Integra completed its internal investigation 18nov2016.The investigation included: method: - review of complaint management database for similar complaints.Results: no information has been provided by complainant that identifies the device as other than a great toe device.No lot number or product id was given therefore the manufacturing record for the implant could not be determined.Complaint records for the same product (or similar products within the product family) for the alleged hazardous situation/failure mode received during the lifetime of the product, typically 5 years or within the stated timeframe, were reviewed.This is the second incident reported of a movement great toe loosening or backing out after implementation for the past two years.(b)(4).Conclusion: given the description of the event and the observations made during the documentary investigation and the lack of returned product or supportive information, the root cause cannot be determined.Per the product line risk documentation, potential root cause may be improper bone preparation, improper size selection, improper placement and alignment.
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