Orthofix CONSTRUX Mini PEEK Instrucciones De Uso página 2

Device System Name:
CONSTRUX Mini PEEK Vertebral Body
®
Replacement System
Description:
The CONSTRUX Mini PEEK VBR (Vertebral Body Replacement) System is comprised of a variety
of implants manufactured from PEEK (Polyetheretherketone), as described by ASTM F2026, with
titanium markers as described by ASTM F67. The implants are available in two footprint sizes,
a small and a large. The implants are available in various heights, in one-millimeter increments.
The superior and inferior surfaces of the implant have a pattern of ripples to provide increased
stability and help prevent anterior/posterior movement of the device.
The CONSTRUX Mini PEEK VBR System is intended for vertebral body replacement to aid in the
surgical correction and stabilization of the spine.
The CONSTRUX Mini PEEK VBR System is not intended to be used as a stand-alone device. The
system must be used with supplemental fixation. The CONSTRUX Mini PEEK VBR device is used
singly and is implanted using an anterior approach. The system is provided non-sterile and
requires sterilization prior to use.
Indications for Use:
The CONSTRUX Mini PEEK VBR 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 system is also indicated for
treating fractures of the thoracic and lumbar spine.
The CONSTRUX Mini PEEK VBR 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 Partial VBR Device is intended to be used with autograft or allograft.
The CONSTRUX Mini PEEK VBR System is intended for use with supplemental fixation. The
supplemental fixation system that may be used with the CONSTRUX Mini PEEK VBR System is the
Orthofix Spinal Fixation System (SFS) or the Firebird Spinal Fixation System.
Contraindications:
The CONSTRUX Mini PEEK VBR 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.
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.
Note: The CONSTRUX Mini PEEK VBR System is intended for use in affected vertebral body
segments that are equal to or smaller than the size of the device. For larger affected vertebral
body segments, a larger device indicated for partial or full VBR is recommended.
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
English
EN
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 CONSTRUX Mini PEEK VBR 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. Reuse of devices labeled as single-use could result in injury or re-operation due to
breakage or infection. Do not re-sterilize single-use implants that come in contact with
body fluids.
MRI Compatibility Information:
The CONSTRUX Mini PEEK VBR 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:
CONSTRUX Mini PEEK VBR System implants are provided clean but not sterile. Once an implant
comes in contact with any human tissue or bodily fluids, it should not be re-sterilized or used.
Please discard all contaminated implants.
All instruments must be thoroughly cleaned and sterilized after each use. Reprocess all
instruments as soon as it is reasonably practical following use to prevent drying. Cleaning
may be done using validated hospital methods or following the validated cleaning process
described below.
None of the instruments require disassembly prior to cleaning.
From Point of Use:
Wherever 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. Any instruments with moving parts (e.g., knobs, triggers and hinges) should be separated
or placed in the open position to allow better access of the cleaning fluid to the difficult
to clean areas.
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 plastic bristle brush to remove any visible soil from the instruments.
Manual Cleaning:
1. Because none of the instruments can be disassembled, use a soft cloth and/or a soft
plastic bristle brush to remove any visible soil from the outside and inside of the
instrument.
2. Prepare Vesphene IIse agent at the use-dilution recommended by label direction
®
– 1 ounce per gallon or 1 mL of Vesphene
manufacturer's recommendations.
3. Bathe instruments in prepared room temperature solution as recommended by the
detergent manufacturer.
4. Manually agitate instruments in Vesphene
5. Scrub instruments with a soft plastic bristle brush if visible soil is noted and use a soft
plastic bristle brush or pipe cleaner long enough to reach the entire length of the interior
lumen to remove the soil.
6. Rinse the instruments in USP <1231> purified water for 1.5 minutes.
7. Hang dry the device.
8. Visually inspect the instruments for visible soil.
9. If visible soil is noted, repeat the steps listed above.
2
0086
Medical Device Safety Service
(MDSS)
Schiffgraben 41
30175 Hannover
Germany
+49 511 6262 8630
www.mdss.com
IIse to 128 mL of potable tap water per
®
solution for 15 minutes.
®