(b)(4).The device will not be returned for analysis as it was not returned by the facility; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2020-00550.Concomitant medical products: ribfix advantage short bridge & 23mm posts, part# 323.1013, lot# ni.Ribfix advantage long bridge & 23mm posts, part# 323.1033, lot# ni.Unknown anterior rib plate, part# ni, lot# ni, unknown manufacturer.
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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.
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