(b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2021-00187.Implantation date was in (b)(6) 2019.Concomitant medical products: traumaone system 2.6mm large angle plate, straight, part# 44-1023, lot# 978940, unknown screw, part# ni, lot# ni, qty: 6.Report source ¿ (b)(6).
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It was reported the patient underwent a revision one (1) year following implantation of a mandible plate due to infection and one (1) loose screw.One (1) screw was found to have fallen off.In the revision, the surgeon removed the plate, debrided the area, and fixed it with a new plate.Attempts have been made and no further information has been provided.
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It was reported the patient underwent a revision six (6) weeks following implantation of a mandible plate due to suspected infection.One (1) screw was found to have fallen off.During the revision, the surgeon noted bone infiltration by cancer tissue rather than infection, and that the screw had fallen off due to softening of the tissue.The planned refixation was not performed to make a definitive diagnosis of the cancer by histological examination.Re-fixation is being considered at a later date.It was reported that no further information is available.
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