MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Unspecified Infection (1930)
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Event Type
Injury
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Manufacturer Narrative
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Occupation: non-healthcare professional.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.Products from multiple manufacturers were implanted during the procedure.Although it is unknown if any of the devices contributed to the reported event, we are filing this mdr for notification purposes.If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported via patient call that on an unknown date in 2003, the patient underwent neck surgery, in which rhbmp-2/acs was implanted.Allegedly, post-op, the patient had e-coli infection.The patient refused to provide any further details.According to the patient's conversation, it appeared that she may had a cervical system from other manufacturer also implanted.
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Search Alerts/Recalls
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