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.If information is provided in the future, a supplemental report will be issued.
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It was reported that the patient underwent s1 disc excision, transforaminal lumbar interbody fusion and posterior fusion due to left l5 hemilaminectomy.Post-op, an infection was introduced to patient's lower spine because products used during the surgery was not properly sterilized.As a result, patient developed a severe infection and sepsis.Patient has endured pain and suffering, had to undergo multiple extended hospital stays for infection, incurred medical bills, and mental anguish.
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