ORTHOFIX PILLAR SA PEEK Spacer System Instruction Manual

: June 12, 2024
: ORTHOFIX

Table of Contents

PILLAR SA PEEK Spacer System
Description:
Contraindications:
Potential Adverse Events:
Warnings and Precautions:
Preparation for Cleaning:
Automated Cleaning:
Product Complaints:
Further Information:
Latex Information:
References
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PILLAR SA PEEK Spacer System
Instruction Manual

INSTRUCTIONS FOR USE
Important Information – Please Read Prior to Use

PILLAR SA PEEK Spacer System

Device System Name:
PILLAR® SA PEEK Spacer System Intervertebral Body Fusion Device Spinal Partial Vertebral Body Replacement Device

Description:

The PILLAR SA PEEK Spacer System is comprised of a variety of implants manufactured from PEEK (Polyetheretherketone) as described by ASTM F2026 with tantalum markers as described by ASTM F560. The implants are available in multiple footprints, a variety of heights, and two angles of lordosis: 7° and 12°. The implants incorporate integrated anterior screw holes to allow for medial placement of screws, as well as a titanium plate for securing the screws once in place. The superior and inferior surfaces of the implant have a pattern of ripples that provide increased stability and help prevent movement of the device. The PILLAR SA PEEK Spacer System is provided non- sterile.
Indications for Use:
When used as an Intervertebral Body Fusion Device:
The PILLAR SA PEEK Spacer System is indicated for use with bone graft (autograft bone or allogenic bone graft composed of cancellous or corticocancellous bone graft) in patients with degenerative disk disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may have up to Grade I Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. Patients with previous non-fusion spinal surgery at the treated level may be treated.
The PILLAR SA PEEK Spacer System is intended for use with the four titanium alloy screws provided with the device. If the physician chooses to use fewer than four of the provided screws, then supplemental fixation must be used to augment stability. As an example, the supplemental fixation system that may be used is the Orthofix Firebird Spinal Fixation System.
The PILLAR SA PEEK Spacer System must be used with autograft or allogenic bone graft composed of cancellous or corticocancellous bone graft.
When used as a Partial Vertebral Body Replacement (VBR) Device:
The PILLAR SA PEEK Spacer System is indicated for use in the thoracolumbar spine (T1-L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The PILLAR SA PEEK Spacer System is also indicated for treating fractures of the thoracic and lumbar spine.
The PILLAR SA PEEK Spacer System is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column, even in the absence of fusion for a prolonged period of time. The PILLAR SA PEEK Spacer System is intended to be used with autograft or allograft.
The PILLAR SA PEEK Spacer System is intended for use with the four titanium alloy screws provided with the device. If the physician chooses to use fewer than four of the provided screws, then supplemental fixation must be used to augment stability. As an example, the supplemental fixation that may be used is the Orthofix Firebird Spinal Fixation System.

Contraindications:

The PILLAR SA PEEK Spacer System, as with other orthopedic implants, is contraindicated for use in patients:

With active infections in which the use of an implant could preclude adequate and appropriate treatment of the infection.
Who have had prior fusion at the level to be treated.

Potential Adverse Events:

Potential adverse events include, but are not limited to:

Failure of the device to provide adequate mechanical stability.
Loss of fixation of the implant.
Device component failure.
Migration or bending of the device.
Loss of bony alignment.
Non-union.
Fracture of bony structures.
Resorption without incorporation of any bone graft utilized.
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:

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. The size and shape of human bones present limiting restrictions on the size and strength of implants. No implant can be expected to withstand the unsupported stresses of full weight bearing.
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 internal stress concentrations, which may become the focal point for eventual failure of the device.
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.
Non-sterile; the PILLAR SA PEEK Spacer System implants and instruments are provided non-sterile, and therefore, must be sterilized before each use.
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.
Patients with previous surgery at the levels to be treated may have different clinical outcomes compared to those without a previous surgery.
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.
Do not attempt to re-sterilize single-use implants that come in contact with body fluids.

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:
The PILLAR SA PEEK 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 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.

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.
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.
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:

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.
Soak the instruments for a minimum of 10 minutes in purified water prior to the manual or automated cleaning process.
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.
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:

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).
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.
Place prepared cleaning solution in a sonication unit. Completely submerge device in cleaning solution and sonicate for 10 minutes.
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.
Repeat the sonication and rinse steps above.
Remove excess moisture from the instrument with a clean, absorbent and non-shedding wipe.
Inspect the instruments for visible soil.
If visible soil is noted, repeat the steps listed above.

Automated Cleaning:

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.
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.
Place instruments in a suitable washer/disinfector basket and process through a standard instrument washer/disinfector cleaning cycle.
Orient instruments into the automated washer’s carriers as recommended by the washer manufacturer.
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)
Inspect the instruments for visible soil.
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 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 end of life. Orthofix reusable instruments have reached End of Life when:

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.
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.
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.
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 PILLAR SA PEEK 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 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| or:
Method: Steam
Cycle: Prevac
Temperature: 270°F (132°C)
Preconditioning: Per manufacturer’s settings
Exposure time: 4 minutes
Drying time: 30 minutes
Double wrapped
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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 PILLAR SA 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 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 Healthcare 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 PILLAR SA PEEK 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

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