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INSTRUCTIONS FOR USE
Important Information – Please Read Prior to Use
Device System Name:
Centurion
®
POCT System
Description:
The Centurion POCT System is a temporary, multiple component system 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 system consists of an assortment of rods,
set screws, 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 Centurion POCT System may be used from
the occiput to T3.
Indications for Use:
The Centurion POCT System is intended to provide immobilization and stabilization of spinal
segments as an adjunct to fusion for the following acute and chronic instabilities of the
craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1 – T3): traumatic
spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions
(e.g., pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease,
including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin
as confirmed by radiographic studies, and degenerative disease of the facets with instability. The
system is also intended to restore the integrity of the spinal column even in the absence of fusion
for a limited time period in patients with advanced stage tumors involving the cervical spine in
whom life expectancy is of insufficient duration to permit achievement of fusion.
The Centurion POCT System can also be linked to the Orthofix Spinal Fixation System using the
Axial or Parallel Rod Connector.
Contraindications:
The Centurion POCT System, as with other orthopedic implants, is contraindicated for use in
patients with:
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 components.
9. Foreign body (allergic) reaction to implants, debris, corrosion products, graft material,
including metallosis, straining, tumor formation, and/or auto-immune 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.
Warnings and Precautions:
1. Potential risks identified with the use of this device system, which may require additional
surgery, include: device component fracture, loss of fixation, non-union, fracture of the
vertebra, neurological injury, and vascular or visceral injury.
2. 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.
3. Non-sterile; the screws, set screws, hooks, rods, offset adapters, cross connectors, plates,
rod connectors, and instruments are sold non-sterile, and therefore must be sterilized
before use.
4. Failure to achieve arthrodesis will result in eventual loosening and failure of the device
construct.
5. Excessive torque applied to the screws may strip the threads in the bone.
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. The implantation of POCT systems should be performed only by experienced spinal
surgeons with specific training in the use of spinal systems and this POCT system because
this is a technically demanding procedure presenting a risk of serious injury to the patient.
Preoperative planning and patient anatomy should be considered when selecting implant
diameter and length.
8. Based on fatigue testing results, the physician/surgeon should consider the levels of
implantation, patient weight, patient activity level, other patient conditions, etc. which
may impact on the performance of the system.
9. Mixing of dissimilar metals can accelerate the corrosion process. Do not use the
components of this system with implants from other manufacturers unless specifically
stated.
10. The correct handling of the implant is extremely important. Implants should not be
excessively or repeatedly 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.
11. PRE-OP PLANNING – Use of cross sectional imaging (i.e., CT and/or MRI) for posterior
cervical screw placement is recommended due to the unique risks in the cervical spine.
The use of planar radiographs alone may not provide the necessary imaging to mitigate
the risk of improper screw placement. In addition, use of intraoperative imaging should
be considered to guide and/or verify device placement, as necessary.
MRI Compatibility Information:
The Centurion POCT 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 Centurion POCT System in the MR environment is unknown. Scanning
a patient who has this device may result in patient injury.
Cleaning:
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.
There is one instrument in the system, the Multi-Axial Screw Driver (PN 69-1036), which
requires disassembly prior to cleaning. All other instruments within the system do not 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.
Orthofix Inc.
3451 Plano Parkway
Lewisville, Texas 75056-9453 U.S.A.
1-214-937-3199
1-888-298-5700
www.orthofix.com
Medical Device Safety Service
(MDSS)
Schiffgraben 41
30175 Hannover
Germany
+49 511 6262 8630
www.mdss.com
Australian Sponsor
Emergo Australia
Level 20, Tower II
Darling Park
201 Sussex Street
Sydney, NSW 2000
Australia
