VELYS 451611000Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 10705034645995), received between Aug 4, 2025 and Sep 29, 2026 — classified as 1 injury, 24 malfunctions.

The most frequently reported specific device problem is “Malposition of Device” (22 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Jul 23, 2026Open, Classified

   Software issue within robotic controller which may cause unintended movement of the robotic arm during bone preparation or instrument positioning.

   Z-3088-2026 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

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

• MalfunctionSep 29, 2026Malposition of Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50933130 ↗
• MalfunctionAug 17, 2026Malposition of Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50287454 ↗
• MalfunctionMar 17, 2026Malposition of Device

  IT WAS REPORTED THAT DURING AN OPEN LUMBAR PROCEDURE, THE DOCTOR WAS USING VERSE. FINAL PLACEMENT OF SCREWS WAS HIGHER THAN WHAT WAS ON THE NAV SCREEN. SURGEON BELIEVES THERE WAS A SHIFT THAT CAUSED THE PLACEMENT TO BE MOVED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO PATIENT TREATMENTS WERE DELAYED OR CANCELLED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24619887 ↗
• MalfunctionMar 17, 2026Malposition of Device

  DURING A MIS LUMBAR PROCEDURE, THE DOCTOR WAS USING VIPER PRIME AND NOTICED FINAL PLACEMENT OF SCREWS WAS HIGHER THAN ON THE NAV PLAN BY 2 MM AND CAUSED THE SURGEON TO FIX THE PLACEMENT ON TWO OF THE SCREWS. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO TREATMENTS WERE DELAYED OR CANCELLED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24617195 ↗
• MalfunctionMar 16, 2026Use of Device Problem; Malposition of Device

  IT WAS REPORTED AN ISSUE OF THE L-4 (RIGHT SIDE) SCREW'S TRAJECTORY BEING UNREACHABLE OCCURRED DURING A L3-L5 SPINAL FUSION. THE SYSTEM DID NOT GIVE ANY ADVANCE WARNING. EVENT OCCURRED WHILE PLACING SCREWS WHILE ROBOT WAS ON PATIENT'S RIGHT SIDE. SURGEON ELECTED TO GO WITH FREE HAND FOR THAT SCREW NEXT DAY OF SURGERY: (B)(6) 2026. ALL INFORMATION HAS BEEN DISCLOSED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24605501 ↗
• MalfunctionMar 12, 2026Malposition of Device

  IT WAS REPORTED THAT VELYS NAVIGATION STATION, VELYS ROBOTIC-ASSIST STATION, VELYS CAMERA STATION, AND VELYS SPINE ARRAY BASE SET WERE INVOLVED IN A REPORTED EVENT DURING A SPINAL PROCEDURE. THE ISSUE WAS DESCRIBED AS TWO SCREWS BEING PLACED 5MM OFF FROM THE PLANNED POSITION, WITH THE ROBOTIC SYSTEM POSITIONED ON THE PATIENT'S RIGHT SIDE. TROUBLESHOOTING INCLUDED CONDUCTING A SECOND SPIN BEFORE REMOVING AND REPLACING THE SCREWS. THERE WAS PATIENT INVOLVEMENT, BUT NO INJURIES, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24578510 ↗
• MalfunctionFeb 9, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT DURING A T4 TO L1 POSTERIOR SPINAL FUSION PROCEDURE, DURING SCREW THE SURGEON DEEMED THAT THE PHANTOM WAS INACCURATE WHEN T7 AND T8 ON THE LEFT SIDE WERE LATERAL TO PLAN. A SECOND SPIN WAS COMPLETED AND WHEN THEY PLACED THE REST OF THE SCREWS IN THE SEGMENT, 4 OF THE SCREWS WERE CONSIDERED INACCURATE TO PLAN: T6 WAS LATERAL ON LEFT SIDE, T5 ON THE RIGHT SIDE WAS DEEMED MEDIAL, T7 ON RIGHT SIDE WAS DEEMED MEDIAL AND T8 ON THE RIGHT SIDE WAS DEEMED MEDIAL. SOME SCREWS WERE REPLACED WITH FREE HAND NAVIGATION AND OTHERS WERE NOT IN THE SPIN WERE COMPLETED FREE HAND WITHOUT NAVIGATION. ROBOT WAS ON THE PATIENT'S RIGHT SIDE. THERE WAS PATIENT INVOLVEMENT, BUT NO INJURIES, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24292112 ↗
• MalfunctionDec 11, 2025Malposition of Device; Malposition of Device

  DURING THE PROCEDURE, THE T9 SCREW INADVERTENTLY ENTERED THE T8/T9 DISC SPACE. AN EXCESSIVE FORCE WARNING APPEARED ON THE SCREEN DURING THE CASE. AFTER DECOMPRESSION, THE T9 SCREW WAS REMOVED AND CORRECTLY REPOSITIONED USING VELYS NAVIGATION ONLY. THERE WAS NO PATIENT HARM. OBSERVED FACTORS DURING THE CASE THE FOLLOWING CONDITIONS WERE NOTED: THE PA WAS POSITIONED ON THE PATIENT¿S RIGHT SIDE, AND THE CAMERA WAS ALSO ON THE PATIENT¿S RIGHT AT THE FOOT OF THE BED. THE PA¿S SHOULDER OBSTRUCTED THE CAMERA¿S LINE OF SIGHT. THERE WAS LATERAL PRESSURE FROM BOTH THE RETRACTOR AND THE SOFT TISSUE INCISION. THE TP WAS OBSTRUCTING THE PATHWAY AND WAS BUMPED DURING THE PROCEDURE. SURGICAL PLAN THE SURGERY WAS INITIALLY PLANNED AS A FULL T6¿T9 PROCEDURE; HOWEVER, THE INTENT WAS TO ADDRESS T6, T9, AND RIGHT T8 ONLY. T7 AND LEFT T8 REQUIRED A TRANSPEDICULAR APPROACH TO DECOMPRESS A CENTRALLY LOCATED HERNIATION. THE CASE WAS PERFORMED AS AN OPEN PROCEDURE USING VIPER PRIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23779413 ↗
• MalfunctionDec 4, 2025Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT THERE WAS DIFFICULTY DOCKING THE DRILL GUIDE, FLICKERING OF ARRAYS AT HARSH ANGLES, AND A SCREW THAT WAS INITIALLY PLACED TOO HIGH BUT SUBSEQUENTLY REPOSITIONED WITHOUT ISSUE. THE EVENT OCCURRED DURING SCREW PLACEMENT IN A NAVIGATION-ONLY, MINIMALLY INVASIVE L5 TO S1 FUSION. TROUBLESHOOTING INVOLVED MOVING THE SCREW, AND THERE WERE NO REPORTED INJURIES, MEDICAL INTERVENTIONS, OR PROLONGED HOSPITALIZATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23714562 ↗
• MalfunctionDec 2, 2025Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT VELYS NAVIGATION STATION AND VELYS CAMERA STATION WERE INVOLVED IN AN EVENT DURING A SPINAL FUSION PROCEDURE. THE ISSUE OCCURRED DURING PLACEMENT OF THE RIGHT L5 SCREW, WHICH WAS POSITIONED HIGH AND OUTSIDE AFTER USING THE NAVIGATION SYSTEM. THE SCREW PLACEMENT WAS REVISED AND THE SURGERY WAS COMPLETED WITHOUT FURTHER INCIDENT. THERE WAS NO REPORTED INJURY, MEDICAL INTERVENTION, OR DELAY IN PATIENT TREATMENT, AND NO PATIENT CONSEQUENCES OR INVOLVEMENT BEYOND THE MISPLACEMENT WERE NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23691977 ↗
• MalfunctionNov 25, 2025Use of Device Problem; Malposition of Device; Device-Device Incompatibility; Use of Device Problem; Malposition of Device; Device-Device Incompatibility

  IT WAS REPORTED THAT VELYS SPINE ARRAY BASE SET, VELYS NAVIGATION STATION, AND VELYS CAMERA STATION WERE INVOLVED IN A REPORTED EVENT DURING A SPINAL FUSION PROCEDURE. THE COMPLAINT DESCRIBED MULTIPLE INTRAOPERATIVE ISSUES: DIFFICULTY ASSEMBLING ARRAYS RESULTING IN SOME BEING STRIPPED, CHALLENGES WITH SYSTEM RECOGNITION OF THE PHANTOM AND PATIENT ARRAYS, AND IMAGING DIFFICULTIES DUE TO PATIENT SIZE. THE NAVIGATION SYSTEM FAILED TO PROVIDE REGISTRATION VERIFICATION, LEADING TO ALTERNATIVE ANATOMICAL CHECKS. ALL FOUR SCREWS WERE FOUND TO BE IMPROPERLY PLACED, REQUIRING REVISION WITH MANUAL INSTRUMENTATION. THE PROCEDURE WAS DELAYED BY 60-90 MINUTES, BUT THERE WERE NO REPORTED INJURIES, MEDICAL INTERVENTIONS, OR PROLONGED HOSPITALIZATION. THE COMPLAINT DEVICES WERE NOT RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23643266 ↗
• MalfunctionNov 13, 2025Malposition of Device; Malposition of Device

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23544865 ↗
• MalfunctionNov 13, 2025Malposition of Device; Malposition of Device

  NAVIGATION CAMERA WAS NOT ABLE TO VISUALIZE ROBOTIC ARM DUE TO THE LACK OF AN EXTRA JOINT. - T8 SCREW HAD TO BE LATERALIZED FROM ORIGINAL PLAN, ORIGINAL TRAJECTORY WAS MEDIAL TO PLAN. - ERROR MESSAGE OF DATA MATRIX CARDS WERE SCANNED. SALES REP CONFIRMS THAT THE THEY HAD NOT BE PREVIOUSLY SCANNED. REP WAS ABLE TO CLEAR THE MESSAGE AND USE THE SAME DATA MATRIX CARDS - LOGS IN THE SYSTEM. - PER SALES REP, FSE NOT REQUIRED. WHAT TYPE OF SPINE SURGERY WAS IT? T3-T12 AIS CASE WAS THIS NAV ONLY OR WITH ROBOT? ROBOT WHAT SIDE WAS THE ROBOT ON? PATIENT RIGHT WHAT STEP WERE THEY ON WHEN THIS ISSUE OCCURRED? TROUBLESHOOTING: PATIENT INVOLVEMENT? YES. WERE THERE REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION? NO ARE PATIENT TREATMENTS DELAYED OR CANCELLED? NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23543374 ↗
• MalfunctionNov 12, 2025Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT DURING SPINE SURGERY - T4 TO L4, THE NAVIGATION CAMERA COULD NOT VISUALIZE ROBOTIC ARM DUE TO THE LACK OF AN EXTRA JOINT. THE TRIALTUS SCREWDRIVER LODGED AFTER SCREW RELEASE MODE AND COULD NOT REMOVE THE SCREWDRIVER FROM TULIP HEAD. THE SCREWDRIVER WAS REMOVED USING SLIGHT FORCE. THE L4 LEFT SCREW RELEASE MODE WAS EXCESSIVE DUE TO SOFT TISSUE, THIS CAUSED THE SCREW TO BE LATERAL TO PLAN. FREEHAND NAVIGATION WAS USED TO REPLACE IT. ALL INFORMATION HAS BEEN DISCLOSED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23534241 ↗
• MalfunctionNov 12, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING SPINE SURGERY: T4 TO L4, THE NAVIGATION CAMERA COULD NOT VISUALIZE ROBOTIC ARM DUE TO THE LACK OF AN EXTRA JOINT. THE TRIALTUS SCREWDRIVER LODGED AFTER SCREW RELEASE MODE AND COULD NOT REMOVE THE SCREWDRIVER FROM TULIP HEAD. THE SCREWDRIVER WAS REMOVED USING SLIGHT FORCE. THE L4 LEFT SCREW RELEASE MODE WAS EXCESSIVE DUE TO SOFT TISSUE, THIS CAUSED THE SCREW TO BE LATERAL TO PLAN. FREEHAND NAVIGATION WAS USED TO REPLACE IT. ALL INFORMATION HAS BEEN DISCLOSED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23534235 ↗
• MalfunctionOct 28, 2025Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT THE L2-L4 MIS PEDICLE SCREW CASE. THE DOCTOR STARTED L2-L3 ON THE RIGHT SIDE. HE STATED THAT HE FELT THAT THE KNIFE JIG WAS NOT HELPING HIM GET THE PROPER TRAJECTORY SO HE TRANSITIONED FROM USING THE ROBOT TO FREEHAND PLACEMENT FOR THE INCISION FOR L4 RIGHT. HE CONTINUED FREEHAND PLACEMENT ON L2 LEFT TO L4 LEFT. THE FINAL X-RAY FOUND AND AN O-ARM SPIN CONFIRMED THAT THE LEFT L2 SCREW WAS BOTH HIGH AND LATERAL COMPARED TO PLAN. THEY COMPLETED ANOTHER SPIN, REPLANNED THE LEFT L2 WITH THE NAVIGATION AND ROBOT AND THE REVISED PLACEMENT WAS ACCEPTABLE TO THE SURGEON. IT WAS APPROXIMATELY A 60 MINUTES DELAY. ALL INFORMATION HAS BEEN DISCLOSED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23405933 ↗
• InjuryOct 21, 2025Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A L4-L5 A TLIF PROCEDURE WITH MIS PRIME SCREWS ON FIRST SIDE AND FACET SCREWS ON THE OPPOSITE SIDE. THE SURGEON PUT THE TWO PEDICLE SCREWS ON ONE SIDE FIRST, THEN THE CAGE AND LASTLY THE SET SCREW ON THE OTHER SIDE. SURGEON DID THE VIPER PRIME WITHOUT ISSUE AND COMPLETED THE SPIN, COMPLETED REGISTRATION. FOLLOWING REGISTRATION, SYSTEM REQUESTED ANATOMY CHECK ¿ SURGEON PERFORMED ANATOMY CHECK AND STATED IT WAS ACCEPTABLE. WHEN THEY REACHED THE POINT WHERE THEY WERE READY TO SEND THE ROBOT ARM TO THE TRAJECTORY ¿ WARNING RECEIVED¿ PATIENT TRACKER ANGLE AND L4 SCREW WOULD BE A COLLISION. PATIENT ARRAY WAS LOCATED ON THE PSIS RIGHT SIDE. THEY ADJUSTED THE ANGLE OF THE SCREWS MORE LATERALLY AND AT THIS POINT THE DOCTOR BUMPED THE PATIENT ARRAY. THEY WENT TO THE FIRST TRAJECTORY, PUT THE CORE DOWN, BROUGHT IN THE 5MM ACORN BIT, REP RECOMMENDED MAKING A KNOCKING POINT. THE DOCTOR WENT DOWN AND THE PATIENT MOVED, DESCRIBED AS THEY BUCKED LIKE THEY WERE IN PAIN. THE DOCTOR PUT THE SCREW IN AND IT WAS TESTING AT A 7. THEY BROUGHT IN THE X-RAY AND FOUND THE SCREW WAS MEDIALIZED. THEY CHANGED THE TRAJECTORY OF THE SCREW AND IT WAS TESTING AT AN 8. THE

  Patient problems: Nerve Damage

  MAUDE report 23353489 ↗
• MalfunctionSep 8, 2025Malposition of Device; Malposition of Device

  PROBLEM REPORTED: CUSTOMER REPORTED ROOM TWO OF TWO ROOMS USING THE SAME SYSTEM BACK AND FORTH. BOTH ROOMS NEEDED SCREW REVISIONS. ROOM 2 PERFORMING L3 TO L4 PTP SCREW WAS IN THE DISC SPACE AND NEEDED TO BE ADJUSTED. WHAT STEP WERE THEY ON WHEN THIS ISSUE OCCURRED? SETTING UP SCREW PLACEMENTS. WAS THIS A ROBOTIC OR NAVIGATION ONLY PROCEDURE? NAVIGATION ONLY TROUBLESHOOTING: REVISED SCREW IN DISC SPACE. VELYS WAS NOT ABORTED. THEY WERE ABLE TO USE THE VELYS SYSTEM TO REVISE THE SCREW AND CORRECT THE ISSUE. COMPLETED CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22994765 ↗
• MalfunctionSep 8, 2025Malposition of Device; Malposition of Device

  PROBLEM REPORTED: CUSTOMER REPORTED ROOM ONE OF TWO ROOMS USING THE SAME SYSTEM BACK AND FORTH. ROOM 1 THEY WERE WORKING ON L5 TO S1 PLIF. LATERAL SCREW WAS OUT AND NEEDED TO BE REVISED. WHAT STEP WERE THEY ON WHEN THIS ISSUE OCCURRED? SETTING UP SCREW PLACEMENTS. WAS THIS A ROBOTIC OR NAVIGATION ONLY PROCEDURE? NAVIGATION ONLY. TROUBLESHOOTING: LATERAL REVISED WITH VELYS. MOVING BACK AND FORTH BETWEEN TWO ROOMS AND BOTH NEEDED REVISIONS. CASE WAS COMPLETED USING THE VELYS SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22993221 ↗
• MalfunctionSep 8, 2025Use of Device Problem; Malposition of Device; Use of Device Problem; Malposition of Device

  CUSTOMER REPORTED FIRST ABORTED CASE USING 3D C-ARM AND THEY COULD NOT KEEP THE PHANTOM IN THE IMAGE AS THE PATIENT WAS VERY LARGE. CUTTING OUT THE INTERIOR SECTIONS OF VERTEBRAL BODY, CUTTING THE PHANTOM OUT OF THE IMAGE. L4 TO S1 PLIFF USING THE LING SIGHTER SYSTEM NOT VELYS. WHAT STEP WERE THEY ON WHEN THIS ISSUE OCCURRED? SPINNING IMAGES. WAS THIS A ROBOTIC OR NAVIGATION ONLY PROCEDURE? NAVIGATION ONLY. TROUBLESHOOTING: FIRST SPIN TAKEN WITH TIGHT MARGINS DIDN'T GET THE PHANTOM IN THE IMAGE; REQUIRED A RE-SPIN. SECOND SPIN WENT THROUGH WITH A SIGNIFICANT PART OF VERTEBRAL BODY CUT OFF, THE PHANTOM MOVED. ANATOMY CHECK WAS FAR OFF, NOT EVEN CLOSE. THIRD SPIN, THE PHANTOM AND IMAGE CUT OFF SIGNIFICANT PORTIONS ON THE ANTERIOR BODIES, USED GUESS WORK TO SEE HOW FAR THEY WENT OUT. PUT IN SOME SCREWS, IMMEDIATELY SPUN AGAIN TO CHECK THE PHANTOM WAS OUT OF THE IMAGE AGAIN AND SCREWS WERE MISPLACED. FOURTH AND SIXTH SCREWS INSERTED WERE BOTH HIGH AND IN THE DISC SPACE. SURGEONS SWORE BY THE ANATOMY CHECK, SURGEON DID THE ANATOMY CHECK BOTH ON THE HARDWARE IN PATIENT AND LANDMARKS LOOKED GOOD. THE SCREWS WERE OFF BUT THEY WERE NOT OFF WHILE NAVIGATING. ABORTED USING THE VELYS SPINE ROB

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22993093 ↗
• MalfunctionSep 5, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING THE SURGERY THE SPIN WITH CO SYSTEM WHICH CUT OFF ANTERIOR PORTIONS OF THE BODIES. TRYING TO INSTRUMENT SCREWS. CUT OFF THE COUNT DOWN OF THE MEASUREMENTS TO THE DISTAL TIP. SECOND ISSUE WAS A DEVIATED SCREW THE L4 RIGHT SCREW. TROUBLESHOOTING: STILL WITHIN PARAMETERS BUT EXCESSIVE PRESSURE WARNING. PUT THE DRIVER IN AND DEVIATED BY A COUPLE MILLIMETERS. STILL CLINICALLY SAFE. FSE SUPPORT REQUESTED TO PULL LOGS AND EVALUATE ISSUES. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION AND PATIENT TREATMENT WAS NO DELAYED OR CANCELLED DUE TO REPORTED ISSUE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22978819 ↗
• MalfunctionAug 21, 2025Malposition of Device; Malposition of Device

  THE CUSTOMER REPORTED THAT THIS WAS A SPINE ROBOTIC CASE FOR L1-S2. DURING THE PROCEDURE THEY MOVED TO S2 THE TOOL HOLDER WAS VIOLATING THE SAFETY BOX OF THE PHANTOM. IT THEN VIOLATED SAFETY BOX DURING EVERY TRAJECTORY. WHEN SENDING IT TO NEXT TRAJECTORY THE ROBOT COLLIDED WITH THE PATIENT. TROUBLESHOOTING INCLUDED: SHUTDOWN THE ROBOT STATION AND RESTARTED. COMPLETED BRAKE TEST BEFORE PROCEEDING. THEY WERE ABLE TO COMPLETE THE CASE HOWEVER, THE SYSTEM CONTINUED TO VIOLATE THE SAFETY BOX. SETTING UP CT IMAGE BEFORE HAND THERE WERE NO ISSUES THEY ATTACHED THE PATIENT ARRAY TO L1 AND THE PHANTOM ARRAY OVER THE OPERATION AREA. PATIENT WAS AVERAGE SIZE. ROBOT COLLIDED WITH PATIENT NEAR THE T12 AREA (RIB) LEFT SIDE OF THE PATIENT. THERE WAS A SURGICAL DELAY OF 10-15 MINUTES. THE PATIENT HAS POTENTIAL BRUISING AS THE ROBOT COLLIDED WITH THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22861033 ↗
• MalfunctionAug 15, 2025Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT DURING SCREW PLACEMENT IN A SPINAL PROCEDURE, THE L4 RIGHT SCREW WAS SLIGHTLY LATERAL FROM PLAN DUE TO SCREWDRIVER HITTING THE RETRACTOR AND DUE TO SCREW RELEASE MODE. SCREW POSITION WAS CONFIRMED BY O-ARM SPIN. 3D IMAGING WAS USED. JUST ONE PORTION OF THE SCREW TRAJECTORY WAS LATERAL. THE SCREWDRIVER COLLIDED WITH THE END OF THE SELF RETAINING RETRACTOR, WHICH ALTERED THE TRAJECTORY. SCREW RELEASE/ACTIE MODE WAS ATTEMPTING TO REDIRECT SCREW BACK TO ORIGINAL POSITION MID-INSERTION DUE TO DEFLECTION BY RETRACTOR. USER REMOVED SCREW AND PLACED WITH FREE-HAND NAVIGATION. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THERE WAS A MINIMAL DELAY DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22817911 ↗
• MalfunctionAug 5, 2025Malposition of Device; Malposition of Device

  IT WAS REPORTED THE ROBOT RAN INTO THE POST OF THE PATIENT ARRAY NEAR THE CLAMP DURING A POSTERIOR SPINAL FUSION - PEDIATRIC. THE CAMERA HAD TO BE POSITIONED IN THE ANESTHESIA AREA MAKING IT HARD TO KEEP THE PATIENT STERILE AS WELL AS CAPTURE THE ARRAYS. THE ISSUE WAS WITH THE ROBOT. THEY WERE SENDING ROBOT TO TRAJECTORY. TROUBLESHOOTING: HAD TO GET A NEW SPIN. WHILE SENDING TO A NEW TRAJECTORY THE ROBOT CAME CLOSE TO HITTING THE PATIENT ARRAY AGAIN HOWEVER, THEY STOPPED THE ROBOT MANUALLY AND MANIPULATED THE ARM OUT OF THE FIELD. THEY WERE ABLE TO SEND THE ROBOT TO THE TRAJECTORY AGAIN AND IT WORKED. SURGERY WAS DELAYED 10 MINUTES. NO PATIENT CONSEQUENCE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22713239 ↗
• MalfunctionAug 4, 2025Malposition of Device; Malposition of Device

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE SURGEON DETERMINED THAT HE WAS MOST LIKELY AT FAULT DUE TO A FEW REASONS. THIS WAS THE SURGEON'S SECOND CASE USING THE SYSTEM, SO HE WAS NOT FULLY TRUSTING THE SYSTEM. THE SURGEON USUALLY ONLY DOES THE DRILL UNDER POWER, AND FOR THIS CASE HE DID THE DRILL, TAP AND SCREW UNDER POWER. IT IS POSSIBLE THAT HE WAS NOT USED TO THE SPEED AND ALSO LACK OF TACTILE FEEDBACK FROM THE POWER INSTRUMENTS AND DID NOT NOTICE HIS PATH HAD CHANGED. ALSO, THE INSTRUMENTS WERE FLICKERING IN AND OUT WHILE HE WAS IMPLANTING, RESULTING IN HIM, LOOKING AWAY FROM THE SCREEN WHILE PLACING SCREWS.

  Patient problems: Insufficient Information

  MAUDE report 22698843 ↗