C-ARM

Description of Event or Problem

SPINE AIBLE REP CALLED IN TO REPORT THAT THE SYSTEM HAD DIFFICULTY REGISTERING DURING L2-L4 LUMBAR FUSION CORPECTOMY AT L3 CASE. SPINE AIBLE REP REPORTED THEY WERE USING A SQUARE C-ARM. SPINE AIBLE REP REPORTED THEY WERE ABLE TO GET A GREEN VALUE AT L4 BUT WERE UNABLE TO RECEIVE GREEN VALUE AT L2 BUT WAS ABLE TO EVENTUALLY GET A YELLOW VALUE THAT WAS ACCURATE. SPINE AIBLE REP REPORTED THEY ALSO HAD A YELLOW VALUE AT L3 BUT THAT L3 WAS NOT A VERTEBRAL BODY AND WAS CORPECTOMY CAGE. SPINE AIBLE REP REPORTED 20 MINUTE DELAY TO THE CASE. SPINE AIBLE REP ALSO REPORTED THAT WHEN THE SURGEON WAS PLANNING THE CASE, A VISUALIZATION ERROR APPEARED IN THE VIEWS. SPINE AIBLE REP REPORTED IN THE PAST THEY COULD CHANGE THE ROD FROM GENERIC TO PRE-BENT AND GO BACK BUT IT WAS STILL DISPLAYING VISUALIZATION ERROR IN ALL VIEWS. SPINE AIBLE REP REPORTED WHEN PLANNING CORPECTOMY CAGE, HE PLANNED WITH A GENERIC SCREW, AND WHEN INCREASING THE DIAMETER OF THE SCREW FROM 3.0 IT SEEMED TO MAKE THE VISUALIZATION ERROR GO AWAY. SPINE AIBLE REP REPORTED THE SCREW CAD MODEL WAS THEN NOT SHOWING ON THE DRIVER AFTER BEING PLANNED WITH THE CORRECT TOOL CARD SELECTED. SPINE AIBLE REP THEN HAD TO MANUALLY BUILD THE MODULEX SCREW CAD MODEL BUT ONLY HAD TO MANUALLY BUILD THE FIRST ONE AND THEN WAS FUNCTIONING AS INTENDED. TS NOTED THAT SPINE AIBLE REP REPORTED IN THE PAST WITH THE MAZORX SYSTEM, THEY WERE ABLE TO SUCCESSFULLY REGISTER THE LEVEL BELOW AND ABOVE THE CORPECTOMY CAGE AT L3 DURING REGISTRATION. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).