EXCELSIUS GPS 6143.1001Recalls & reported problems

Summary

The FDA's MAUDE database contains 444 adverse event reports that list this exact device (DI 00889095481297), received between Jun 14, 2021 and Sep 25, 2026 — classified as 1 death, 320 injuries, 123 malfunctions.

The most frequently reported specific device problem is “Human-Device Interface Problem” (413 reports).

1 other recall cover devices cleared under the same FDA submission (K171651); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 444 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2026Human-Device Interface Problem

  It was reported that screws using E3D needed to be revised and replaced. There was an intra-op CT using E3D. The previous hardware starts at L3 and goes up to thoracic spine. The surgeon was doing new hardware connecting to rod around L2 and L3, and new screws at L4, L5, S1, and S2AI. The screws on the left side were all accurate. The screws on the right side were all high into the disc space. Our screw cadence was right L4, left L4, right L5, left L5, etc. The screws appeared to go on well with minimal offset or deflection. We used Reline open screws. high speed, pilot drill, screw were our steps. We needed to revise the Right L4, Right L5, Right S1, and right S2AI robotically placed screws.

  Patient problems: Spinal Column Injury

  MAUDE report 50900589 ↗
• InjurySep 15, 2026Human-Device Interface Problem

  It was reported the surgeon just had to respin because the spin wasn't accurate. Checked his C7 screws and they were incorrect north/south (lower than they were planned) his C2 screws were thankfully correct. We respun and it seems to be accurate again.

  Patient problems: Spinal Column Injury

  MAUDE report 50774359 ↗
• InjurySep 15, 2026Human-Device Interface Problem

  It was reported that after performing intraoperative spin and successful navigation checks, first screw was placed far lateral and outside the pedicle/vertebral body. The navigation appeared to be off 3-5mm left to right. The lateral screw was removed and replaced after performing a second spin. The case was completed using egps & e3d.

  Patient problems: Spinal Column Injury

  MAUDE report 50774352 ↗
• InjurySep 14, 2026Human-Device Interface Problem

  Patient problems: Spinal Column Injury

  MAUDE report 50763543 ↗
• InjurySep 11, 2026Human-Device Interface Problem

  Patient problems: Spinal Column Injury

  MAUDE report 50736215 ↗
• InjurySep 11, 2026Human-Device Interface Problem

  It was reported that this was a t10-l2 perc screw case with gps using pre-op workflow and registration. The merge was completed and determined to be successful. The l1 and l2 pedicle screws on the right were placed with no issues. After moving to t11, the md realized when he felt the drill hitting bone that the drill appeared on the screen as if the drill was halfway down the pedicle already. Because the robot was acting weird, we checked the screws under fluro and the t11 screw was proud and medial. All three screws were then removed.

  Patient problems: Spinal Column Injury

  MAUDE report 50736214 ↗
• InjuryJul 30, 2026Human-Device Interface Problem

  It was reported that the initial surgery for an l1 fracture with fusion from t11 to l3 was performed in (b)(6) 2026. The inraoperative control x-rays were obtained and did not show any evidence of abnormal screw placement. Some time later, the patient underwent a second procedure consisting of an l1 corpectomy. The patient has now returned with pain, and a recent ct scan demonstrates that the screws at t11, t12, and l2 are laterally misplaced to the right side.

  Patient problems: Pain; Spinal Column Injury

  MAUDE report 50086781 ↗
• InjuryJul 27, 2026Migration

  It was reported the surgery was an L2-S1 and we had two screws misplaced while using gps with the end effector. The first screw was revised using freehand navigation. The second one was left out after trying to replace with freehand navigation but was unsuccessful.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50017015 ↗
• InjuryMay 14, 2026Human-Device Interface Problem

  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.

  Patient problems: Spinal Column Injury

  MAUDE report 25175633 ↗
• InjuryMay 11, 2026Human-Device Interface Problem

  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.

  Patient problems: Spinal Column Injury

  MAUDE report 25137132 ↗
• InjuryMay 6, 2026Human-Device Interface Problem

  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.

  Patient problems: Spinal Column Injury

  MAUDE report 25094093 ↗
• InjuryMay 6, 2026Human-Device Interface Problem

  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.

  Patient problems: Spinal Column Injury

  MAUDE report 25093727 ↗
• InjuryMay 5, 2026Human-Device Interface Problem

  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.

  Patient problems: Spinal Column Injury

  MAUDE report 25082105 ↗
• InjuryMay 4, 2026Human-Device Interface Problem

  IT WAS REPORTED THAT WHILE USING THE EXCELSIUS GPS SYSTEM, THE ROBOT MISPLACED L2 SCREWS AFTER PLACING L3 SCREWS PERFECTLY.

  Patient problems: Spinal Column Injury

  MAUDE report 25070578 ↗
• InjuryMay 1, 2026Human-Device Interface Problem

  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

  Patient problems: Spinal Column Injury

  MAUDE report 25058106 ↗
• InjuryMay 1, 2026Human-Device Interface Problem

  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.

  Patient problems: Spinal Column Injury

  MAUDE report 25057896 ↗
• InjuryApr 29, 2026Human-Device Interface Problem

  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.

  Patient problems: Spinal Column Injury

  MAUDE report 25031864 ↗
• InjuryApr 14, 2026Human-Device Interface Problem

  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.

  Patient problems: Spinal Column Injury

  MAUDE report 24872184 ↗
• InjuryApr 14, 2026Human-Device Interface Problem

  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.

  Patient problems: Pneumothorax

  MAUDE report 24872119 ↗
• InjuryApr 8, 2026Human-Device Interface Problem

  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.

  Patient problems: Spinal Column Injury

  MAUDE report 24817407 ↗
• InjuryApr 2, 2026Human-Device Interface Problem

  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.

  Patient problems: Spinal Column Injury

  MAUDE report 24765412 ↗
• MalfunctionApr 1, 2026Human-Device Interface Problem

  IT WAS REPORTED THAT THE PLACEMENT OF SCREW (DESPITE TRAJECTORY'S BEING ALL IN THE CORRECT TRAJECTORY) ENDED IN A LOW TRAJECTORY. LOOKING FOR SIGNS OF SKIVE, EE AND OFFSET BEING HIGH. SURGEON FOUND THE SCREWS WERE LOW TO PLAN, ONE SIDE LOWER THAN THE OTHER. THIS WAS FOUND ON A POST-OP E3D SPIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24755719 ↗
• InjuryMar 25, 2026Human-Device Interface Problem

  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.

  Patient problems: Spinal Column Injury

  MAUDE report 24690435 ↗
• InjuryMar 20, 2026Human-Device Interface Problem

  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.

  Patient problems: Insufficient Information

  MAUDE report 24653796 ↗
• InjuryMar 18, 2026Human-Device Interface Problem

  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.

  Patient problems: Spinal Column Injury

  MAUDE report 24630144 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K171651. One submission often covers many models, so check the product and lot details in each record.

• Z-1007-2024 · Dec 15, 2023 · Open, Classified
  ExcelsiusGPS Cannula A, 9mm x 250mm, Cannula used with ball tip probes, Model No. 6143.2844