(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-00514, 0001822565-2023-00516, 0002648920-2023-00029, 0001822565-2023-00518.Bone screw self-tapping 6.5 mm dia.25 mm length/00625006525/j7051454, bone screw self-tapping 6.5 mm dia.30 mm length/00625006530/j7144345, bone screw self-tapping 6.5 mm dia.35 mm length/00625006535/64129635, g7 osseoti multihole 70mm i/110010273/6416662.It is unknown which screws contributed to this event,so all the screws were included.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
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