Model Number N/A |
Device Problem
Positioning Failure (1158)
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Patient Problem
Bone Fracture(s) (1870)
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Event Type
Injury
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Manufacturer Narrative
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Zimmer biomet complaint (b)(4).Medical product: unknown left mandible.Unknown left fossa.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Foreign: (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2021-00522 and 0001032347-2021-00523.
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Event Description
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It was reported the patient underwent a left tmj procedure on an unknown date.Subsequently, the patient was revised due to trauma with failed orif of mandible fracture and malocclusion with open bite right side and pathologic overjet, on an unknown date.Attempts have been made and no further information has been provided.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; g3; g6; h1; h2; h3; h6; h10.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Part and lot identification are necessary for review of device history records, neither were provided.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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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Event Description
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No further event information available at the time of this report.
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Search Alerts/Recalls
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