Zimmer biomet complaint (b)(4).D10 ¿ medical products: item# 76-2601, lot# ni; ribfix blu 12 hole prebent plt qty 2; item# 76-2602, lot# ni; ribfix blu 12 hole prebent plt qty 2; item# 76-2410, lot# ni; ribfix blu screw qty 21; item# 76-2710, lot# ni; ribfix blu screw qty 8.The device was returned for analysis; however, an investigation of the reported event is still 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: 0001032347-2023-00204, 0001032347-2023-00205, 0001032347-2023-00303, 0001032347-2023-00302.
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It was reported that patient underwent a sternal procedure.Subsequently, the patient underwent a revision to remove bursitis and rib plate removal as well.After removal of the bursitis, a second mass was discovered that had formed over or through the plates.Surgeon reported it did not appear to be malignant or an allergic reaction.No implants were reinserted as the patient's fracture had healed.
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This follow-up report is being submitted to relay additional information.A visual inspection was conducted on the returned plates and screws.The plates have been bent to fit the patient's anatomy and show signs of scratching as well from being implanted.The screw heads all show signs of use as well with marking on both the screw head and threads.Medical records were not provided.Lot identification is necessary for review of device history records, lot identification was not provided.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.
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