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.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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It was reported that patient underwent balloon kyphoplasty on (b)(6) 2016 for compression fracture at l1 due to osteoporosis.On (b)(6) 2016, post-op, patient suffered with l1 nerve root paralysis due to leakage of cement outside the vertebral body.Patient issue has not been resolved.
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