Model Number N/A |
Device Problem
Fracture (1260)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).The complaint cannot be confirmed since the medical records or x-rays were not provided.Device history records were review and no deviations/ anomalies were found that would affect the reported event.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.Mw# 5201030000-2018-8004.
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Event Description
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It was reported that when placing the screw the head broke off and the remaining portion was left in the patient.Attempts have been made and additional information on the reported event is unavailable.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.It was identified an internal software error produced and submitted an invalid device product code in the previous submissions related to this reporting.The device product code has been updated with no further changes.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 information available.
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Search Alerts/Recalls
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