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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Information was received from healthcare professional via manufacturer representative regarding patient with symptoms of tumor involved in posterior fusion procedure used in spinal therapy.Levels implanted- t8 3a3b.It was reported post-op, product at ps medial side ruptured.As a result, patient symptoms-numbness in the lower limbs was reported.Also, bone ruptured in the patient was reported.There was no delay in the surgery.Patient was not hospitalized for prolong.Patient outcome- health damage in the patient was reported.Received updated information that screw was penetrated into the medial spinal canal.The direction of the screw was shifted, and the trajectory of the screw has passed inside the pedicle.It was reported due to the their technical error the screw was penetrated into the medial spinal canal or deviated.There is no malfunction reported with the screw.Deviations was confirmed at t6 and t7 on the left.Reported patient had recovered from the problem.
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