Outcomes to adverse event: other: fracture, delirium symptoms.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 presented with l1 pseudoarthrosis; and underwent replacement of vertebral body by anterior approach.Placement of cage was performed at l1 in the first stage surgery; and oblique lumbar interbody fusion was performed at l2-l3.No complications or malfunctions were reported after this surgery.The second stage of surgery was to be performed on (b)(6) 2019.On the weekend after the first stage surgery, it was reported that the patient kicked the nurse with severe symptoms of delirium.In the morning of (b)(6) 2019, the surgeon was worried and x-rays taken before the operation revealed that the cage sank towards l2 endplate and the superior endplate of l2 fractured.There was a possibility that the l2 superior endplate got fractured because of the cage back-out.Bone quality of the patient was weak.It was unknown exactly what the cause was, but it seemed that the angle of the self-adjusting end cap had changed.Since it was not a major back-out, only the second stage surgery was performed (as it was planned).Posterior fixation was performed at t10-l4.Follow-up observations were planned for the patient.At the end of (b)(6), no further back-out of the cage has been reported.
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