(b)(4).Concomitant medical products: sl blu 60d jl 12 holes plate; cat#sp-3215; lot#unk.Screw 2.4x16mm cancellous 5pk 4x16mm; cat# 73-5416; lot#ni -qty:7.Scrw 2.4x14mm cancelous lockng; cat# 73-2414; lot#ni.Scrw 2.7x14mm cancelous lockng; cat# 73-2714; lot#ni.Report source: (b)(6).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.It is alleged that the surgeon did not use several plates or a large ladder plate.The ifu for these products (01-50-1215) recommends 5 cuttable rigid plate sections to close a complete mid-line sternotomy.However without medical records a definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2021-00126, 0001032347-2021-00544, 0001032347-2021-00545, 0001032347-2021-00546, 0001032347-2021-00547, 0001032347-2021-00548, 0001032347-2021-00549, 0001032347-2021-00550, 0001032347-2021-00551, 0001032347-2021-00552.
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