It was reported that a patient had an alleged infection and underwent a revision procedure to explant onkos devices.The patient's primary surgery occured on (b)(6) 2023, where the patient was implanted with a my3d pelvic implant, which was approved through the compassionate use pathway.The patient was also implanted with my3d personalized pelvic reconstruction cancellous bone screws, my3d personalized pelvic reconstruction locking cortical bone screws, and a my3d personalized pelvic reconstruction apical hole plug.As the patient underwent a revision procedure, this event will be reportable to the fda as a serious injury.This report captures a my3d personalized pelvic reconstruction cancellous bone screw.
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It was reported that a patient had an alleged infection and underwent a revision procedure to explant onkos devices.The explanted devices were not returned for additional evaluation.Production records could not be reviewed for the device captured in this report as the lot number is unknown.Based on the available information, the root cause of the event could not be determined.The following mfrs were submitted for the devices involved in this event: 3013450937-2024-00093, 3013450937-2024-00095, 3013450937-2024-00096, 3013450937-2024-00097, 3013450937-2024-00098, 3013450937-2024-00099, 3013450937-2024-00100, 3013450937-2024-00101, 3013450937-2024-00102, 3013450937-2024-00103, 3013450937-2024-00104, 3013450937-2024-00105, 3013450937-2024-00106.
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