This medwatch is submitted to send the result of the investigation of this complaint.Date of report; description of event or problem; type of report ; follow up type; evaluation codes & additional narrative were updated.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 likely cause of the event is mishandling r while removing peek jaws from the implant.It points out that the surgeon probably did not follow surgical technique.As described in surgical technique, "if the peek cartridge is difficult to extract, rotate one side of the cartridge 90° caudal, then remove with forceps.Repeat on the remaining side." however, for the lack of information received from the reporter this hypothesis could not be validated.The cause for the device disassembly is unknown.Requests for additional information did not receive a response.The investigation found no evidence to indicate a device issue.If additional information was received that allo to draw a conclusion on this event another report will be sent.
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Mobi-c p&f us : disassembly.When user tried to remove the peek jaws, it caused a disassembly of the implant a second implant was opened, but when inserter was removed it caused a rotation of the implant.Both events are related to a user error.Both disassembly happen in the same level c4-c5.This report is about the first case of disassembly.
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