Orthofix Firebird Wirbelsäulen-Fixationssystem Gebrauchsanleitung Seite 3

24. The JANUS Fenestrated Screw when used with KYPHON HV-R Fenestrated Screw Cement
may include other reported adverse events for acrylic bone cements intended for use in the
spine including leakage of the bone cement beyond the site of its intended application with
introduction into the vascular system resulting in, but not limited to, embolism of the lung
and/or heart or other clinical sequelae.
Note: Potential risks identified with the use of the device system may require additional surgery.
Warnings and Precautions:
1. The safety and effectiveness of this device has not been established for use as part of a
growing rod construct. This device is only intended to be used when definitive fusion is
being performed at all instrumented levels.
2. The use of pedicle screw fixation in the pediatric population may present additional risks
when patients are of smaller stature and skeletally immature. Pediatric patients may have
smaller spinal structures (pedicle diameter or length) that may preclude the use of pedicle
screws or increase the risk of pedicle screw malpositioning and neurological or vascular
injury. Patients who are not skeletally mature undergoing spinal fusion procedures may
have reduced longitudinal spinal growth or may be at risk for rotational spinal deformities
(the "crankshaft phenomenon") due to continued differential growth of the anterior spine.
3. The implantation of pedicle screw spinal systems in pediatric patients should be performed
only by experienced spinal surgeons with specific training in the use of this pedicle screw
spinal system in pediatric patients because this is a technically demanding procedure
presenting a risk of serious injury to the patient.
4. Preoperative and operating procedures, including knowledge of surgical techniques, good
reduction, and proper selection of placement of the implants are important considerations
in the successful utilization of the system in pediatric patients.
5. The selection of the proper size, shape and design of the implant for each patient is crucial
to the safe use of this device in pediatric patients.
6. The safety and effectiveness of pedicle screw systems have been established only for
spinal conditions with significant mechanical instability or deformity requiring fusion with
instrumentation. These conditions are: significant mechanical instability or deformity of the
thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of
the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurological
impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous
fusion (pseudoarthrosis). The safety and effectiveness of these devices for any other
condition are unknown.
7. The benefit of spinal fusion utilizing any pedicle screw fixation system has not been
adequately established in patients with stable spines.
8. 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.
9. 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.
10. Non-sterile; the screws, hooks, rods, dominoes, lateral offsets, spacers, staples, washers,
locking nuts, cross connectors, and instruments are sold non-sterile and therefore must be
sterilized before use.
11. To facilitate fusion, a sufficient quantity of autologous bone or other appropriate material
should be used.
12. Failure to achieve arthrodesis will result in eventual loosening and failure of the device
construct.
13. Excessive torque applied to the screws may strip the threads in the bone.
14. 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.
15. The implantation of pedicle screw spinal systems should be performed only by experienced
spinal surgeons with specific training in the use of this pedicle screw spinal system because
this is a technically demanding procedure presenting a risk of serious injury to the patient.
16. 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 the performance of the system.
17. Mixing of dissimilar metals can accelerate the corrosion process. Do not use the titanium
alloy or cobalt chrome alloy components of this system with implants of other material
composition or components from different manufacturers unless specifically stated.
18. The Firebird Spinal Fixation System and Phoenix MIS Fixation System have not been
evaluated for safety and compatibility in the MR environment, nor have the Firebird Spinal
Fixation System or the Phoenix MIS Fixation System been tested for heating or migration in
the MR environment.
19. Do not attempt to re-sterilize single-use implants that come in contact with body fluids.
20. When using the offset connectors to connect the Firebird spinal construct to the ilium,
pedicle screws must be used at the S1 or S2 level of the spine. Do not use the offset
connectors to connect the ilium without this intermediate screw fixation.
21. The safety, efficacy and performance of the system have been established for conditions
in which the system is used as intended and when used as identified in the Indications
for Use. Performance of the system has not been evaluated for use that is contrary to
the Intended Use, Indications for Use or for use that is contraindicated. Failure to use the
system as indicated could detrimentally affect the performance of its components.
22. Other adverse effects related to pedicle screw fixation, such as screw or rod bending,
breakage, or loosening, may also occur in pediatric patients. Pediatric patients may be at
increased risk for device-related injury because of their small stature.
23. 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.
24. HA coated screws are provided STERILE. Do not use if the package is opened or damaged
or if the expiration date has passed.
25. DO NOT re-sterilize the HA coated screws as this could result in injury or require
reoperation due to breakage.
26. The JANUS Fenestrated Screw when used with KYPHON HV-R Fenestrated Screw Cement,
refer to the Medtronic HV-R Fenestrated Screw Cement instructions for use for additional
indications, contraindications, warnings, precautions and cement preparation instruction.
27. The JANUS Fenestrated Screw when used with KYPHON HV-R Fenestrated Screw Cement
may include the potential for cement leakage which may cause tissue damage, nerve or
circulatory problems, and other serious adverse events. These risks may increase with the
number of spinal levels where bone cement is utilized, and also with the volume of bone
cement used.
28. The JANUS Fenestrated Screw when used with KYPHON HV-R Fenestrated Screw Cement,
monitor patients carefully for any change in blood pressure during and immediately
following the application of bone cement. Adverse patient reactions affecting the
cardiovascular system, including Bone Cement Implantation Syndrome (BCIS), have
been associated with the use of bone cements. Hypotensive reactions have occurred
between 10 and 165 seconds following application of bone cement and have lasted
from 30 seconds to 5 or more minutes. Some have progressed to cardiac arrest. Patients
should be monitored carefully for any change in blood pressure during and immediately
following the application of bone cement, especially those potentially at increased risk
for peri-operative death, including elderly patients, patients with underlying cardiac or
pulmonary compromise, and patients being treated for multiple vertebral body fractures in
one procedure.
29. The JANUS Fenestrated screws when used with the Medtronic KYPHON HV-R Fenestrated
Screw Cement should NOT be placed bicortically. It is important not to breach the
pedicle wall or anterior cortex of the vertebral body to avoid cement extrusion into the
retroperitoneal space.
MRI Compatibility Information:
The 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
the Systems in the MR environment is unknown. Scanning a patient who has this device may
result in patient injury.
Cleaning:
The HA coated screw implants are sterilized using gamma radiation sterilization. Do not re-
sterilize. All other system 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.
For Firebird Spinal Fixation System Cases 44-9010, 44-9011, 44-9012, 44-9013,
44-9020, 44-9030, 44-9040, 44-9050 and 61-9060:
All instruments and implants must first be cleaned using established hospital methods before
sterilization and introduction into a sterile field. Additionally, all instruments and implants that
have been previously taken into a sterile surgical field must first be cleaned using established
hospital methods before sterilization and reintroduction into a sterile surgical field. Cleaning
can include the use of neutral cleaners followed by a deionized water rinse. All products should
be treated with care. Improper use or handling may lead to damage and possible improper
functioning of the device.
For All Other Firebird System Cases and Caddies:
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.
Instructions for Disassembly and Assembly:
Prior to cleaning please see the operative technique for disassembly and assembly instructions
for the five instruments which require disassembly prior to cleaning, the: Multi-Axial Screw Driver
(20-0200), Mono-Axial Screw Driver (20-0300), Multi-Axial Screw Driver (36-1831), Modular
Screw Driver (36-1832) and the Midline Modular Screw Driver (36-1833). No other instruments
within 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.
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