The lot number is unknown, therefore a review of the lot record could not be conducted to determine if there were any indication of problems in fabrication that could have caused or contributed to the complaint.Product not returned to integra, failure analysis could not be conducted, and no definitive root cause could be determined.
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It was reported that during a clinical study, the patient had a fracture of both malleoli during implantation.The patient's bones were osteoporotic.An osteosynthesis of peroneal and tibial malleoli was performed.The event lead to surgical delay, not communicated for how long.
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