Mazor X System TPL0059-04Recalls & reported problems

Summary

The FDA's MAUDE database contains 131 adverse event reports that list this exact device (DI 07290109180465), received between Oct 31, 2017 and Feb 19, 2026 — classified as 1 death, 21 injuries, 109 malfunctions.

The most frequently reported specific device problem is “Imprecision” (66 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 131 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 19, 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 THEY TRIED TO REGISTER USING CT TO FLUORO, IT WAS HARD AND TOOK LONG TIME. THEY PLACED 2 SCREWS IN T12 AND MOVED TO T11 THEN THE SURGEON SAID IT WAS NOT ACCURATE. THEY TRIED TO REGISTER AGAIN BUT NO IMPROVEMENT, THEY MOVED TO SCAN AND PLAN AND STILL NOT ACCURATE. THE THREE DIMENSIONAL (3D) MARKER FOUND AT LOW ACCURACY. THEY FREEHANDED THE PROCEDURE. THERE WAS A 20 MINUTE DELAY. IMPACT ON PATIENT OUTCOME UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24395147 ↗
• MalfunctionJan 30, 2026Mechanical Problem; Incorrect, Inadequate or Imprecise Result or Readings

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT AN ALLEGED INACCURACY OCCURRED DURING A L3-L5 CASE. ALL SCREWS WERE ALL SHIFTED BILATERALLY TO THE RIGHT. IT WAS ADDITIONALLY REPORTED THAT WHEN PERFORMING THE BUILT-IN SELF-TEST (BIST) AT THE BEGINNING OF THE CASE, THE BIST WOULD FAIL AND THE SYSTEM HAD TO BE REBOOTED TO PERFORM THE BIST AGAIN AND SUCCESSFULLY PASS. WHEN NOTICING THE INACCURACY AFTER SPIN, THE SURGEON INITIALLY THOUGHT IT WAS A NAVIGATIONAL SHIFT AS ANATOMY LOOKED TO BE GOOD, BUT WHEN PERFORMING THE TURKEY FOOT ARM TEST, IT LOOKED TO BE A LITTLE OFF THE DIVOT BUT VERY CLOSE TO DIVOT. THE ROBOT WAS ABORTED FROM THE CASE AND THE CASE PROCEEDED USING NAVIGATION. AFTER THE CASE, THE ADVANCED ACCURACY TEST WAS PERFORMED AND ONE WAS RUNNING AGAINST THE WALL. THERE WAS NO IMPACT TO PATIENT'S OUTCOME. THERE WAS A DELAY TO THE PROCEDURE OF APPROXIMATELY 20-30 MINUTES. THE AMOUNT OF INACCURACY WAS LESS THAN 3.5MM, CLOSER TO 2MM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24223412 ↗
• MalfunctionJan 30, 2026Incorrect, Inadequate or Imprecise Result or Readings

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM. IT WAS REPORTED THAT THE DOCTOR FELT SOMETHING WAS NOT RIGHT WITH THE SYSTEM. THERE WAS AN INDICATION THAT A CALIBRATION WAS NEEDED. THERE WAS NO PATIENT HARM REPORTED. IT WAS ALSO NOTED THAT DURING THE SYSTEM CHECKOUT IT WAS FOUND THAT THE ACCURACY POINTER WAS SLIGHTLY CROOKED. THE TYPE OF SURGERY THAT WAS PERFORMED WHEN THE EVENT OCCURRED WAS TO ADDRESS SCOLIOSIS. THERE A DELAY OF 20-30 MINUTES TO THE PROCEDURE. IT WAS REPORTED THAT WHAT WAS NOT RIGHT WAS THAT THE ROBOT AND NAVIGATION WERE NOT ACCURATE. THE INACCURACY WAS LESS THAN 3.5MM. USE OF THE GUIDANCE SYSTEM WAS NOT ABORTED. IT WAS ALSO IDENTIFIED THAT NO CALIBRATION WAS NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24223199 ↗
• MalfunctionJan 28, 2026Incorrect, Inadequate or Imprecise Result or Readings

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM USED IN A 2 LEVEL ANTERIOR LUMBAR INTERBODY FUSION (ALIF). IT WAS REPORTED THAT GREEN REGISTRATION WAS ACHIEVED AND SENT TO TWO TRAJECTORIES, BUT THE TRAJECTORIES LOOKED HIGH, TOWARDS THE HEAD OF THE PATIENT. AS A RESULT, THE SURGEON ABORTED THE USE OF THE GUIDANCE SYSTEM AND PLACED 6 SCREWS BY HAND. 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 DEVIATION WAS LIKELY BETWEEN 3.5 AND 10 MILLIMETERS (MM).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24200961 ↗
• MalfunctionJan 15, 2026Incorrect, Inadequate or Imprecise Result or Readings; Use of Device Problem

  ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE REPORTED THAT THE TRAJECTORY WAS INACCURATE BY LESS THAN 3.5MM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24087428 ↗
• MalfunctionDec 29, 2025Use of Device Problem; Unintended Application Program Shut Down; Use of Device Problem; Unintended Application Program Shut Down

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT DURING THE SEMI-ANNUAL PLANNED MAINTENANCE (PM), THERE WERE SYSTEM ISSUES. THE ACCURACY POINTER WAS FOUND BENT. THERE WAS ALSO A PC FAILURE. THEY LOST DISPLAY ON BOTH THE MAIN MONITOR AND SURGEON MONITOR. DURING LOG COLLECTION AND SAVING, THE APPLICATION COLLAPSED AND CAME BACK AFTER A FEW MINUTES TO THE LOGIN SCREEN. THE LOGS WERE ABLE TO BE COLLECTED ON A SECOND ATTEMPT. AND FINALLY, THERE WAS AN ISSUE WITH SYSTEM SHUTDOWN. THERE WAS A WINDOWS BLUE SCREEN OF "COLLECTION SOME ERROR" (STOP CODE: MEMORY) MANAGEMENT). IT WAS DETERMINED THE PC AND ACCURACY POINTER WERE TO BE REPLACED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23918432 ↗
• MalfunctionDec 29, 2025Use of Device Problem; Use of Device Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THERE WAS AN OCCURRENCE OF THE 3DEFINE FAILING. THERE WAS NO IMPACT TO PATIENT'S OUTCOME. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WAS A 7-MINUTE DELAY TO THE PROCEDURE AND THE CASE WAS COMPLETED BY RE-ATTEMPTING THE 3DEFINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23918187 ↗
• MalfunctionDec 23, 2025Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THE SYSTEM BECAME UNRESPONSIVE DURING A SCAN AND PLAN PROCEDURE. THE ISSUE OCCURRED WHEN ATTEMPTING TO UPLOAD THE MEDTRONIC IMAGING SCAN VIA A UNIVERSAL SERIAL BUS (USB), LEADING TO A DELAY OF ABOUT FIVE MINUTES. THE TEAM DECIDED NOT TO ATTEMPT RELOADING THE SCAN TO AVOID FURTHER RISK AND INSTEAD PERFORMED A SECOND SCAN, WHICH LOADED WITHOUT ISSUES. THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23883312 ↗
• MalfunctionDec 23, 2025Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT WHILE USING SCAN AND PLAN, THE GUIDANCE SYSTEM BECAME UNRESPONSIVE WHEN ATTEMPTING TO UPLOAD AN MEDTRONIC IMAGING SCAN VIA A UNIVERSAL SERIAL BUS (USB). THIS ISSUE CAUSED A DELAY OF APPROXIMATELY FIVE MINUTES, AND THE PATIENT HAD TO BE RESCANNED DUE TO THE FAILURE OF THE INITIAL SCAN UPLOAD. THE SECOND SCAN WAS SUCCESSFULLY UPLOADED WITHOUT FURTHER ISSUES. THERE WAS NO IMPACT TO PATIENT'S OUTCOME. ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE REPORTED THAT THE ISSUE WAS RESOLVED AFTER REMOVING THE FIRST SCAN AND REBOOTING THE SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23882993 ↗
• MalfunctionDec 17, 2025Computer Software Problem; Application Program Freezes or Fails to Launch; Computer Software Problem; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THE SYSTEM BECAME UNRESPONSIVE WHILE OBTAINING AP/OBLIQUE IMAGES, AND EMITTED A WINDOWS ALERT CHIME WHEN AN ATTEMPT WAS MADE TO CLICK ON THE SCREEN. UPON REBOOT, THE SYSTEM PROMPTED A LOGIN INSTEAD OF DISPLAYING THE OPERATING SCREEN, AND ONCE IN OPERATE MODE, IT DIRECTED TO THE IMAGE ACQUISITION SCREEN. THE REPRESENTATIVE PERFORMED A SOFT REBOOT, RE-LOGGED INTO THE SURGEON PROFILE, AND PROCEEDED TO OPERATE MODE. THE SYSTEM WAS UNMOUNTED FROM THE BED, AND 3DEFINE WAS RESTARTED. NEW X-RAYS WERE OBTAINED, AND THE SURGERY CONTINUED WITHOUT FURTHER ISSUES. ALL SCREWS WERE ACCURATELY PLACED BY THE END OF THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT AND SURGICAL DELAY WAS LESS THAN ONE-HOUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23828341 ↗
• MalfunctionAug 19, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE SYSTEM WAS CONFIRMED TO BE PERFORMING AS INTENDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22840456 ↗
• MalfunctionAug 12, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THE CASE WAS COMPLETED USING SCAN AND PLAN. THE DEVIATION WAS BETWEEN 3.5-10MM. FOLLOWING THE PROCEDURE IT WAS NOTED THE LEFT L4 SCREW WAS TRENDING MORE LATERAL THAN PLAN. AN ACCURACY CHECK SHOWED TRUE TO ARM AND ANATOMY. STAR MARKER WAS SEATED PROPERLY. A SNAPSHOT WAS PERFORMED AS WELL AS A 3RD SPIN AND REPLAN OF ONLY THE LEFT L4 TO FINISH THE PROCEDURE. THE TOTAL DELAY WAS 30 MINUTES. THERE WAS NO IMPACT TO PATIENT'S OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22785450 ↗
• MalfunctionJun 25, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE, A T12-L4 SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE SURGEON PLACED SCREWS ACCURATELY, BUT THE DILATOR, TAP, AND DRILL APPEARED TO BE 5 MILLIMETERS (MM) DEEPER THAN INTENDED. AN ACCURACY CHECK WAS PERFORMED, AND REGISTRATION AND NAVIGATION WERE CONFIRMED TO BE ACCURATE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT AND THERE WAS NO SURGICAL DELAY TIME. ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE REPORTED THAT THE SITE REVERIFIED THE INSTRUMENTS AND EVEN SWAPPED TRACKERS, BUT THE DILATOR, DRILL, AND TAP CAD MODELS WERE ALL DEEPER THAN FLUORO SHOWED. THE SCREWS APPEARED TO BE ACCURATE THE WHOLE TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22328035 ↗
• MalfunctionJun 17, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THE 3DEFINE SCAN WAS COMPLETED DURING THE PROCEDURE AND THE WORK VOLUME WAS TRANSLATED TOWARD THE FLOOR BY ABOUT AN INCH. THE SURGICAL ARM WAS ABOUT TO CONTACT THE PATIENT WHEN BEING SENT AND THE EMERGENCY STOP BUTTON HAD TO BE PRESSED. A GENERIC WORK VOLUME WAS USED TO MOVE FORWARD AND COMPLETE THE PROCEDURE. THERE WERE NO ACCURACY ISSUES DURING THE PROCEDURE. THERE WAS NO PATIENT HARM AND THE PROCEDURE WAS DELAYED LESS THAN AN HOUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22236238 ↗
• InjuryMay 28, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THE RIGHT L4 SCREW WAS ENTERED MEDIALLY, BREACHING THE CANAL. THIS WAS DISCOVERED AFTER A CONFIRMATION SPIN WITH A POST-OPERATIVE COMPUTED TOMOGRAPHY. THE CASE REQUIRED REVISION SURGERY, WHICH WAS PLANNED FOR THE FOLLOWING DAY. THE PATIENT WAS NOTED TO BE AFFECTED. THERE WAS NO SURGICAL DELAY TIME. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED NO SYMPTOMS RELATED TO THE SCREW CANAL BREACH AND THE DEVIATION APPEARED TO BE ABOUT 10 MILLIMETERS (MM).

  Patient problems: Unspecified Tissue Injury

  MAUDE report 22099893 ↗
• MalfunctionFeb 24, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT GUIDANCE SYSTEM WAS ALLEGEDLY INACCURATE. THERE WAS NO REPORTED IMPACT TO PATIENT'S OUTCOME. ADDITIONAL INFORMATION WAS NOT PROVIDED. ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE REPORTED THAT THE INACCURACY WAS 3.5-10 MILLIMETERS (MM). THE PROCEDURE WAS COMPLETED FREEHAND. THERE WAS NO PATIENT HARM AND THE PROCEDURE WAS DELAYED 30 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21446916 ↗
• MalfunctionFeb 18, 2025Imprecision; Use of Device Problem; Imprecision; Use of Device Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THERE WERE DIFFICULTIES DURING REGISTRATION ON A L4-L5 FUSION. THEY REGISTERED THE PATIENT AND GOT YELLOW VALUES AT L5. THE MANUFACTURER REPRESENTATIVE ASKED THE SURGEON IF THEY WOULD LIKE THEM TO MAKE ADJUSTMENTS IN ATTEMPTS TO GET A BETTER REGISTRATION AND THE SITE DID NOT WANT TO AND THOUGHT IT WOULD BE FINE. WHEN SENDING THE ARM TO THE LEFT L5 TRAJECTORY, IT WAS COMING IN LATERALLY. THEY TRIED TO MAKE SOME ADJUSTMENTS AND WERE UNABLE TO GET A SATISFACTORY TRAJECTORY THAT THE SURGEON WAS COMFORTABLE OPERATING AT. THE SITE DECIDED TO RE-REGISTER THE PATIENT AND WERE UNABLE TO GET IT TO PASS. THE SURGEON PLACED THE LAST SCREW FREE-HAND. THE PATIENT WAS FIXATED TO THE SYSTEM USING A BONE MOUNT BRIDGE WITH A SCHANZ PIN IN THE RIGHT PSIS. THE PATIENT HAD A BMI OF 60. THERE WAS ABOUT A 15 MINUTE DELAY TO THE PROCEDURE DUE TO THE ISSUES. THERE WAS NO IMPACT TO THE PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21403450 ↗
• MalfunctionFeb 18, 2025Imprecision; Imprecision

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THERE WAS A DEVIATION DURING A L3-L5 POSTERIOR FUSION PROCEDURE. REGISTRATION WAS COMPLETED WITH NO ISSUES. THE SURGEON STARTED AT RIGHT L3 AND SUCCESSFULLY PLACED THE K-WIRE. THE SURGEON MOVED TO RIGHT L4. WHEN STARTING TO PLACE THE K-WIRE, THE SURGEON BELIEVED THEY WERE NOT INTERSECTING WITH BONE. REGISTRATION WAS CHECKED AND SEEMED TO BE FINE. THE SURGEON DECIDED TO ABORT THE USE OF THE GUIDANCE SYSTEM. A C-ARM WAS BROUGHT IN TO CHECK PLACEMENT AND THE RIGHT L3 K-WIRE WAS 5 MM LATERAL. THE SURGEON WAS REPOSITIONED THE RIGHT L3 K-WIRE AND COMPLETED THE PROCEDURE. THE SURGICAL ARM PASSED AN ADVANCED ACCURACY TEST AFTER THE PROCEDURE. THERE WAS NO PATIENT HARM AND THE PROCEDURE WAS DELAYED LESS THAN AN HOUR. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE MANUFACTURER REPRESENTATIVE AND SURGEON BOTH AGREED THAT THE MISSED TRAJECTORIES WERE MORE THAN LIKELY A RESULT OF SKIVES AT BOTH LEVELS. THE PLANNED TRAJECTORIES WERE NOTED TO HAVE POTENTIAL FOR SKIVES BEFOREHAND AND THE SURGEON FEELS THAT HE PROBABLY INDUCED IT AS HE WAS EXECUTING THE PLAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21399635 ↗
• MalfunctionFeb 13, 2025Imprecision; Imprecision

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT AN INACCURACY WAS REPORTED. THE SURGEON DECIDED TO USE NAVIGATION OF THE GUIDANCE SYSTEM AND SUCCESSFULLY COMPLETED SCREW PLACEMENT OF L4, L5, AND S1. THE IMAGING SYSTEM CONFIRMED ACCURATE SCREW PLACEMENT. THERE WAS NO PATIENT HARM REPORTED AND THE PROCEDURE WAS DELAYED BY 25 MINUTES. THE DEVIATION MEASUREMENT IS UNKNOWN. ESTIMATION IS LESS THAN 3.5MM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21376276 ↗
• MalfunctionFeb 12, 2025Imprecision; Imprecision

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT ALL SCREWS WERE INACCURATE. THE LEFT SIDE WAS LATERAL ON ALL LEVELS, THE RIGHT SIDE WAS MEDIAL ON ALL LEVELS, AND ALL OF THE SCREWS WERE INFERIOR. THE SITE USED CT TO FLOURO REGISTRATION. NAVIGATION WAS REPORTED AS ACCURATE. THE SURGEON REMOVED ALL OF THE SCREWS AND COMPLETED THE CASE FREE HANDEDLY WITH THE C-ARM. THE GUIDANCE SYSTEM AND NAVIGATION WAS ABORTED. THERE WAS NO PATIENT HARM AND THE PROCEDURE WAS DELAYED LONGER THAN AN HOUR. ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE REPORTED THAT THE DEVIATIONS WERE BETWEEN 3.5MM AND 10MM, BUT CLOSER TO 10MM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21368813 ↗
• MalfunctionFeb 12, 2025Imprecision; Imprecision

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THERE WAS A SCREW DEVIATION. AN ANATOMY LANDMARK CHECK WAS PERFORMED BETWEEN TRAJECTORIES. THE CT FLUORO REGISTRATION PASSED. THE SCREWS WERE PLACED L5 LEFT, L4 LEFT, L5 RIGHT, AND THEN L4 RIGHT. BOTH THE L4 SCREWS WERE LATERAL BY 5-10MM. THE MANUFACTURER REPRESENTATIVE BELIEVED THE CAUSE WAS SKIVING. IT WAS REPORTED THAT NAVIGATION WAS ABORTED. THERE WAS NO PATIENT HARM AND THE PROCEDURE WAS DELAYED MORE THAN AN HOUR. ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE REPORTED THAT THE CASE WAS COMPLETED FREEHAND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21368459 ↗
• MalfunctionFeb 12, 2025Imprecision; Imprecision

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THERE WAS AN ALLEGED INACCURACY DURING THE CASE. THEY SENT THE ARM TO THE FIRST TRAJECTORY AND THE DRILL WAS TOO LOW IN THE PEDICLE. THERE WERE NO ISSUES WITH THE REGISTRATION. THE DEVIATION WAS ABOUT 3-4MM LOW ON THE PEDICLE. THE SURGEON ABORTED USE OF THE SYSTEM AND COMPLETED THE CASE BY HAND. THERE WAS NO PATIENT HARM AND THE PROCEDURE WAS DELAYED LESS THAN ONE HOUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21367853 ↗
• MalfunctionFeb 11, 2025Imprecision; Imprecision

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THE SYSTEM INSTALLED A SCREW MORE LATERALLY THAN THE SURGEON PREFERRED. THE SCREW WAS THEN REPLACED UNDER FLUORO. THERE WAS NO IMPACT ON THE PATIENT OUTCOME. ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE REPORTED THAT THE DEVIATION WAS 3.5 TO 10 MILLIMETERS. THE PROCEDURE WAS DELAYED 10 MINUTES TO TAKE OFF THE ROD, TAKE OUT THE SCREWS, AND REPLACE NEW SCREW IN THE PROPER TRAJECTORY. THE SUSPECTED OR MOST LIKELY CAUSE WAS A POTENTIAL SKIVE OR PATIENT ANATOMY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21357283 ↗
• MalfunctionFeb 11, 2025Imprecision; Imprecision

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT DURING A L3-L5 CASE THE SURGEON PLACED ALL WIRES ON THE RIGHT SIDE OF THE PATIENT. THE SURGEON MOVED TO THE LEFT SIDE AND PLACED WIRES. THE SURGEON NOTICED SOME SKIVING WITH THE DRILL GUIDE ON L4 AND PLACED THE SCREW MANUALLY. THE SURGEON USED NAVIGATION WITHOUT ISSUE FOR THE FINAL SCREW IN L5. THE ISSUE EXTENDED THE SURGICAL TIME BY LESS THAN 1 HOUR. THERE WAS NO IMPACT ON THE PATIENT OUTCOME. ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE CORRECTED THAT THE RIGHT SIDE WAS COMPLETED FIRST AND THEN THE ISSUE AT LEFT L4 WAS ENCOUNTERED. THE TRAJECTORIES WERE DEVIATED MORE THAN 3.5MM AND LESS THAN 10MM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21357186 ↗
• MalfunctionFeb 11, 2025Imprecision; Imprecision

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THE SURGICAL ARM WAS ATTACHED USING THE SCHANZ PIN IN THE LEFT PSIS WITH THE BONE MOUNT BRIDGE. THREE SCREWS WERE ACCURATE HOWEVER L5 LEFT WAS INACCURATE WITH A DEVIATION LEADING TO A SUPERIOR L5 ENDPLATE VIOLATION. DURING THE L5 LEFT PLACEMENT, THE SURGEON FELT THAT THE SCREW WAS NOT MOVING FURTHER INSIDE THE BONE USING THE DRILL, SO THEY COULD NOT REACH THE CORRECT DEPTH. THE SURGEON DECIDED TO USE A MANUALLY NAVIGATED SCREWDRIVER TO REACH THE FINAL POSITION. THE SCAN SHOWED THE ERROR AT THE TARGET POINT WAS APPROXIMATIVELY 10MM, BUT THE ENTRY POINT WAS NOT INACCURATE. THE SCREW WAS REMOVED. THERE WAS NO PATIENT HARM REPORTED AND THE PROCEDURE WAS DELAYED LESS THAN ONE HOUR. ADDITIONAL INFORMATION WAS PROVIDED THE CAUSE OR SUSPECTED CAUSE OF THE DEVIATION WAS STATED TO DUE TO SKIVING DUE TO A BAD PLAN OF L5 LEFT IN THE SOFTWARE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21356152 ↗