(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 the patient underwent a posterior lumbar interbody fusion and an anterior lumbar interbody fusion using rhbmp-2/acs with a metal cage.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, 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 severe injuries and damages, including bone overgrowth causing nerve compression, chronic pain and radiculitis.
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