Mazor X System TPL0059-06Recalls & reported problems

Summary

The FDA's MAUDE database contains 392 adverse event reports that list this exact device (DI 07290109183213), received between Jun 7, 2019 and Apr 10, 2026 — classified as 2 deaths, 55 injuries, 335 malfunctions.

The most frequently reported specific device problem is “Imprecision” (189 reports).

2 FDA recall records name this device's identifier, 2 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. Dec 10, 2025Open, Classified

   Software errors that can result in incorrect surgical instrument positioning during spinal surgery.

   Z-1122-2026 · Root cause: Under Investigation by firm · FDA record ↗

2. Sep 5, 2023Open, Classified

   Software update

   Z-0101-2024 · Root cause: Software design · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 392 reports, in the reporter's own words as published by the FDA.

• InjuryApr 10, 2026Incorrect, Inadequate or Imprecise Result or Readings

  ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THERE WAS NO ISSUE WITH THE DRILL ITSELF. THE 3DEFINE, THE SNAPSHOT, AND THE FUSION OF THE FLUOROSCOPY IMAGES WITH THE PREOPERATIVE CT WAS CARRIED OUT AS USUAL. THE FUSION APPEARED ACCURATE, AND THEY PROCEEDED WITH THE SURGERY. THE SCREWS ON THE RIGHT SIDE WERE CORRECTLY PLACED, EXACTLY AS PLANNED USING THE NAVIGATION THAT ALSO APPEARED TO BE CORRECT. THE PROBLEM STARTED WITH THE LEFT SIDE. ALTHOUGH THE NAVIGATION STILL APPEARED TO BE CORRECT, WHEN THE DRILL WAS USED, THE PATIENT'S LEG SUDDENLY MOVED (JERKED), AND THE NEUROPHYSIOLOGIST OBSERVED THAT THE NERVE ROOT HAD BEEN AFFECTED. THEY RE-CHECKED THE SURGICAL PLAN AGAIN IN CASE THEY HAD MADE A MISTAKE, BUT IT WAS CORRECT. THE POTENTIALS OF THE LEFT L4 NERVE ROOT DROPPED BY MORE THAN 50 PERCENT WHEN THE DRILL WAS USED DURING THE SURGERY. WHEN THE PATIENT WOKE UP, NO NEUROLOGICAL DEFICITS WERE APPRECIATED. TWO DAYS AFTER, THE SURGEON CONFIRMED THAT THE PATIENT WAS OK. THE DELAY WAS MORE THAN 40 MINUTES.

  Patient problems: Dyskinesia; Unspecified Tissue Injury

  MAUDE report 24840917 ↗
• MalfunctionMar 30, 2026Incorrect, Inadequate or Imprecise Result or Readings

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT AT THE END OF A CASE AND CHECKING FOR ACCURACY, THE PELVIC SCREW WAS ALLEGEDLY INACCURATE. THEY RE-REGISTERED AND RESTARTED, ATTEMPTING TO PUT THE PELVIC SCREW IN AGAIN. THE PELVIC SCREW WAS MEDIAL COMPARED TO TRAJECTORY OF THE PLAN. THEY REMOVED THE SCREW COMPLETELY. THIS RESULTED IN 15 MINUTE DELAY. NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24713276 ↗
• MalfunctionMar 20, 2026Incorrect, Inadequate or Imprecise Result or Readings

  ON 2026-MAR-18 (B)(4) (REP, HCP): MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THE WORKFLOW WAS CT TO FLOURO WITH DOT REGISTRATION. L4 ON THE LEFT WAS INSERTED FIRST. HOWEVER, WHEN THE SURGEON MOVED TO L5 ON THE LEFT, HE FOUND THAT THE BONE WAS MORE DIFFICULT TO DRILL AND TAP. AFTER FEELING THAT THE TAP WAS NOT ADVANCING, THE SURGEON RE-DRILLED AND TAPPED AGAIN. IT DID NOT APPEAR TO BE DEVIATING AT THIS TIME. THE SCREW WAS INSERTED. THE SHOTS REVEALEDTHAT L5 SCREW WAS LATERAL ON THE LEFT. AROUND THAT TIME, THE PATIENT JUMPED WITH THE DRILL STILL INSIDE. THE SURGEON ELECTED TO SWITCH TO SCAN AND PLAN. THE IMAGING SYSTEM SCAN REVEALED THAT RIGHT L4 WAS BREACHED AS A RESULT OF THE PATIENT JUMPING. FOR SCAN AND PLAN, THE SURGEON DID NOT DISMOUNT FROM THE ORIGINAL MOUNT, BUT STILL STARTED FROM SCRATCH. L5 ON THE LEFT SCREW WAS INSERTED AGAIN. THE SURGEON THEN SWITCHED TO THE OTHER SIDE OF THE BED TO WORK ON L4. THE GUIDANCE SYSTEM ARM STAYED ON THE SAME SIDE. THE ARM WAS SENT TO L4 AND THE SCREW WAS INSERTED. WHEN THE SURGEON RE-EXAMINED L5, HE STATED THE SCREW FELT WEIRD, AS IF IT WASN'T IN ALL THE WAY. AN X-RAY W

  Patient problems: Dyskinesia

  MAUDE report 24651329 ↗
• InjuryFeb 27, 2026Incorrect, Inadequate or Imprecise Result or Readings; Failure to Advance

  ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE SCREWS WERE REMOVED AFTER THE FAULTY POSITION WAS SEEN INTRA-OPERATIVELY AND WERE NOT SEEN ON POST-OPERATIVE THREE-DIMENSIONAL (3D) SCANS. THE AMOUNT OF DEVIATION WAS ESTIMATED TO BE 10-15MM.

  Patient problems: Paralysis; Perforation

  MAUDE report 24474793 ↗
• MalfunctionFeb 23, 2026Incorrect, Inadequate or Imprecise Result or Readings

  ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE PATIENT WAS FINE AND NO ISSUES WERE REPORTED. THE SURGEON STATED SHE DIDN¿T SEE A DURAL TEAR DURING PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24415380 ↗
• MalfunctionFeb 23, 2026Incorrect, Inadequate or Imprecise Result or Readings

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT ONCE THEY PLACED THE RED DOT AND LABELED THE BODIES, THEY RECEIVED GREEN VALUES. WHEN PLAYING THROUGH THE SLICES AT T5, THEY WOULD SEE A SHIFT IN THE BODIES. THEY ATTEMPTED TO REGISTER OFF A DIFFERENT BODY AND AGAIN RECEIVED GREEN VALUES BUT COULD SEE THE SHIFT. THE OTHER LEVELS WERE ALSO GREEN BUT THE SHIFT WAS NOT NOTICEABLE. THEY TOOK NEW ANATOMICAL PLANE (AP) AND OBLIQUE IMAGES WITH MARKED THE BODIES AND RECEIVED GREEN VALUES AGAIN BUT STILL HAD A SHIFT. THEY ATTEMPTED TO RECALIBRATE THE IMAGING SYSTEM AND DID A NEW DRAW SPINE. THEY TOOK NEW AP AND OBLIQUE IMAGES AND AGAIN RECEIVED GREEN VALUES BUT SAW THE SAME SHIFT IN T5. AFTER ATTEMPTING TO RESOLVE THE ISSUE FOR ABOUT 25 MINUTES, THEY ABORTED THE ROBOT AND PLACED THE SCREWS FREEHAND. THE COMPUTED TOMOGRAPHY (CT) SCAN THEY USED WAS 1.0 MILLIMETER (MM) CT MYELOGRAM. THERE WAS LESS THAN AN HOUR DELAY. NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24414515 ↗
• InjuryFeb 13, 2026Incorrect, Inadequate or Imprecise Result or Readings

  ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE PROCEDURE WAS A SPINE PROCEDURE. IT WAS NOTED THAT THERE WAS ONE CASE WITH A SCREW PLACEMENT DEVIATION, AND ANOTHER CASE FROM ANOTHER DAY, WHERE REGISTRATION OF THE SECOND SEGMENT WAS NOT SUCCESSFUL AND SURGERY WAS COMPLETED WITHOUT THE USE OF THE GUIDANCE SYSTEM.

  Patient problems: Paralysis

  MAUDE report 24337236 ↗
• MalfunctionFeb 5, 2026Incorrect, Inadequate or Imprecise Result or Readings; Communication or Transmission Problem; Data Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THE GUIDANCE SYSTEM DISPLAYED THE ERROR MESSAGE "3D MARKER IS UNDETECTED" DURING THE SCAN AND PLAN PHASE, REQUIRING THREE SPINS BEFORE A FINAL SCAN WAS USED FOR A COMPUTED TOMOGRAPHY TO FLUOROSCOPY WORKFLOW. AFTER REGISTRATION, THE FIRST INSTRUMENT TRAJECTORY WAS INACCURATE, WITH THE INSTRUMENT APPEARING MUCH DEEPER THAN ITS ACTUAL POSITION. THE PATIENT HAD TWO METAL CAGES PUT IN AT L4-S1. THE PATIENT WAS FLIPPED PRONE ONTO A FOUR POST BED WITH HIP AND CHEST PADS. THE SURGEON FIXATED THE ROBOT TO THE PATIENT USING THE BONE-MOUNT BRIDGE (BMB), SCHANZ BOND, AND 120 MILLIMETER (MM) SCHANZ SCREW IN THE RIGHT POSTERIOR SUPERIOR ILIAC SPINE (PSIS). THE 3DEFINE AND SNAPSHOT WERE COMPLETED. THE STAR MARKER WAS SENT TO ROUGHLY L5. THE FOUR BEADS WERE SEEN IN THE AP SCOUT SHOT AND LATERAL SCOUT SHOT. WHILE IN THE AP, THE BONE AND METAL WAS CLEAR, THE BONE AND METAL HAD LOW VISIBILITY IN THE LATERAL SCOUT BUT THE BEADS WERE EASILY SEEN. THE SURGICAL TEAM WAS NOTED TO BE CAREFUL TO INCLUDE THE BODIES NEED AND THE BEADS ALL WITHIN THE RED BOX AND NOT HIDDEN BY METAL. THE FIST SP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24272106 ↗
• MalfunctionJan 26, 2026Incorrect, Inadequate or Imprecise Result or Readings

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM. IT WAS REPORTED THAT ALLEGED INACCURACY OCCURRED DURING A CASE. THERE WAS NO IMPACT TO PATIENT'S OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24179773 ↗
• MalfunctionJan 7, 2026Incorrect, Inadequate or Imprecise Result or Readings

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THE SITE EXPERIENCED AN ALLEGED INACCURACY WHILE IN SURGERY. THE SITE PLACED FOUR SCREWS. THE LEFT SCREW ON L4 WAS 2 MM LATERAL FROM PLAN AND THE RIGHT SCREW ON L3 WAS MEDIAL BY 2 MM. SURGEON REPLACED SCREWS USING C-ARM. THERE WAS NO PATIENT HARM AND THE PROCEDURE WAS DELAYED LESS THAN ONE HOUR. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED FREEHANDEDLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23993972 ↗
• MalfunctionJan 1, 2026Computer Software Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT DEFECT-23339 WAS IDENTIFIED. THE WEDGE WAS INCORRECTLY SIMULATED AFTER IT HAS BEEN DRAGGED. STEPS TO REPRODUCE WERE AS FOLLOWS. FIRST, PROCEED TO PLANNING SCREEN. SECOND, MARK A WEDGE. THIRD, DRAG THE WEDGE. FOURTH, SIMULATE THE WEDGE. THE ACTUAL RESULT WAS THAT THE WEDGE WAS INCORRECTLY SIMULATED AFTER IT HAS BEEN DRAGGED. ADDITIONALLY, DEFECT-23336 WAS IDENTIFIED. THE WEDGE'S VALUE DIFFERS SIGNIFICANTLY BETWEEN THE ORIGINAL AND SIMULATED VIEWS WHEN THE USER DRAGS IT BY A PIXEL (MINIMAL DRAGGING). THE STEPS TO REPRODUCE WERE AS FOLLOWS. FIRST, PROCEED TO THE PLANNING SCREEN. SECOND, SELECT THE ALIGNMENT LAYOUT, WHILE ONE VIEW IS ORIGINAL AND THE SECOND ONE IS SIMULATED. THIRD, ON THE ORIGINAL VIEW, MARK A WEDGE, AND FINALLY, DRAG THE WEDGE MINIMALLY. THE ACTUAL RESULT WAS THAT THERE WAS A SIGNIFICANT DIFFERENCE IN THE WEDGE'S VALUE BETWEEN THE ORIGINAL AND SIMULATED VIEWS.DEFECT-23338 WAS ALSO IDENTIFIED. THE WEDGE DISPLAY DOESN'T REMAIN THE SAME AFTER CLOSING AND REOPENING THE SYSTEM [WHEN MARKING THE SECOND DOT HIGHER THAN THE FIRST DOT]. THE STEPS TO REPRODUCE WERE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23939642 ↗
• MalfunctionJan 1, 2026Computer Software Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT DEFECT-23573 WAS IDENTIFIED. TO REPRODUCE THE ISSUE THE USER MUST LOAD A CASE PROCESS TO PLANNING. THE USER MUST THEN ADD SOME SCREWS & CAGES. AT L4 THE MANUFACTURER REPRESENTATIVE ADDED A 5.5/6.0 SCREW AND AT L5 THEY ADDED A 4.75 SCREW. THEY MUST PROCEED TO OPERATION AND PERFORM A SNAPSHOT AND VERIFY THE TRACKER. THE ARM MUST THEN BE SENT TO L4 WITH THE 5.5/6.0 DRIVER AND THE SCREW WAS AUTO-MOUNT COMPATIBLE WITH THE SELECTED DRIVER. WHEN THE SAME IS DOWN WITH THE 4.75 DRIVER USER COULD ONLY SEE THE TOOL CAD MODEL. NEXT WHEN THE USER SENDS TO THE L5 SCREW WITH THE 4.75 DRIVER, THE SCREW WAS AUTO-MOUNTED COMPATIBLE TO THE SELECTED DRIVER, BUT WHEN ANTERALIGN WAS SELECTED, A MESSAGE STATING "INVALID IMPLANT SELECTION". WHEN ROTATING SHAVER, IF THE USER CLICKS ON VIRTUAL TRIAL, AND SELECTS ANTERALIGN AGAIN, THE MESSAGE WILL STILL DISPLAY. IN SUMMARY WHEN USING THE 5.5/6.0 DRIVER THERE IS NO AUTOMOUNTED SCREW. NEXT, FOR T HE 4.75 DRIVER THE SCREW WAS AUTO-MOUNTED, COMPATIBLE TO THE SELECTED DRIVER, BUT IT WAS NOT THE PLANNED SCREW. FINALLY, ALL THE DETAILS WERE NOT COMPATI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23939641 ↗
• MalfunctionJan 1, 2026Computer Software Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT DEFECT-23633 WAS IDENTIFIED. FOR THE USER TO REPRODUCE THE ISSUE THEY MUST PERFORM ALL NECESSARY STEPS AND REACH OPERATION SCREEN, OPEN THE REVIEW PLANNING SCREEN, SELECT AN IMPLANT (FOR EXAMPLE - RIGHT SCREW), AND WHILE THE IMPLANT WAS SELECTED, SWITCH THE CONTROL TO SURGEON SCREEN. IN THE SURGEON SCREEN THE USER MUST PRESS ON THE SAME IMPLANT, WHICH RESULTS IN THE "TOOLS" TAB DISAPPEARING WHEN SWITCHING CONTROL BETWEEN THE WORKSTATION AND THE SURGEON SCREEN. WHEN PRESSING THE SELECTED IMPLANT - THE TOOLS TAB DOES NOT OPEN. THE USER NEEDS TO SELECT A DIFFERENT IMPLANT FOR THE "TOOLS" TAB TO REAPPEAR. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23939638 ↗
• MalfunctionJan 1, 2026Computer Software Problem; Unintended Application Program Shut Down

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT DEFECT-23435 WAS IDENTIFIED. IN THE SCAN AND PLAN WORKFLOW, THERE WAS AN UNEXPECTED EXIT WHEN THE USER ATTEMPTS TO RETURN TO PLANNING AFTER A LOG-OUT. IT WAS NOTED THE SOFTWARE BEHAVED CORRECTLY IN THE REGULAR FLOW OF CT-FLUORO. TO REPRODUCE THE ISSUE THE USER MUST START A SCAN AND PLAN AUTO REGISTRATION AND STAR MARKER WORKFLOW. TH USER MUST THEN PROCEED TO THE REVIEW PLANNING SCREEN, AND EXIT TO PATIENT FILE WITH THE MOUNT LOCKED. THEY MUST THEN LOG OUT, LOG BACK IN, AND PROCEED TO PLANNING. AT THIS POINT AN UNEXPECTED EXIT WILL OCCUR. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23939637 ↗
• MalfunctionJan 1, 2026Computer Software Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT DEFECT-23605 WAS IDENTIFIED. TO REPRODUCE THE ISSUE THE USER MUST IMPORT A CASE AND CREATE A SCENARIO IN WHICH THE BONE SEGMENTATION IS FAILING. THE USER WILL NEXT OPEN THE LOG AND ENSURE THE ALGORITHM WAS INDEED FAILED. NEXT, THE USER WILL CLOSE THE APPLICATION AND LAUNCH IT. FINALLY, THE USER MUST SELECT THE CASE AND PROCEED TO PLANNING. WHEN THE USER OPENS THE LOG, THE ALGORITHM WILL HAVE RE-EXECUTING ON THE CASE ALTHOUGH IT WAS FAILED BEFORE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23939636 ↗
• MalfunctionJan 1, 2026Computer Software Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT DEFECT # 22575 WAS IDENTIFIED. DURING TESTING OF AN UNRELEASED SOFTWARE VERSION, IT WAS FOUND THAT AFTER IDENTIFYING POTENTIAL FOR SURGICAL ARM COLLISION WITH THE WORK VOLUME (WV) AREA DURING PROCEDURE (OPERATION); WHEN INSERTING SCREWS VIA TOWERS AND EDITING THE 3DEFINE SCAN, A SOFTWARE ANOMALY OCCURS. THE WORKFLOW TO REPRODUCE WAS AS FOLLOWS: FIRST, PROCEED TO OPERATION SCREEN. NEXT, PROCEED TO ¿EDIT WORK VOLUME¿ SCREEN AND THEN SEND THE SURGICAL ARM TO A NEW 3DEFINE SCAN. THE RESULT WAS THAT THE ARM MOVED THROUGH THE TOWER AFTER THE WORK VOLUME VANISHED. THE WORK AROUND NOTED WAS TO EDIT THE WORK VOLUME ON THE OPERATION SCREEN (WHEN THE TOWERS WERE DELETED ONCE THE WV IS REPLACED) ALLOWS THE USER TO CONTINUE AS EXPECTED. THIS ISSUE WAS ALSO REPRODUCED IN A RELEASED SOFTWARE VERSION, 5.1.2. IT WAS FOUND DURING R<(>&<)>D TESTINGTHERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23939620 ↗
• MalfunctionJan 1, 2026Computer Software Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT DEFECT #23171 WAS IDENTIFIED. THE INCORRECT WORK VOLUME (WV) WAS DISPLAYED WHEN SAME PATIENT ID IS PRESENT ON THE MEDTRONIC IMAGING SCAN (STAR MARKER WORKFLOW) WHEN IMPORTED TO THE EXISTING CT-FL. THE ISSUE WAS INITIALLY IDENTIFIED AND DISCUSSED ON TRIAGE MEETINGS ON (B)(6) 2023 AND TIER 1 MEETINGS OCCURRED ON (B)(6) 2023. THE ANOMALY COULD OCCUR WHEN REVISING A SURGERY OR WHEN THE USER DECIDES TO CHANGE THE SURGERY METHOD (FROM CT-FL TO SCAN & PLAN (S & P)). AFTER IMPORTING THE S & P TO THE EXISTING CT- FL CASE, THE WORK VOLUME SHOULD HAVE BEEN EITHER DEFAULT WV OR A NEW WORK VOLUME (BY PERFORMING A NEW 3D SCAN). HOWEVER, THE WV THAT WAS PRESENTED WAS FROM THE PREVIOUS CT SCAN. THIS MAY LEAD TO TOWERS BEING SHOWN UPSIDE DOWN IN THE WORK VOLUME AND/OR CAUSE POTENTIAL SURGICAL WORKFLOW DISRUPTION. AFTER THE FIRST SEGMENT IN OPERATION, THE USER CONTINUES TO 2ND SEGMENT (IN PLANNING) AND THE SOFTWARE ENABLES THE USER TO PROCEED TO PLANNING WITHOUT A NEW 3D SCAN, HOWEVER, THE USER WILL NOT BE ABLE TO PROCEED TO THE OPERATION PHASE. THE WORK AROUND NOTED WAS EDITING THE WV

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23939619 ↗
• MalfunctionJan 1, 2026Computer Software Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT DURING INTERNAL TESTING IT WAS FOUND THAT ACCURACY IS AFFECTED AND COMPROMISED WHEN ADJUSTING PBRS POSITION FROM PLANNING (5.0.1) OR AXIS VALIDATION (5.1.1) AND RETURNING TO OPERATION IN DEFECT # 21991. IN BOTH VERSIONS: THE USER CAN EDIT THE PBRS AFTER EXITING OPERATION, ADJUSTING PBRS FROM PLANNING (5.0.1) OR AXIS VALIDATION (5.1.1) AND RETURNING TO OPERATION. THE REGISTRATION IS STILL 'VALID' FOR THE VERTEBRAE ¿ DIFFERENTLY AS IN POSTERIOR ELEMENTS SCREEN WHERE THE SW CLEARS THE APPROVED LEVELS. ACCURACY IS AFFECTED AND COMPROMISED ¿ WE SENT TO THE SAME BB BEFORE AND AFTER CHANGING THE PBRS AND THE ARM WAS SENT INTO TWO DIFFERENT TRAJECTORIES. AFTER CHANGING THE PBRS AND RETURNING BACK TO OPERATION, THE UI DISPLAYS "NOT ON TRAJECTORY". IF THE CHANGE IS SIGNIFICANT, UPON ENTERING APPROVE REGISTRATION SCREEN THERE IS A WARNING MESSAGE SAYING THAT REGISTRATION FOR VERTEBRAE X, Y, Z ARE AFFECTED DUE TO MULTIPLE POSSIBLE REASONS (DON'T REMEMBER EXACTLY THE WORDING BUT IT IS SOMETHING IN GENERAL). HOWEVER, IF THE CHANGE IS MINOR - NO INDICATION IS PRESENTED TO THE USER. T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23939613 ↗
• MalfunctionJan 1, 2026Computer Software Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT DEFECT-25081 OCCURRED. THE SPINE SHIFT DID NOT OCCUR WHILE THE NAVIGATION WITH DEDICATED TOOL OUTSIDE OF THE AREA OF THE SELECTED FACET DECORTICATION. THE STEPS TO REPRODUCE WERE AS FOLLOWS. FIRST PERFORM OPERATION ON ANY WORKFLOW. SECOND, PAIR ANY DISC PREP TOOL TO THE NAVLOCK. NEXT, SELECT ANY FACET DECORTICATION TRAJECTORY (FD). AND FINALLY, NAVIGATE WITH THE TOOL MENTIONED ABOVE IN THE AREA OUTSIDE OF THE FD'S VERTEBRAE. THE EXPECTED RESULT WAS THAT THE SPINE SHIFT WOULD OCCUR ON ANY PART OF THE REGISTERED SPINE WITHOUT ANY LIMITATION RELATED TO THE SELECTED IMPLANT. THE ACTUAL RESULT WAS THAT THE SPINE SHIFT ONLY OCCURRED IN THE AREA OF THE SELECTED FD'S VERTEBRAE. IT WAS POSSIBLE TO NAVIGATE IN THE REGISTERED AREA WITHOUT A SPINE SHIFT. THE DEFECT WAS REPLICATED ON THE SYSTEM UNDER 5.1.2.48 SOFTWARE VERSION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23939612 ↗
• MalfunctionJan 1, 2026Computer Software Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT DEFECT-22475 WAS FOUND WHEN RETURNING FROM PLANNING TO THE SEGMENTATION SCREEN, CHANGING THE SEGMENTATION, AND LOGGING OUT, AFTER LOGIN ONLY THE MIDLINE APPEARS IN THE PLANNING SCREEN AND ADDING INTERBODY IS NOT PLACED CORRECTLY. IN ORDER TO REPLICATE, A PERSON MUST GO TO PLANNING AND ADD SIX SCREWS. NEXT, THEY MUST GO BACK TO THE SEGMENTATION SCREEN AND ADD SEGMENTATION LINES. THE SEGMENTS SHOULD BE LABELLED, AND THEN THE USER MUST GO BACK TO THE PATIENT FOLDER, LOG LOUT, LOG BACK IN, AND PROCEED TO PLANNING. THE USER MUST ADD AN INTERBODY ON THE LOWEST VERTEBRA, AND AS A RESULT ONLY THE MIDLINE APPEARS AND THE INTERBODY IS FAR AWAY FROM THE ENDPLATES. THE DEFECT WAS FIXED AND VERIFIED IN 5.2 SOFTWARE VERSION. NO PATIENT WAS PRESENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23939610 ↗
• MalfunctionJan 1, 2026Computer Software Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT DEFECT-23622 WAS IDENTIFIED. THIS ISSUE CAN BE REPRODUCE BY IMPORTING THE CASE SAVED IN - W:\SQA\5.2\DEFECT-236222, PROCEEDING TO PLANNING, AND THEN EXIT TO THE PATIENT FOLDER. THE PROCESS INDICATION WAS DISPLAYED FOR THREE MINUTES UNTIL THE SPINE FEATURES ALGORITHM WAS COMPLETE. WHEN THE PATIENT FOLDER WAS OPENED RETURN TO PLANNING SCREEN, AND THE USER OPENS THE LOGS, THE ALGORITHM WAS RE-EXECUTING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23939609 ↗
• MalfunctionJan 1, 2026Computer Software Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT DEFECT-23751 WAS IDENTIFIED. IN ORDER TO REPRODUCE THE ISSUE, THE USER MUST IMPORT AN UNID PLAN, SELECT THE ALIGNMENT LAYOUT, TOGGLE TO THE ORIGINAL IMAGE IN ONE OF THE VERTICAL VIEWS, AND RESET ALL SIMULATIONS. FROM THERE IT CAN BE SEEN THAT THE BENT RODS EXIST IN THE VIEW WHERE THE SIMULATED IMAGE WAS DISPLAYED BEFORE RESETTING THE SIMULATION, WHILE THE RODS ARE MISSING IN THE VIEW WITH THE ORIGINAL IMAGE. THE EXPECTED RESULTS WAS THAT THE SIMULATION SHOULD BE TURNED OFF AND THE RODS SHOULD APPEAR ON ALL RELEVANT VIEWS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23939602 ↗
• MalfunctionJan 1, 2026Computer Software Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT DEFECT-24251 WAS IDENTIFIED. THE STEPS TO REPRODUCE ARE AS FOLLOWS: PERFORM ALL NECESSARY SETUP STEPS. GO TO INSTRUMENT SETUP SCREEN. SELECT "NAVLOCK" AND PAIR IT WITH A DRIVER. PLACE THE "NAVLOCK" IN THE REFERENCE FRAME DIVOT WITH A LARGE ANGLE. WAIT A FEW SECONDS UNTIL THE NOTIFICATION FOR FAILED VERIFICATION APPEARS. THE EXPECTED RESULTS WERE THAT THE FOLLOWING MESSAGE WOULD APPEAR: "VERIFICATION FAILED...INCORRECT ANGLE TO DIVOT.....".¿DISTANCE TO DIVOT: XX.X MM, ANGLE TO DIVOT: XX.X DEG¿ SHOULD HAVE BEEN DISPLAYED ON THE "MDT" BANNER. THE ACTUAL RESULTS WERE AS FOLLOWS: THE MESSAGE: "VERIFICATION FAILED...TOO FAR FROM DIVOT....." WAS NOT DISPLAYED WHEN THE TOOL VERIFICATION FAILED DUE TO A HIGH ANGLE. ONLY THE MESSAGE: " VERIFICATION FAILED... DISTANCE TO DIVOT: XX.X MM, ANGLE TO DIVOT: XX.X DEG WAS DISPLAYED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23939591 ↗
• MalfunctionJan 1, 2026Computer Software Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT DEFECT-24497 WAS IDENTIFIED. TO REPRODUCE THE USER MUST PROCEED TO THE OPERATION SCREEN AND CHOOSE TOWERS ON, SEND THE ARM TO A SCREW IN ORDER TO CREATE A TOWER, CHOOSE THE TOWER IN THE TOWERS TAB (TOWER COLOR IS RED), AND ENTER EDIT WORK VOLUME(WV). THE ACTUAL RESULT WAS THAT THE TOWER COLOR WAS RED IN THE "EDIT WV" SCREEN, WHICH IS THE WRONG BEHAVIOR. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION RECEIVED INDICATED THE PROBLEM OCCURRED ON SOFTWARE VERSION 5.1.1.30.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23939590 ↗
• MalfunctionJan 1, 2026Unintended Application Program Shut Down

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THERE WAS A SOFTWARE DEFECT, DEFECT-24784. WHEN STARTING A NEW CT TO FLUORO FLOW, THE USER SHOULD HAVE IMPLANTS PLANNED WITH TOWERS AND PROCEED TO THE OPERATION SCREEN. THE SURGICAL ARM SHOULD THEN BE SENT TO ALL THE REGISTERED SCREWS, AND THE TOWERS APPEAR IN THE VISUALIZATION TOOL KIT. THE USER MUST THEN EXIT THE PATIENT FILE, UNLOCK THE MOUNT, MARK THE SAME CASE, AND ENTER 'PLAN'. THE USER THEN MUST CHOOSE 'SEGMENTATION' FROM THE DROP-DOWN MENU AND DELETE ONE OF THE VERTEBRAE THAT GOT THE TOWER IN THE PREVIOUS FLOW. THE USER MUST THEN EXIT THE PATIENT FILE AND START A NEW OPERATE PROCESS WITH THE SAME CASE, PROCEED TO APPROVE, AND REGISTER AND CONFIRM ALL THE VERTEBRAE. FINALLY, USER MUST CHOOSE SKIP. THIS RESULTS IN AN UNEXPECTED EXIT. THEN WHEN THE USER GETS THE SYSTEM TO RECOVER, WHEN THE USER CLICKS OPERATION, THE SYSTEM UNEXPECTEDLY EXITS AGAIN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23939584 ↗