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INSTRUCTIONS FOR USE
Important Information – Please Read Prior to Use
Orthofix Inc.
3451 Plano Parkway
Lewisville, Texas 75056-9453 U.S.A.
1-214-937-3199
1-888-298-5700
www.orthofix.com
Medical Device Safety Service
(MDSS)
Schiffgraben 41
30175 Hannover
Germany
+49 511 6262 8630
www.mdss.com
Device System Name:
PILLAR
®
SA PTC Spacer System
Description:
The PILLAR SA PTC Spacer System is comprised of a variety of implants that have a PEEK core
with integrated porous titanium end plates. The implants incorporate integrated anterior screw
holes to allow for medial placement of bone screws as well as a titanium plate for securing the
bone screws once in place. The implants are designed with a roughened surface on the inferior
and superior faces of the implant to provide increased stability and help prevent anterior/poste-
rior movement of the device.
The PILLAR SA PTC Spacer System is intended for intervertebral body fusion to aid in the surgical
correction of the spine and is implanted using an anterior approach.
The PILLAR SA PTC spacers are provided sterile. The cover plate, screws and instruments are
provided non-sterile and require sterilization prior to use.
The PILLAR SA PTC implants are designed to be used with PILLAR SA PEEK Spacer System instru-
mentation. The implants are not compatible with components from any other manufacturer’s
system.
Indications for Use:
The PILLAR SA PTC 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 a previous non-fusion
surgery at the involved level(s).
The PILLAR SA PTC Spacer System is intended for use with autograft and/or allograft comprised
of cancellous and/or corticocancellous bone graft.
The PILLAR SA PTC Spacer System is intended for use with four of the titanium alloy screws pro-
vided with the system. 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, a supplemental
fixation system that may be used is the Orthofix Firebird
®
Spinal Fixation System.
Patients must have undergone a regimen of at least six months of non-operative treatment prior
to being treated with the PILLAR SA PTC Spacer System.
Contraindications:
The PILLAR SA PTC 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.
5. Any circumstances not listed under the heading indications.
Potential Adverse Events:
Potential adverse effects 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, perma-
nent 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 the 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. PILLAR SA PTC spacers 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 PILLAR PTC spacers as this could result in injury or require reoperation
due to breakage.
5. PILLAR SA bone screws and plates are provided non-sterile, and therefore, must be
sterilized prior to each use.
6. SINGLE USE ONLY – PILLAR SA PTC Spacer System implants are intended for 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. Reuse could result in injury or require
reoperation due to breakage or infection.
7. Non-Sterile; the PILLAR SA PEEK Spacer instruments are provided non-sterile, and therefore,
must be thoroughly cleaned and sterilized after each 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 the dynamic testing results, the physician should consider the levels of
implantation, patient weight, patient activity level, other patient conditions, etc., which
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 this device because it is a
technically demanding procedure presenting a risk of serious injury to the patient.
11. Patients with previous surgery at the levels to be treated may have different clinical
outcomes compared to those without a previous surgery.
MRI Compatibility Information:
The PILLAR SA PTC 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 PTC spacers are provided STERILE. Please discard all opened and unused
implants.
The PILLAR SA bone screws and plates 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.
The PILLAR SA PEEK Spacer instruments are compatible for use with the PILLAR SA PTC Spacer
implants. All instruments must be thoroughly cleaned after each use. Cleaning may be done us-
ing 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 instru-
ments prior to manual or automated cleaning. Use a soft plastic bristle brush or a pipe
cleaner to remove soil from any inner lumens.
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