Mazor X — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THERE WAS AN ACCURACY ISSUE AT LEFT L5. THE PATIENT EXPERIENCED LEFT FOOT DROP. THE PROCEDURE WAS DELAYED AN HOUR. ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE REPORTED THAT THE FOOT DROP WAS NOT TEMPORARY AND WAS NOT RESOLVED. THE DEVIATION WAS FIVE TO TEN MILLIMETERS INFERIOR FROM THE PEDICLE AND PLANNED TRAJECTORY. THE SUSPECTED OR MOST LIKELY CAUSE WAS THAT THE L5 ROBOTIC REGISTRATION WAS NOT ACCURATE.

Mazor X — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT MULTIPLE CONTROLLER ERROR MESSAGES WERE OBSERVED. "ERROR 3489 NO CONNECTION DUE TO CONTROLLER ERROR" APPEARED RIGHT AFTER THE SYSTEM WAS MOUNTED TO THE BED. A SOFT REBOOT DID NOT CLEAR THE ISSUE, AND A SEPARATE ERROR POPPED UP STATING "CONTROL ISSUE ENCOUNTERS SHUT DOWN WORKSTATION AND TURN ON AGAIN". THE MANUFACTURER REPRESENTATIVE HAD TO THEN REDO THE SET-UP STEPS TO CONTINUE WITH CASE. HALFWAY THROUGH THE CASE THE ERROR ISSUE HAPPENED AGAIN WHILE MOUNTED TO THE PATIENT, SO THE MANUFACTURER REPRESENTATIVE HAD TO REDO THE 3 DEFINE. THE ERROR ISSUE HAPPENED A 3RD TIME AFTER UN-MOUNTING FROM THE BED. THE OUTLET WAS SWAPPED AFTER THE FIRST OCCURRENCE, HOWEVER THE ISSUE CONTINUED TO PERSIST. L4 TO L2 WERE FREEHANDED. IT WAS DURING THE FREEHAND PORTION THAT THE CONTROLLER ERROR/REBOOT REQUEST INITIALLY OCCURRED. AFTER RESETTING THE SYSTEM A CONFIRMATION SPIN WAS TAKEN. THE GUIDANCE SYSTEM THEN PRESENTED THE SAME CONTROLLER ERROR MESSAGES AND HAD TO BE SHUT DOWN/RESET BEFORE DOING THE FIRST REGISTRATION. THE FIRST SEGMENT OF SCREWS WERE PLACED ROBOTICALLY FROM L1 TO T8,