Orthofix CONSTRUX Mini PTC Gebrauchsanleitung Seite 2

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:
CONSTRUX Mini PTC Spacer System
®
Description:
The CONSTRUX Mini PTC Spacer System is comprised of a variety of implants that have a PEEK
core with integrated porous titanium end plates. CONSTRUX Mini PTC 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 PTC 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 PTC implants are provided sterile.
CONSTRUX Mini PTC implants are design to be used with CONSTRUX Mini PEEK Spacer System
instrumentation. The CONSTRUX Mini PTC implants are not compatible with components or
metal from any other manufacturer's system.
Indications for Use:
The CONSTRUX Mini PTC 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 PTC 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 PTC Spacer System in the cervical spine.
Contraindications:
The CONSTRUX Mini 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.
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.
INSTRUCTIONS FOR USE
Important Information – Please Read Prior to Use
Australian Sponsor
Emergo Australia
Level 20, Tower II
Darling Park
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Sydney, NSW 2000
Australia
English
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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 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 CONSTRUX Mini 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.
MRI Compatibility Information:
The CONSTRUX Mini PTC 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 PTC Spacer System in the
MR environment is unknown. Scanning a patient who has this device may result in patient injury.
Cleaning:
CONSTRUX Mini 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 open and
unused implants. Do not re-sterilize an opened and unused implant.
The CONSTRUX Mini PEEK Spacer System instruments are compatible for use with the CONSTRUX
Mini 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.
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.
2
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(MDSS)
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www.mdss.com