The event did not result in a death or a life-threatening injury.There was no device defect or malfunction reported with the devices.The patient experienced unrelieved numbness and weakness of the left arm since the initial cage implantation whose cause is uncertain.When a ct and emg scan was performed, the surgeon observed the cages were placed too medially.As a result, the surgeon performed a surgical re-intervention to remove all implanted cages from c4-c7 and, in addition, performed a laminotomy and foraminotomy.To date, the patient's symptoms still have not been resolved.For this reason, this event was reported.It is noted that this case used three different cage implant lots during procedure on the same day for the same patient.This mdr is for lot 1005037.The other two lots for this exact same case will be reported on separate mdrs.
|