Zimmer biomet complaint cmp (b)(4).The device will not be returned for analysis as it remains implanted; 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: 0001032347-2020-00474, 0001032347-2020-00475.Medical products pectus system smooth pectus bar 25.4cm (10in)(l), part# 01-3710-p, lot# 787280, pectus system smooth pectus bar 25.4cm (10in)(l), part# 01-3710-p, lot# j3839223, pectus system smooth pectus bar 27.9cm (11in)(l), part# 01-3711-p, lot# j3805905.The user facility is foreign; therefore, a facility medwatch report will not be available.(b)(6).
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It was reported the patient developed a pneumothorax and underwent emergency surgery forty-three (43) days following implantation of four (4) pectus support bars, fourteen (14) days following a revision to correct device migration of the pectus support bars, and one (1) day following an additional surgery due to pneumothorax.The position of devices was not modified during the emergency surgeries for the pneumothorax.It was reported that no further information is available.
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