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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:
Ascent
Posterior Occipital
®
Cervico-Thoracic (POCT) System
Ascent
LE Posterior Occipital
®
Cervico-Thoracic (POCT) System
Description:
The Ascent POCT and Ascent LE POCT Systems are temporary, multiple component systems
comprised of a variety of non-sterile, single use components made of titanium alloy or cobalt
chrome alloy that allow the surgeon to build a spinal implant construct. The Ascent POCT and
Ascent LE POCT Systems consist of an assortment of rods, set screws, cross connectors, axial
connectors, lateral offset adapters, multi-axial screws, hooks, plates, and bone screws.
Levels of Use:
When used in the occipito-cervico-thoracic spine, the Ascent POCT and Ascent LE POCT Systems
may be used from the occiput to T3.
Indications for Use:
When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction
(occiput-T3), the Ascent POCT and Ascent LE POCT Systems are indicated for:
1. Degenerative disc disease (defined as neck pain of discogenic origin with degeneration of
the disc confirmed by patient history and radiographic studies).
2. Spondylolisthesis.
3. Fracture/dislocation.
4. Spinal stenosis.
5. Atlanto-axial fracture with instability.
6. Occipito-cervical dislocation.
7. Tumors.
8. Revision of previous cervical spine surgery.
The occipital bone screws are limited to occipital fixation only. The use of the multi-axial
screws is limited to placement in the upper thoracic spine (T1-T3) for the treatment of thoracic
conditions only. They are not intended to be placed in the cervical spine. The lateral offset
adapter is indicated for use in the upper thoracic spine (T1-T3). The hooks are intended to be
placed from C1 to T3.
The Ascent POCT and Ascent LE POCT Systems can also be linked to the Orthofix Spinal Fixation
System using the Axial or Parallel Rod Connector.
Contraindications:
1. Morbid obesity.
2. Mental illness.
3. Alcoholism or drug abuse.
4. Pregnancy.
5. Metal sensitivity/allergies.
6. Severe osteopenia.
7. Patients unwilling or unable to follow post-operative care instructions.
8. Any circumstances not listed under the heading Indications.
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. Device component fracture.
2. Loss of fixation.
3. Non-union.
4. Fracture of the vertebra.
5. Neurological injury.
6. Vascular or visceral injury.
7. Early or late loosening of any or all of the components.
8. Disassembly and/or bending of any or all of the components.
9. Foreign body (allergic) reaction to implants, debris, corrosion products, graft material,
including metallosis, straining, tumor formation, and/or autoimmune disease.
10. Pressure on the skin from component parts in patients with inadequate tissue coverage
over the implant possibly causing skin penetration, irritation and/or pain.
11. Post-operative change in spinal curvature, loss of correction, height and/or reduction.
12. Infection.
13. Pain, discomfort or abnormal sensations due to the presence of the device.
14. Hemorrhage.
15. Cessation of any potential growth of the operated portion of the spine.
16. Death.
Note: Potential risks identified with the use of the device system may require additional surgery.
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
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. 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.
3. Non-sterile; the screws, plates, rods, connectors, adapters, and instruments are sold non-
sterile and therefore must be sterilized before each use.
4. Mixing of dissimilar metals can accelerate the corrosion process. Do not use the
components of this system with implants of other material composition or components
from different manufacturers unless specifically stated.
MRI Compatibility Information:
The Ascent POCT and Ascent LE POCT Systems have 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 Ascent POCT and Ascent LE POCT Systems in the
MR environment is unknown. Scanning a patient who has this device may result in patient injury.
Cleaning:
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 process 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.
4. Rinse instrument in purified water for at least 3 minutes or until there is no sign of blood
or soil on the device or in the rinse stream. Thoroughly and aggressively flush lumens,
holes and other difficult to reach areas.
5. Repeat the sonication and rinse steps above.
6. Remove excess moisture from the instrument with a clean, absorbent and non-shedding
wipe.
2
Medical Device Safety Service
(MDSS)
Schiffgraben 41
30175 Hannover
Germany
www.mdss.com
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