Integra has completed their internal investigation on january 23, 2017.The investigation included: methods: review of device history records, review of complaints history.Results: attempts for additional information and product return have been unsuccessful to date; therefore, no failure analysis has been performed.Dhr review; review of manufacturing records showed no evidence of a nonconformance that may have caused or contributed to the reported event.Complaints history; a search of the results of the field containing ¿mcp¿ january 2012 to present showed no previous complaints of an mcp implant being implanted upside down.During this period of time, there have been (b)(4) mcp surgeries performed.This represents a (b)(4) overall failure rate.Conclusion: as the device has not been returned and attempts for additional information have been unsuccessful to date, the root cause of the report cannot not be confirmed at this time; however, based on the information provided, the event appears to be due to surgeon difficulties encountered during the implant process.Should additional information be provided, the investigation will be updated accordingly.
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