Model Number N/A |
Device Problem
Osseointegration Problem (3003)
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Patient Problem
Impaired Healing (2378)
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Event Date 11/18/2015 |
Event Type
Injury
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Manufacturer Narrative
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This user facility is outside of the united states.The necessary manufacturing history was not provided for review.Current information is insufficient to permit a conclusion as to the cause of the event.Corrective action was initiated to address the reported issue.Product location unknown.
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Event Description
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It was reported that patient underwent an oral bone grafting procedure.Subsequently, the patient experienced non-integration, non-healing wound, and bone loss which required the product to be removed.
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Manufacturer Narrative
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This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.Corrective action was initiated to address the reported issue.
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Search Alerts/Recalls
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