ORTHOFIX AW-65-9902 Ascent Posterior Occipital Cervico-Thoracic System Instruction Manual

Important Information – Please Read Prior to Use
Device System Name:
Ascent® Posterior Occipital
Cervico-Thoracic (POCT) System
Ascent® LE Posterior Occipital
Cervico-Thoracic (POCT) System

Description:

The Ascent POCT and Ascent LE POCT Systems are temporary, multiple component systems comprised of a variety of non-sterile, single-use components made of titanium alloy or cobalt chrome alloy that allow the surgeon to build a spinal implant construct. The Ascent POCT and Ascent LE POCT Systems consist of an assortment of rods, set screws, cross connectors, axial connectors, lateral offset adapters, multi-axial screws, hooks, plates, and bone screws.

Levels of Use:

When used in the occipital-cervicothoracic spine, the Ascent POCT and Ascent LE POCT Systems may be used from the occiput to T3.

Indications for Use:
When intended to promote fusion of the cervical spine and occipital- cervicothoracic junction (occiput-T3), the Ascent POCT and Ascent LE POCT Systems are indicated for:

1. Degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies).
2. Spondylolisthesis.
3. Fracture/dislocation.
4. Spinal stenosis.
5. Atlanto-axial fracture with instability.
6. Occipito-cervical dislocation.
7. Tumors.
8. Revision of previous cervical spine surgery.

The occipital bone screws are limited to occipital fixation only. The use of the multi-axial screws is limited to placement in the upper thoracic spine (T1-T3) for the treatment of thoracic conditions only. They are not intended to be placed in the cervical spine. The lateral offset adapter is indicated for use in the upper thoracic spine (T1-T3). The hooks are intended to be placed from C1 to T3.
The Ascent POCT and Ascent LE POCT Systems can also be linked to the Orthofix Spinal Fixation System using the Axial or Parallel Rod Connector.

Contraindications:

1. Morbid obesity.
2. Mental illness.
3. Alcoholism or drug abuse.
4. Pregnancy.
5. Metal sensitivity/allergies.
6. Severe osteopenia.
7. Patients are unwilling or unable to follow post-operative care instructions.
8. Any circumstances not listed under the heading Indications.

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. Device component fracture.
2. Loss of fixation.
3. Non-union.
4. Fracture of the vertebra.
5. Neurological injury.
6. Vascular or visceral injury.
7. Early or late loosening of any or all of the components.
8. Disassembly and/or bending of any or all of the components.
9. Foreign body (allergic) reaction to implants, debris, corrosion products, and graft material, including metallosis, straining, tumor formation, and/or autoimmune disease.
10. Pressure on the skin from component parts in patients with inadequate tissue coverage over the implant possibly causes skin penetration, irritation, and/or pain.
11. Post-operative change in spinal curvature, loss of correction, height, and/or reduction.
12. Infection.
13. Pain, discomfort or abnormal sensations due to the presence of the device.
14. Hemorrhage.
15. Cessation of any potential growth of the operated portion of the spine.
16. Death.

Note: Potential risks identified with the use of the device system may require additional surgery.

Warnings and Precautions:

1. Single-use only. Reuse of devices labeled as single-use (e.g. implants, drills, tacks, trial rods) could result in injury or reoperation due to breakage or infection.
2. 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.
3. Non-sterile; the screws, plates, rods, connectors, adapters, and instruments are sold nonsterile and therefore must be sterilized before each use.
4. The mixing of dissimilar metals can accelerate the corrosion process. Do not use the components of this system with implants of other material compositions or components from different manufacturers unless specifically stated.

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.

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:

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 re- sterilized 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 process 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 risks.

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. Manufacturers’ 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. The 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 a 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-minute 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-minute 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, gouges, or are otherwise found defective. Do not use defective instruments.

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 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, fails 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 to Orthofix for disposal.

Sterilization:

Sterilization in Ascent Cases:
The Ascent POCT System should be sterilized by the hospital using one of the following recommended cycles:

Sterilization in Ascent LE Cases:
The Ascent and Ascent LE POCT Systems’ implants and instruments are supplied NON-STERILE. Prior to use, all implants and instruments should be placed in the  instrumentation/implant case which will be wrapped in an FDA approved sterilization wrap and placed in the autoclave for sterilization by the hospital using one of the following recommended cycles:

Ascent LE cobalt chrome occipital rods can be sterilized by placing them in the bottom of the Auxiliary Case. Ascent LE cobalt chrome straight rods can be sterilized by placing them in the bottom of the middle section of the Implant Case.

Physician Information:

Patient Selection:
Patient selection is an extremely important factor in the success of implant procedures. It is important that the candidates be carefully screened and the optimal therapy selected.

Preoperative:

1. Carefully screen the patient, choosing only those that fit the indications described above.

2. Care should be exercised in the handling and storage of the implant components. The implants should not be scratched or otherwise damaged. Store away from corrosive
   environments.

3. The construct should be assembled prior to surgery. An adequate inventory of implants of those expected to be used should be available at the surgery.

4. All components and instruments should be cleaned and sterilized prior to use. Additional sterile components should be available in case of an unexpected need.

Intraoperative:

1. Instructions should be carefully followed.
2. Extreme caution should be used around the spinal cord and nerve roots.
3. The implant surface should not be scratched or notched since such actions may reduce the functional strength of the construct.
4. Bone cement should not be used, as it will make removal of the components difficult or impossible.
5. Before closing soft tissue, check each screw to make sure that none have loosened.

Postoperative:

1. Detailed instructions should be given to the patient regarding care and limitations if any.
2. To achieve maximum results, the patient should not be exposed to excessive mechanical vibration. The patient should not smoke or consume alcohol during the healing process.
3. The patient should be advised of their limitations and taught to compensate for this permanent physical restriction in body motion.
4. If a non-union develops, or if the components loosen, the devices should be revised or removed before serious injury occurs. Failure to immobilize the non-union, or a delay in such will result in excessive and repeated stresses on the implant. It is important that immobilization of the spinal segment be maintained until fusion has occurred.
5. The implants are temporary internal fixation devices. Internal fixation devices are designed to stabilize the spine during the normal healing process. After the spine is fused,
   the devices serve no functional purpose and should be removed.

Patient Information:

The temporary internal fixation devices used in your recent spinal injury are metallic implants that attach to the bone and aid in the healing of bone grafts. These implants have been shown to be valuable aids to surgeons in the treatment of bony fusions. These devices do not have the capabilities of living bone. Intact living bone is self-repairing, flexible, and occasionally breaks and/or degrades. The anatomy of the human body places a size limitation on any artificial fixation device used in surgery. The maximum size limit increases the chances of the mechanical complications of loosening, bending, or breaking of the devices. Any of these complications could result in the need for additional surgery. Accordingly, it is very important that you follow the recommendations of your physician. Use braces as instructed. By following these instructions, you can increase your chances of a successful result and reduce your risk of injury and/or additional surgery.

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 Ascent POCT and Ascent LE POCT Systems’ instruments and implants are provided in modular cases specifically intended to contain and organize each system’s components. The systems’ 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 Inc., 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 Ascent and Ascent LE POCT Systems 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

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

| See Instructions for Use
Orthofix.com/IFU| | Catalog Number
| Manufacturer
| Single-Use Only
Do Not Reuse| | Authorized
Representative
| Provided Non-Sterile| | Serial Number
| Lot Number| | MR Conditional

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-65-9902 Rev. BF
AT-2102 © Orthofix Inc. 09/2021

References

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

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