This report is for an unknown rod/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.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.
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It was reported that on (b)(6) 2021, the patient came in for irrigation and debridement of a wound with the possibility of the veptr spine instrumentation having to be removed.An incision was made near the wound and dissected down to the implant and the rods were not together.Part of the one rod was sheared off, the opposite side of the rod was sheared and sticking off the side.This should have been one piece.This report is for one (1) unknown rod.This is report 3 of 3 for complaint (b)(4).This report is related to user facility report # (b)(4).
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