Integra Ti6 Gebrauchsanweisung Seite 6

EN – ENGLISH
3. Metal sensitivity or allergic reaction to a foreign body.
4. Migration of the implant: loosening of the implant.
5. Delayed wound healing or deep wound infection resulting in possible removal of the implant.
6. Fracture of the implant due to non-compliance to post-operative regimen, improper implant selection,
or non-union.
Warnings
1. Re-operation to remove or replace implants (screws) may be required at any time due to medical reasons
or device failure. If corrective action is not taken, complications may occur.
2. Plates and screws, wires, or other appliances of dissimilar metals should not be used together in or near the
implant site.
3. Instruments, guide wires and screws are to be treated as sharps.
4. Use of an undersized screw in areas of high functional stresses may lead to implant fracture and failure.
5. The Ti6 screw 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 Ti6 screws in the MR environment
is unknown. Scanning a patient who has this device may result in patient injury.
6. No metallic surgical implant should be reused. Any metal implant, once used, should be discarded. Even though
it appears undamaged, it may already have small defects and internal stress patterns which may lead to implant
fracture, particulate debris, and/or fatigue failure. Reuse of the implant may cause infection to the patient.
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