Integra Ti6 Gebrauchsanweisung Seite 5

Contraindications
Use of the Ti6 Internal Fixation System is contraindicated for:
• Cases of active or suspected infection or in patients who are immunocompromised, in patients previously
sensitized to titanium, or in patients with certain metabolic diseases.
• Patients exhibiting disorders which would cause the patient to ignore the limitations of internal fixation.
• Conditions which tend to retard healing such as blood supply limitations, previous infections, insufficient
quantity or quality of bone to permit stabilization of the fracture complex, and conditions that restrict the
patient's ability or willingness to follow postoperative instructions during the healing process.
• Cases with malignant primary or metastatic tumors which preclude adequate bone support or screw fixations,
unless supplemental fixation or stabilization methods are utilized.
• Foreign body sensitivity – where material sensitivity is suspected, appropriate tests should be made and
sensitivity ruled out prior to implementation.
Possible Adverse Effects
The following are specific adverse effects which should be understood by the surgeon and explained to the patient.
These do not include all adverse effects which can occur with surgery in general, but are important considerations
particular to metallic internal fixation devices. General surgical risks should be explained to the patient prior to
surgery.
1. Infection.
2. Pain, discomfort or abnormal sensations due to the presence of the implant.
EN – ENGLISH
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