Zimmer biomet complaint (b)(4).The device will not be returned for analysis as it was discarded; 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: 0001032347-2020-00404, 0001032347-2020-00405, 0001032347-2020-00406, 0001032347-2020-00430.Medical products : htr*pmi 2025734 left frontal temporal parietal implant, part# pm623210-b, lot# 986060.1.5mm system 6 hole extra long double y plate, part# 01-7114, lot# j416200.1.5mm system high torque (ht),sd,x-dr,scr,5/pk, part# 91-6104, lot# j416220.1.5mm system high torque (ht),sd,x-dr,screw 1.5mm x 5mm, part# 91-6105, lot# ni.1.5mm system high torque (ht) cross-drive screw 1.8 x 5mm, part# 91-1805, lot# ni.(b)(6).The user facility is foreign; therefore, a facility medwatch report will not be available.Foreign report source: (b)(6).
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It was reported a custom cranioplasty plate was removed due to necrosis two (2) months after implantation.A few days after surgery, a bruise was observed in the skin over the middle of the implant, and the bruise did not improve.Two (2) weeks prior to removal, the spot on the skin opened up with fluid escaping.It has not been determined if the back-up implant will be used or if a new custom plate will be implanted in the coming months.No additional patient consequences have been reported.
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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 for two of the reported screws.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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