ORTHOFIX FORZA XP Expandable Spacer System Instructions

ORTHOFIX FORZA XP Expandable Spacer System

Description

The FORZA XP Expandable Spacer System is comprised of an assortment of non- sterile, single-use, titanium alloy (Ti-6Al-4V ELI per ASTM F136) and Polyetheretherketone (PEEK) Polymer (PEEK OPTIMA® LT1 per ASTM F2026) spacers with height expansion capability. The expandable interbody spacer is inserted into the lumbar disc space and expanded to fit the patient’s anatomy. The implants are offered in parallel, lordotic, and hyperlordotic configurations to help restore the natural curvature of the spine. The implants can be used in single placement or pairs with typical approaches being transforaminal lumbar interbody fusion (TLIF) and posterior lumbar interbody fusion (PLIF).

The implants feature a bulleted nose for ease of insertion and anti-migration ripples on both the inferior and superior surfaces to provide increased stability and help prevent anterior/posterior movement of the device. The FORZA XP Expandable Spacer System is not intended to be used as a stand-alone device. The system must be used with a supplemental fixation system, is provided non-sterile and requires sterilization prior to use.

Indications for Use

The FORZA XP Expandable Spacer System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved levels. These patients may have had previous non-fusion surgery at the involved level(s).

The FORZA XP Expandable Spacer System is intended for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft; and supplemental fixation system.
Patients must have undergone a regimen of at least six months of non-operative treatment prior to being treated with the FORZA XP Expandable Spacer System.

Contraindications

The FORZA XP Expandable Spacer System, as with other orthopedic implants, is contraindicated for use in patients with:

1. Active infections in which the use of an implant could preclude adequate and appropriate treatment of the infection.
2. Rapidly progressive joint disease or bone absorption syndromes such as Paget’s disease, osteopenia, osteoporosis, or osteomyelitis may prevent adequate fixation.
3. Conditions that may place excessive stresses on bone and implants, such as severe obesity, pregnancy or degenerative diseases. The decision to use this system in such conditions must be made by the physician taking into account the risks versus the benefits to the patient.
4. Prior fusion at the level to be treated.
5. Any circumstances not listed under the Indications for Use section.

Potential Adverse Events

Potential adverse events include, but are not limited to:

1. Failure of the device to provide adequate mechanical stability.
2. Loss of fixation of the implant.
3. Device component failure.
4. Migration or bending of the device.
5. Loss of bony alignment.
6. Non-union.
7. Fracture of bony structures.
8. Resorption without incorporation of any bone graft utilized.
9. Immunogenic response to the implant materials.

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

The surgeon should be aware of the following when using implants:

1. The correct selection of the implant is extremely important. The potential for success is increased by the selection of the proper size, shape, and design of the implant. No implant can be expected to withstand the unsupported stresses of full weight bearing. The size, shape, and condition of human bones are also contributing factors to the success of the surgery.
2. Do not use damaged implants. The correct handling of the implant is extremely important. Implants should not be bent, notched or scratched. These operations can produce defects in surface finish and may cause internal stress concentrations which may become the focal point for the eventual failure of the device.
3. FORZA XP implants must be expanded upon insertion to reduce the risk of expulsion or migration post-operatively.
4. Do not place a bone graft in the FORZA XP spacer prior to both final positioning and expansion of the implant. The bone graft will prevent the Stabilizer Driver from being able to seat into the implant expansion drive and will limit the FORZA XP spacer height adjustments.
5. Non-sterile; the FORZA XP Expandable Spacer implants and instruments are provided non-sterile, and therefore, must be thoroughly cleaned and sterilized prior to each use.
6. 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.
7. 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.
8. Do not re-sterilize single-use implants that come in contact with body fluids.
9. Postoperative care is important. The patient should be instructed in the limitations of the implant and should be cautioned regarding weight bearing and body stress on the device prior to secure bone healing.
10. Based on the dynamic testing results, the physician should consider the levels of implantation, patient weight, patient activity level, other patient conditions, etc., which may impact on the performance of the intervertebral body fusion device.
11. The implantation of the intervertebral body fusion device should be performed only by experienced spinal surgeons with specific training in the use of this device because this is a technically demanding procedure presenting a risk of serious injury to the patient.
12. Patients with previous surgery at the levels to be treated may have different clinical outcomes compared to those without previous surgery.

MRI Compatibility Information

Non-clinical testing and MRI simulations that included in-vivo, clinically relevant modeling were performed to evaluate the entire family of the Interbody System. Non-clinical testing demonstrated that the entire family of the system is MR Conditional. A patient with an implant from this family can be scanned safely in an MR system under the following conditions:

• Static magnetic field of 1.5-Tesla or 3-Tesla, only
• Maximum spatial gradient magnetic field of 4,000-gauss/cm (40-T/m)
• Maximum MR system reported, whole body averaged specific absorption rate (SAR) of 2-W/kg for 15 minutes of scanning (i.e., per pulse sequence) in the Normal Operating Mode

Under the scan conditions defined, an implant from the Interbody System is expected to produce a maximum temperature rise of 4.4°C after 15 minutes of continuous scanning (i.e., per pulse sequence). In non-clinical testing, the image artifact caused by an implant from the Interbody System extends approximately 4-mm from this device when imaged with a gradient echo pulse sequence and a 3-Tesla MR system.

Cleaning

FORZA XP Expandable Spacer 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 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 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 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. 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. 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 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 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.
   • 2-minute prewash with cold tap water
   • 1 minute prewash with hot tap water
   • 2-minute detergent wash with hot tap water (64-66°C/146-150°F)
   • 1-minute hot tap water rinse
   • 2-minute thermal rinse with purified water (80-93°C/176-200°F)
   • 1 minute purified water rinse (64-66°C/146-150°F)
   • 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, 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 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 Orthofix Cases with Blue Wrap:
The FORZA XP Expandable Spacer 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 or: Method: Steam
• Cycle: Gravity Cycle: Prevac
• Temperature: 270°F (132°C) Temperature: 270°F (132°C)
• Exposure time: 15 minutes Preconditioning: Per manufacturer’s settings
• Drying time: 30 minutes Exposure time: 4 minutes
• Double wrapped Drying time: 30 minutes
• Double wrapped

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 (recommended 23¼” long x 11¼” wide container). Based on the rigid sterilization container size, the FORZA® Discectomy tray may require the removal of the lid prior to insertion into the sterilization container. The following sterilization cycle has been validated:

• Method: Steam
• Cycle: Prevac
• Temperature: 270°F (132°C)
• Preconditioning: Per manufacturer’s 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 FORZA XP Expandable Spacer 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 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 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 FORZA XP Expandable Spacer 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.

• 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
• Single Use Only Do Not Reuse.
• Catalogue Number
• Provided Non-Sterile
• Lot Number
• Manufacturer
• Authorized Representative
• Serial 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.

References

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

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