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
Discomfort (2330)
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Event Type
Injury
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Manufacturer Narrative
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Although it is unknown whether these products caused or contributed to the reported event, we are filling this mdr for notification purpose.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.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Procedure: navigated lower back spine fusion procedure it was reported as per the phone call of patient's son-in-law, that the patient had a lower back spine fusion procedure using hardware and bone morphogenetic protein (bmp).Procedure was successful with no allegations of deficiency with the system or hardware placed.Post-op, approximately 3-4 weeks after the procedure the patient started having issues with his liver.Patient had several minor minimally invasive liver procedures since the onset of symptoms.The patient¿s "g.I." doctor suspects the cause could potentially be related to the bmp powder that the patient received during the spine procedure.
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Search Alerts/Recalls
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