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INSTRUCTIONS FOR USE
Important Information – Please Read Prior to Use
Device System Name:
FORZA
®
PTC Spacer System
Description:
The FORZA PTC Spacer System is comprised of a variety of implants that have a PEEK (OPTIMA
LT1) core with integrated porous titanium (Ti-6Al-4V) end plates as well as a tantalum marker
that acts as a visual aid for the surgeon in determining the location of the implant both
intraoperatively and postoperatively.
FORZA PTC Spacer System implants are offered in two geometric shapes – straight and curved,
and offered in parallel and lordotic profiles to restore the natural curvature of the spine. The
implants can be used in single placement or in pairs. Both the curved and straight implants
feature a bulleted nose for ease of insertion and a roughened surface on both the inferior and
superior faces of the implant to provide increased stability and help prevent anterior/posterior
movement of the device.
The FORZA PTC Spacer System is intended for intervertebral body fusion to aid in the surgical
correction of the spine and are implanted using a posterior approach.
The FORZA PTC Spacer System is not intended to be used as a standalone device. The FORZA PTC
Spacer System must be used with a supplemental fixation system.
The FORZA PTC Spacer System implants are provided sterile.
FORZA PTC implants are designed for use with FORZA PEEK Spacer System instrumentation. The
FORZA PTC spacers are not compatible with components or metal from any other manufacturer’s
system.
Indications for Use:
The FORZA 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 levels.
The FORZA PTC Spacer System is intended for use with autograft and/or allograft comprised
of cancellous and/or corticocancellous bone graft and supplemental fixation, e.g., the 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 FORZA PTC Spacer System.
Contraindications:
The FORZA 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 for Use.
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. 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. FORZA PTC 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 FORZA PEEK 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.
11. Patients with previous surgery at the levels to be treated may have different clinical
outcomes compared with those without a previous surgery.
MRI Compatibility Information:
The FORZA PTC Spacer System has not been evaluated for safety and compatibility in the
MR environment. It has not been tested for heating, migration, or image artifact in the MR
environment. The safety of FORZA PTC Spacer System in the MR environment is unknown.
Scanning a patient who has this device may result in patient injury.
Cleaning:
FORZA PTC 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 opened and
unused implants. Do not re-sterilize an opened and unused implant.
The FORZA PEEK Spacer System instruments are compatible for use with the FORZA PTC 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.
FORZA modular Implant Inserters require disassembly prior to cleaning. None of the other FORZA
Spacer System 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.
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
Australian Sponsor
Emergo Australia
Level 20, Tower II
Darling Park
201 Sussex Street
Sydney, NSW 2000
Australia
