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Orthofix Inc.
3451 Plano Parkway
Lewisville, Texas 75056-9453 U.S.A.
1-214-937-3199
1-888-298-5700
www.orthofix.com
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:
1. With active infections in which the use of an implant could preclude adequate and
appropriate treatment of the infection.
2. Who have had 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.
INSTRUCTIONS FOR USE
Important Information – Please Read Prior to Use
Australian Sponsor
Emergo Australia
Level 20, Tower II
Darling Park
201 Sussex Street
Sydney, NSW 2000
Australia
English
EN
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. 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.
2. 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.
3. Single use only. No surgical implants should be reused. Any implant once used should be
discarded. Even though the device appears undamaged, it may already have small defects
and internal stress patterns that may lead to fatigue failure.
4. Non-sterile; the PILLAR SA PEEK Spacer System implants and instruments are provided
non-sterile, and therefore, must be sterilized before each use.
5. 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.
6. Patients with previous surgery at the levels to be treated may have different clinical
outcomes compared to those without a previous surgery.
7. Reuse of devices labeled as single-use could result in injury or re-operation due to
breakage or infection. Do not attempt to re-sterilize single-use implants that come in
contact with body fluids.
MRI Compatibility Information:
The PILLAR SA PEEK Spacer System has not been evaluated for safety and compatibility in the
Magnetic Resonance (MR) environment. This system has not been tested for heating or migration
in the MR environment.
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 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.
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 which are difficult to clean.
2. Soak the instruments for a minimum of 10 minutes in sterile 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.
Manual Cleaning:
1. Upon completing the preparation for the cleaning procedure, prepare the Vesphene
agent per the dilution recommended on the label directions (1 ounce per gallon), or 1 mL
of Vesphene
IIse to each 128 mL of potable tap water per the manufacturer's Directions
®
for Use label.
2. Bathe instruments in prepared room temperature solution.
3. Manually agitate instruments in Vesphene
4. If visible soil is noted, scrub instruments with a soft plastic bristle brush and use the
brush or a pipe cleaner long enough to reach the entire length of any interior lumen(s) to
remove the soil.
5. Rinse the instruments in USP <1231> purified water for 1.5 minutes.
6. Hang dry the device.
7. Inspect the instruments for visible soil.
8. If visible soil is noted, repeat the steps listed above.
2
Medical Device Safety Service
(MDSS)
Schiffgraben 41
30175 Hannover
Germany
+49 511 6262 8630
www.mdss.com
IIse solution for 15 minutes.
®
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