This medwatch is submitted to send the result of the investigation od this complaint.Product was received and visual examination was performed.Product was found complaint.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, the examination of the returned product and the recurrence of this type of event for this implant, the likely cause of the event is user error while removing peek jaws from the implant.It points out that the surgeon did not follow surgical technique.Indeed, the surgeon encountered resistance while using the clamp to remove peek parts.He should have rotated the convex jaw first (as it is the less bulky) by 90° caudal & pull it back along the disc axis (described in the 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." the investigation found no evidence to indicate device issue.Root cause : instruction was not followed.
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