Patient identifier field not sufficient to hold all digits, should read: (b)(6).A medtronic representative went to the site to test the equipment.The representative was unable to replicate the reported issue.The hardware, software, and instruments passed the system checkout.The system was found to be fully functional.The software investigation found that a probable cause was unable to be determined without further information since the on-going investigation proved to be inconclusive based on the information provided.
|
A site representative reported that, while in a l2-t10 spinal fusion, screws were accurately placed on the left side of the anatomy.However the right side screws were found to be placed medial at the same angle.It was noted that the screws breached and were in the canal of the patient.The screws were removed, a new image acquisition was performed, and kaywires were placed prior to placing the screws.It was suspected that the reference frame was bumped, resulting in the imprecision.There was a reported delay to the procedure of more than 1 hour due to this issue.No additional information was provided.
|