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 WAS AN ISSUE WHILE CONNECTED TO A DESIGNATED RED (EMERGENCY POWER) OUTLET, THE ROBOT UNEXPECTEDLY SHUT DOWN WITHOUT WARNING. AFTER ATTEMPTING TO POWER THE SYSTEM USING MULTIPLE OUTLETS THROUGHOUT THE HOSPITAL, WE WERE STILL UNABLE TO MAINTAIN POWER. THE PLUG INDICATOR LIGHT DOES NOT ILLUMINATE WHEN CONNECTED, AND THE BATTERY INDICATOR ONLY FLASHES. AS A RESULT, THE ROBOT CANNOT BE KEPT POWERED ON. WE WERE FORCED TO ABORT THE PROCEDURE AND CANCEL MULTIPLE SCHEDULED CASES OVER THE NEXT SEVERAL DAYS.

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 A S2AI SCREW WAS PLACED MEDIAL AND INFERIOR. THE NAVIGATION IMAGES SHOWED THAT THE SCREW WAS ON PLAN AND IN THE PROPER PLACE HOWEVER THAT WAS NOT THE CASE. UPON X-RAY IMAGES TO CONFIRM, THE SURGEON NOTICED THAT THE SCREW WAS MEDIAL AND INFERIOR. THE SURGEON REMOVED THE SCREW AND REPLACED THE SCREW IN THE CORRECT SPOT WITHOUT TO USE OF THE ROBOT OR 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 DURING A EGPS SURGERY THAT THE SCREW WAS FIGHTING US AS IT ADVANCED. WE DECIDED TO BACK OUT SCREW. THE SCREW WAS FIGHTING US. THERE WAS A STABILIZER FAILURE. THE SURGEON REMOVED POWER BLOCK AND USED T. WE STILL COULDN'T BACK OUT. WE NOTICED STAR TIP OF CUP DRIVER LODGED INTO THE FEMALE STAR OF SCREW. WE REMOVED ROBOT FROM FIELD. WE TOOK AN X-RAY AND THE L4 WAS LOW AND MEDIAL AND NOT IN THE PLANNED TRAJECTORY. THE SURGEON TESTED DRB RIGIDITY WITH FINGERS AND IT WAS COMPLETELY OUT OF BONE. THE SURGEON PROCEEDED TO REMOVE SCREW VIA DRILLING AROUND IT. THE SCREW WAS REMOVED. WE PROCEEDED WITH LAMI/DECOMPRESSION. WE PLACED SCREWS NON ROBOTICALLY POST DECOMPRESSION.

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, T10-L2 OPEN FUSION INSTRAOP MERGE WITH E3D, T10/T11/T12 WERE ALL MEDIAL/LATERAL MISSED SCREWS, T12 RIGHT AND LUMBAR SCREWS WERE PERFECT. T10 BILATERAL AND T11 RIGHT WERE REMOVED AND REPLACED AFTER THE SECOND E3D SPIN.

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 WAS AN ISSUE WITH THE END EFFECTOR AND ACCURACY, AND THERE WAS ALSO AN ISSUE WITH REHOMING AFTER INITIAL ACCURACY CONCERNS. WE PLANNED LEVELS L4, L5, AND S1 BUT ONLY COMPLETED THE LEVELS L4, L5 DURING THE PROCEDURE. ALL 4 SCREWS WERE NOT PLACED AS PLANNED; THEY WERE ALL CONSIDERED LOWER THAN THE INITIAL PLAN THE SURGEON CREATED. THEN WE DID X-RAYS AND CONFIRMED THE SCREWS WERE OUT OF PLACEMENT. ROBOT WAS REMOVED FROM THE PROCEDURE ARE BUT STILL IN THE OR UNTIL THE CASE WAS COMPLETED.

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 THERE WAS A RADIAL ERROR OF GREATER THAN 1.5MM AT MULTIPLE TRAJECTORIES. THE RIGHT OF ELECTRODE WAS REMOVED AND NO OTHER ELECTRODE WAS PLACED ALONG THIS PLANNED TRAJECTORY. NO FURTHER REVISION IS NEEDED.

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 PLACING CRANIAL LEADS WITH THE EXCELSIUS GPS THE LEFT SIDE LEAD SHIFTED SUPERIOR AT THE VENTRICLE. THE SURGEON STATED THAT THE LEAD RAN ALONG THE SUPERIOR EDGE OF THE HIPPOCAMPUS BUT DECIDED TO PLACE THE LEAD AGAIN. THE EGPS WAS PUSHED BACK IN AFTER LMCS VERIFIED CONTINUED ACCURACY. THE EGPS ARM WAS ALIGNED TO THE LEFT TRAJECTORY AND THE PROCESS REPEATED. THE O-ARM WAS BROUGHT BACK IN AND THE SPIN WAS PERFORMED AND TRANSFERRED. THE LEAD WAS FOUND TO HAVE HIT THE VENTRICLE AND SHIFTED SUPERIOR AGAIN BUT WAS INFERIOR TO THE PREVIOUS LEAD PLACEMENT AND WAS THUS MORE ON TRAJECTORY. THE SURGEON WAS SATISFIED WITH THE PLACEMENT AND CLOSING BEGAN.

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 FIRST SCREW LOOKED TO PLAN. THE SECOND SCREW, L4R, LOOKED LIKE IT WAS TO PLAN, BUT THE OFFSET WAS RED, AND DOC WAS WORRIED. THERE WERE NO NAV SHIFTS AFTER LANDMARK CHECK. HE DIDN'T LIKE, CAME BACK IN WITH DURA PRO, PUT IN SCREW AGAIN, BUT THIS TIME WAS LATERAL. HE DID A LANDMARK CHECK, EVERYTHING ACCURATE. HE DID THE SCREW FREEHAND NAV, WHICH WAS TO PLAN. THE L4L SCREW OFFSET WAS RED, AND SCREW LOOKED LATERAL, BUT DOC SAID THAT IT FELT GOOD TO HIM AND DURA PRO WAS GREEN AND RIGHT ON TRAJECTORY. THE SCREW WAS LATERAL. IT WAS POSSIBLY LATERAL DUE TO RETRACTOR, OR PATIENT MOVEMENT. THE DR. TOOK OUT SCREW, AND REPLACED SCREW FREEHAND WITHOUT NAVIGATION USING FLOUROSCOPY. ALL SCREWS TO PLAN AT END.

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 THE SURGEON'S EGPS 1L L5/S1 PLIF ON A GRADE 1 SPONDYLOLISTHESIS PATIENT. THEY PLANNED PEDICLE SCREWS RELATIVELY STRAIGHT ON, AS HE INTENDED A MIDLINE INCISION. THE SURGEON APPROVED THE PLAN. THEY PLACED THE LONG QUATTRO SPIKE AND LONG SURVEILLANCE MARKER DUE TO PATIENT HYPERLORDOSIS, AND PERFORMED THE MERGE, WHICH WAS APPROVED. THEY BROUGHT IN THE ROBOT AND MARKED THE SKIN, BUT THE SURGEON SWITCHED TO MINI WILES INCISIONS. BETWEEN THE MERGE AND SCREW INSERTION, THE SURGEON BUMPED EITHER THE SM OR DRB TWICE, SHIFTING THE RED MARKER. HE VERIFIED NAVIGATION ACCURACY USING THE CHICKEN FOOT ALONG THE QUATTRO BASE, SM, AND SPINOUS PROCESS BEFORE RE-REGISTERING THE SM. THE RIGHT L5 SCREW FAILED TO PENETRATE THE POSTERIOR VB WALL, SO THEY PLACED RIGHT S1 FIRST TO CHECK DRILL SHARPNESS, THEN CHANGED TO A NEW DRILL. THE LEFT L5 AND S1 SCREWS WERE PLACED NEXT. THE POST-OP X-RAYS SHOWED LEFT L5 COMPLETELY OUT OF THE PEDICLE IN AP BUT PERFECT LATERALLY. THEY PERFORMED ANOTHER MERGE, APPROVED BY THE SURGEON, AND REPLACED LEFT L5.

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 CASE WAS A T11-L3 PERC SPINE FUSION WITH A SPINE TUMOR AT L1. WE PLACED THE DRB IN THE RIGHT PSIS AND THE SURVEILLANCE IN THE LEFT ILIAC CREST. AFTER THE FIRST SPIN WHEN DR. (B)(6) CLICKED ON HIS FIRST SCREW HE NOTED THAT THE NAV WAS WAY OFF (TOWARDS THE PATIENTS MIDLINE). IT WAS DISCOVERED AT THIS TIME THAT THE SURVEILLANCE WAS NOT SET PRIOR TO SPINNING SO WE WANTED TO PLAY IT SAFE AND RE SPIN. AFTER RESPINNING WE PLACED THE T12, L2 AND ONE L3 SCREW ON THE LEFT AND WHEN WE WENT TO PLACE THE L3 SCREW ON THE RIGHT HE NOTED THAT THE NAV WAS WAY OFF AGAIN. THIS TIME THE SURVEILLANCE HAD BEEN PROPERLY SET AND WAS STILL GREEN. THEN WE MOVED THE DRAPE NORTH (THE PATIENTS T11 ENTRY POINT WAS PREVIOUSLY NOT DRAPED OUT ENOUGH TO ACCESS) AND RE SPUN AGAIN. IMMEDIATELY AFTER THE 3RD SPIN WHEN HE WENT TO CHECK ACCURACY, HE NOTED THAT IT WAS AGAIN OFF AND THAT HE DIDN'T TRUST THE NAV MOVING FORWARD. THE SURVEILLANCE WAS ALSO STILL GREEN AT THIS TIME AS WELL.

ExcelsiusGPS — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT AT THE HOSPITAL THEIR ELDERLY PATIENT WITH A THORACIC FRACTURE. THE PATIENT WAS UNWELL AND EVEN HAD AN ISSUE DURING THE SURGERY. EGPS WAS USED WITH E3D AND ALL SCREWS WERE EXECUTED. UNFORTUNATELY THE NEXT DAY THE PATIENT PASSED AWAY. POST OP IMAGING CONFIRMS SCREWS WERE ACCURATE BUT THERE WERE QUESTIONS ABOUT THE ROBOTIC CASE. NO SCREWS WERE FOUND DEVIATED TO HAVE A CLINICAL DEFICIT.

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 HAS HAD ISSUES WITH ACCURACY WHEN PLACING THE DRILL IN END EFFECTOR. OUR PLANS LOOK REALLY GOOD AND THEN THIS CHANGES WHEN A DRILL IS PLACED IN END EFFECTOR. THE TRAJECTORY IS WAY OFF AND MEDIAL FROM CHOSEN PLAN. WE DID EVERYTHING THAT CSR RECOMMENDED TO TROUBLE SHOOT, BUT THE PROBLEM PERSISTED. AFTER ATTEMPTING TO TROUBLESHOOT IS WHEN WE ABORTED SCREW 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 SCREWS USING THE EXCELSIUS GPS SYSTEM A SCREW WAS MISPLACED DURING A PROCEDURE WITH EGPS. THE SURGEON FOUND OUT VIA POST-OPERATIVE CT, BEFORE THIS THERE WAS NO AWARENESS THAT THERE HAD BEEN A MISPLACED SCREW. CASE WAS AN MIS TRAUMA STABILIZATION FOR T12 FRACTURE, T10, 11, L1 AND L2 INSTRUMENTS. THE SCREWS IN QUESTION WERE AN L2 RIGHT PEDICLE SCREW, BREACHING MEDIALLY AND AN L2 LEFT PEDICLE SCREW BREACHING LATERALLY. SURGEON STATED THAT PATIENT DIDN'T EXHIBIT ANY NEUROLOGICAL DEFICIT HOWEVER THE SCREWS NEEDED TO BE REVISED. WE JUST COMPLETED REVISION SURGERY AND CONFIRMED CORRECT PLACEMENT OF L2 SCREWS AND EXTENDING DOWN TO L3. SCREW PLACEMENT CONFIRMED WITH INTRA-OPERATIVE CONE BEAM CT. SURGEON WAS UNSURE AND WASN'T ABLE TO POINT SPECIFICALLY TO ANY SIGNIFICANT EVENT E.G. FRAME SHIFT THAT WOULD HAVE CONTRIBUTED TO THE DEVIATION, SHE STATED THAT THE PATIENT HAD VERY SCLEROTIC BONE AND TISSUE AND THIS MAY HAVE MECHANICALLY PULLED THE SCREWS OFF COURSE, SHE STATED THAT INSERTING THE SCREWS WAS "TOUGH" AND WAS CONSTANTLY FIGHTING FORCES. THE PATIENT ALSO HAD VERY NARROW PEDICLES, AND INSTRUMENTATION WAS GOING TO BE CHALLENGING IN ANY SCENARIO. I WASN'T PRESENT IN T

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 PATIENT IS SUFFERING PARAPLEGIA POST EGPS SURGERY. THE SURGEON IMPLIED HE FELT EGPS INSTRUMENTATION MAY HAVE CONTRIBUTED TO THE OUTCOME. SEPARATE CASE SUMMARY SUBMITTED DETAILING OBSERVED SURGICAL EVENTS. FROM INITIAL INFORMATION GATHERING WE HAVE BEEN INFORMED THAT THERE APPEARS TO BE HEMATOMA AND BONE FRAGMENTS IN THE CANAL SPACE AT AROUND THE T9 ANATOMICAL AREA. FROM CONVERSATIONS WITH THE CLINICIAN'S SURGICAL IMPLANTATION FROM THE PROCEDURE APPEARS TO BE CORRECTLY POSITIONED AND IMPLANT ACCURACY APPEARS TO NOT BE IN QUESTION. INITIAL REPORTING FROM THE SURGEON USER APPEARED TO INDICATE HE FELT THAT THE HIGH-SPEED DRILL OR THE PILOT DRILL COULD HAVE MOVED BONE FRAGMENTS INTO THE CANAL AT THIS AREA. IT IS UNCLEAR WHETHER THERE IS ANY EVIDENCE OF INSTRUMENTATION BREACH E.G. CLEARLY DEFINED INSTRUMENT TRACKS, INTO THE CANAL, HOWEVER THE SUGGESTION APPEARED TO BE THE SURGEON FELT THAT THESE INSTRUMENTS MAY HAVE MECHANICALLY DISLODGED THE BONY ANATOMY AND HAD A CAUSATIVE EFFECT.

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 SINGLE POSITION LATERAL USING EGPS AND AIRO. L3-S1 FIXATION WITH L3-4 L4-5 LATERAL FUSION. THERE WERE HIGH SKIVE WARNINGS ON R L4 SCREW INSERTION. THE SCREW PLACED SLIGHTLY SUPERIOR AND LATERAL TO PLAN. THE SURGEON ATTEMPTED TO PLACE SCREW MULTIPLE TIMES AND EACH ATTEMPT GAVE HIGH SKIVE WARNINGS DESPITE HS DRILL AND SIDE CUTTING DRILL FOLLOWING TRAJECTORY. IT WAS NOT TAPPED. THERE WERE NO SURVEILLANCE WARNINGS. IT WAS THEIR FIRST CASE WITH EGPS 6.1 SOFTWARE USING RELINE SCREWS. THE R L5 SCREW HAD SIMILAR ISSUE AND WAS FINALLY PLACED OVER K-WIRE. (AWL - K-WIRE - NON-NAVIGATED DRIVER) ON AIRO SCAN REVIEW THE R L4 SCREW WAS PLACED SLIGHTLY SUPERIOR AND LATERAL TO PLAN. SCREW WAS REMOVED AND NOT REPLACED. THE PATIENT SHOWED NO ADVERSE EFFECTS FROM MISPLACED 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 DR. (B)(6) USED THE EXCELSIUS ROBOT (INTRA-OP WORKFLOW) FOR A T11-L1 POSTERIOR LATERAL FUSION. IT IS TO BE NOTED HE ONLY PLACED PEDICLE SCREWS AT T11AND L1 SKIPPING T12 DUE TO A TUMOR SURROUNDING THE T12 VERTEBRAL BODY. DR. (B)(6) DECIDED TO PERFORM HIS DECOMPRESSION THROUGH A POSTERIOR MIDLINE INCISION PRIOR TO PLACING PEDICLE SCREWS BECAUSE HE WANTED TO KNOW HOW FAR THE TUMOR HAD SPREAD. DR. (B)(6) WANTED TO USE THE DRB AND SURVEILLANCE MARKER AND PLACED THEM IN THE PSIS AFTER DECOMPRESSION. AFTER SCREWS WERE PLACED AND ANOTHER CT SCAN WAS PERFORMED VIA E3D THE PEDICLE SCREWS ON THE PATIENT'S RIGHT SIDE WERE MEDIAL OF THE PLANNED TRAJECTORY. LEFT PEDICLE SCREWS WERE IN THE PROPER TRAJECTORY. SURVEILLANCE SHOWED THAT THE DRB HAD NOT MOVED DURING THE CASE. DR. HAMILTON REMOVED THE RIGHT SCREWS AND IMPLANTED THEM FREEHAND. HE ADVISED HE DID NOT SEE ANY DURAL LEAKS AND LATER TOLD US THE PATIENT WAS DOING WELL.

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 THE REGISTRATION PROCESS, HD INTRAOPERATIVE 3D SPIN WAS USED FOR REGISTRATION. AFTER THE SPIN WAS COMPLETED, AN XRAY GENERATOR FAILURE POP UP WAS OBSERVED. THE SCAN ACQUIRED WAS UNUSABLE, WHITED OUT AND GRAINY. THE SURGEON ABANDONED E3D AND ROBOT FOR THE DURATION OF THE CASE. ADDITIONALLY, AUTO REGISTRATION FAILED AND SCAN DID NOT PUSH OVER TO ROBOT 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 THE CANNULA WAS INSERTED INTO THE CENTER TRAJECTORY, MER TESTING WAS PERFORMED. THE CANNULA WAS THEN MOVED TO THE MEDIAL TRAJECTORY. HOWEVER, RESULTS WERE NOT AS DESIRED AND THE TARGET WAS MOVED 3MM MEDIAL FROM THE ORIGINAL CENTER TRAJECTORY. THE LEAD WAS PLACED. DURING TESTING, IT WAS DECIDED TO MOVE THE CANNULA/LEAD TO THE POSTERIOR TRAJECTORY. AT THIS POINT, THE PATIENT APPEARED TO HAVE A STROKE AND THE PATIENT WAS CLOSED AND TAKEN TO THE ER. FOLLOW UP WITH THE SURGEON REVEALED THAT THERE WERE TWO BLEEDS UNILATERALLY ON THE RIGHT AT THE INTERNAL CAPSULE. THE SURGEON STATED THAT EVERY TRACK PLACED IS A 1% RISK OF THIS OCCURRING (4 TOTAL TRACKS ON RIGHT SIDE). THE LAST INFORMATION RECEIVED WAS THAT THEY WERE WAKING THE PATIENT UP, BUT IT IS UNKNOWN IF ANY DEFICITS ARE TEMPORARY AT THIS TIME.

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 SCREWS USING THE EXCELSIUS GPS SYSTEM WERE MISPLACED AND REVISED INTRA-OPERATIVELY.

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 SCREWS USING THE EXCELSIUS GPS SYSTEM WERE MISPLACED AND REVISED INTRA-OPERATIVELY.

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 A L4 ACCURACY ISSUE WITH PLACEMENT OF THE SCREW. THE SCREW WAS REMOVED AND REPLACED.

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 SURGERY WAS PERFORMED AT THE L3-4 SITE, INSTEAD OF THE L3-5 SITE. THIS WAS NOT DISCOVERED DURING THE SURGERY OR DURING THE PATIENT'S STAY IN THE HOSPITAL. UPON THE PATIENT'S RETURN VISIT, HE WAS ADVISED BY THE SURGEON THAT THE SURGERY WAS PERFORMED AT THE WRONG LEVEL. AN ADDITIONAL SURGERY AT THE CORRECT SITE WAS SCHEDULED FOR ON (B)(6) 2025. THE PATIENT CLAIMS TO HAVE SEVERE PAIN, DIFFICULTY IN AMBULATING AND FOOT DROP.

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 SCREWS USING EXCELSIUS GPS WERE GUIDED IN INACCURATE TRAJECTORIES IN A T10-PELVIS.

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 THERE WAS A RADIAL ERROR >1.5MM AT ENTRY FOR I' J'AND K'. DEFLECTION VERBALIZED BY CSR DURING DRILLING. J' DRILL BIT WAS RE-DRILL AND REPOSITIONED ONE TIME.

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 CASE WAS ABORTED DUE TO ROBOTIC ERROR, AND SCREWS WERE THEN PLACED WITHOUT ROBOT.

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 RELINE MAS REDUCTION SCREWS WERE UTILIZED WITH THE ROBOT FOR THIS CASE. BLACK EXCELSIUS ARRAY WITH AN ADAPTER WAS UTILIZED. TWO EXCELSIUS ARRAYS WERE SET UP WITH MAS REDUCTION DRIVERS AND VERIFICATION OF THESE ARRAYS WAS CHALLENGING. THE CAMERA WAS HAVING A HARD TIME SEEING THESE ARRAYS. SPHERES WERE MANIPULATED MULTIPLE TIMES AND BOTH DRIVER ARRAYS WERE TRIED. ONCE THE CAMERA WAS ABLE TO SEE THE ARRAYS, IT TOOK MULTIPLE VERIFICATION ATTEMPTS AND MANIPULATION.

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 EXCELSIUSHUB SYSTEM, AN INTRA-OPERATIVE CORRECTION WAS REQUIRED FOR A MISPLACED IMPLANT.

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 IMPLANTS USING THE EXCELSIUS GPS SYSTEM WERE MISPLACED INTRA-OPERATIVELY AND THEN REMOVED AND REPLACED.

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 CASE WAS ABORTED DUE TO PATIENT INJURY.

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 SCREWS USING THE EXCELSIUS GPS SYSTEM WERE MISPLACED INTRA-OPERATIVELY AND THEN REMOVED AND REPLACED.

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 CASE WAS ABORTED AFTER BLEEDING WAS NOTICED. SHORTLY AFTER, THE PATIENT DISPLAYED SUSPECTED PRESENCE OF STROKE AND/OR HEMATOMA.

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 SCREWS USING THE EXCELSIUS GPS SYSTEM WERE MISPLACED INTRA-OPERATIVELY AND THEN REMOVED AND REPLACED.

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 SCREWS USING THE EXCELSIUS GPS SYSTEM WERE MISPLACED.

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 SCREWS USING THE EXCELSIUS GPS SYSTEM WERE MISPLACED AND ADJUSTED INTRA-OPERATIVELY.

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 SCREWS USING THE EXCELSIUS GPS SYSTEM WERE MISPLACED INTRA-OPERATIVELY.

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 SCREWS USING THE EXCELSIUS GPS SYSTEM WERE MISPLACED INTRA-OPERATIVELY AND THEN REMOVED AND REPLACED.