It was reported that the patient had a fusion at l2-l5 using rhbmp-2/acs with titanium screws and rods.Post-operatively, patient complained of having back pain.Numerous ct scans and mris show some fusion, but not completely.Patient has parva (fifths disease), the virus that attached the spine and joints.It was reported that at pre-surgery, the fluid caused facet swelling which caused her spine to degenerate.Ivig antibody injections were given for the virus.Patient continues with swollen joints and has developed immune deficiencies.She continues with fluid buildup in her spine.Due to asymptomatic meningitis as a result of the virus, a spinal tap was recently done.
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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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