Patient identifier not available from the site.A medtronic representative went to the site to test the equipment.The representative reported that the navigation system functioned as designed.The hardware, software, and instruments passed the system checkout.The system was found to be fully functional.
|
A site representative reported that, while in a cervical spinal fusion, the screw placed in the c3 vertebrae slightly breached the vertebral foramen.The screw was then removed and the remaining screws were placed a c-arm.It was noted that the reference frame came loose after the image acquisition.The surgeon stated that the reported issue was not related to the navigation system, as the patient had soft/loose bone and the head might have moved relative to the mounting point of the reference frame.Accuracy was deemed acceptable prior to placing the screw.The surgeon opted to complete the procedure without the use of the navigation system.The surgeon opted to complete the procedure without the use of the imaging system.There was a reported delay to the procedure of less than 1 hour due to this issue.No additional information was provided.
|