It was reported that the patient underwent a posterior lumbar lnterbody fusion using rhbmp-2/acs.It was reported that 4 months later, the patient underwent a plif revision surgery using rhbmp-2/acs.The patient's post-operative period was marked by severe pain.Following the surgery the patient suffered from autonomic neuropathy, small fiber neuropathy, peripheral neuropathy, muscle atrophy and nerve damage, inflammatory reactions, chronic radiculitis, retrograde ejaculation, sterility, osteolysis (bone resorption), displacement or migration of the spacer cage, pseudoarthrosis, dysphagia, difficulty breathing, difficulty gripping and holding items, and chronic pain.The patient now suffers from bone overgrowth causing nerve compression, chronic pain and radiculitis, and emotional distress and mental anguish.
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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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It was reported that on (b)(6) 2009 the patient underwent a posterior lumbar interbody fusion surgery at l4-5, l5-s1 using bmp2_acs.It was reported that on (b)(6) 2009 the patient underwent a plif revision surgery at l4-5, l5-s1 using bmp2_acs.The patient's post-operative period was marked by nerve damage and chronic pain in limbs.
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