Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Reaction (2414)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).(b)(6).Product is currently not expected to return to zimmer biomet for investigation as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up medwatch will be submitted.
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Event Description
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It was reported that the patient is experiencing a possible allergic reaction to a trauma plate that was implanted on an unknown date.No additional patient consequences were reported.Attempts have been made and additional information on the reported event is unavailable at this time.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.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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