Mazor X System TPL0059-05Recalls & reported problems

Summary

The FDA's MAUDE database contains 65 adverse event reports that list this exact device (DI 07290109181158), received between Mar 7, 2019 and Dec 29, 2025 — classified as 7 injuries, 58 malfunctions.

The most frequently reported specific device problem is “Imprecision” (27 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 65 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 29, 2025Use of Device Problem; Use of Device Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SYSTEM HAD WORK VOLUME PROBLEMS WITH THE 3DEFINE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23918559 ↗
• MalfunctionSep 12, 2025Use of Device Problem; Use of Device Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE GUIDANCE SYSTEM COVER WAS DIFFICULT TO OPEN AND CLOSE, REQUIRED FORCEFUL OPENING. IT WAS NOTED THAT IT SLAMMED SHUT, MAKING A LOUD NOISE. THESE ISSUES WERE NOTED AFTER THE SURGICAL PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23042062 ↗
• 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 PATIENT'S SPINE WAS STICKING OUTSIDE OF THE WORK VOLUME AFTER THE 3DEFINE SCAN WAS COMPLETED DURING THE PROCEDURE. THE MANUFACTURER REPRESENTATIVE STATED THE WORK VOLUME WAS LOWER THAN IT SHOULD HAVE BEEN. THERE WAS NO TROUBLESHOOTING DONE AS THIS WAS NOTICED AFTER THE GUIDANCE SYSTEM PORTION OF THE CASE WAS COMPLETED. THE CASE WAS FULLY PERFORMED WITH THE GUIDANCE SYSTEM WITH NO ISSUES. THERE WAS NO PATIENT HARM AND THE PROCEDURE WAS DELAYED LESS THAN AN HOUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22236606 ↗
• MalfunctionJun 4, 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 DURING A TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) SURGICAL PROCEDURE, THE NAVIGATION INSTRUMENTS WERE OFF-PLAN. THE DIFFERENCE BETWEEN THE ORIGINAL TRAJECTORY AND THE LIVE INSTRUMENT WAS NOTICEABLE, AND THE NAVIGATION PICTURE APPEARED DIFFERENT FROM THE CARM PLATE. A SNAPSHOT WAS PERFORMED, AND THE INSTRUMENTS WERE REGISTERED AGAIN, BUT THE SAME PROBLEMS PERSISTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT AND THERE WAS NO SURGICAL DELAY TIME. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE SURGICAL ARM WAS REPLACED PROACTIVELY AND THERE WERE NO SOFTWARE ISSUES ENCOUNTERED DURING THE REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22142770 ↗
• MalfunctionApr 28, 2025Mechanical Problem; Incorrect, Inadequate or Imprecise Result or Readings; Use of Device Problem; Mechanical Problem; Incorrect, 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 SITE PROCEEDED USING A CT TO FLOURO WORKFLOW. THE MANUFACTURER REPRESENTATIVE OBTAINED GOOD IMAGES FROM THE C-ARM, BUT ULTIMATELY COULD NOT GET THE ROBOT TO REGISTER. THE REPRESENTATIVE TOOK NEW C-ARM IMAGES, BUT THE ISSUE PERSISTED. THE SURGEON AND REPRESENTATIVE DECIDED TO SWITCH TO A SCAN AND PLAN. A SPIN WAS TAKEN, AND SCREWS WERE PLANNED WITHOUT ISSUE. HOWEVER, WHEN THE ARM WAS SENT TO THE FIRST TRAJECTORY, IT BECAME CLEAR THAT NAVIGATION WAS OFF BY SEVERAL MILLIMETERS. THE REPRESENTATIVE CONFIRMED THIS BY TAKING ANOTHER C-ARM IMAGE. AT THIS POINT, THE REPRESENTATIVE NOTICED THAT THE ARM GUIDE WAS WIGGLING EXCESSIVELY. THE REPRESENTATIVE RETIGHTENED THE ARM GUIDE, AND TOOK ANOTHER SPIN. HOWEVER, THIS SPIN DID NOT HAVE MATCHING PATIENT ID'S, SO IT COULD NOT BE USED. THE REPRESENTATIVE SWITCHED BACK TO CT TO FLOURO, AND THE NEW SET OF IMAGES PRODUCED BY THE C-ARM RESULTED IN THE PATIENT GETTING REGISTERED WITHOUT ISSUE. THERE WAS NO PATIENT HARM AND THE PROCEDURE WAS DELAYED ONE HOUR OR LONGER. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT IT WAS BELI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21918669 ↗
• MalfunctionApr 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 THE S1 SCREW TRAJECTORY WAS UNEXPECTED. THE DOCTOR REVIEWED THE S1 SCREW ON THE RIGHT AND NOTED THE TRAJECTORY ISSUE. SUBSEQUENTLY, THE DOCTOR REPOSITIONED THE S1 SCREW. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT AND SURGICAL DELAY WAS ONE-HOUR OR LONGER. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT AFTER THE SURGERY WAS DONE, A 3D SCAN WAS PERFORMED AND AT THAT POINT, THE DOCTOR FOUND THAT THE SCREW WASN'T WHERE THEY WANTED. THE SCREW WAS REMOVED AND REPLACED WITH A NEW ONE AND A NEW TRAJECTORY WAS PLANNED. THE DEVIATED TRAJECTORY WAS BETWEEN 3.5 MILLIMETERS (MM) AND 10MM. ADDITIONAL INFORMATION WAS RECEIVED. THE CASE WAS COMPLETED WITH A NEW TRAJECTORY USING THE GUIDANCE SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21900060 ↗
• MalfunctionApr 22, 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 TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF). IT WAS REPORTED THAT THE RIGHT SIDE SHIFTED TOWARDS THE MIDLINE. A 3D SCAN WAS PERFORMED AT THE END OF THE SURGERY, WHICH REVEALED THE SHIFT. THE SURGEON SUBSEQUENTLY REMOVED AND REPOSITIONED THE SCREWS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS ADDITIONALLY NOTED THE SURGERY WAS RESCHEDULED. ADDITIONAL INFORMATION WAS RECEIVED. THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS AND TRAJECTORIES DEVIATED BETWEEN 3.5 MILLIMETERS (MM) AND 10MM. IT WAS CLARIFIED THAT THE "RESCHEDULE" WAS THE DOCTOR REPLACED THE SCREWS THE SAME DAY AT A LATER TIME. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS CLARIFIED THAT ALL THE SCREWS WERE SEEN SHIFTED TO THE LEFT. THE SCREWS ON THE RIGHT MOVED MEDIAL AND THE ONES ON THE LEFT MOVED LATERAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21881762 ↗
• MalfunctionFeb 18, 2025Imprecision; Imprecision

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THE SURGEON ATTEMPTED AN L4-5 PERC FUSION. THE SURGEON DID A DIRECT LATERAL APPROACH WITH A TITAN TITANIUM CAGE AND FLIPPED THE PATIENT TO UTILIZE THE GUIDANCE SYSTEM FOR PERC SCREWS STARTED AT L3-4 SCREWS FIRST THEN MOVED TO THE OTHER SIDE. ALL SCREWS WERE PLACED AND THEN USING C- ARM TO ACQUIRE CONFIRMATION SHOTS, IT APPEARED BOTH L3 AND L4 WERE PLACED LATERALLY ON THE RIGHT SIDE BY ~5MM. LEFT SCREWS WERE ACCURATE. DURING THE VERIFICATION PORTION OF REGISTRATION THEY DID HAVE AN IMAGE SHIFT WHICH REQUIRED THEM TO TAKE NEW IMAGES. ONCE NEW IMAGES WERE ACQUIRED, THE SITE THEN GOT A "YELLOW" VALUE AT L4. THEY PAID EXTRA ATTENTION TO MAKE SURE THERE WAS NOT A SHIFT. THE SITE THEN PROCEEDED. THEY ABORTED USE OF THE GUIDANCE SYSTEM AND REPLACED THE DEVIATED SCREWS MANUALLY. THE ISSUE EXTENDED THE SURGICAL TIME BY LESS THAN 1 HOUR. THERE WAS NO KNOWN IMPACT ON THE PATIENT OUTCOME. ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE REPORTED THAT ANOTHER CASE WAS SUCCESSFULLY COMPLETED AND THEY BELIEVED THE DEVIATION WAS DUE TO A PATIENT SHIFT. THERE WAS NO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21403673 ↗
• 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/L4 MIS FUSION PROCEDURE. THE SURGICAL SYSTEM WAS ATTACHED TO THE PATIENT USING A SCHANZ PIN PLACED IN THE PSIS CONNECTED TO A BONE MOUNT BRIDGE. BOTH SCREWS ON THE RIGHT SIDE OF THE CONSTRUCT SKIVED INFERIOR BASED ON CONFIRMATION IMAGES. THE LEFT SIDE OF THE CONSTRUCT WAS ACCURATE. THE PLAN WAS ADJUSTED AND THE SURGICAL ARM WAS RESENT TO RIGHT L3. THE SCREWS WERE REDIRECTED. THE RIGHT L4 LOOKED ACCURATE WITH THE C-ARM, BUT NOT WITH THE O-ARM. THE RIGHT L4 SCREW WAS REDIRECTED WITH A JAMSHIDI. THE REPRESENTATIVE NOTED THAT THERE WERE HIGH SKIVE POTENTIALS AND THERE WAS A LARGE ROTATION IN THE SPINAL ANATOMY. THE SURGEON DID MAKE THE SKIN INCISIONS SO THE SURGEON DID NOT HAVE TO APPROACH AT SUCH A LATERAL TRAJECTORY. THERE WAS NO PATIENT HARM AND THE PROCEDURE WAS DELAYED LESS THAN AN HOUR. ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE REPORTED THAT THE TRAJECTORIES WERE DEVIATED BETWEEN 2-4 MM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21401583 ↗
• MalfunctionFeb 18, 2025Imprecision; Imprecision

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THERE WERE DEVIATIONS DURING A L4-L5 TLIF SINGLE LEVEL PROCEDURE. WHEN LOOKING AT THE PLAN AND NAVIGATION, EVERYTHING LOOKED TO BE ON TRACK, BUT WHEN THE SURGEON USED THE DRILL TO BURR DOWN THE BONE AND MAKE AN ENTRY POINT, THE MONITORING WAS SHOWING UNUSUAL ACTIVITY. THE PLAN WAS REDONE WITH THE O-ARM. WHEN THE MANUFACTURER REPRESENTATIVE WENT BACK TO THE SCREENS UNTIL THE PART WHERE THE IMAGES ARE SENT, BUT BEFORE SENDING THEM, THEY REALIZED THE PLAN DID NOT MATCH THE TRAJECTORY. ADJUSTMENTS WERE MADE TO THE PLAN AND THE CASE WAS CONTINUED. THE PLAN LOOKED GOOD, BUT THE POST-OP SCANS SHOWED A DEVIATION OF RIGHT AND LEFT L4 SCREWS. THE L4 SCREW WAS OFF IN THE AXIAL DIRECTION BY A COUPLE OF MILLIMETERS. MONITORING SHOWED SOME ACTIVITY AND THE DEVIATION WAS CONFIRMED WITH AN IMAGING SPIN. A NEW PLAN WAS MADE AND THE SCREWS WERE ABLE TO BE PLACED. THE CAUSE OF THE INACCURACY WAS UNKNOWN. THERE WAS NO PATIENT HARM AND THE PROCEDURE WAS DELAYED LESS THAN AN HOUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21400894 ↗
• MalfunctionFeb 13, 2025Imprecision; Imprecision

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT DURING THE T9-L3 CONSTRUCT CASE THE HEALTHCARE PROFESSIONALS HAD TO RE-REGISTER THE PATIENT AFTER DRILLING AND TAPPING. THEY TOOK A BALL-TIPPED PROBE TO FEEL THE TAPPED HOLE AND FELT IT WAS MEDIAL. THE TRAJECTORY DEVIATED BY LESS THAN 3.5MM. THE NAVIGATION LOOKED MEDIAL ALSO, SO THEY REDID THE SNAPSHOT AND IT RESOLVED THE NAVIGATION ISSUE, BUT THEY STILL RE-REGISTERED THE PATIENT SINCE THE ARM TRAJECTORY WAS STILL OFF. THE SITE GOT GREEN REGISTRATION VALUES AND PROCEEDED TO SEND THE ARM TO THE PLANNED TRAJECTORIES AND THE SURGEON FELT THE TAPPED HOLE AGAIN WITH A PROBE AND FELT IT WAS STILL OFF. THE PATIENT WAS FIXATED USING BMB AND SPINOUS PROCESS CLAMP. THE SURGEON ABORTED USE OF THE SYSTEM. THERE WAS A 45 MINUTE DELAY. AFTER THE CASE THE MANUFACTURER REPRESENTATIVE RAN AN ADVANCED ACCURACY AND STRESS TEST AND THEY BOTH PASSED. THE REPRESENTATIVE ALSO CONFIRMED THAT THE BUILT IN SELF TEST PASSED PRIOR TO THE CASE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21376749 ↗
• MalfunctionFeb 13, 2025Imprecision; Imprecision

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT DURING A L4-S1 CT-FLURO FUSION, BOTH SCREWS AT S1 WERE COMPLETELY OFF. THERE WERE TWO TITANIUM CAGES LOCATED AT L4-L5 AND L5-S1. THE SITE GOT GREEN REGISTRATION VALUES EXCEPT FOR AT S1, WHICH WAS YELLOW. CHECKED TO CONFIRM THAT IT WAS GOOD AND COULD PROCEED WITH CASE. THE TIP OF THE S1 SCREWS WERE BOTH IN THE DISC SPACE AND MUCH HIGHER AND AT A DIFFERENT ANGLE THEN PLANNED. THEY WERE PUSHING ON THE ALIF INTERBODY. THERE WAS A 3-4 HOUR DELAY. THERE WAS NO IMPACT ON THE PATIENT OUTCOME. ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE REPORTED THAT THE TRAJECTORY WAS DEVIATED BY 10 MM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21375168 ↗
• MalfunctionFeb 11, 2025Imprecision; Imprecision

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT A POST OPERATIVE CHECK REVEALED A SCREW TO BE DEVIATED FROM THE PLAN. IT WAS SUSPECTED THERE MAY HAVE BEEN SOFT TISSUE PRESSURE. THE DEVIATION WAS ABOUT 3.5 MM MEDIALLY. THERE WAS NO PATIENT HARM AND THE PROCEDURE WAS NOT DELAYED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21356314 ↗
• MalfunctionFeb 4, 2025Imprecision; Imprecision

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THERE WAS A DEVIATED K-WIRE PLACEMENT DURING THE PROCEDURE TODAY. DURING THE K-WIRE PLACEMENT AT THE FIRST TRAJECTORY THE REP NOTICED THAT THE TOOL MAY HAVE SKIVED AND INFORMED THE SURGEON. THE SURGEON PROCEEDED TO PLACE THE K-WIRE. AFTER PLACEMENT, THE SURGEON NOTICED THE K-WIRE MAY HAVE BEEN PLACED OUTSIDE OF ITS PLANNED TRAJECTORY AND THEN TOOK AP AND LATERAL FLUORO SHOTS TO CONFIRM THE K-WIRE PLACEMENT WAS OFF. THE DEVIATION WAS 4 MM LATERAL. THE SURGEON ATTEMPTED TO REPLACE THE K-WIRE AND IT STILL SEEMED OFF. THE SURGEON DECIDED TO MOVE TO LEFT SIDE TRAJECTORIES AND COMPLETED THE CASE WITH NO FURTHER INCIDENTS, BUT ONLY WITH UNILATERAL LEFT SCREWS. THE ISSUE EXTENDED THE SURGICAL TIME BY LESS THAN 1 HOUR. THERE WAS NO IMPACT ON THE PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21307074 ↗
• MalfunctionFeb 4, 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 MIS L4-L5 FUSION. THEY HAD PERFORMED AN ALIF FIRST, FLIPPED THE PATIENT, AND REGISTERED WITH NO ISSUES. THE BONE MOUNT BRIDGE WAS USED WITH A SCHANZ PIN IN THE LEFT PSIS. THE ARM WAS SENT TO L4 RIGHT AND THE SURGEON PLACED THE DRILL. THE SURGEON FELT BONE, BUT THE DEPTH SEEMED OFF. THEY ACQUIRED A LATERAL IMAGE, BUT THE TRAJECTORY APPEARED TO BE ON, SO THE SURGEON DRILLED. WHEN GOING TO PLACE THE K-WIRE, THE SURGEON DID NOT FEEL ANY BONE, THEY TOOK AN AP AND SAW THAT THEY WERE 3-4 MM LATERAL AND WERE OFF THE SIDE OF THE PEDICLE. THEY BELIEVE THAT THIS WAS DUE TO SKIVING. THE SURGEON DECIDED TO ABORT THE USE OF THE GUIDANCE SYSTEM AND JUST USED FLUORO. THIS CAUSED A 10 MINUTE DELAY. THERE WAS NO IMPACT ON THE PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21305524 ↗
• MalfunctionFeb 4, 2025Imprecision; Imprecision

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THERE WERE ALIGNMENT ISSUES DURING AN OPEN T7 TO L2 FUSION SURGERY. REGISTRATION WAS COMPLETED FOR T7 TO L1. AS THE SURGEON WAS NAVIGATING WITH THE DRILL, THEY FELT A NERVE ON TWO OF THE SPINOUS PROCESSES. A SYSTEM CHECK WAS DONE AND THE ALIGNMENT ISSUE APPEARED TO BE RESOLVED, BUT WHEN MOVING THE SURGICAL ARM TO THE NEXT POSITION, THE ARM WAS NOT ALIGNING PROPERLY AGAIN. THE MISALIGNMENT WAS AROUND 3.5 MM. TROUBLESHOOTING INVOLVED TAKING TWO NEW SNAPSHOTS, REPEATING REGISTRATION WITH THE ORIGINAL IMAGES AND REPEATING REGISTRATION AFTER TAKING NEW IMAGES. THE USE OF THE GUIDANCE SYSTEM WAS ABORTED AND THE PROCEDURE WAS COMPLETED USING NAVIGATION. THERE WAS NO PATIENT HARM AND THE PROCEDURE WAS DELAYED LESS THAN AN HOUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21305463 ↗
• MalfunctionFeb 4, 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 THE SURGEON OPERATED ON THE WRONG LEVEL DURING AN OPEN PROCEDURE WITH A FRACTURED T10 VERTEBRAE. THE PLAN WAS TO FUSE T8-L1 WHILE SKIPPING T10 DUE TO THE FRACTURE. TWO SEGMENTS WERE PLANNED SINCE THE ANATOMY WAS TOO LONG. THE FIRST SEGMENT USED A REGION OF INTEREST FROM T7-T11 WITH MOUNT PLACED AT T9. THE PLAN WAS TO PLACE SCREWS AT T8 AND T9. REGISTRATION WAS COMPLETED AND MATCHED TO WHAT THEY THOUGHT WAS T8 AND T9. T7-T9 HAD GREEN VALUES, T10 HAD RED VALUES DUE TO THE FRACTURE AND T11 HAD YELLOW REGISTRATION VALUES. THE SURGEON MATCHED WHAT THEY THOUGHT WAS T8 IN THE SOFTWARE AND BEGAN INSERTING SCREWS, BUT THEY WERE ACTUALLY AT T7. THE SURGEON DID NOT REALIZE THE ERROR UNTIL THEY MOVED TO REGISTER THE SECOND SEGMENT. THE LEVEL TESTED FINE WITH NEUROMONITORING AFTER THE SCREWS WERE IMPLANTED. THE SECOND SEGMENT HAD A REGION OF INTEREST FROM T11-L1 WITH A MOUNT PLACED AT T12. THE PLAN WAS TO PLACE SCREWS AT T11-L1. A K-WIRE WAS PLACED AT T11 AND A 2D LATERAL SHOT WAS TAKEN. THE IMAGE SHOWED THAT THEY WERE TWO VERTEBRAE ABOVE T11 WITHOUT SCREWS. THE SURGEON CONFIRME

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21304937 ↗
• MalfunctionFeb 4, 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 L5-S1 PERCUTANEOUS FUSION PROCEDURE. THE SURGEON STARTED AT S1 LEFT AND CONTINUED TO L5 LEFT BEFORE MOVING TO THE RIGHT SIDE AND COMPLETING S1 RIGHT AND L5 RIGHT. THE FIRST TRAJECTORY WAS ACCURATE. THE SECOND TRAJECTORY WAS APPROXIMATELY 4 MM INFERIOR TO PLAN. THE SURGEON REDIRECTED THE TRAJECTORY WITH A TAP AND GUIDE WIRE FOR PLACEMENT OF THE SCREW. THE THIRD AND FOURTH TRAJECTORIES WERE ACCURATE. THE DEVIATION WAS KNOWN BEFORE THEY DRILLED AND IT WAS CONVEYED TO THE SURGEON. THE SURGEON CHOSE TO CHANGE WHAT WAS PLANNED FOR THIS SCREW AND WHAT WAS EXPLAINED REGARDING THE POTENTIAL FOR AN INFERIOR SKIVE. THERE WAS NO PATIENT HARM AND THE PROCEDURE WAS DELAYED LESS THAN AN HOUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21304699 ↗
• MalfunctionJan 28, 2025Imprecision; Imprecision

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THERE WAS A SCREW DEVIATION THE RIGHT L5 SCREW. THE SCREW WAS LATERAL. THE TRAJECTORIES WERE DEVIATED GREATER THAN 10 MM. THE PLAN WAS ADJUSTED. SCREWS WERE ACCURATELY PLACED AFTER THAT. THE DEVIATION WAS CAUSED BY A SKIVE. THERE WAS NO PATIENT HARM AND THE PROCEDURE WAS DELAYED LESS THAN ONE HOUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21253842 ↗
• MalfunctionJan 22, 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 THERE WAS AN ALLEGED INACCURACY. THE DEVIATIONS WERE LESS THAN 3.5 MM. THE WORKING CONSTRUCT WAS T10 TO S2. THE SITE DID IT IN TWO REGISTRATIONS, WHERE THE FIRST REGISTRATION, L3 TO S2, WENT FINE. DURING THE SECOND REGISTRATION, L2 TO T10, THE SITE WAS ABLE TO PLACE SCREWS AT L2, L1, AND T12, BUT ONCE THEY GOT TO THE RIGHT SIDE OF T11 AND PLACED THE DILATOR DOWN, THEY NOTICED THERE HAD BEEN AN ANATOMY SHIFT, SO THE TRAJECTORY WAS TOO MEDIAL. THE SURGICAL ARM WAS TO T11 ON THE LEFT SIDE, BUT THE TRAJECTORY WAS TOO LATERAL. THE SITE CONFIRMED THAT THERE WAS A PATIENT SHIFT. FOR THE REMAINING FOUR SCREWS THE SURGEON OPTED TO DO ANOTHER SPIN WITH IMAGING SYSTEM, USED NAVIGATION TO COMPLETE THE PROCEDURE. THE MANUFACTURER REPRESENTATIVE PERFORMED A BUILT IN SELF TEST AND THE SYSTEM PASSED AFTER THE SURGERY. THERE WAS NO PATIENT HARM AND THE PROCEDURE WAS NOT DELAYED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21211017 ↗
• MalfunctionJan 22, 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 FIVE OF THE SIX SCREWS WERE MISPLACED. THE SCREWS PLACED ON THE RIGHT SIDE (L4, L5, AND S1) WERE REPORTED TO BE 5 MM LATERAL AND THE 2 SCREWS PLACED ON THE LEFT SIDE (L4 AND L5) WERE REPORTED TO BE 5 MM MEDIAL. THE SURGEON RE-DIRECTED SCREWS AND PROCEEDED WITH CASE. THERE WAS NO PATIENT HARM AND THE PROCEDURE WAS DELAYED AN HOUR OR LONGER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21210685 ↗
• MalfunctionJan 22, 2025Imprecision; Imprecision

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT ALL THE SCREWS WERE SHIFTED IN THE SAME DIRECTION AFTER TAKING A CONFIRMATION SPIN. THE DEVIATION WAS LESS THAN 3.5MM. NOTHING HAD TO BE REDIRECTED. THE SYSTEM PASSED A BUILT IN SELF TEST BEFORE THE CASE. THERE WAS NO PATIENT HARM AND THE PROCEDURE WAS NOT DELAYED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21208107 ↗
• MalfunctionJan 21, 2025Imprecision; Imprecision

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT AFTER PLACING THE SCREWS THE SITE DID AN IMAGING SYSTEM SPIN AND THE L2 AND L3 LEFT SCREWS WERE LATERAL, AND THE L2 AND L3 RIGHT SCREWS WERE MEDIAL. THE SITE PROCEEDED TO DO A SYSTEM CHECK WITH NAVIGATION, SO THE SURGEON PUT THE PASSIVE PLANAR PROBE IN THE DIVOT. THE SYSTEM WAS FOUND TO BE INACCURATE, SO THE SITE TOOK ANOTHER SNAPSHOT, BUT IT WAS STILL INACCURATE. THE SURGEON PROCEEDED TO CORRECT THE LEFT SCREWS BY HAND. THE SURGEON MENTIONED THAT THEY MIGHT HAVE SEEN THE C-ARM HIT THE SURGICAL ARM, BUT IT WAS NOT HARD AND NO NOTIFICATION HAPPENED ON THE SYSTEM. THE DEVIATION WAS 3.5MM AND UNDER. THERE WAS NO PATIENT HARM AND THE PROCEDURE WAS DELAYED LESS THAN ONE HOUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21200461 ↗
• MalfunctionJan 17, 2025Imprecision; Imprecision

  STONE L, BROUGHTON A, LEWIS C, PHAM M. SINGLE POSITION ROBOT-ASSISTED PEDICLE SCREW PLACEMENT WITH S2-ALAR-ILIAC FIXATION IN LATERAL DECUBITUS: CADAVERIC FEASIBILITY STUDY AND EARLY CLINICAL EXPERIENCE. EUROPEAN SPINE SURGERY. 30 JUNE 2023. HTTPS://DOI.ORG/10.1007 /S00586-023-07832-Z ABSTRACT: OBJECTIVES SINGLE POSITION LATERAL FUSION WITH ROBOTIC ASSISTANCE ELIMINATES THE NEED FOR SURGICAL STAGING WHILE HARNESSING THE PRECISION OF ROBOTIC ADJUNCTS. WE EXPAND ON THIS TECHNIQUE BY DEMONSTRATING THE TECHNICAL FEASIBILITY OF PLACING BILATERAL PEDICLE SCREWS WITH S2-ALAR-ILIAC (S2AI) FIXATION WHILE IN THE LATERAL POSITION. METHODS A CADAVERIC STUDY WASPERFORMED USING 12 HUMAN SPECIMENS. A RETROSPECTIVE CLINICAL SERIES WAS ALSO PERFORMED FOR PATIENTS WHO HAD UNDERGONE ROBOT-ASSISTED PLACEMENT OF S2AI SCREWS IN LATERAL DECUBITUS BETWEEN JUNE 2020 AND JUNE 2022. CASE DEMOGRAPHICS, IMPLANT PLACEMENT TIME, IMPLANT SIZE, SCREW ACCURACY, AND COMPLICATIONS WERE RECORDED. EARLY POSTOPERATIVE RADIOGRAPHIC OUTCOMES WERE REPORTED. RESULTS IN THE CADAVERIC SERIES, A TOTAL OF 126 SCREWS WERE PLACED WITH ROBOTIC ASSISTANCE IN 12 CADAVERS OF WHICH 24 SCREWS WERE S2AI. THERE WERE FOUR BREACHES FROM PED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21180832 ↗
• MalfunctionDec 13, 2024Incorrect, 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 THERE WAS A DEVIATED SCREW. THERE WAS NO IMPACT TO PATIENT'S OUTCOME AND SURGICAL DELAY WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20925790 ↗