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 Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
Injury
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Event Description
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It was reported that on (b)(6) 2007, the patient underwent spine fusion surgery on the thoracic and lumbar region at levels t4-s1.The patient was implanted with rhbmp-2 collagen sponge which was applied from posterior approach.The rhbmp-2 collagen sponge was used to fuse more than one level of the spine and was placed outside a cage (i.E.In the posterolateral gutters).Post-op, the patient complained of progressively worsening low back pain with radiculopathy in her lower extremities, due to which patient underwent for 4 revision surgeries.On (b)(6) 2008, patient underwent spine fusion surgery on the thoracic and lumbar regions at levels t12-s1.The patient was implanted with rhbmp-2 collagen sponge to the thoracic spine which was applied from posterolateral approach.The rhbmp-2 collagen sponge was used to fuse more than one level of the spine and was placed outside a cage (i.E.In the posterolateral gutters).The patient underwent spine fusion surgery on the thoracic and lumbar region at levels t12-s1.The patient was implanted with rhbmp-2 collagen sponge to the thoracic spine which was applied from posterolateral approach.The rhbmp-2 collagen sponge was used to fuse more than one level of the spine and was placed outside a cage (i.E.In the posterolateral gutters).
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Manufacturer Narrative
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(b)(4).Neither the device nor applicable medical records or imaging studies were returned nor provided for evaluation.
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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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It was reported that on: (b)(6) 2012: patient presented with pre-op diagnoses: 1 flat back deformity, scoliosis, infection, nonunion.Procedure: removal of t4 to the pelvis segmental spinal instrumentation, legacy quarter-inch stainless steel.Insertion of 5.5 mas with titanium rods t4 to s1.T12 to s1 bilateral posterolateral fusion using local autogenous bone, 2 large kits of bone morphogenic protein and 20 ml of bone graft matrix.Exploration of fusion.Per op notes: the bone graft, which was local bone that was used with 2 large kits of bone morphogenic protein and 20 ml of bone graft matrix were placed.No other information was provided.
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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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