ORTHOFIX Centurion Poct System Instructions

INSTRUCTIONS FOR USE
Important Information – Please Read Prior to Use

Device System Name:
Centurion® POCT System

Description:

The Centurion POCT System is a temporary, multiple component system 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 system consists of an assortment of rods, set screws, axial connectors, lateral offset adapters, multi-axial screws, hooks, plates, and bone screws.

Levels of Use:

When used in the occipito-cervico-thoracic spine, the Centurion POCT System may be used from the occiput to T3.

Indications for Use:

The Centurion POCT System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1 – T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The system is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
The Centurion POCT System can also be linked to the Orthofix Spinal Fixation System using the Axial or Parallel Rod Connector.

Contraindications:

The Centurion POCT System, as with other orthopedic implants, is contraindicated for use in patients with:

1. Morbid obesity.
2. Mental Illness.
3. Alcoholism or drug abuse.
4. Pregnancy.
5. Metal sensitivity/allergies.
6. Severe osteopenia.
7. Patients 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 components.
9. Foreign body (allergic) reaction to implants, debris, corrosion products, graft material, including metallosis, straining, tumor formation, and/or auto-immune disease.
10. Pressure on the skin from component parts in patients with inadequate tissue coverage over the implant possibly causing 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. 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.
2. 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.
3. Non-sterile; the screws, set screws, hooks, rods, offset adapters, cross connectors, plates, rod connectors, and instruments are sold non-sterile, and therefore must be sterilized before use.
4. Failure to achieve arthrodesis will result in eventual loosening and failure of the device construct.
5. Excessive torque applied to the screws may strip the threads in the bone.
6. 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.
7. The implantation of POCT systems should be performed only by experienced spinal surgeons with specific training in the use of spinal systems and this POCT system because this is a technically demanding procedure presenting a risk of serious injury to the patient. Preoperative planning and patient anatomy should be considered when selecting implant diameter and length.
8. 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 on the performance of the system.
9. Mixing of dissimilar metals can accelerate the corrosion process. Do not use the components of this system with implants from other manufacturers unless specifically stated.
10. 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 eventual failure of the device.
11. PRE-OP PLANNING – Use of cross sectional imaging (i.e., CT and/or MRI) for posterior cervical screw placement is recommended due to the unique risks in the cervical spine. The use of planar radiographs alone may not provide the necessary imaging to mitigate the risk of improper screw placement. In addition, use of intraoperative imaging should be considered to guide and/or verify device placement, as necessary.

MRI Compatibility Information:

The Centurion POCT System has not been evaluated for safety and compatibility in the MR environment. It has not been tested for heating, migration, or image artifact in the MR environment. The safety of Centurion POCT System in the MR environment is unknown. Scanning a patient who has this device may result in patient injury.

Cleaning:

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.
There is one instrument in the system, the Multi-Axial Screw Driver (PN 69-1036), which requires disassembly prior to cleaning. All other instruments within the system do not 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 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. Manufacturer’s instructions for 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 optimal performance of 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 device in cleaning solution and sonicate for 10 minutes.
4. Rinse 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 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 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). Use of a syringe or water jet will improve 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 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.

Instrument End of Life Determination:

Do not reuse Single Use instruments. Visually inspect the reusable instruments to determine if the instrument has reached 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 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 which reached End of Life. Discard End of Life instruments per your hospital procedure or return to Orthofix for disposal.

Sterilization:

Sterilization in Orthofix Cases with Blue Wrap:

The Centurion POCT System implants and instruments are supplied NON-STERILE. Prior to use, all implants and instruments should be place in the appropriate Orthofix case which will be wrapped in a 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| or:| Method: Steam
Cycle: Pre-vacuum
Preconditioning: Per manufacturer settings
Temperature: 270°F (132°C)
Exposure time: 4 minutes
Drying time: 30 minutes
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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 as 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.

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. Only patients that meet the criteria described in the indications should be selected.
2. Patient conditions and/or predispositions such as those addressed in the aforementioned contraindications should be avoided.
3. Correct selection of the implant is extremely important.
4. Use care in handling and storage of implant components. Cutting, bending, or scratching the surface of metal components can significantly reduce the strength and fatigue resistance of the implant system and should be avoided. These, in turn, may cause cracks and/or internal stresses that are not obvious to the eye and may lead to fracture of the components. Inspection should be made to determine if components have been damaged during storage or previous procedures.
5. An adequate inventory of implant sizes should be available at the time of surgery.
6. Certain special surgical instruments are required to perform this surgery. Review of the use and handling of these instruments is very important.
7. PRE-OP PLANNING – Use of cross sectional imaging (i.e., CT and/or MRI) for posterior cervical screw placement is recommended due to the unique risks in the cervical spine. The use of planar radiographs alone may not provide the necessary imaging to mitigate the risk of improper screw placement. In addition, use of intraoperative imaging should be considered to guide and/or verify device placement, as necessary.

Intraoperative:

1. Whenever possible, use pre-cut rods of the length needed. The rods should not be repeatedly or excessively bent any more than absolutely necessary. The rods should not be reverse bent in the same location. Use great care to insure that the implant surfaces are not scratched or notched in any way. If the rods are cut to length, they should be cut in such a way as to create a flat, non-sharp surface perpendicular to the midline of the rod.
2. The use of two rods and cross connecting the rods will provide a more rigid construct.
3. The placement of screws should be checked radiographically prior to assembly of the rod construct.
4. Care should be taken when positioning the implants to avoid neurological damage.
5. To facilitate proper fusion below and around the location of the instrumentation, a bone graft should be used.
6. Confirm that the rods are fully seated in the bottom of the screw head. Rods that are not fully seated may prevent the device from locking together.
7. Before closing the soft tissues, all of the set screws should be tightened firmly with a torque wrench and set screw driver according to the operative technique. Recheck the tightness of all screws to make sure that none loosened during the tightening of the other set screws. Failure to do so may cause loosening of the other components.
8. Bone cement should not be used since this material will make removal of the component difficult or impossible. The heat generated from the curing process may also cause neurological damage and bone necrosis.

Postoperative:

1. Detailed instructions on the use and limitations of the implant should be given to the patient. The patient must be made aware of the limitations of the implant. Physical activity and load bearing have been implicated in premature loosening, bending, or fracture of internal fixation devices.
2. Periodic X-rays for at least the first year postoperatively are recommended for close comparison with postoperative conditions to detect any evidence of changes in position, nonunion, loosening, and bending or cracking of components.
3. Surgical implants must never be reused. Any retrieved devices should never be reused in another surgical procedure. The retrieved parts should be handled and disposed of in such a manner as to ensure that reuse is not possible.
4. To allow the maximum potential for a successful surgical result, the patient or device should not be exposed to mechanical vibration that may loosen the device construct.
5. These implants are temporary internal fixation devices. Internal fixation devices are designed to assist in the stabilization of the operative site during the normal healing process. After healing occurs, these devices serve no functional purpose and should be removed. In most cases removal is indicated because the implants are not intended to transfer or support forces developed during normal activities. If the device is not removed following completion of its intended use, complication may occur as follows: a. Corrosion, with localized tissue reaction or pain.
   b. Migration of implant position resulting in injury.
   c. Risk of injury from postoperative trauma.
   d. Bending, loosening and/or breakage, which could make removal impractical or difficult.
   e. Pain, discomfort or abnormal sensations due to the presence of the device.
   f. Possible increased risk of infection.
   g. Bone loss caused by stress shielding.

Adequate postoperative management to avoid fracture, re-fracture or other complications should follow implant removal.

Patient Information:

The temporary internal fixation devices used in your recent spinal surgery 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 limitation 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 Centurion POCT System instruments and implants are provided in modular cases specifically intended to contain and organize the system’s components. The system’s instruments are organized into trays within the modular case for easy retrieval during surgery. These trays also provide protection to the system components during shipping. Additionally, individual instruments and implants will be provided in sealed poly bags with individual product labels attached to them.

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 in 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 [email protected].

Further information:

A recommended surgical technique for the use of this system is available upon request from Orthofix at the numbers provided above.

Latex Information:

The implants, instruments and/or packaging material for the Centurion POCT 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.

R x Only  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| Manufacturer
Authorised
Representative
Single Use Only
Do Not Reuse| Serial Number
Catalogue Number| **** Lot Number
Provided Non-Sterile|

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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