Model Number N/A |
Device Problem
Osseointegration Problem (3003)
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Patient Problem
Abscess (1690)
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Event Date 07/14/2016 |
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 to review was not provided.Current information is insufficient to permit a conclusion as to the cause of the event.A corrective action has been initiated to correct 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 bone graft was removed approximately four days post-implantation due to non-integration and an abscess.
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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.(b)(4).Corrective action was initiated to address the reported issue.
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Search Alerts/Recalls
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