Mri Safety Information - Orthofix Unity Mode D'emploi

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:
Unity Lumbosacral Fixation System
®
Description:
The Unity Lumbosacral Fixation System is a supplemental fixation construct that consists of
two implantable titanium alloy plates – the Unity LX Lumbar Fixation Plate and the Unity 51
Lumbosacral Fixation Plate – and screws that are provided non-sterile.
Indications for Use:
The Orthofix Unity 51 Lumbosacral Fixation Plate is indicated for use as an anteriorly placed
supplemental fixation device for the lumbosacral (L5-S1) level below the bifurcation of the
vascular structures. The Orthofix Unity LX Lumbar Fixation Plate is indicated for use as an
anteriorly or anterolaterally placed supplemental fixation device for the lumbar region of the
spine above the bifurcation of the vascular structures. When properly used, this system will help
provide temporary stabilization until a solid spinal fusion develops. Specific indications include:
1. Degenerative disc disease (defined as back pain of discogenic origin with degenerative
disc confirmed by history and radiographic studies).
2. Pseudoarthrosis.
3. Spondylolysis.
4. Spondylolisthesis.
5. Fracture.
6. Neoplastic disease.
7. Unsuccessful previous fusion surgery.
8. Lordotic deformities of the spine.
9. Idiopathic thoracolumbar or lumbar scoliosis.
10. Deformities (i.e., scoliosis, kyphosis, and/or lordosis) associated with deficient posterior
elements such as that resulting from laminectomy, spina bifida, or myelomenigocele.
11. Neuromuscular deformity (i.e., scoliosis, lordosis, and/or kyphosis) associated with pelvic
obliquity.
Contraindications:
The Orthofix Unity Lumbosacral Fixation System is contraindicated in patients with a systemic
infection, with a local inflammation at the bone site, or with rapidly progressive joint disease or
bone absorption syndromes such as Paget's disease, osteopenia, osteoporosis, or osteomyelitis.
Do not use this system in patients with known or suspected metal allergies. Use of the system
is also contraindicated in patients with any other medical, surgical or psychological condition
that would preclude potential benefits of internal fixation surgery such as the presence of
tumors, congenital abnormalities, elevation of sedimentation rate unexplained by other disease,
elevation of white blood cells or a marked shift in white blood cell differential count.
Potential Adverse Events:
All of the possible adverse events associated with spinal fusion surgery without instrumentation
are possible. With instrumentation, a listing of possible adverse events includes, but is not
limited to:
1. Early or late loosening of any or all of the components.
2. Disassembly, bending, and/or breakage of any or all of the components.
3. Foreign body (allergic) reaction to implants, debris, corrosion products and graft material,
including metallosis, straining, tumor formation, and/or auto-immune disease.
4. Pressure on the skin from component parts in patients with inadequate tissue coverage
over the implant possibly causing skin penetration, irritation, and/or pain.
5. Post-operative change in spinal curvature, loss of correction, height, and/or reduction.
6. Infection.
7. Vertebral body fracture at, above, or below the level of surgery.
8. Loss of neurological function, including paralysis (complete or incomplete).
9. Non-union, delayed union.
10. Pain, discomfort, or abnormal sensations due to the presence of the device.
11. Hemorrhage.
12. Cessation of any potential growth of the operated portion of the spine.
13. Death.
Note: Additional surgery may be necessary to correct some of these anticipated adverse events.
Warnings and Precautions:
1. 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.
2. The Unity Lumbosacral Fixation System is not approved for screw attachment or fixation to
the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
3. Non-sterile; the plates, screws and instruments are sold non-sterile, and therefore, must
be sterilized before each use.
4. When using the plate anteriorly, always orient the plate along the midline of the spine.
5. To optimize bony union, perform an anterior microdiscectomy or corpectomy as indicated.
6. To facilitate fusion, a sufficient quantity of autologous bone or other appropriate material
should be used.
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
7. Excessive torque applied to the screws when seating the plate may strip the threads in
the bone.
8. Failure to achieve arthrodesis will result in eventual loosening and failure of the device
construct.
9. 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.
10. When choosing a metallic implant system, the physician/surgeon should consider factors
such as: levels of implantation, patient weight, patient activity level, and other patient-
specific conditions which may impact the performance of the system as it relates to
fatigue of the implants.
11. Do not re-sterilize single-use implants that come in contact with body fluids.

MRI SAFETY INFORMATION

Non-clinical testing and electromagnetic/thermal simulations were performed
to evaluate the entire family of implants from the Orthofix Plate Systems. An
implant from the Plate System is MR Conditional. A patient with an implant or
implants from the Plate System may be safely scanned under the following
conditions. Failure to follow these conditions may result in injury to the patient.
MR CONDITIONAL
PARAMETER
NOMINAL VALUES OF STATIC MAGNETIC
FIELD (T)
MAXIMUM SPATIAL FIELD GRADIENT
(T/M AND GAUSS/CM)
TYPE OF RF EXCITATION
TRANSMIT RF COIL INFORMATION
OPERATING MODE OF MR SYSTEM
MAXIMUM WHOLE BODY AVERAGED SAR 2-W/KG (NORMAL OPERATING MODE)
LIMITS ON SCAN DURATION
MR IMAGE ARTIFACT
Cleaning:
Unity Lumbosacral Fixation 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.
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.
2
Medical Device Safety
Service (MDSS)
Schiffgraben 41
30175 Hannover
Germany
www.mdss.com
CONDITION
1.5-T AND 3-T
30-T/M (3,000-GAUSS/CM)
CIRCULARLY POLARIZED (CP)
VOLUME BODY TRANSMIT RF COIL
NORMAL OPERATING MODE
Whole body averaged SAR of 2-W/kg for 60 minutes
of continuous RF exposure.
THE PRESENCE OF THIS IMPLANT PRODUCES AN
IMAGING ARTIFACT APPROXIMATELY 4 MM FROM
THIS DEVICE. THEREFORE, CAREFULLY SELECT PULSE
SEQUENCE PARAMETERS TO MINIMIZE ARTIFACTS
IF THE IMPLANT IS LOCATED IN THE AREA OF
INTEREST.