Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.If information is provided in the future, a supplemental report will be issued.
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Patient underwent oral and maxillofacial surgery in which rhbmp-2/acs was implanted.Post-op, patient complained redness, swell in right ear, and nerve related under tongue odd sensation.Reportedly, patient has difficulty sitting down.This has been ongoing and gotten worse.Contrary to patient, surgeon does not believe rhbmp to have caused issue.
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