Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
Device report from (b)(6) reports an event as follows: it was reported that the patient underwent revision surgery on (b)(6) 2021, due to unknown reason.During the procedure, a screw couldn¿t be removed.The surgeon tried to remove the screw with the two extraction screws, but both extraction screws were broken at their neck, and the screw couldn¿t be removed.The surgeon gave up removing the implants and closed the incision with the implants and the fragment of the extraction screw still in the body.The surgery was completed with thirty (30) minutes delay.This report is for a conical extraction screw for large screws & 4.9mm bolts.This is report 1 of 3 for (b)(4).
|