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 WHILE USING THE EXCELSUS GPS SYSTEM, THE SCREW MISSED TARGET AND APPEARED TOO HIGH IN PEDICLE.THEY BELIEVE THE TRAJECTORY WAS SLICED BUT NEED AN ACCURACY CHECK REGARDLESS. THEY REPLACED SCREW WITH NEW PLAN.

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 SURGEON DECIDED TO ABORT A EXCELSIUS GPS SI LOK SURGERY ON (B)(6) 2026. HE WAS NOT CONFIDENT WITH THE ACCURACY AND SAFETY CHECKS. THE ENTIRE SURGERY WAS ABORTED AND THE PATIENT WAS ALREADY UNDER ANESTHESIA.

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 REVISION CASE WITH THE SURGEON WE HAD A SCREW PLACED LATERALLY OF THE INTENDED PLANNED SCREW, THE SCREW THAT WAS PLACED LATERALLY WAS THE LEFT L3 SCREW. WE ALSO HAD SOME DIFFICULTY WITH MOTION ON THE MERGE, WHICH WAS SURPRISING BECAUSE THE PATIENT HAD PREVIOUSLY IMPLANTED HARDWARE WHICH USUALLY MAKES THE PROCESS EASIER. THE LATERALLY PLACED SCREW WAS BACKED OUT AND RE-DIRECTED MANUALLY WITHOUT THE ROBOT. NONE OF THIS CAUSED ANY ISSUES WITH THE PATIENT OR PROCEDURE. THE SURGEON HAS REQUESTED THAT THE CALIBRATION OF THE ROBOT BE CHECKED.

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, A SCREW WAS MISPLACED DURING A T11-L3 PERCFUSION CASE TODAY. THE SCREW WAS REMOVED, AND WE DID THE REST UNDER FLUORO WITHOUT THE ROBOT. EVERY INSTRUMENT HE PUT DOWN THE END EFFECTOR WAS SUPER OFF EVEN THE ANATOMY CHECKS WERE ACCURATE. IT COULD'VE BEEN A SCAN ISSUE WE DON'T KNOW.

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 WHEN DOING AN SI JOINT FUSION WITH OUR SURGEON, OUR MERGE SEEMED TO BE GOOD. HOWEVER, UPON STARTING THE FIRST SCREW, THE HIGHSPEED DRILL WAS NOTICEABLY DEEPER THAN ITS ACTUAL DEPTH. WE TRIED TO FIX IT AND WHEN STANDARD TROUBLE SHOOTING WAS DONE NOTHING CHANGED BUT THE SURGEON WANTED TO PROCEED. THE SCREW PLACED WAS POSTERIOR AND INFERIOR TO THE PLAN. WE DECIDED TO COMPLETELY REMERGE. SIMILAR SHOTS WERE TAKEN AND THE SCREWS WERE PLACED TO PLAN WITH NO DEPTH ISSUES.

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, PEDICLE SCREWS WERE NOT PLACED AS PLANNED WITH THE E3D INTRAOP EXCELSIUS 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 THE SURVEILLANCE HAS BEEN UNABLE TO HOLD GREEN STATUS AND DRIFTS TO YELLOW AND RED CONSTANTLY FOR THE LAST SEVERAL WEEKS. TODAY ANOTHER SCREW WAS PLACED LATERAL TO THE PEDAL SIMILAR TO WHAT HAPPENED TWO WEEKS AGO ON THE SAME UNIT EXHIBITING THE SAME PROBLEMS. THIS HAPPENED ONE OTHER TIME A FEW WEEKS EARLIER. THE SURGEON REMOVED THE BREACHED SCREW AND REPLACED USING TRADITIONAL NON-ROBOTIC/NAVIGATED MANNER. THE SURGEON HAS PUT OVER A THOUSAND SCREWS IN WITH THE ROBOT AND THIS IS THE SECOND TIME THIS HAS HAPPENED IN THE LAST TWO WEEKS WITH THE SAME UNIT EXHIBITING THE SAME ISSUE.

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 E3D TO PRE OP MERGE, NAVIGATION LOOKED CORRECT BUT UPON TAKING X-RAYS, NAVIGATION WAS OFF A SIGNIFICANTLY ANTERIORLY. THE DISC PREP THAT WAS DONE BASED OFF THE GPS NAVIGATION ON THE ROBOT RESULTED IN VIOLATING THE INFERIOR ENDPLATE OF THE SUPERIOR VERTEBRAL BODY, WHICH CAUSE THE SABLE CAGE TO SUBSIDE. ON THE NAVIGATION, THE CAGE LOOKED LIKE IT WAS WELL WITHIN THE DISC SPACE, BUT UNDER X-RAY IT WAS CLEARLY NOT. WE TRIED TO RE-PLACE THE CAGE BUT HAD THE SAME RESULT.

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, IT WAS NOTICED THAT AFTER TAKING X-RAYS IN THE OR FOR THE PRE OP CT WORKFLOW AND DOING THE MERGE, THE PLANNED SCREWS WERE TOTALLY WRONG IN THE X-RAY. WE TOOK THEM OUT TO BE NOT HASSITATED. WHEN WE PLACED THE FIDUCIALS INTO THE LATERAL VIEW VERTEBRA, THE AP ONES WERE COMPLETELY OFF AND NEEDED TO BE PLACED IN THE CENTRE. THEN WE HAD AN ANATOMICAL SHIFT IN LATERAL VIEW. WE COULD NOT CHOOSE ALL THE DIFFERENT VIEWS LIKE STANDARD OR STANDARD OPTIMIZED OR L2 SEED AUTOMATICALLY.

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 ROBOT WOULD NOT START. IT TURNED ON, BUT THE SCREEN WAS BLACK. THIS HAPPENED TWICE. THE THIRD TIME IT STARTED WITHOUT ANY PROBLEMS. IT UNDOCKED ITSELF DURING THE OPERATION. WE DOCKED IT MANUALLY AND CONTINUED THE OPERATION. EVERYTHING WENT WELL. HOWEVER, AFTER THE INTRAOPERATIVE CT SCAN, 3 OUT OF 8 SCREWS WERE INCORRECTLY INSERTED. WE CLOSED THE CASE IN THE ROBOT AND STARTED A NEW ONE AS IF IT WERE A NEW OPERATION. WE DID A 3D SCAN AGAIN, PLANNED THE SCREWS AND INSERTED THEM. EVERYTHING WENT WELL AND AFTER THE CONTROL SCAN THE SCREWS WERE ALREADY INSERTED CORRECTLY. THE PATIENT DID NOT SUFFER ANY HARM.

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 L1-L5 OPEN TLIF, USING INTEROP WORKFLOW WITH E3D. WE PLACED L1 LEFT SCREW FIRST. THEN CHECKED ALL SCREWS WITH FLUORO AFTER THEY WERE ALL PLACED AND BOTH L1 SCREWS WERE SHIFTED TO THE LEFT. WE THEN WENT IN TO FIX THEM AND DID ANOTHER SPIN, AND IT WAS STILL OFF. WE ENDED UP PLACING BOTH TOP SCREWS FREEHAND 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 WHILE USING THE EXCELSIUS GPS SYSTEM ROBOT-PLANNED SCREWS WERE NOT ACCURATE. THE PLAN AND MERGER LOOK FINE. I CAN MAIL OR TRANSFER THE FILE LOG FROM THE ROBOT.