Zimmer biomet complaint (b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2020-00411, 0001032347-2020-00412, 0001032347-2020-00413, 0001032347-2020-00414, 0001032347-2020-00415.Concomitant medical products: sternalock blu system plate, 4 hole l-plate 100 degrees, part# 73-2643, lot# ni.Sternalock blu system screw, cancellous cross-drive locking 2.4 x 10mm, part# 73-2410, lot# ni.Sternalock blu system screw, cancellous cross-drive locking 2.4 x 12mm, part# 73-2412, lot# ni.Sternalock blu system screw, cancellous cross-drive locking 2.4 x 14mm, part# 73-2414, lot# ni.Sternalock blu system screw, cancellous cross-drive locking 2.4 x 16mm, part# 73-2416, lot# ni.
|
This follow-up report is being submitted to relay additional information.This report is being submitted to update additional information in section b5, h2, h3, h6 and h10.
|
This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Lot identification is necessary for review of device history records, lot identification was not provided.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.This report is being submitted to update additional information in section h2, h3, h6 and h10.
|