ORTHOFIX CONSTRUX Mini Ti Spacer System Instruction Manual

ORTHOFIX CONSTRUX Mini Ti Spacer System

Description:

The CONSTRUX Mini Ti Spacer System is comprised of a variety of 3D printed implants that have porous titanium end plates and a functional gradient porous structure. CONSTRUX Mini Ti spacers are implanted in the cervical intervertebral disc space and are intended to facilitate vertebral fusion by stabilizing adjacent vertebrae, maintaining disc height and preventing the collapse of one vertebra onto another. The CONSTRUX Mini Ti Spacer System is not intended to be used as a stand-alone device and must be used with supplemental fixation. The implants are used singly and are implanted using an anterior approach. The CONSTRUX Mini Ti implants are provided sterile.
CONSTRUX Mini Ti implants are design to be used with CONSTRUX Mini Spacer System instrumentation. The CONSTRUX Mini Ti implants are not compatible with components or metal from any other manufacturer’s system.

Indications for Use:
The CONSTRUX Mini Ti Spacer System is indicated for spinal fusion procedures at one or two contiguous levels within the cervical spine (C2-T1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. The CONSTRUX Mini Ti Spacer System is intended for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation system; the hyperlordotic implants (≥10°) are required to be used with an anterior cervical plate. Patients must have undergone a regimen of at least six weeks of non-operative treatment prior to being treated with the CONSTRUX Mini Ti Spacer System in the cervical spine.

Contraindications:
The CONSTRUX Mini Ti 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 which 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.

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.
10.  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. In rare instances, 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 eventual failure of the device.
3. CONSTRUX Mini Ti implants are provided STERILE. Do not use if the package is opened or damaged or if the expiration date has passed.
4.  DO NOT re-sterilize these implants as this could result in injury or require reoperation due to breakage or infection.
5.  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.
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.  Non-Sterile; the CONSTRUX Mini Spacer System instruments are provided non-sterile, and therefore, must be thoroughly cleaned and sterilized before initial use and after each subsequent use.
8.  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.
9.  Based on dynamic testing results, the physician should consider the levels of implantation, patient weight, patient activity level and other patient conditions that may impact the performance of the intervertebral body fusion device.
10. The implantation of the intervertebral body fusion device should be performed only by experienced spinal surgeons with specific training in the use of the device because it is a technically demanding procedure presenting a risk of serious injury to the patient.

MRI Compatibility Information

The CONSTRUX Mini Ti Spacer System has not been evaluated for safety and compatibility in the Magnetic Resonance (MR) environment. It has not been tested for heating, migration, or image artifact in the MR environment. The safety of CONSTRUX Mini Ti Spacer System in the MR environment is unknown. Scanning a patient who has this device may result in patient injury.

Cleaning

CONSTRUX Mini Ti Spacer System implants are provided STERILE. Do not use the implant if the package is opened or damaged or if the expiration date has passed. Please discard all open and unused implants. Do not re-sterilize an opened and unused implant. The CONSTRUX Mini Spacer System instruments are compatible for use with the CONSTRUX Mini Ti Spacer System. All instruments must be thoroughly cleaned and sterilized after each use. Cleaning may be done using validated hospital methods or following the validated cleaning processes described below. None of the instruments 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.
6.  2 minute prewash with cold tap water
7.  1 minute prewash with hot tap water
8.  2 minute detergent wash with hot tap water (64-66°C/146-150°F)
9.  1 minute hot tap water rinse
10.  2 minute thermal rinse with purified water (80-93°C/176-200°F)
11. 1 minute purified water rinse (64-66°C/146-150°F)
12. 7 to 30 minute hot air dry (116°C/240°F)
13.  Inspect the instruments for visible soil.
14. 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:
CONSTRUX Mini Ti Spacer System implants are provided STERILE. They are sterilized using gamma irradiation sterilization. Do not re-sterilize.

Sterilization in Orthofix Cases with Blue Wrap:
The CONSTRUX Mini Spacer System instruments are supplied NON-STERILE and are compatible for use with the CONSTRUX Mini Ti Spacer System. Prior to use, all 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
• 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). The following sterilization cycle has been validated:

• Method: Steam
• Cycle: Prevac
• Temperature: 270°F (132°C)
• Exposure time: 4 minutes
• Drying time: 30 minutes

Note : Rigid sterilization containers with solid bottoms cannot be used in gravity steam cycles. 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:

CONSTRUX Mini Ti implants are provided STERILE. Do not use if the package is opened or damaged or if the expiration date has passed. 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 CONSTRUX Mini Spacer System instruments are provided in modular cases 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 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 CONSTRUX Mini Ti 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 this device to sale by or on the order of a physician.

References

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

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