MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
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Catalog Number 7510800 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Inadequate Pain Relief (2388)
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Event Type
Injury
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Manufacturer Narrative
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(b)(6) (b)(4).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.
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Event Description
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It was reported that, on (b)(6) 2015, patient underwent spinal fusion with correction for scoliosis.The patient was implanted with rhbmp-2 to posterior spine.On an unknown date, post-op, the patient experienced increase in pain.The patient is allergic to nickel.
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Event Description
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On (b)(6) 2016, patient underwent revision surgery.
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Manufacturer Narrative
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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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On (b)(6) 2016, patient underwent revision surgery in which rhbmp-2 and mdt instrumentation was used.
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Search Alerts/Recalls
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