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 Date 07/19/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Medical product:- a 4.0mm solid canc scr 30mm catalog#: 1436930 lot#: sc3937; 4.0mm solid canc scr 30mm catalog#: 1436930 lot#: j-dmj cd3; 3.5 cort bone screw 18mm catalog#: 1437718 lot#: j3798154; 3.5 cort bone screw 18mm catalog#: 1437718 lot#: j3798154.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted.The investigation is in process.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: 0001825034-2018-08331, 0001825034-2018-08336, 0001825034-2018-08338, 0001825034-2018-08339.
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Event Description
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It was reported that the patient developed eczema caused by an allergic reaction following implantation of the trauma plate.Attempts have been made, however, no further information is available at this time.
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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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Manufacturer Narrative
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Udi# (b)(4).Reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies were found.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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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.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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Search Alerts/Recalls
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