Catalog Number XXX-CADENCE IMPLANT |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Injury (2348)
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Event Type
Injury
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Manufacturer Narrative
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The device involved in the reported incident is not available for evaluation.An investigation has been initiated based on the reported information.
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Event Description
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It was reported that during implantation of cadence prosthesis, the 2 malleolus were broken, so the surgeon had to perform osteosynthesis.The surgeon indicated the event could be linked to procedure.The event lead to surgical delay, unknown for how long.
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Manufacturer Narrative
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As the lot number was not submitted, a review of the lot records could not be conducted to discover if there were any indications of problems that could have caused or contributed to the complaint.No components were returned to integra for investigation.As such, the failure could not be confirmed and a possible root cause could not be found.
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Search Alerts/Recalls
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