Mazor X System TPL0059-09Recalls & reported problems

Summary

The FDA's MAUDE database contains 137 adverse event reports that list this exact device (DI 07290115751376), received between Dec 9, 2022 and Sep 28, 2026 — classified as 1 death, 18 injuries, 118 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (102 reports).

3 FDA recall records name this device's identifier, 3 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. Jul 17, 2024Open, Classified

   Software anomalies which can result in two separate issues: A lagging screen display during a navigated procedure; or the potential for a mismatch between the navigated screw and the screw information presented on the screen.

   Z-3156-2024 · Root cause: Device Design · FDA record ↗

3. 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 137 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50916343 ↗
• MalfunctionSep 25, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50905743 ↗
• MalfunctionMay 5, 2026Incorrect, Inadequate or Imprecise Result or Readings

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT DURING A T9-L3 FUSION CASE, THE SCREWS ON T9 AND T10 WERE MEDIAL. THE SURGEON FREEHANDED THESE SCREWS. UNKNOWN HOW MANY MILLIMETERS (MM) THIS ALLEGED INACCURACY WAS. UNKNOWN IF THERE WAS A DELAY. NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25083968 ↗
• MalfunctionMay 4, 2026Incorrect, Inadequate or Imprecise Result or Readings; Use of Device Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT DURING A L4-L5 ONE LEVEL CT-FLUORO CASE, THEY HAD DIFFICULTY REGISTERING WITH SINGLE-ARM RETRACTORS. SHE ATTEMPTED REGISTERING MULTIPLE LEVELS WITH NO RESOLUTION. THEY COMPLETED REGISTRATION BY REMOVING THE RETRACTORS. SHE STATED THE SCREENS HAD GONE BLACK. SYSTEM SOFT REBOOTED TO GET THE MONITORS BACK. SHE NOTED THERE WAS ALSO A SHOULDER SHIFT AFTER PLACING LEFT L4. WHEN THEY WENT TO PLACE RIGHT L4 SCREW, THEY NOTICED THE ARM WAS SHIFTED MEDIALLY, BUT THEY DID NOT PLACE THE SCREW. DOCTOR TRIED TO CORRECT THE ISSUE BY PHYSICALLY PUSHING THE ARM, RESULTING IN ANOTHER SHOULDER SHIFT. THERE WAS A 30 MINUTE DELAY. NO IMPACT ON PATIENT OUTCOME. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THERE WAS A CONFIRMED INACCURACY AT RIGHT L4, ESTIMATED LESS THAN 3.5 MILLIMETERS (MM) INACCURATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25071529 ↗
• MalfunctionApr 9, 2026Incorrect, Inadequate or Imprecise Result or Readings

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING AN ELECTRODE AND PROBE PLACEMENT PROCEDURE. IT WAS REPORTED THAT DURING CT-FLUORO CASE, AFTER REGISTRATION, MARKING OUT INCISIONS, THEY DID NOT MATCH THE PLAN. LEFT SIDE INCISIONS WERE MORE LATERAL (1/2 INCH) AND RIGHT SIDE INCISIONS WERE MORE MEDIAL (1/2 INCH) THAN PLAN. THEY RE-REGISTERED AND THEN THE NAVIGATION WAS ACCURATE. THERE WAS LESS THAN AN HOUR DELAY. NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24832092 ↗
• MalfunctionMar 13, 2026Incorrect, Inadequate or Imprecise Result or Readings

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT DURING A THORACIC FUSION T4-T10 CASE ON (B)(6) 2026, AFTER PLACING A SCREW, THEY BROUGHT IN X-RAY SYSTEM FOR DECOMPRESSION PURPOSES AND FOUND DEVIATED SCREW. THEY NOTICED THAT T4 ON THE LEFT LOOKED MEDIAL AND THE SURGEON IMMEDIATELY REMOVED THE SCREW. THEY ABORTED SYSTEM AND PROCEEDED WITH THE IMAGING SYSTEM AND NAVIGATION SYSTEM FOR THE CASE. THERE WAS LESS THAN AN HOUR DELAY. NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24590549 ↗
• MalfunctionMar 6, 2026Incorrect, Inadequate or Imprecise Result or Readings

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT DURING L4-L5 T RANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) CT-FLOURO REGISTRATION, THE K-WIRE WAS MEDIAL IN THE PEDICLE OF L4 (RIGHT SIDE). THEY REGISTERED THE PATIENT AGAIN WHICH RESOLVED THE ISSUE. THERE WAS LESS THAN AN HOUR DELAY. NO IMPACT ON PATIENT OUTCOME. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THIS WAS NOT A REGISTRATION ISSUE. THEY REGISTERED TO ENSURE ACCURACY MOVING FORWARD. IT WAS SUSPECTED THAT THE ANATOMY SHIFTED DURING THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24535915 ↗
• MalfunctionFeb 27, 2026Incorrect, Inadequate or Imprecise Result or Readings

  ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THERE WAS NO KNOWN IMPACT TO THE PATIENT. THE MANUFACTURING REPRESENTATIVE (REP) ALSO STATED THE DEVIATION AMOUNT WAS HARD TO SAY, BUT MAYBE 3.5 MILLIMETERS (MM).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24470695 ↗
• MalfunctionFeb 25, 2026Incorrect, Inadequate or Imprecise Result or Readings

  ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE REPORTED THAT SCREWS WERE IMPLANTED WITH A FULL SPEED DRILL, TAPPING, AND THEN SCREW PLACEMENT. IN COME SITUATIONS THE SURGEON PREPARED THE ENTRY POINT BY REMOVING BONE. LEFT SIDE SCREWS WERE OPERATED ON THE LEFT SIDE OF THE PATIENT, AND ON THE RIGHT SIDE OF THE PATIENT FOR RIGHT SCREWS. BOTH LEFT SIDE SCREWS WERE DEVIATED MEDIALLY BY 1-2MM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24446933 ↗
• MalfunctionFeb 25, 2026Incorrect, Inadequate or Imprecise Result or Readings

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THERE WAS NO ANATOMY SHOWING ON NAVIGATION, JUST THE SCREW. THEN NAVIGATION ALL LOOKED OFF AT ONE TRAJECTORY. THEY PLACED THE OTHER SCREWS, AND EVERYTHING LOOKED ACCURATE, INCLUDING THE INITIAL TRAJECTORY THAT APPEARED TO BE OFF. THERE WAS NO DELAY AND NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24443700 ↗
• MalfunctionFeb 13, 2026Incorrect, Inadequate or Imprecise Result or Readings

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT DURING AN OPEN PROCEDURE, L2-S1, PLACING SCREWS, PATIENT HARDWARE AT L3, L5, THERE WAS AN ALLEGED INACCURACY. MANUFACTURING REPRESENTATIVE (REP) REPORTED THAT REGISTRATION PASSED WITH ALL GREEN VALUES. THE SURGEON PLACED S1 SCREWS FIRST. AFTER SENDING ARM TO FIRST TRAJECTORY, SURGEON DECIDED TO EXTEND THE S1 INCISION. SURGICAL TEAM RETURNED TO PLANNING TAB ON GUIDANCE SYSTEM APPLICATION TO ROTATE THE SCREWS MORE MEDIALLY ON BOTH SIDES TO ENSURE THE TRAJECTORIES WOULD FIT WITHIN THE WOUND. SURGEON SENT ROBOT ARM TO TRAJECTORY FOR LEFT SCREW ON L2, USED A BALL TIP PROBE TO CHECK ACCURACY, AND DECIDED TO PROCEED WITH PLACING SCREW. FOR RIGHT SCREW ON L2, ROBOT ARM WAS SENT TO TRAJECTORY, THE HEALTHCARE PROFESSIONAL (HCP) DRILLED THE HOLE, AND SURGEON TAPPED, BUT DECIDED IT DID NOT FEEL PROPERLY PLACED. SURGEON REMOVED TAP AND TOOK X-RAYS OF INSERTED SCREWS. FROM X-RAY IMAGES, SURGEON DETERMINED THAT ALL SCREWS WERE SHIFTED RIGHT, SOME NOT EVEN APPEARING TO BE PLACED IN THE PEDICLE. AN APPROXIMATE DISTANCE FROM INTENDED LOCATION WAS NOT PROVIDED. AT THE TIME OF CALL, RO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24337456 ↗
• DeathFeb 13, 2026Incorrect, Inadequate or Imprecise Result or Readings; Use of Device Problem

  ADDITIONAL INFORMATION WAS RECEIVED THE MANUFACTURING REPRESENTATIVE THAT INDICATED SOLERA VOYAGER SCREWS WERE USED DURING A T3-T7 PERCUTANEOUS FIXATION PROCEDURE. ADDITIONALLY, ALTHOUGH THERE IS AN ALLEGATION THAT THE REPORTED SERIOUS INJURY AND DEATH WERE CAUSED BY THE GUIDANCE SYSTEM, MEDTRONIC DOES NOT HAVE ENOUGH INFORMATION TO CONFIRM THE ALLEGATION. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN ADDITIONAL EVENT DETAILS. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MDR WILL BE SUBMITTED.

  Patient problems: Cardiac Arrest; Cerebrospinal Fluid Leakage; Myocardial Infarction; No Clinical Signs, Symptoms or Conditions; Spinal Cord Injury

  MAUDE report 24332976 ↗
• MalfunctionFeb 11, 2026Incorrect, Inadequate or Imprecise Result or Readings

  ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE REPORTED THE INACCURACY WAS LESS THAN 3.5MM, CLOSER TO 2MM. THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24317077 ↗
• MalfunctionFeb 11, 2026Incorrect, Inadequate or Imprecise Result or Readings

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT DURING A T10-L2 CASE, AFTER PERFORMING SUCCESSFUL REGISTRATION AND VERIFYING THE X-RAY LOOKED GOOD, THE MAIN MONITOR AND SURGEON MONITOR APPEARED TO LOOK OFF LATERALLY ON THE LEFT AND MEDIAL ON THE RIGHT. THE LOCAL REPRESENTATIVE (CC) REPORTED THAT BOTH MONITORS SEEMED TO SHOW A VISUAL SHIFT. THE CC REPORTED THEY TRIED SNAPSHOT AND AN ADVANCED ACCURACY TEST, AND IT LOOKED OFF ON THE DIVOT. THEY ALSO ATTEMPTED TO RE-REGISTER AND ISSUE PERSISTED. THE ROBOT WAS ABORTED FROM THE CASE AND THEY PROCEEDED USING NAVIGATION WITH THE NAVIGATION SYSTEM. AFTER THE CASE, THE ADVANCED ACCURACY TEST AND STRESS TEST WERE PERFORMED AND BOTH PASSED. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF LESS THAN ONE HOUR. THERE WAS NO REPORTED IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24316887 ↗
• MalfunctionFeb 5, 2026Incorrect, Inadequate or Imprecise Result or Readings

  ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE REPORTED THAT SCREWS WERE IMPLANTED WITH A FULL SPEED DRILL, TAPPING, AND THEN SCREW PLACEMENT. IN COME SITUATIONS THE SURGEON PREPARED THE ENTRY POINT BY REMOVING BONE. LEFT SIDE SCREWS WERE OPERATED ON THE LEFT SIDE OF THE PATIENT, AND ON THE RIGHT SIDE OF THE PATIENT FOR RIGHT SCREWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Tissue Injury

  MAUDE report 24272072 ↗
• MalfunctionJan 29, 2026Incorrect, Inadequate or Imprecise Result or Readings

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT ROBOTIC ARM WAS NOT MOVING CORRECTLY ACCORDING TO THE PLANNING. THE ARM'S MOVEMENT WAS NOT ALIGNING WITH THE PLANNED SCREW PATH. A STRESS TEST, 10 POINT ACCURACY TEST AND BUILT IN SELF TEST WERE PERFORMED AND PASSED. IT WAS REPORTED THAT NAVIGATION AND THE SURGERY WAS ABORTED. THERE WAS NO PATIENT HARM AND THE PROCEDURE WAS DELAYED LESS THAN ONE HOUR. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE ARM'S SCREW TRAJECTORY WAS INACCURATE GREATER THAN 10 MILLIMETERS (MM).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24215940 ↗
• MalfunctionJan 29, 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 TRAJECTORIES ON THE RIGHT SIDE WERE OFF. THEY REPLANNED THE SCREWS AND RESPUN. THE SITE COMPLETED THE LEFT SIDE WITH NO REPORTED ISSUE, BUT PROCEEDED WITH NAVIGATION ON THE RIGHT SIDE. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24210893 ↗
• MalfunctionJan 27, 2026Incorrect, Inadequate or Imprecise Result or Readings

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THEY HAD AN ALLEGED INACCURACY. THE NAVIGATION SYSTEM SAID THAT THEY WERE INFERIOR TO THE PLAN IN THE SCREW. WHEN THEY SCREWED IN, IT WAS ACCURATE. THERE WAS NO DELAY AND NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24192715 ↗
• MalfunctionJan 26, 2026Incorrect, Inadequate or Imprecise Result or Readings

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT SKIVING OF A SCREW INTO THE LATERAL SPACE OF THE DISC OCCURRED. THE SURGEON PLACED SCREWS AT L4-R, L5-R, L4-L, AND L5-L. AFTER ROD PLACEMENT, A CONFIRMATION X-RAY SHOWED THE SCREW ON L5-R WAS SKIVING INTO THE LATERAL SPACE OF THE DISC, BUT WAS NOT IMPACTING ANY CRITICAL ANATOMY. THE SURGEON REMOVED THE ROD, RESENT THE TRAJECTORY FOR L5-R, AND MANUALLY PLACED THE SCREW USING A K-WIRE, RESULTING IN AN ACCURATE REVISED TRAJECTORY AND SUCCESSFUL REVISION. NO DEFECTS WERE OBSERVED DURING NEUROMONITORING OR ON THE CONFIRMATION X-RAY. A MEDTRONIC POWERED DRILL WAS USED TO TAP AND CREATE A PILOT HOLE, AND NAVIGATION WAS REPORTED AS ACCURATE. BOTH THE SURGEON AND THE SITE, INCLUDING THE REPRESENTATIVE, SUSPECTED THAT THE SCREW MAY HAVE BEEN POORLY LOADED ONTO THE DRIVER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT AND SURGICAL DELAY WAS LESS THAN ONE-HOUR. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE TRAJECTORY WAS OFF BUT THE DISTANCE IS UNKNOWN. THE ONLY TRAJECTORY THAT WAS OFF WAS THE SCREW. BOTH THE DRILL AND THE TAP STAYED ON T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24179886 ↗
• InjuryJan 22, 2026Incorrect, Inadequate or Imprecise Result or Readings; Failure to Advance

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT DURING AN L2-S1 OPEN BACK PROCEDURE USING THE GUIDANCE SYSTEM, AN ALLEGED INACCURACY OF THE GUIDANCE SYSTEM OCCURRED. THE PATIENT HAD PREVIOUSLY UNDERGONE PLACEMENT OF FOUR INTERBODY CAGES AT L2, L3, L4, AND N5-1. ON THE DAY OF THE EVENT, A COMPUTED TOMOGRAPHY-TO-FLUORO IMAGING PROCEDURE WAS SET UP, AND ALL REQUIRED STRUCTURES WERE CONFIRMED TO BE IN VIEW. DURING THE INITIAL INCISION, ONLY L3-S1 WAS EXPOSED, AND WHEN THE ARM WAS SENT TO L2 ON THE LEFT SIDE, IT WAS CLAIMED THAT THE ARM HAD NOT NAVIGATED TO L2. AFTER RETAKING THE IMAGE AND EXPOSING L2, THE ARM WAS SENT TO THE LEFT SIDE OF L2 AGAIN. WHILE DRILLING FOR THE GUIDANCE SYSTEM, THE PATIENT'S LEG EXHIBITED INVOLUNTARY MOVEMENT ("JUMPED"), PROMPTING THE SURGEON TO STOP AND SWITCH TO TAPPING. THE PATIENT'S LEG JUMPED AGAIN DURING TAPPING, A ND CERVICAL SPINAL FLUID WAS OBSERVED. THE USE OF THE GUIDANCE SYSTEM WAS ABORTED FOR THE REMAINDER OF THE PROCEDURE, AND THE SURGEON CONTINUED USING MEDTRONIC IMAGING AND NAVIGATION. IT WAS NOTED THERE WAS THERE WAS NO IMPACT TO PATIENT'S OUTCOME.

  Patient problems: Cerebrospinal Fluid Leakage; Insufficient Information

  MAUDE report 24149604 ↗
• MalfunctionJan 15, 2026Incorrect, Inadequate or Imprecise Result or Readings

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT ONE SCREW WAS PLACED LATERALLY COMPARED TO THE PLANNED TRAJECTORY DURING AN L3-S1 CASE. THE SURGEON BEGAN AT S1 RIGHT, WORKED UPWARDS TO L3, AND THEN MOVED TO THE LEFT SIDE. A CONFIRMATION SPIN CONFIRMED THAT L3 RIGHT WAS PLACED TOO LATERALLY BY 3.5 TO 10 MM. THE SURGEON ACKNOWLEDGED THAT THIS WAS A CHALLENGING CASE DUE TO THE PATIENT'S BMI OF 41, COMPLEX ANATOMY, AND A SIGNIFICANT AMOUNT OF SOFT TISSUE. THE SITE DECIDED TO USE THE NAVIGATION SYSTEM TO REPLACE THE SCREW AT L3 RIGHT. THERE WAS NO PATIENT HARM AND THE PROCEDURE WAS DELAYED LESS THAN ONE HOUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24080408 ↗
• MalfunctionJan 14, 2026Incorrect, Inadequate or Imprecise Result or Readings; Use of Device Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A 2 LEVEL TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF). IT WAS REPORTED THAT THERE WAS A DEVIATED SCREW DURING A SURGERY. THE LEFT SIDE OF THE PATIENT WAS INSTRUMENTED FIRST. L4 WAS INSERTED, FOLLOWED BY L5. DURING L5, NAVIGATION LOOKED STRANGE. THERE WAS A BIG GAP THAT DIDN'T LOOK RIGHT. AS A RESULT, THE REPRESENTATIVE WENT BACK TO SEGMENTATION. THE SEGMENTATION LINES LOOKED OUT OF PLACE EVEN THOUGH THEY WERE ALL AT GREEN VALUES. THE LINES WERE ADJUSTED AND EVERYTHING LOOKED NORMAL, THE GAPS WEREN'T PRESENT ANYMORE. THE REST OF THE CASE CONTINUED, BUT WHEN CONFIRMATION SHOTS WERE TAKEN, IT WAS FOUND THAT THE L5 SCREW WAS DEVIATED. AS A RESULT, THAT SCREW NEEDED TO BE REMOVED. THERE WAS NO IMPACT TO PATIENT'S OUTCOME AND SURGICAL DELAY WAS LESS THAN ONE-HOUR. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS A L3-L5 POSTERIOR FUSION. THE LEFT SIDE WAS INSTRUMENTED FIRST. FIRST L5 AND IT WAS SEEN THAT THE SEGMENT OF L3-L4 LOOKED COLLAPSED ON EACH OTHER. L4 WAS THEN INSTRUMENTED. SEGMENTATION STILL LOOKED COLLAPSED, SO THE MANUFACTURER REPRESENTATIVE WENT BACK TO THE ¿CON

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24069409 ↗
• MalfunctionDec 30, 2025Mechanical Problem; Use of Device Problem; Unintended Application Program Shut Down; Mechanical Problem; Use of Device Problem; Unintended Application Program Shut Down

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT WHEN THE MANUFACTURER REPRESENTATIVE TURNED THE SYSTEM ON IN STORAGE TO COMPLETE THE BUILT-IN SELF-TEST (BIST), THE SYSTEM WOULD NOT LET THE REPRESENTATIVE SELECT THE SETUP PROCESS TO COMPLETE THE SURGICAL ARM SETUP AND RUN THE BIST. A SOFT RESTART WAS PERFORMED AND THE BIST WAS ABLE TO BE COMPLETED. THE SYSTEM WAS TURNED OFF UNTIL THE CASE HAPPENED LATER. ONCE BOOTED UP IN THE ROOM, THE SCREEN WENT BLACK. IT CAME ON AFTER ABOUT ONE MINUTE AND THEY COMPLETED THE ACCURACY TEST AND REGISTERED THE PATIENT. THEY WENT TO SEND THE ARM TO TRAJECTORIES AND THE SCREEN WENT BLACK AGAIN. IT WAS OFF FOR ABOUT 20 SECONDS AND WHEN IT CAME BACK UP THEY HAD TO NAVIGATE THROUGH THE SOFTWARE TO GET TO THE OPERATE PROCESS AGAIN TO SEND THE ARM TO SCREW TRAJECTORIES. THERE WAS ABOUT A 5 MINUTE DELAY TO THE PROCEDU RE. THERE WAS NO IMPACT TO THE PATIENT. ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE REPORTED THAT DURING THE SYSTEM CHECKOUT THE BIST ACCURACY CHECK THE SURGICAL ARM HIT THE DIVOT ON LEFT SIDE. IT WAS ALSO NOTED THAT THE COMPUTER RANDOMLY RESTARTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23927846 ↗
• MalfunctionDec 26, 2025Unintended Application Program Shut Down; Unintended Application Program Shut Down

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT WHILE ATTEMPTING TO LOAD AN EXAM TO THE SYSTEM THE SCREEN WENT BLACK AND FORCED THE SOFTWARE TO RESTART. THE MANUFACTURER REPRESENTATIVE THEN ATTEMPTED TO IMPORT THE SCAN ON THE SOFTWARE ON HER LAPTOP AND THE ISSUE OCCURRED AGAIN. SHE HAD TO DOWNLOAD TO THE NAVIGATION SYSTEM AND THEN EXPORT TO A USB BEFORE THE SYSTEM WOULD ACCEPT THE SCAN. ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE REPORTED THAT DURING A TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) PROCEDURE THERE WERE ISSUES UPLOADING THE DISC AND SCREEN WENT BLACK. THE CASE WAS COMPLETED AND THE SCREWS WERE ACCURATE. NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE REPORTED THAT THE PROCEDURE WAS DELAYED BY 10 MINUTES. CASE WAS COMPLETED WITH GUIDANCE SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23900674 ↗
• MalfunctionDec 26, 2025Unintended Application Program Shut Down; Unintended Application Program Shut Down

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SYSTEM WOULD SOFT REBOOT ITSELF DURING THE ARM SETUP. ONCE THE ARM SETUP WAS COMPLETE AND THE ARM WAS MOVING TO THE CLEAR UP POSITION, BOTH SCREENS THEN TURNED BLACK FOR ABOUT 10 SECONDS. THE SYSTEM APPEARED TO REBOOT ITSELF AND LOADED BACK ONTO THE PATIENT SELECTION SCREEN. THE ARM SETUP SHOWED AS COMPLETE. THE MANUFACTURER REPRESENTATIVE WANTED TO SEE IF THE ARM SETUP COMPLETION WAS A GLITCH DUE TO THE SOFT REBOOT. WHEN HE PERFORMED THE ARM SETUP AGAIN, THE SYSTEM SOFT REBOOTED YET AGAIN. HE WENT INTO THE ARM SETUP A THIRD TIME, AND IT ALSO REBOOTED AGAIN. SINCE THE SOFTWARE SHOWED THAT THE ARM SETUP WAS PASSING, THEY SKIPPED A FOURTH ITERATION OF THE ARM SETUP AND PROCEEDED WITH THE CASE. NO PATIENT WAS PRESENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23899241 ↗