MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
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Catalog Number 7510200 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Fall (1848); Muscle Spasm(s) (1966); Neuropathy (1983); Pain (1994); Swelling (2091); Inadequate Pain Relief (2388); Ambulation Difficulties (2544)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).
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Event Description
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Procedure: anterior lumbar interbody fusion surgery levels implanted: l4-s1 it was reported that on (b)(6) 2007, the patient underwent spine fusion surgery from vertebrae l4-s1 wherein rhbmp-2/acs was implanted.The rhbmp-2 collagen sponge was used to fuse more than one level of the spine.Post-op, the patient complained of increasing low back pain and associated radiculopathy in his lower extremities.The patient continued to experience extreme back pain, with pain radiating down to his hips and legs, muscle spasms in his left leg, numbness in his left toes, and occasional swelling in his back.The patient experienced difficulty in walking and falls constantly due to paralyzing 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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Event Description
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It was reported that the patient presented with following pre-op diagnosis: degenerative joint disease, disc space l5-s1 and disc space l4-5; postlaminectomy instability l5-s1.Internal disc derangement l4-5, l5-s1.Patient underwent following procedures: anterior approach for anterior discectomy, lumbar fusion with cages and bone morphogenic protein, placement of anterior plates; anterior retroperitoneal approach l4-5, l5-s1; complete discectomy l4-5, l5-s1; anterior interbody fusion with bone morphogenic protein and cage l4-5, l5-s1; fixation with plate l4-5, l5-s1.As per operative notes, "a series of sizing devices were used and a 10 degree 14mm, medium size cage was chosen and implanted with bone morphogenic protein in the substance of the cage.The fit seemed quite good.A 43 mm l5-s1 plate was chosen, implanted with 24 mm screws.Sizing devices were again used and a 16 mm,5 degree, medium size cage was implanted with bone morphogenic protein within the substance of the cage.The fit seemed quite good.A 43 mm l4-5 plate was; chosen and implanted with 26 mm screws." non intra-operative complications were reported.On 22 nov 2007 the patient got discharged from the facility.
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