Orthofix Hallmark 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:
Hallmark Anterior Cervical
®
Plate System
Description:
The Hallmark Anterior Cervical Plate System is comprised of a variety of non-sterile, single
use, titanium alloy (6AL-4V ELI, per ASTM F136) components that allow a surgeon to build an
anterior cervical implant construct. The system is attached to the anterior aspect of the vertebral
body by means of screws to the cervical spine. The system consists of an assortment of screws,
plates and associated instrumentation, which assists in the surgical implantation of the devices.
Indications for Use:
The Hallmark Anterior Cervical Plate System is a temporary implant intended for anterior fixation
to the cervical spine from C2 to C7. The specific clinical indications include:
1. Degenerative disc disease (defined as back pain of discogenic origin with degenerative
disc confirmed by patient history and radiographic studies).
2. Spondylolisthesis.
3. Fracture.
4. Spinal stenosis.
5. Deformities (i.e., scoliosis, kyphosis, and/or lordosis).
6. Tumor.
7. Pseudoarthrosis.
8. Revision of previous surgery.
Contraindications:
The Hallmark Anterior Cervical Plate 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, 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.
14. Dysphagia
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 Hallmark Anterior Cervical Plate 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, bone screws and instruments are sold non-sterile, and therefore,
must be sterilized before each use.
4. Always orient the plate along the midline of the spine.
5. When performing a corpectomy procedure using a Hallmark anterior cervical plate, ensure
that the top locking mechanisms are only used on the superior and inferior portions of
the cervical plate prior to final tightening the top locking plates to avoid potential plate
performance deterioration.
6. To optimize bony union, perform an anterior microdiscectomy or corpectomy as indicated.
INSTRUCTIONS FOR USE
Important Information – Please Read Prior to Use
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7. To facilitate fusion, a sufficient quantity of autologous bone or other appropriate material
should be used.
8. Excessive torque applied to the screws when seating the plate may strip the threads in
the bone.
9. Failure to achieve arthrodesis will result in eventual loosening and failure of the device
construct.
10. 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.
MRI Compatibility Information:
The Hallmark Anterior Cervical Plate 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 Hallmark Anterior Cervical Plate System in the MR environment is
unknown. Scanning a patient who has this device may result in patient injury.
Cleaning:
Hallmark Anterior Cervical Plate 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.
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.
4. Enzymatic detergent should be used for manual and automated cleaning. All enzymatic
detergents should be prepared at the use dilution and temperature recommended by
the manufacturer. Softened tap water may be used to prepare the enzymatic detergents.
Use of recommended temperatures is important for optimal performance of enzymatic
detergent.
Manual Cleaning:
1. Completely submerge instruments in an enzymatic detergent and allow to soak for 20
minutes. Use a soft-bristled, nylon brush to gently scrub the device until all visible soil has
been removed. Particular attention must be given to crevices, lumens, mated surfaces,
connectors and other hard-to-clean areas. Lumens should be cleaned with a long, narrow,
soft-bristled brush (i.e. pipe cleaner brush).
2. Remove the instruments from the enzymatic detergent and rinse in tap water for a
minimum of 3 minutes. Thoroughly and aggressively flush lumens, holes and other
difficult to reach areas.
3. Place prepared cleaning solution in a sonication unit. Completely submerge device in
cleaning solution and sonicate for 10 minutes.
2
Medical Device Safety Service
(MDSS)
Schiffgraben 41
30175 Hannover
Germany
www.mdss.com