetra Anterior Cervical Plate System instruments and implants are supplied NON-STERILE. Prior to use, all instruments and implants should be placed in the appropriate Orthofix case which will be wrapped in an FDA-cleared sterilization wrap and placed in the autoclave for sterilization by the hospital using one of the following recommended cycles:

Method: Steam
Cycle: Gravity
Temperature: 270°F (132°C)
Exposure time: 15 minutes
Drying time: 30 minutes
Double wrapped| Method: Steam
Cycle: Privacy
Temperature: 270°F (132°C)
Preconditioning: Per manufacturer’s settings
Exposure time: 4 minutes
Drying time: 30 minutes
Double wrapped
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Sterilization in Rigid Sterilization Containers:
When using rigid sterilization containers, clean, inspect, and prepare the rigid sterilization container according to the manufacturer’s instructions.
Select the appropriate rigid sterilization container with either a filtered or solid bottom to properly enclose the Orthofix case(s) or caddies (recommended 23¼” long x 11¼” wide container). The following sterilization cycle has been validated:
Method: Steam
Cycle: Pre-vacuum
Temperature: 270°F (132°C)
Preconditioning: Per manufacturer settings
Exposure time: 4 minutes
Drying time: 30 minutes
Validation and routine monitoring should be performed per ANSI/AAMI ST79 Comprehensive guide to steam sterilization and sterility assurance in health care facilities. Other cycles may be used as long as they comply with the above practices and provide a sterility assurance level of 10 -6

Packaging:

Packages for each of the components should be intact upon receipt. If a consignment system is used, all sets should be carefully checked for completeness and all components should be carefully checked for damage prior to use. Damaged packages or products should not be used and should be returned to Orthofix.
The Cetra Anterior Cervical Plate System instruments and implants are provided in a modular case specifically intended to contain and organize the system’s components. The system’s instruments are organized into trays within each modular case for easy retrieval during surgery. These trays also provide protection to the system components during shipping. Additionally, individual instruments and implants are provided in sealed poly bags with individual product labels.
Product Complaints:
Any Health Care Professional (e.g., customer or user of this system of products) who has any complaints or who has experienced any dissatisfaction with the product quality, identity, durability, reliability, safety, effectiveness and/or performance, should notify Orthofix, 3451 Plano Parkway, Lewisville, TX 75056, USA, by telephone at 1-214-937-3199 or 1-888-298-5700 or by e-mail at complaints@orthofix.com.
Further Information:
A recommended operative technique for the use of this system is available upon request from Orthofix at the phone numbers provided above.
Latex Information:
The implants, instruments, and/or packaging material for the Cetra Anterior Cervical Plate System are not formulated with and do not contain natural rubber. The term “natural rubber” includes natural rubber latex, dry natural rubber, and synthetic latex or synthetic rubber that contains natural rubber in its formulation.
Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician. CAPA Symbols Chart revised – CETRA

Rx Only Federal (U.S.A.) law restricts this device to sale by or on the order of a physician

| See Instructions for Use| ****| Manufacturer
| Single Use Only  Do Not Reuse| | Authorized Representative
| Catalog Number| | Serial Number
| Provided Non-Sterile| | Lot Number

****Orthofix Inc.
3451 Plano Parkway
Lewisville, Texas 75056-9453 U.S.A.
1-214-937-3199
1-888-298-5700
www.orthofix.com| Australian Sponsor
Emergo Australia
Level 20, Tower II
Darling Park
201 Sussex Street
Sydney, NSW 2000
Australia| medical Device Safety
Service (MDSS)
Schiffgraben 41
30175 Hannover
Germany
www.mdss.com
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AW-19-9901- Rev AG
CT-2203-PL-US © Orthofix US LLC 07/2022

Documents / Resources

| ORTHOFIX CETRA Anterior Cervical Plate System [pdf] Instruction Manual
CETRA, Anterior Cervical Plate System, CETRA Anterior Cervical Plate System, Cervical Plate System, Plate System
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References

• EU Authorized Representative Services For Medical Devices
• Orthofix - Medical Devices & Solutions

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