MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
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Catalog Number 7510400 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Loss of Range of Motion (2032); Cramp(s) (2193); Inadequate Pain Relief (2388); Neck Pain (2433)
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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) 2008, the patient underwent spine fusion surgery from vertebrae c3-c7 wherein rhbmp-2/acs was implanted.The rhbmp-2 collagen sponge was used to fuse more than one level of the spine.The rhbmp-2 collagen sponge was placed outside a cage (i.E in the disc space, anterior cervical spine).Post-op, the patient complained of increasing neck pain and difficulty swallowing.The patient continued to experience chronic neck pain, cramping and swelling, difficulty swallowing, limited range of motion in his neck, and inability to lay head back due to extreme pain.These injuries prevent patient from practicing and enjoying the activities of daily life.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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