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Model Number N/A |
Device Problems
Loss of or Failure to Bond (1068); Migration (4003)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/09/2023 |
Event Type
Injury
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Manufacturer Narrative
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Zimmer biomet complaint (b)(4).Concomitant medical products: item#76-2410, lot# unk, ribfix blu scr s/d-lk 2.4x10mm qty 2.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.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2023-00018, 0001032347-2023-00019.
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Event Description
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It was reported that the patient underwent a rib fixation procedure.Subsequently, the patient was revised due to the screws loosening and backing out of the plate and the bone.Attempts have been made and additional information on the reported event is unavailable at this time.
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Event Description
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No further event information is available at the time of this report.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Lot identification is necessary for review of device history records, lot identifications were not provided.Review of the device history record(s) identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Search Alerts/Recalls
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