Description of Event or Problem · 0
DID AN INACCURACY OCCUR? YES. WHAT WAS THE ESTIMATED AMOUNT OF INACCURACY? (MM) 10-20MM. WHAT WAS THE DIRECTION OF INACCURACY; MEDIAL DIRECTION ON THE PATIENT'S RIGHT SIDE, LATERAL DIRECTION ON THE PATIENT'S LEFT SIDE. REGISTRATION METHOD AUTO-REGISTRATION (O-ARM, C-ARM). WHEN DID THE INACCURACY OCCUR? DURING NAVIGATION. WHICH INSTRUMENTS WERE BEING USED WHEN INACCURACY WAS DETECTED? STRYKER DRILL WITH SURTRAC DEVICE, AWL TIP TAP, VOYAGER 5.5 SCREWDRIVER MAS, PASSIVE PLANER PROBE. IS THE INACCURACY ISOLATED TO ONE INSTRUMENT, ALL, OR SOME? PLEASE DESCRIBE ALL INSTRUMENTS SEEMED INACCURATE. PHYSICIAN WAS USING A STRYKER ANGLED DRILL WITH A SURTRAC TRACKER ON THE DRILL AND IT WAS REGISTERED APPROPRIATELY PRIOR TO THE INITIAL O-ARM SPIN. THE SURGEON WAS TOLD BY SEVERAL PEOPLE THAT THE DRILL ISN'T AS TRUSTWORTHY AS A NAVIGATED STEALTH MIDAS AND TO NOT TRUST ANY PROJECTIONS FROM THAT DRILL AND TO INSTEAD SHOOT NEGATIVE/ POSITIVE PROJECTIONS OFF THE PASSIVE PLANER PROBES, TAPS, ETC. I SAVED PROJECTIONS OFF THOSE INSTRUMENTS TO ENSURE THEY ALL LINED UP, AND THEY DID WHICH LEAVES ME TO CONFIRM THERE WAS MOVEMENT IN THE FRAME ITSELF, AND IT WASN'T APPROPRIATELY SECURED ON THE PATIENT'S SPINOUS PROCESS. AND AFTER REVIEWING THE SCAN THE PHYSICIAN REMOVED THE T12 AND L1 SCREWS BILATERALLY AND DID NOT REPLACE THEM. THE NOTED INACCURACY WAS 10-20MM. THERE WAS A DELAY OF LESS THAN ONE HOUR. THERE WAS NO IMPACT ON THE PATIENT'S OUTCOME. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2). REF REPORT: MW5170979.