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
Ossification (1428); Nerve Damage (1979); Pain (1994); Stenosis (2263); No Code Available (3191)
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Event Type
Injury
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Event Description
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It was reported that the patient underwent a l3-l4, l4-l5 and l5-s1 anterior interbody fusions, femoral ring allografts l3-l4, l4-l5 and l5-s1 and l3-l4, l4-l5 and l5-s1 posterolateral fusions.Rhbmp-2/acs was used in this surgery.Following surgery, patient followed up with his physician.He began to develop radiating pain to his leg, nerve injury, severe back pain and bony overgrowth.Patient has never recovered from his surgery, and he continues to have daily, disabling pain that prevents him from performing many basic activities of daily living.
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Manufacturer Narrative
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(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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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that on: (b)(6) 2010: the patient presented with l3-l4 degenerative disk disease and stenosis with l4-l5 and l5-s1 anterior inter-body non-union and underwent the following procedures: removal of the anterior cage implants.L3-l4, l4-l5 and l5-s1 anterior inter-body fusions.Femoral ring allografts l3-l4, l4-l5 and l5-s1.Anterior instrumentation l3-l4 and l5.L3-l4 laminectomy.Bilateral l5 foraminotomies.L3 to sacrum posterior segmental instrumentation.Bilateral iliac screw supplemental fixation.L3-l4, l4-l5 and l5-s1 posterolateral fusions.Local bone graft plus rhbmp-2/acs.As per-op notes, ¿¿the left-sided previously placed pedicle screws at l4-l5 and s1 were disassembled and the rods and screws were removed.Pedicle screws were placed bilaterally in the l3-l4, l5 and s1 pedicles and in the intra-iliac location.L3-l4 laminectomies were performed.Both l5 nerve roots were decompressed¿.At each level trial spacers were placed and ultimately at the l5-s1 and the l4-l5 levels, 16 mm lordotic femoral ring allografts were placed.These contained rhbmp-2 soaked sponges.Diskectomy was performed at l3-l4 levels.A 14 mm graft was placed¿.Rhbmp-2/acs soaked sponges were then placed laterally spanning these decorticated posterior elements¿¿ on (b)(6) 2013: the patient presented with lumbar pseudoarthrosis, l2-l3 and l3-l4 along with lumbar stenosis and spondylosis.Failed back syndrome and underwent the following procedures: removal of retained hardware.Re-instrumentation of retained hardware at l2-l3 and l3-l4 with pedicle screw instrumentation using spinal usa pedicle screws.Exploration of the fusion mass.L2-l3, l3-l4, l4-l5 decompression and l5-s1 decompression.Neuro-monitoring throughout the procedure.Post-op fusion l2-l3 and l3-l4 with pedicle screw instrumentation and use of autograft and allograft.
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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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