Model Number N/A |
Device Problems
Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Hypersensitivity/Allergic reaction (1907)
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Event Date 12/12/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: biomet microfixation tmj system left narrow mandibular component, catalog #: 01-6551, lot #: 541890a.Therapy date: (b)(6) 2018.Customer has indicated that the product will not be returned to zimmer biomet for investigation.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: 0001032347-2018-00872.
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Event Description
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It was reported a revision was performed due to an allergic reaction.It was confirmed that the mandibular component was removed and replaced with a titanium implant.The surgeon elected to leave the existing fossa in place and used the same screws that were originally implanted in the mandible with the new mandible.No additional patient consequences were reported.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Reported event was confirmed by evidence that the revision surgery was performed.The standard mandible component was replaced with a titanium implant.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Investigation results concluded that the reported event was due to the patient's condition of allergic reaction.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.Date explanted - the distributor stated the surgeon elected to leave the existing fossa in place and used the same screws that were originally implanted in the mandible with the new mandible ((b)(6) 2018).
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Event Description
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This follow-up is being submitted to relay additional information.
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Search Alerts/Recalls
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