Review of device history records show the lot released with no recorded anomaly or deviation.The user facility is foreign; therefore a facility medwatch report will not be available.It is reported the facility disposed of the explanted devices.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.Report one of five for the same event, reference 1032347-2016-00416 through 1032347-2016-00419.
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It is reported the original procedure, a coronary artery bypass, occurred (b)(6) 2016.The patient fell on (b)(6) 2016 and the plate deviation was confirmed by x-ray.On (b)(6) 2016 acute renal failure and mediastinitis appeared, it was confirmed (b)(6) was present.On (b)(6) 2016 debridement for the mediastinitis and (revision) removal of the plate and grafting of part of the peritoneum were conducted.The patient passed away on (b)(6) 2016.The cause of death listed on the death certificate is acute respiratory insufficiency and aspiration pneumonia.
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