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 provider (hcp) regarding an event occurred during a spinal procedure in a patient.It was reported that during the surgery, there were difficulties in assembling/twisting the cement sleeve into the tulip and subsequently there was cement leakage inside the patient.For the patient, it was reported that there was delay of 75 minutes, procedure change, screws were not cemented in the end and remaining cement, metal abrasion, one screw was replaced.There was no malfunction related to the screw.
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