Integra Total Foot System 2, Instructions For Use Manual

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5
EN – ENGLISH
CONTRAINDICATIONS
• Plates and screws are contraindicated in: active infection, 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, conditions that restrict the patient’s ability or willingness to follow postoperative instructions during the
healing process and foreign body sensitivity.
• 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 implementations.
• These implants are intended as a guide to normal healing, and are NOT intended to replace normal body structure
or bear the weight of the body in the presence of incomplete bone healing. Delayed unions or non-unions in the
presence of load bearing or weight bearing might eventually cause the implant to break due to metal fatigue. All
metal surgical implants are subjected to repeated stress in use, which can result in metal fatigue.
WARNINGS AND PRECAUTIONS
• 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 fatigue failure.
• Correct handling of the implant is extremely important. Avoid contouring metallic implants whenever possible. If
necessary, or allowed by design, the device should not be bent sharply, reverse bent, notched or scratched. All of
these operations can produce defects in the surface finish and internal stress concentrations, which may become
the focal point for eventual failure of the appliance.