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 in 2004, patient started experiencing back pain.Patient was diagnosed with spondylolisthesis.In (b)(6) 2006, patient underwent a surgery in which rhbmp-2/acs was implanted.Post-op, patient continued to experience pain without improvement.Patient underwent physical therapy.Patient experienced excruciating pain while engaging in everyday activities like running.Reportedly, patient has increased fear of cancer.On (b)(6) 2009, patient underwent revision surgery because one of the rods in her back bent and damaged vertebrae.During revision surgery, surgeon added two more screws and replaced the rod.Patient lost significant flexibility after the surgery.Patient is still unable to run, has decreased range of motion and flexibility, and is unable to lie on her back without experiencing pain.
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