ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: It was reported there was problems on verification process with the new arrays. Tracking with turkey foot was accurate but when placing screws it was lateral. We switched arrays, reverified but had placed the l5 right screw and when taking x-ray it was completely out of the body. We had to remove and replace under xray.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: It was reported that during an Excelsius GPS surgery, screws were removed and replaced without navigation. The surgeon was navigating with the robot L3-S1 pedicle screws in an open surgery. All screws were on trajectory and all screens were green, showing good screw insertion. Upon post CT scan with E3D, the left L4 was lateral outside of the vertebral body. There was no prior indication for this.The lateral screw was removed and replace without navigation. There was no navigation issue during screw prep and insertion.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: It was reported that the EGPS nav screws were all off planned trajectory.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: It was reported that a radial error at the target exceeded 1.5 mm. As a result, the leads were removed and repositioned through an alternative channel rather than the originally planned trajectory. The implants were successfully placed using the alternative channel and remained implanted in the patient. The surgeon reviewed and accepted the final implant placement.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: t was reported that the MIS drivers exhibited lateral screw drift. The post-placement evaluation by the surgeon showed bilateral lateral deviation of the screws after placement.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT IN A EXCELSIUSGPS SURGERY, THE ARM LOST MOTION COMPLETELY AFTER REACHABILITY CHECK. THE REACHABILITY CHECK WAS SMOOTH WITHOUT ANY PROBLEMS. THE CSR WENT TO EXTEND ARM FOR DRAPING AND ARM WOULD NOT MOVE WHEN PRESSING THE CONTROL PANEL BUTTONS. NO WARNINGS APPEARED. THE CSR ATTEMPTED TO MOVE THE ARM WITH THE SURGEON'S BRACELET, HOWEVER ARM STILL WOULD NOT MOVE. NO WARNING APPEARED. THE CSR DID THE FOLLOWING TROUBLESHOOTING: MULTIPLE SOFTWARE RESETS, MULTIPLE HARD SHUTDOWNS AND REBOOTS, MULTIPLE ATTEMPTS TO RE-HOME THE ARM AND RECEIVED A "ROBOT ARM HOMING FAILED" WITH INFORMATION RING TURNING RED. THE MOTION OF ARM WAS NEVER REGAINED, ARM WAS NOT ABLE TO BE DOCKED EITHER. THE SURGEON HAD TO CANCEL THE CASE DUE TO ROBOT BEING UNUSABLE AFTER PATIENT WAS INTUBATED.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED A RELIGHT-SIDED DBS ELECTRODE WAS IMPLANTED USING EGPS. THE RADIAL ERROR WAS 1.8MM. SURGEON DECIDED TO REMOVE THE ELECTRODE, AND PLACE A NEW ONE IN A DIFFERENT LOCATION. THE ACCURACY WAS DEEMED ACCEPTABLE.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING AN EXCELSIUSGPS SURGERY, WE SPUN WITH E3D, SCAN LOOKED GREAT, WE PLACED ALL SCREWS, LOW OFFSET, GREEN DRB AND SURVEILLANCE, THEN WE TOOK X-RAYS POST-ROBOT AND LEFT T10/11 WERE MEDIAL INTO THE CANAL. WE REMOVED SCREWS AND THE SURGEON SAW CSF. WE RESPUN, AND REPLACED BOTH SCREWS. THE T11 WAS CORRECTED BUT T10 WENT EXACTLY WHERE IT WAS PREVIOUSLY, AGAIN ALL INDICATORS ON THE ROBOT WERE GREEN. WE REMOVED THE SCREW. THERE WAS ALSO A DURAL TEAR. THE PATIENT WAS DOING WELL THE NEXT DAY WITH NO DEFICITS.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING AN EXCELSIUSGPS SURGERY THEY HAD A FAILURE WITH ROBOT IN WHICH ALL OF THE SCREWS WERE OFF TRAJECTORY, FORCING THE SURGEON TO REMOVE THE HARDWARE. THERE WAS NOT SURVEILLANCE WARNING OR SKIVE/ OFFSET WHEN PLACING THE SCREWS.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING AN EXCELSIUS GPS L3-5 PRONE XLIF WITH RISE-L AND RELINE SCREWS. THE DRB PLACED IN LEFT PSIS, SM IN RIGHT PSIS. THE E3D REGISTRATION SCAN, AND PLANNING WAS DONE BY THE SURGEON. WE STARTED ON LEFT L3, HIGH SPEED DRILL APPEARED ACCURATELY ON PEDICLE AS EXPECTED. PILOT DRILL THEN HAD TROUBLE DRILLING FULL DEPTH. THE SCREW IMPLANTED WITHOUT FULLY DRILLING PILOT HOLE THE RIGHT L3 SCREW PLACED QUICKLY BY THE SURGEON. WE NOTICED THAT THE HIGH SPEED DRILL APPEARED SLIGHTLY INACCURATE SO WE ASKED THE SURGEON TO CHECK ACCURACY ON BONE. AS THE PROCEDURE WAS MIS WE CHECKED ON THE LEFT L3 BONE, WHICH AGAIN APPEARED ACCURATE. WE PLACED LEFT L4 SCREW WHICH AGAIN APPEARED ACCURATE, BUT HAD THE SAME ISSUE WITH DRILLING DEPTH. WE THEORISED THAT PILOT DRILL WAS A LITTLE BLUNT, AND SOME VISIBLE SCLEROSIS IN THE LEFT PEDICLES MIGHT BE CAUSING ISSUES. WE WENT TO RIGHT L4 AND AGAIN SAW THE SAME INACCURACY AS AT RIGHT L3. THIS TIME WE STOPPED THE CASE AND RESCANNED. THE SCAN FOUND THAT LEFT L3 AND L4 HAD BREACHED MEDIALLY BY A FEW MM. THE RIGHT L3 APPEARED WELL PLACED. WE EXPLANTED LEFT SIDE L3-4 SCREWS, PLACED ALL SO-FAR UNPLACED SCREWS, THEN RE-IMPLANTED LEFT L4 AND L3. THE PO

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING AN EXCELSIUSGPS SURGERY THE ACCURACY SEEMED OFF WITH DISC PREP INSTRUMENTS, THEY WERE SHOWING MORE CRANIAL THAN THEY APPEARED ON FLUORO. THE RIGHT L4 SCREW WAS LATERAL TO PLAN. THEY REDIRECTED SCREW. FLUORO WAS USED TO ASSIST IN DISC PREP AND INTERBODY PLACEMENT.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT IN AN L4-5 TLIF CASE PERFORMED ON (B)(6) 2026, WE HAD BOTH L4 SCREWS MISS, UP SUPERIOR INTO THE DISC SPACE. WE USED E3D TO DO AN AUTO-REGISTRATION INTRA OP SPIN. L4L WAS THE FIRST SCREW. WHEN DURAPRO WAS BROUGHT IN, IT SHOWED ON TRAJECTORY, BUT ALREADY TO DEPTH IN THE BODY. I ALERTED THE SURGEON THAT LOOKED WRONG, HE SAID THE PATIENT HAD VERY POOR BONE AND PUSHED PRETTY HARD ON THE DRILL. I HAD HIM MOVE THE ARM TO L5, AND THEN BRING IN DURAPRO TO SEE IF THERE WAS AN ACCURACY ISSUE. HE TOUCHED BONE AND CONFIRMED ON THE SCREEN THAT IT WAS CORRECT ALIGNMENT. WE WENT AHEAD AND DROPPED ALL 4 SCREWS. L4 SCREWS WERE SHOWING ACCURATE INSTRUMENTATION , BUT THE SURGEON ADMITTEDLY SAID THAT THE SKIVE METER WAS ALERTED DUE TO HIM PUTTING COUNTER PRESSURE ON THE DRIVER. AFTER SCREWS WERE PLACED, WE TOOK FLOURO SHOTS AND BOTH L4 SCREWS WERE FAR OFF OF THE PLAN. WE REMOVED, AND THEN TOOK THE NAV DILATOR AND STUCK THAT THRU THE MAS REDUCTION SCREW IN BOTH SIDES, AT L5. NAVIGATION LOOKED ACCURATE. TRIED TO ADJUST THE SCREW PLAN AT L4 AND WENT AGAIN WITH TAP, AWL. INSTRUMENTS FOLLOWED RIGHT WHERE WE HAD PLANNED. LEFT THE TAP IN, AND TOOK A FLOURO SHOT. IMAGE WAS CORRECT ON SCREE

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING AN EXCELSIUSGPS SURGERY, VERIFICATION OF ALL INSTRUMENTS AND END EFFECTORS WAS COMPLETED SUCCESSFULLY. WE WORKED ON MIS T12-L2 ROBOT-ASSISTED FRACTURE CASE WITH THE SURGEON BUT ENCOUNTERED AN ISSUE WITH ACCURACY. AFTER PLACING THREE SCREWS ON THE RIGHT SIDE, A SPIN REVEALED THAT THE L1 SCREW WAS OFFSIDE TOWARD THE MEDIAL CANAL, DESPITE THE PLAN BEING CORRECT. THE SURGEON WAS CONCERNED ABOUT THIS PLACEMENT ERROR, AS THE DRB AND SURVEILLANCE MARKERS WERE ALL CORRECTLY POSITIONED. HE DECIDED TO CHANGE THE PLAN AND COMPLETED THE CASE USING MEDTRONIC FREE HAND NAVIGATION. THE OPERATION WAS COMPLETED SUCCESSFULLY, AND THE PATIENT IS DOING WELL POST-OP.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING AN EXCELSIUS GPS CERVICAL CASE WITH EXTENSION TO C2/C1 SUPERIORLY AND TO C7, T1, AND T2 INFERIORLY. THE OLD CONSTRUCT WAS AT C3-C5. THE C1-C2 SCREWS WERE PLACED ACCURATELY AND CONFIRMED WITH THE CONTROL SCAN. AFTER PLACEMENT OF THE C7-T2 K-WIRES AND COMPLETION OF A CONTROL SCAN, THE C7 RIGHT-SIDED TRAJECTORY WAS FOUND TO BE MEDIAL. THE SURGEON CORRECTED THE TRAJECTORY USING THE TRADITIONAL TECHNIQUE. ALL OTHER SCREWS WERE PLACED CORRECTLY. IT SHOULD BE NOTED THAT NAVIGATION ACCURACY WAS CHECKED MULTIPLE TIMES DURING THE PROCEDURE AND WAS CONFIRMED TO BE ACCURATE THROUGHOUT THE CASE. THE SURGEON ALSO REPORTED THAT IN THE LAST COUPLE OF CASES HE EXPERIENCED SIMILAR INACCURACY WITH LEFT-SIDED SCREWS.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT IN A SURGERY USING THE EXCELSIUS GPS, WHILE NAVIGATING SCREWS THE SURGEON BELIEVED THE NAVIGATION WAS INACCURATE. HE LEFT ONE SCREW OUT. AFTER TAKING X-RAY WE SAW THAT ONE OF THE 7 SCREWS PLACED WAS SUPERIOR AND LATERAL TO THE PLANNED TRAJECTORY. HE REMOVED THAT SCREW AND REVISED IT WITH FREEHAND NAVIGATION AS WELL AS THE OTHER SCREW THAT WAS NOT PLACED.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT AFTER AN EGPS CRANIAL SURGERY, THE PATIENT WAS THEN TAKEN DOWN FOR A POST-OP CT. ONCE COMPLETED, THE SURGEON BROUGHT THE SCAN TO THE EGPS FOR EVALUATION. WHEN REVIEWING THE POST-OP CT FOR EVALUATION, THE SURGEON NOTED THAT THERE WAS A HEMORRHAGE AROUND TWO OF THE CLOSELY PLACED LEADS.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING AN EXCELSIUS GPS SURGERY THE DRB WAS BUMPED/SHIFTED DURING CASE. THE PATIENT WAS ON THE HEAVIER SIDE; THERE WAS LOT OF TISSUE PUSHING. THE FIRST SCREW ENDED UP BEING A MISS. WE ENDED UP BRINGING IN THE C-ARM TO RETAKE SHOTS. FIRST SCREW WAS NOT PLACED WITH DURA-PRO AS WE COULD NOT GET IT TO VERIFY THIS MORNING. HIGH SPEED BURR, TAP THAN SCREW WAS USED. AFTER THE RE-MERGE WE FINALLY GOT DURAPRO TO VERIFY SO WE PLACED L5 RIGHT AN L4 LEFT NORMALLY. THE DOCTOR PLACED L5 LEFT, BUT HE DID NOT LIKE THE SCREW PLACEMENT SO HE ABORTED THE ROBOT. THE SURGEON ENDED UP REPOSITIONING THE SCREW, PLACING IT BY HAND. HE DID THE REST OF THE CASE WITHOUT NAVIGATION.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT AN EXCELSIUS GPS SURGERY OF AN O-ARM/ICT INTRA-OP CASE RESULTED IN 2 MISPLACED SCREWS. THE CASE WAS C7-T1. THE SURGEON PLACED BOTH LEFT SIDE SCREW FIRST, THEN PLACED BOTH RIGHT SIDE SCREWS. ONCE SCREWS WERE PLACED,AN X-RAY SHOWED BOTH C7 AND T1 RIGHT SCREWS WERE SUPERIOR AND MEDIAL TO PLAN (T1 R SCREW WAS ENTIRELY IN THE DISC SPACE); NOTHING WAS INDICATED WHILE NAVIGATING THAT THESE SCREWS WERE OFF - THERE WERE GREEN BOARDERS,LOW OFFSET, LOW/NO DEFLECTION, IMPLANT RECEIVED "CHECK MARK". THE LEFT SIDE SCREWS WERE PLACED TO PLAN AND LANDMARK CHECKS WERE SUCCESSFULLY DONE AFTER SPIN PRIOR TO ANY SCREWS BEING PLACED .BOTH RIGHT SIDE SCREWS WERE REMOVED, ICT WAS RE-POSITIONED AND WE DID A NEW O ARM SPIN. C7 R AND T1 R WERE RE-PLANNED AND REPLACED THROUGH THE EE. THEN, X-RAY SHOWS T1 R IS GOOD BUT C7 R TO NOW BE TOO LOW IN THE PEDICLE- AGAIN NOTHING INDICATING OUR SCREW WAS OFF FROM THE PLAN. THIS SCREW WAS REMOVED, RE-PLANNED AND SUCCESSFULLY REPLACED. CASE WAS COMPLETED, NO ADVERSE REACTIONS RECORDED.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING AN EXCELSIUS GPS SURGERY, RECENTLY WE REPLACED OUR 12" FLUORO FIXTURE WITH A FLAT PANEL. HE HAVE HAD A FEW SCREWS MISPLACE AND ALWAYS ON THE LEFT PEDICLES. WE BELIEVE THESE ARE DUE TO SKIVE ISSUES BECAUSE OF HYPERTROPHIC FACETS. THE SCREWS HAVE BEEN LOW AND LATERAL DEVIATION FROM STARTING POINT ALTHOUGH THE END EFFECTOR PLUMB LINE IS TRUE. WHEN WE DRAG THE CENTROID AND PLACE IT ON THE LATERAL PROJECTION WE HAVE NOTICED THAT THE AP CENTROID IT IS ALWAYS OFF OF THE SPINE IN THE AP PROJECTION. THE 12" ROUND ALWAYS HAD IT WITHIN THE BONY PARAMETERS ON THE VERTEBRAL BODY. THEN WE WOULD TWEAK IT.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT IN AN EXCELSIUS SURGERY, AFTER THE CASE WE TOOK POST OP X-RAYS AND NOTED THAT RIGHT L5 HAD BREACHED THE PEDICLE LATERALLY AND THE ROD HAD ROTATED. WE DID GET A SKIVE READING WITH THE BURR OFF THIS SCREW HOLE PREP BUT WE THOUGHT WE HAD CORRECTED IT AS THE REST OF THE INSTRUMENTS- DRILL, TAP AND DRIVER ALL HAD THEIR GREEN BORDER AROUND THE SCREEN AND LOOKED TO BE ON TARGET. THIS SURGEON DOES NOT LIKE TO TAKE POST OP IMAGES AFTER INSERTING HIS SCREWS, HE WAITS UNTIL HE HAS DECOMPRESSED AND INSERTED HIS RODS AND DOES A FINAL X-RAY. IT'S ONLY THEN DID WE GET TO SEE THAT THE SCREW HAD BREACHED THE PEDICLE LATERALLY. WE CAN'T SAY WHETHER IT WAS BREACHED DURING INSERTION OR DUE TO HIM HAVING MAJOR DIFFICULTY IN SEATING THE ROD WHICH THEN ROTATED AND POSSIBLY CAUSED THE SCREW TO BREAK OUT THE PEDICLE WALL. THE PATIENTS ANATOMY WAS CHALLENGING SO THE SCREW WAS PLANNED QUITE LATERALLY IN ORDER TO LINE UP THE HEADS FOR EASIER ROD INSERTION.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING AN EXCELSIUS GPS CASE, WE WERE RUNNING A PRE-OP MERGE FOR ROBOTIC REGISTRATION, AND THE ROBOT FROZE. IT KICKED ME BACK TO THE INITIAL LOG IN SCREEN. WE HAD TO RE LOG IN TO SURGEON PROFILE AND GO BACK INTO CASE. WE WENT BACK TO REGISTER AND PROCEEDED. THIS IS THE SECOND TIME WE HAVE SEEN THIS. SECONDLY, RIGHT L4 SCREW WAS PLACED SUPERIORLY. DURING CASE, IT APPEARED THAT THE PA PLACING SCREW SKIVVED THE HS BURR AND DRILL SUPERIORLY, IN WHICH WE SPOKE UP ABOUT AND SUGGESTED THAT THEY RE-DO THIS SEQUENCE. AS HE WAS PLACING SCREW, THE SCREW ALSO LOOKED SUPERIOR AND NOT TO PLAN, WE ONCE AGAIN SPOKE UP AND SUGGESTED TO RE PLACE SCREW. ONCE FINALLY PLACED SCREW AND TOOK IMAGE, SCREW WAS SUPERIOR TO PEDICLE. WE REPLANNED A NEW TRAJECTORY. THE DOCTOR TOOK OUT SCREW AND TRIED TO DO FREE-HAND NAV BUT STILL FELT THE SCREW WAS NOT TO PLAN. HE ENDED UP USING JAMSHIDI TECHNIQUE AND NO NAV OR ROBOT TO PLACE.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT IN AN EXCELSIUS GPS SURGERY, AFTER REGISTRATION, ROBOT WAS BROUGHT INTO THE FIELD. THE SURGEON SELECTED LL2 AND ARM MOVED TO TRAJECTORY BUT INSTEAD OF MOVING TOWARDS THE PATIENT THE ARM, WHILE ON TRAJECTORY, MOVED BACK AWAY FROM THE PATIENT. THIS KEPT HAPPENING UNTIL A NEW SCREW TRAJECTORY WAS SELECTED, THEN ARM MOVED TOWARDS PATIENT. EXCEPT, THE ARM WAS COMING AS CLOSE AS IT COULD TO THE SKIN AND STOPPING DUE TO FORCE AGAINST THE EE. AFTER MARKING, ARM WAS MOVED OUT OF THE FIELD FOR EXPOSURE. THE ARM WAS MOVED BACK INTO THE FIELD AND MOVE TO TRAJECTORY BUT INSTEAD OF TOUCHING SKIN IT STOPPED A MORE EXPECTED HEIGHT ABOVE THE PATIENT'S SKIN. WE THOUGHT THAT NAV WAS OFF BECAUSE AT THE SAME TIME, SM WENT TO RED AND DRB/SM SHIFT ALERT OCCURRED. THE SURGEON DID A NAVIGATIONAL CHECK WITH VERIFICATION PROBE AND IT WAS DETERMINED THE NAV WAS OKAY DESPITE THE NEW HEIGHT ON THE ARM. THE SM WAS RESET USING UI BUTTON. THE RIGHT/DOWNSIDE L2-L5 PLACED WITHOUT ISSUES. THE LEFT L2 THEN ATTEMPTED TO BE PLACED BUT KEPT SKIVING LATERALLY BUT PLAN SEEMED GOOD. THE SCREW WAS SKIPPED. THE LL3-4 PLACED WITHOUT ISSUE. THE LL5 SKIPPED. NO ISSUES DURING INTERBODY PORTION OF NAVIGATION O

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT IN A SURGERY WITH THE EXCELSIUS GPS, AFTER REGISTRATION WAS COMPLETED, AND BEFORE THE SURGEONS BEGAN SCREW PLACEMENT, A "DRB SHIFT" MESSAGE APPEARED ON THE MONITOR. IT IS UNCLEAR WHETHER NAVIGATION ACCURACY WAS AFFECTED AT THAT POINT AND IF THE SURGEONS CHECKED THE NAV. ACCURACY. THE SURGEONS PROCEEDED WITH SCREW PLACEMENT. THE CONTROL X-RAYS LATER SHOWED THAT ALL SCREWS WERE MISPLACED TOWARD THE DISC, BREACHING THE ENDPLATES. THE SCREWS WERE SUBSEQUENTLY REVISED AND REPOSITIONED USING THE CONVENTIONAL METHOD WITH X-RAY GUIDANCE. WE HAVE BEEN INFORMED THAT THERE WERE NO POSTOPERATIVE SIDE EFFECTS FOR THE PATIENT. THIS EVENT OCCURRED IN GERMANY.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A SURGERY USING THE EXCELSIUS GPS, THE MERGE WAS APPROVED AND SURGEON PROCEEDED WITH ROBOT NAVIGATION. THE HIGH SPEED BURR AND TAP WERE USED AND SHOWED ON TRAJECTORY OF L2 LEFT. THE SCREW WAS PLACED BUT SHOWED OFF TRAJECTORY. THE SCREW WAS TAKEN OUT. WE USED AWL AND TOOK X-RAY AND IT WAS ON PLAN. WE DID A NEW SECOND MERGE AND PROCEEDED WITH ROBOT NAVIGATION. THE LEFT L2 SCREW WAS PLACED. THE X-RAY SHOWED CORRECT PLACEMENT OF L2 SCREW LEFT. THE L2 RIGHT DRILL AND TAP SHOWED ON TRAJECTORY. THE SCREW WAS PLACED AND SHOWED LOW AND TAKEN OUT. THE X-RAY WAS CHECKED. WE PROCEEDED WITH SCREW AGAIN AND SCREW SHOWED MEDIAL BREACH ON X-RAY. THE SCREW WAS TAKEN OUT AND ROBOT WAS ABORTED. THE SURGEON PROCEEDED WITH ANOTHER VENDOR, DEPUY VIPER PRIME TO COMPLETE THE CASE.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT IN A EXCELSIUS GPS SURGERY THE SURGEON DID A 2 LEVEL ALIF L4-S1. THE MERGE AND ALL SCREWS WENT WELL EXCEPT L5 ON RIGHT. THE SCREW MISSED HIGH AND WAS HITTING THE CAGE. WE DID GET AN ERROR MESSAGE AT THE BEGINNING OF THE CASE. AFTER FIRST MERGE THE ROBOT WOULD NOT RAISE OR LOWER SO WE HAD TO DO A HARD SHUTDOWN AS A SOFTWARE REST DID NOT WORK. ALL SCREWS WERE SUCCESSFULLY PLACED AFTER DOING A NEW MERGE.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A SURGERY USING THE EXCELSIUS GPS, THE LEFT T5 SCREW INITIALLY WAS PLACED MEDIALLY BREACHING CANAL A FEW MILLIMETERS (VIA CT SCAN WITH E3D). ONCE IDENTIFIED, WE SUGGESTED TO DOCTOR TO REPLAN AND RE PLACE SCREW ON A NEW CT SCAN REGISTRATION, AND RE PLACE SCREW LATERALLY. WE SUGGESTED USING A LARGER SCREW, BUT HE WANTED TO STAY AT A 4.5 SCREW. THE NEW SCREW PLACED MORE LATERALLY IN PEDICLE AND NOT BREACHING CANAL FROM WHAT WE COULD TELL ON FINAL X-RAYS. WE ARE REPORTING BECAUSE WE FELT AS THOUGH WE WERE KEEPING A KEEN EYE ON THE EGPS SCREEN FOLLOWING PROTOCOLS FOR NAVIGATION, AND WE DID NOT FEEL ALERTED/ALARMED WHEN PLACING SCREW, FOR THE SCREW TO LOOK MEDIAL AS IT APPEARED ON CT SCAN. WE DID HOWEVER NOTICE WHEN HE FIRST USED THE HS DRILL ON T5L, IT DID LOOK MEDIAL TO US. WE RE-SETTLED THE ROBOTIC ARM ON TO TRAJECTORY AND PROCEEDED. THE REPLACED SCREW WAS TO PLAN, NO SCREW LEFT BREACHING CANAL.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT AT A REVISION SURGERY USING THE EXCELSIUS GPS THE DURAPRO, HSB, TAP, AWL, PROBE, AND CREO 5.5 DRIVER WERE VERIFIED. THE SURGEON EXPOSED AND REMOVED HARDWARE AT L3-5. THE DRB WAS PLACED IN RIGHT PSIS AND SM IN LEFT PSIS. THE SM ACTIVATED PRIOR TO SPIN USING UI BUTTON. THE E3D SPIN WAS PERFORMED WITHOUT ISSUE. THE ARM LINED UP ON LL1 AND DURA PRO INITIALLY USED. THE SURGEON DID NOT LIKE HOW IT LOOKED INFERIOR ON NAVIGATION. SHE HAS HAD CONCERNS ABOUT HOW DURAPRO HAS BEEN LOOKING ON NAV, SPECIFICALLY THE 260MM 3.5/4.5 TAPER BIT, FOR THE LAST FEW CASES. THE SURGEON SWITCHED TO HSB, TAP, DRIVER WORKFLOW. FOR LL1, HSB AND TAP LOOKED GOOD. AS SHE WAS PLACING SCREW AND IT REACHED 50% IN THE PEDICLE IT STARTED TO SHOW IT PUSHING LATERALLY AND BY THE TIME IT WAS DOWN, THE SCREW SHOWED LATERAL. THE XRAY WAS BROUGHT IN AND SHOWED SCREW WAS GOOD. THE PROCESS WAS REPEATED WITH RL1 WITH SCREW LOOKING LATERAL AND X-RAY CONFIRMED GOOD PLACEMENT. THE SURGEON MOVED TO LL2 WITH SIMILAR NAVIGATION AND OUTCOME. AT THIS POINT, TAP WAS ALSO STARTING TO LOOK LATERAL. THE SURGEON HAD TO TRY MULTIPLE TIMES TO GET SCREW TO ENTER PEDICLE AT A POSITION THAT WAS NOT CONCERNING TO HER BUT IN

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A SURGERY WITH AN EXCELSIUS GPS THERE WAS AN ISSUE, BEGINNING WITH VERIFICATION. WE VERIFIED ALL INSTRUMENTS AND WHEN WE WENT TO USE THE SYSTEM HAD LOST VERIFICATION OF THE HIGH SPEED DRILL. THE SYSTEM HAS PREVIOUSLY LOST VERIFICATION OF THIS INSTRUMENT, AND THE END EFFECTOR. NO MATTER WHAT THOUGH, THE PROJECTIONS OF THE INSTRUMENTS NEVER SEEM TO MATCH UP TO THE TRAJECTORY OF THE END EFFECTOR. WE HAVE EXPLAINED THE INHERENT NOISE ASSOCIATED WITH SPHERES, BUT ITS HARD TO TELL THE SURGEON TO TRUST A TRAJECTORY WHEN THE SCREWS ARE MISSING. WHICH LEADS TO OUR NEXT ISSUE, THOUGH THE BIT AND TAP LOOKED PRETTY ACCURATE (NOT 100% AND HAD TO ADJUST THE ARRAY), THE SCREW MISSED LATERAL AND WE HAD TO REMOVE. SHE RESETTLED HER OFFSET AGAIN, AND PLACED THE SCREW BY HAND AND WE THINK ITS GOOD.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT WHILE USING THE EXCELSIUS GPS SYSTEM, ALL SCREWS WERE LATERAL, DESPITE L3 OBVIOUSLY BEING LATERAL. WE ARE NOW LEAVING THAT SCREW OUT AND HOPING FOR UNILATERAL FUSION AT THAT LEVEL.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING A CASE WE PLACED A SP CLAMP ON S1 TO INSTRUMENT L5-S1 WITH FREEHAND NAVIGATION. DURING THE CASE, AT SEVERAL TIMES, THE DRB HAD SHIFTED DUE TO OVER-MOBILITY OF THE BODY- WE WERE ALERTED FROM WHAT WE VISUALLY SAW, AS WELL AS THE SM GOING RED. WE PERFORMED LANDMARK CHECKS THE FIRST TWO TIMES, AND SM WAS RESET ACCORDINGLY. AFTER A THIRD TIME, THE LANDMARK CHECK WAS OFF WITHOUT A DOUBT. AFTER SCREWS WERE PLACED (RIGHT SIDE ONLY), HE BELIEVED THAT L5 WAS PLACED LATERAL TO PLAN, AS WELL AS S1.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT AT AN EXCELSIUSGPS SURGERY, IT WAS AN SPL CASE INVOLVING T12-L2, WITH A CORPECTOMY AT L1. THE INTRAOPERATIVE CONTROL X-RAYS DID NOT SHOW ANY VISIBLE SCREW MALPOSITION, AND THE SURGEONS PROCEEDED WITH THE SURGERY. HOWEVER, THE POSTOPERATIVE CT SCAN REVEALED THAT THE RIGHT L2 SCREW WAS PLACED MORE LATERALLY THAN INITIALLY PLANNED. ORIGINALLY, THE SCREW HAD BEEN PLANNED USING AN IN-OUT-IN TECHNIQUE DUE TO THE SMALL PEDICLE. FOLLOWING THE CT SCAN RESULTS, REVISION SURGERY WAS PERFORMED, AND THE SCREW WAS REPOSITIONED USING THE TRADITIONAL TECHNIQUE.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT THE DURING SURGERY. SCREWS WERE PLACED STARTING AT T10 ALL THE WAY TO THE PELVIS. E3D SPINS WERE PERFORMED FOR CONFIRMATION AND THE T10R HAD BREACHED MEDICAL 1-2 MM. THIS WAS THE SECOND SCREW PLACED BY THE ROBOT. THE SCREW WAS REPLACELY CORRECTLY.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT WHILE USING THE EXCELSIUS GPS SYSTEM, THE ROBOT MISPLACED L2 SCREWS AFTER PLACING L3 SCREWS PERFECTLY.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT THE SURGEON HAD PLACED DRB ON RIGHT SIDE WITH LPQS, AND SM ON LEFT WHICH WAS ACTIVATED WITH VERIFICATION PROBE. A SPIN WAS COMPLETED WITH E3D, AND MOVED OVER TO THE ROBOT. THE SURGEONS THEN PLANNED SCREWS AT L5 AND S1 BILATERALLY. WILTSE APPROACH WAS PERFORMED ON BOTH SIDES. THE LEFT SIDE L5 AND S1 SCREWS WENT IN WITH NO ISSUES. ON RIGHT L5, SURGEON WENT DOWN WITH HSB THEN TAP, TAP STARTED SKIVING LATERALLY. THE SURGEON TOOK THE TAP OUT, WE RESETTLED ON TRAJECTORY AND SURGEON TRIED TAP AGAIN SAME ISSUE OCCURRED. AT THIS POINT IT WAS DECIDED TO ADJUST PLAN, AFTER SCREW WAS ADJUSTED BACK TO NAVIGATION. THE SURGEON USED HIGH SPEED BURR THEN TAP, IT WAS STILL SKIVING, AT THIS POINT IT WAS SUGGESTED TO USE THE PILOT DRILL. THE PILOT DRILL WAS USED THEN TAP, SURGEON WAS RETRACTING WITH ARMY NAVY. THE PILOT DRILL LOOKED GOOD ON NAVIGATION, THEN TAP WAS USED AND IT SEEMED TO FOLLOW PREVIOUS TRAJECTORY. THE SURGEON THEN PROCEEDED WITH SCREW, WE WERE GETTING HIGH FORCE ON ROBOT AS HE WAS PUTTING IT IN. WE DID GET A CHECK MARK FOR SCREW PLACED. THE RIGHT S1 WAS THEN PUT IN WITH NO ISSUES. THE E3D WAS BROUGHT IN FOR FLURUO SHOTS TO CONFIRM SCREW PLACEMENT. THE AP AND LATER

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT WHILE USING THE EXCELSIUS GPS SYSTEM, AN L1-L3 FUSION OCCURRED AT AN ACCOUNT THAT HAS REPORTED PREVIOUS PROBLEMS WITH THE ROBOT MISSING SCREWS. FSE CAME OUT LAST WEEK AND FOUND THAT THE CAMERA WAS OUT OF SPEC. CUSTOM PERC IN WAS PLACED IN PSIS, AND DRB AND SM WERE ATTACHED TO THE SAME POST. THE WORKFLOW WAS HIGH-SPEED BURR, STRAIGHT PEDICLE PROBE TAP, AND DRIVER. NAVIGATION SHOWED PERFECT PLACEMENT OF SCREW-DOWN PEDICLE. WHEN MOVING TO THE RIGHT L1 TRAJECTORY, THE SURGEON REPORTED THAT THE TACTILE FEEL WITH THE PEDICLE PROBE DIDN'T FEEL RIGHT AND WANTED TO DO ANOTHER SPIN WITH E3D. UPON TAKING OUR FIRST AP SCOUT SHOT TO PREPARE FOR SPIN, WE SAW THAT THE FIRST SCREW AT LEFT L1 WAS COMPLETELY LATERAL TO THE PEDICLE. A NEW SPIN WITH E3D WAS DONE, AND WE COULD SEE THE TRAJECTORY OF THE RIGHT L1 SCREW THAT WE WERE WORKING ON WAS LATERAL AND SUPERIOR WITH O-ARM AND MEDTRONIC STEALTH. IN THE PREVIOUS CASES, WHERE MISSED SCREWS WERE REPORTED, THE ROBOT PLACED SCREWS VERY SIMILARLY TO HOW WE OBSERVED IN THIS CASE. NO DRB SHIFTS WERE OBSERVED BY THE ROBOT OR THE SURGICAL TEAM.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT WHILE USING THE EXCELSIUS GPS SYSTEM, THERE WERE SOME MISPLACED SI-LOC SCREWS THAT WERE REMOVED AND REPLACED UNDER FLUORO. ALL 3 SI R SCREW TRAJECTORIES WERE POSTERIOR TO PLAN. DR. NAVIGATED THE HSB, 3.5 MM DRILL, AND 6.5 MM DRILL, THEN USED THE CANNULATED TAP TO DROP A K-WIRE AND PLACE A COMPETITOR'S SCREWS. WE HAD GREEN BOARDERS AND A LOW OFFSET FOR EACH SCREW.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A SURGERY WITH THE EXCELSIUS GPS, WE HAVE HAD 2 DAYS IN A ROW OF ACCURACY ISSUES. MONDAY WE PLACED 4 QUARTEX SCREWS USING THE 6143.2932 DRIVER. WE DID A FOLLOW-UP 3D SPIN TO VERIFY PLACEMENT AND 3 OF 4 SCREWS WERE PLACED SEVERELY OFF PLAN AND HAD TO BE REPOSITIONED. THE 4TH SCREW WAS NOT PERFECT TO PLAN BUT ACCEPTABLE. OFFSET WAS MEDIAL-LATERAL TO THE LEFT AND INFERIOR. IT WAS THE 1ST,3RD AND 4TH SCREWS THAT NEEDED REPOSITIONING. THE SURGEON OPTED TO FREEHAND NAVIGATE THE REPOSITIONED SCREWS AND OBSERVED QUESTIONABLE ACCURACY DURING THAT. SPIN WAS PERFECT, NO ONE MOVED THE DRB. WE CAN THINK OF NOTHING WE DID THAT WOULD HAVE COMPROMISED ACCURACY.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT WHILE USING THE EXCELSIUS GPS SYSTEM, THIS WAS A T3-T9 FUSION WITH THE ROBOT USING COMPETITIVE HARDWARE. ONLY NAVIGATED INSTRUMENTS WERE THE HSB, DRILL, TAP, AND AWL. A SPINOUS PROCESS CLAMP WAS PLACED AT T10, AND SM WAS PLACED ON TOP OF THE CLAMP. THE SURGEON WAS INFORMED ABOUT THE CAVEATS OF DOING THIS. AFTER THE HSB AND DRILL WERE USED ON THE FIRST TRAJECTORY ON THE RIGHT T3, THE SURGEON PLACED THE TAP AT THE BEGINNING OF THE PILOT HOLE AND PLACED A K-WIRE DOWN THE TAP WITHOUT THE USE OF ANY IMAGING. THE SURGEON REPORTED THAT K-WIRE FELT LIKE IT WAS "BOUNCING" AND NOT IN BONE. HE WAS CONCERNED THAT NAVIGATION WAS INACCURATE AND PLACED THE SCREW USING A PEDICLE FINDER AND C-ARM FOR IMAGING. SHORTLY AFTER MOVING TO THE LEFT, T3 ANESTHESIA REPORTED THE PATIENT'S BLOOD PRESSURE WAS DROPPING. THE SURGICAL TEAM QUICKLY CLOSED THE PATIENT AND FLIPPED TO THE STRETCHER. AFTER FLIPPING ONTO A STRETCHER, ANESTHESIA REPORTED THE PATIENT'S LUNG WAS COLLAPSING AND THAT SHE HAD A POSSIBLE PNEUMOTHORAX. A CHEST TUBE WAS PLACED, AND THE PATIENT WAS STABILIZED TO GET HER TO CT FOR IMAGING.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING AN EXCELSIUSGPS SURGERY THE SURGEON BELIEVED THAT THE EGPS NAVIGATION WAS OFF TRAJECTORY. BOTH THE DOCKING WITH THE RETRACTOR AND IMPLANT PLACEMENT RESULTING IN ANTERIOR PLACEMENT, ALTHOUGH PLANNING AND REAL TIME NAVIGATION WERE DISPLAYING MIDLINE PLACEMENT. THE SURGEON HAD TO CLOSE RETRACTOR, RE-MERGE, AND ADJUST PLACEMENT OF THE RISE-L CAGE. HE WAS UNEASY ABOUT THE DANGERS OF GOING TOO ANTERIOR AT THE L2-4 LEVELS WITH THE GREAT VESSELS BEING THERE AND THE POSSIBILITY OF PUNCTURING/RUPTURING THE ALL. THE IMPLANT WAS REMOVED AND REDIRECTED. THE NAV IMAGING SHOWED THE SURGEON WAS PLACING THE IMPLANT MIDLINE BETWEEN THE TWO VERTEBRA AS PRE PLANNED. THE XR AFTER PLACEMENT SHOWED THE IMPLANT SIGNIFICANTLY MORE ANTERIOR. THE ALL DID NOT SEEM TO BE COMPROMISED, BUT WE REMERGED AND USED THE SAME IMPLANT TO COLLAPSE AND REDIRECT. ULTIMATELY, SURGERY WAS COMPLETED WITH NO PATIENT COMPLICATIONS.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING AN EXCELSIUS GPS SURGERY THERE WAS 4 SCREW CREO MIS BACKUP OF ALIF. THE SM ON RIGHT PSIS DRB ON LEFT PSIS, ICT PLACE ON DRB LP QUATRO SPIKE. THE INTRA OP SPIN WITH O-ARM AND FILES TRANSFERER TO EGPS VIA USB. ALL 4 SCREWS PLANNED BY SURGEON. THE ICT WAS REMOVED AND SM VERIFIED. THE POSTOP SPIN SHOWED 4 SCREWS HAD SHIFTED OF PLAN BY APPROX 2-3MM LATERAL. NO IOM ISSUES. THE SURGEON DECIDED TO REPOSITION THE L5 SCREWS BY HAND.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING AN EXCELSIUS GPS SURGERY, WE DID A INTRA-OP SPIN WITH DRB IN PSIS WITH OPEN INCISION, DOING A PARTIAL REVISION AND ADDING A LEVEL ABOVE AT L2. THE SURGEON REMOVED SCREWS AT L3 LEFT AND L4 LEFT BEFORE SPIN. WE DID OUT INTRA-OP SPIN WITH E3D AND THEN PLANNED SCREWS. THE PATIENT HAD SOME SCOLIOSIS AT THE LOWER LEVELS AND WE PLANNED THE NEW SCREW TRAJECTORIES A LITTLE MORE LATERAL. ALL OF THE SCREWS WERE PLACED CORRECTLY EXCEPT L4 LEFT (LAST SCREW) WHICH ENDED UP BEING DEEP. WE CHECKED NAV BEFORE PLACING SCREWS AND EVERYTHING LOOKED CORRECT. AS WE WERE DOING LAST SCREW, THE REP TOLD SURGEON THAT IT LOOKED LIKE THEY WERE DOWN EVEN THOUGH THEY DID NOT RECEIVE "CHECK MARK" FOR IMPLANT PLACED. THE SURGEON PROCEEDED TO CONTINUE TWISTING SCREW AND UP ON X-RAY THE SCREW WAS DEEP. THE REP BELIEVES THAT THE SCREW FELL INTO THE OLD HOLE TRAJECTORY AND THEN THEY OVER TIGHTENED SCREW.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT AT AN EXCELSIUS GPS SURGERY, WE HAD A MISPLACED SCREW. IT WAS E3D INTRA-OP, MIS, CREO MIS IMPLANTS. THERE WAS A KYPHOPLASTY DONE BEFORE THE SPIN AT L1. THEN THE SCREWS PLANNED FOR T12 AND L2. THERE WAS A SPIN DONE AFTER KYPHOPLASTY. THE SCREWS PLANNED WITH THE SURGEON AND THE END EFFECTOR BROUGHT IN. WE WENT: HIGH SPEED BURR, PILOT DRILL, TAP, SCREW. THE FIRST SCREW DID NOT GIVE US A GREEN CHECK MARK. THE SURGEON DECIDED TO CHECK THE SCREW VIA FLUORO AND FOUND THAT IT WAS PLACED OUTSIDE OF THE PEDICLE. THE SCREW WAS REMOVED AND REPLACED IN AN APPROPRIATE POSITION IN PEDICLE AFTER A SECOND SPIN. THE NEUROMONITORING DID NOT DETECT ANY RISE IN NUMBERS FROM THE SCREW. THE PATIENT WAS SAID TO BE IN STANDARD RECOVERY FROM SURGERY. A RE-SPIN WAS DONE AND ALL FOUR SCREWS WERE PLACED ACCURATELY AND CONFIRMED VIA FLUORO.