This medwatch is submitted to send the result of the investigation of this complaint.It's considered as a product problem not an adverse event as mentioned in the first report.The review of the device history records did not reveal any non-conformances to specifications or deviations in procedures that might have contributed to the reported event.From information provided, based on the product history records and the recurrence of this type of event for this implant, the cause for the event is a user error while removing the screw holding the two peek parts.Indeed, an incomplete unscrewing of the screw in peek cartridge would cause difficulty to disengage peek and or inserter.The mobi-c surgical technique warns to continue turning until the cartridge screw is completely released from peek cartridge.The investigation found no evidence to indicate device issue.Root cause: user error (instruction was not followed).Device not returned to manufacturer.
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