Mazor X System TPL0059-08Recalls & reported problems

Summary

The FDA's MAUDE database contains 110 adverse event reports that list this exact device (DI 07290109184838), received between May 13, 2021 and Sep 29, 2026 — classified as 14 injuries, 96 malfunctions.

The most frequently reported specific device problem is “Imprecision” (58 reports).

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

1 other recall cover devices cleared under the same FDA submission (K203005); they may or may not involve this specific model.

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 ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 110 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Incorrect, Inadequate or Imprecise Result or Readings; Use of Device Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50935938 ↗
• MalfunctionMar 3, 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 A LATERAL SKIVE AND INACCURATE PLACEMENT OF A SCREW. SCREW WAS PLACED 3 MILLIMETERS (MM) INACCURATE IN LATERAL DIRECTION ON L5 VERTEBRAE RIGHT SIDE. AS A RESULT, SURGEON RE-PLACED THE SCREW WITHOUT NAVIGATION AND WAS THEN ACCURATE. SURGEON AND MANUFACTURING REPRESENTATIVE (REP) DISCUSSED FACET FUSION PRIOR TO SCREW PLACEMENT MAY HAVE DISRUPTED BONE, THEREFORE CAUSING ANATOMICAL SHIFT AND BEEN A POTENTIAL CAUSE FOR THE SKIVE. THERE WAS A 15 MINUTE DELAY. NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24498260 ↗
• MalfunctionFeb 10, 2026Incorrect, Inadequate or Imprecise Result or Readings

  ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE REPORTED THAT NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24304715 ↗
• 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 WHEN DOING A SCAN AND PLAN, THE FIRST SCREW ON THE T12 LEFT SIDE WAS PLACED CORRECTLY, BUT THE SCREWS PLACED AT L1 AND L2 ON THE LEFT SIDE WERE MEDIAL BY APPROXIMATELY 2 MILLIMETERS (MM). THE RIGHT SIDE SCREWS WERE PLACED ACCURATELY. THE SCREWS AT L1 AND L2 LEFT SIDE WERE RE-SPUN AND RE-PLACED; AFTER REPLACING THE SCREW AT L2 LEFT SIDE, IT REMAINED MEDIAL BY AROUND 2MM. THE SCREW WAS RE-SPUN AND RE-PLACED A THIRD TIME, AND THIS PLACEMENT WAS SUCCESSFUL. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT AND SURGICAL DELAY WAS ONE-HOUR OR LONGER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23994202 ↗
• MalfunctionDec 26, 2025Data Problem; Application Program Freezes or Fails to Launch; Data 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 WHEN DOING A SCAN AND PLAN AND TRYING TO IMPORT THE SCAN FROM A USB, THE SOFTWARE WOULD NOT MOVE PAST LOADING THE FIRST SLICE. THE MANUFACTURER REPRESENTATIVE PERFORMED TWO SPINS AND ATTEMPTING TO IMPORT THE SCANS, BUT THE SCANS WAS STUCK LOADING SLICE 0 OF 196. A SOFT REBOOT WAS PERFORMED, BUT THE ISSUE WAS UNRESOLVED. THE REPRESENTATIVE THEN HAD TO SEND THE ARM BECAUSE IT WAS NO LONGER ALIGNED, BUT THAT DID NOT RESOLVE THE ISSUE EITHER. THE REPRESENTATIVE THEN ATTEMPTED TO PERFORM A CT TO FLUORO AND IMPORTED KNOWN WORKING SCANS. THERE WAS NO PATIENT HARM REPORTED. ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE REPORTED THAT THE DELAY TO THE CASE WAS 30-45 MINUTES. THE CASE WAS COMPLETED USING THE ROBOT. THE REPRESENTATIVE EXITED THE SCAN AND PLAN PROCEDURE AND LOADED THE SCAN AS THEIR CT AND THEY DID A CT TO FLUORO REGISTRATION. ADDITIONAL INFORMATION WAS RECEIVED. THERE WAS NO IMPACT TO PATIENT'S OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23899009 ↗
• MalfunctionDec 26, 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 GUIDANCE SYSTEM BECAME UNRESPONSIVE WHEN ATTEMPTING TO IMPORT IMAGES FROM THE IMAGING SYSTEM. THIS OCCURRED DURING A SCAN AND PLAN PROCEDURE. THE SYSTEM BECAME UNRESPONSIVE A SECOND TIME AFTER RESTARTING THE SYSTEM, RESCANNING THE PATIENT, AND CHANGING THE PATIENT'S NAME IN THE SYSTEM. AS A RESULT, THE SURGERY WAS ABORTED. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE REPORTED THAT THERE WAS 30 MINUTES OF DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23898714 ↗
• MalfunctionDec 19, 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 DURING A CASE. THE SURGEON DID CT TO FLUORO REGISTRATION FOR SCREWS. AS THEY WERE PUTTING INSTRUMENTS DOWN THE END EFFECTOR AND DOCKING TO BONE, ON SCREEN THE INSTRUMENT APPEARED 4 MM INSIDE OF THE BONE. AFTER REDOING REGISTRATION 4-5 TIMES WITH CT TO FLUORO, THE SAME RESULT APPEARED ON SCREEN ON MULTIPLE LEVELS EACH TIME. EVENTUALLY THE SURGEON ABANDONED USE OF THE SYSTEM AND PROCEEDED USING TRADITIONAL GUIDEWIRES AND A 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 SITE DID NOT USE GUIDE WIRES TO FINISH THE CASE, THEY USED NAVIGATION AND PERCUTANEOUS SCREWS, AND EVERYTHING LOOKED GREAT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23851701 ↗
• MalfunctionDec 2, 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 SCAN AND PLAN CASE, AFTER PLACING SCREWS ON THE PATIENT'S RIGHT SIDE, THERE WAS SUDDEN MOVEMENT WITH THE PATIENT THAT PROMPTED THE SITE TO RE-REGISTER. AFTER RESCANNING THE PATIENT, THE SITE OBSERVED THAT THE L5 SCREW POSITIONING APPEARED TO BE LOW COMPARED TO INITIAL PLACEMENT. THERE WAS ALSO SIGNIFICANT SCATTER ARTIFACT AROUND THE TOWERS IN THE IMAGE. THE SUSPECTED DEVIATION WAS BETWEEN 3.5-10MM. THE SITE ABANDONED USE OF GUIDANCE SYSTEM AND CONTINUED THE CASE WITH NAVIGATION. THERE WAS NO PATIENT HARM AND THE PROCEDURE WAS DELAYED LESS THAN ONE HOUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23697100 ↗
• MalfunctionNov 18, 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 SCAN AND PLAN CASE FROM LEVELS L3-L5. IT WAS REPORTED THAT THE SURGEON REVISED THE INITIAL PLAN TO MAKE THE SCREWS ON THE RIGHT MORE MEDIAL. THEY WERE INFORMED THAT IF THE SCREWS ARE PLACED ON THE OUTER ASPECT OF THE FACET, THEY WERE MORE LIKELY TO SKIVE. ALL 3 SCREWS ON THE RIGHT SIDE WERE SKIVED LATERALLY OF THE PEDICLE. THE SURGEON TOOK OUT ALL 3 SCREWS AND DID A UNILATERAL FUSION ON THE LEFT SIDE. THERE WAS NO IMPACT TO PATIENT'S OUTCOME AND THERE WAS NO SURGICAL DELAY. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT SCREWS DEVIATED BETWEEN 3.5 AND 10 MILLIMETERS (MM).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23584771 ↗
• MalfunctionOct 15, 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 INSTANCE OF ERRANT PEDICLE SCREW PLACEMENT. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23292322 ↗
• MalfunctionSep 18, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE REPORTED THAT THE DEVIATION WAS SUSPECTED TO BE BETWEEN 3.5 AND 10 MM. THE REPRESENTATIVE SUSPECTED A SHIFT ON THE IMAGES AFTER GETTING YELLOW VALUES ON THE VERIFICATION SCREEN, BUT THE SURGEON WANTED TO GO AHEAD AND SEE WHAT THE SKIN INCISIONS LOOKED LIKE FOR CONFIRMATION. THE SITE MARKED THE SKIN INCISIONS WITH THE USE OF THE ROBOT ON THIS CASE AND THE SITE WAS ABLE TO TELL THAT THE LEFT SIDE SCREWS WERE GOING TO BE PLACED MEDIALLY SO THAT IS WHEN THEY DECIDED TO GET THE PATIENT RESCANNED WITH THE ANTERIOR HARDWARE IN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23085995 ↗
• MalfunctionAug 21, 2025Incorrect, Inadequate or Imprecise Result or Readings; Data Problem; Incorrect, Inadequate or Imprecise Result or Readings; Data Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT PRIOR TO THE PROCEDURE; THERE WAS A BOOT UP ISSUE. A DELL WINDOWS RESTART AND CONFIGURATION. DURING THE PROCEDURE, ISSUES WITH SPIN UPLOAD AND ROBOTIC INACCURACY WERE NOTED. WHEN TRYING TO IMPORT THE FIRST SPIN FROM THE MEDTRONIC IMAGING SYSTEM, USING A USB TO TRANSFER TO GUIDANCE SYSTEM, IT WAS INITIALLY UPLOADED WITH CORRECT PATIENT NAME BUT THERE WAS INCORRECT ANATOMY (AKA INCORRECT SCAN) AS DETECTED BY THE FELLOW AS THERE WAS AN INCORRECT L1 FRACTURE PRESENTATION. THEY RE-ATTEMPTED UPLOADING USING THE SAME USB, WHICH WAS THEN IMPORTED THAT SAME INCORRECT SCAN, BUT UNDER A DIFFERENT PATIENT NAME. AT WHICH POINTS THEY TRIED AN EMPTY UNIVERSAL SERIAL BUS (USB) WITH NO PRIOR NAVIGATION OR GUIDANCE SYSTEM FILES, ON THE OFF CHANCE THE SCAN WAS BEING CORRUPTED ON THE DEVICE. AT WHICH POINTS THE MOBILE VIEWING STATION (MVS) ERRORED "THERE ARE NO REMOVABLE DEVICES ON THIS SYSTEM" ON ALL PORTS. THEY TRIED AGAIN WITH A SECOND EMPTY USB WHICH RESULTED IN SAME ERROR TEMPORARILY BUT EVENTUALLY SHOWED UP. DUE TO THE CONCERN, IT MIGHT BE TO DO WITH THESE USB PORTS, T HEY THEN T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22864319 ↗
• MalfunctionAug 11, 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 WHEN PLACING THE RIGHT L4 SCREW, WITH THE DEVIATION DESCRIBED AS 5 TO 6 MILLIMETERS IN THE CRANIAL DIRECTION. THE GUIDANCE SYSTEM WAS ABORTED DURING THE PROCEDURE. THE SCREWS WERE RE-INSERTED USING MEDTRONIC IMAGING AND NAVIGATION SYSTEMS. INTRAOPERATIVE NAVIGATION AND IMAGING WERE UTILIZED DURING THE RE-INSERTION. THE EVENT OCCURRED INTRAOPERATIVELY AND EXTENDED THE SURGICAL TIME BY LESS THAN ONE HOUR. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22772435 ↗
• MalfunctionAug 11, 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 SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT AN ALLEGED NAVIGATION INACCURACY OCCURRED INTRAOPERATIVELY. AFTER THE SCAN AND PLAN WERE PERFORMED, ACCURACY WAS CHECKED USING A PASSIVE PLANAR PROBE, WHICH WAS TOUCHING BONE, BUT THE SYSTEM DISPLAYED THE INSTRUMENT AS BEING "WAY ABOVE" THE BONE. ADDITIONAL IMAGING WAS CONDUCTED AND NEW IMAGES WERE IMPORTED; HOWEVER, NAVIGATION REMAINED INACCURATE, SHOWING THE PROBE AS BEING INSIDE THE BONE WHEN IT WAS ACTUALLY TOUCHING THE BONE. THE PROCEDURE EXPERIENCED A DELAY OF LESS THAN ONE HOUR. THE SURGEON ABANDONED USE OF THE GUIDANCE SYSTEM AND PROCEEDED WITH MEDTRONIC NAVIGATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT ONE ANATOMICAL LANDMARK SHOWED BETWEEN 3.5 AND 10 MILLIMETERS (MM) ABOVE BONE AND ANOTHER LANDMARK SHOWED BETWEEN 3.5 AND 10MM IN BONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22772369 ↗
• MalfunctionJul 16, 2025Incorrect, Inadequate or Imprecise Result or Readings; Data Problem; Unintended Application Program Shut Down; Incorrect, Inadequate or Imprecise Result or Readings; Data Problem; Unintended Application Program Shut Down

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THE IMAGES IMPORTED INTO THE SYSTEM WERE IN THE WRONG ORIENTATION AND THAT THE DEPTH OF THE IMAGE WAS OFF. THE MANUFACTURE REPRESENTATIVE REPORTED ATTEMPTING A SCAN AND PLAN CASE FOR 2-LEVEL TLIF. THE REPRESENTATIVE IMPORTED THE SCAN WITH USB AND THE SCREEN ON SYSTEM WENT BLACK. THE REPRESENTATIVE PERFORMED A SOFT REBOOT AND IMPORTED THE SCAN A SECOND TIME. THE REPRESENTATIVE WAS ABLE TO CONTINUE WITH SETUP UNTIL ARRIVING AT THE FIRST TRAJECTORY, WHERE THEY OBSERVED THAT NAVIGATION WAS OFF. THIS WAS IDENTIFIED BY OBSERVING THE NAVIGATION AND SEEING THE IMAGE FLIPPED UPSIDE DOWN AS WELL AS THE PASSIVE PLANAR PROBE POINTING ON THE WRONG SIDE OF THE BODY. THE REPRESENTATIVE INDICATED THAT WHEN THEY SENT TO THE FIRST TRAJECTORY RIGHT L3 AND IT LOOKED LIKE THE PROBE WAS POINTING TO THE LEFT SIDE OF T HE PATIENT'S STOMACH/BODY OF THE VERTEBRA. THE REPRESENTATIVE BELIEVED THE REASON FOR THIS ISSUE WAS INCORRECT PATIENT PARAMETERS SET ON THE IMAGING SYSTEM. NAVIGATION WITH THE GUIDANCE SYSTEM WAS ABORTED AND THE SURGICAL TEAM COMPLETED THE SURGERY WITH A DIFFERENT NAVIGATIO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22521828 ↗
• MalfunctionJul 1, 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 PRONE SCAN AND PLAN PROCEDURE, MULTIPLE ISSUES OCCURRED PRIOR TO AND DURING THE PROCEDURE. ALLEGATIONS INCLUDED A 3DEFINE SCAN ISSUE, SNAPSHOT ACCURACY ISSUE, AND AN ARM MOVEMENT DELAY, RESULTING IN A ONE-HOUR SURGICAL DELAY. THE 3DEFINE CAMERA PANEL WAS REPORTED AS BROKEN AND MECHANICALLY LOOSE, WITH THE PANEL EASILY DETACHING. DURING SURGICAL ARM SETUP, THE ARM BECAME STUCK IN AN EXTENDED POSITION DURING THE 3DEFINE CHECK, SUSPENDING MOVEMENT AND LEAVING THE "START SET UP" BUTTON IN A TEMPORARY STATE. RE-RUNNING THE SETUP INITIALLY FAILED, BUT AFTER FIRMLY PRESSING THE CAMERA PANEL TO ENSURE FULL ATTACHMENT AND RERUNNING THE SETUP, THE ISSUE WAS RESOLVED. A SOFTWARE ERROR WAS REPORTED. DURING THE CASE, A SIGNIFICANT NAVIGATION ERROR WAS OBSERVED, WITH INSTRUMENTS NOT AT THE PLANNED LEVEL BUT PROJECTING INTO THE LEVEL ABOVE, RESULTING IN A NAVIGATION SHIFT OF AN ENTIRE LEVEL. THIS WAS RESOLVED BY TAKING A NEW SNAPSHOT. ADDITIONAL SOFTWARE ISSUES INCLUDED LAG OR GLITCHES WHEN MOVING TO TRAJECTORIES, DOUBLE BEEPING WITH LAG UPON MOVEMENT COMPLETI ON, AND RES

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22372124 ↗
• MalfunctionJun 9, 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 A SCREW IMPLANT DEVIATION. THERE WAS NO REPORTED IMPACT TO PATIENT'S OUTCOME. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THERE WAS NO SURGICAL DELAY TO THE PROCEDURE. THE PATIENT EXPERIENCED NUMBING IN THE FOOT POST SURGERY. THE SURGEON BROUGHT PATIENT BACK INTO SURGERY AFTER THE ORIGINAL PROCEDURE TO FIX THE MISPLACED SCREWS. THE SCREWS DEVIATED LESS THAN 3.5 MILLIMETERS (MM). IT WAS THOUGHT IT WAS ROUGHLY A 2 MM DEVIATION.

  Patient problems: Numbness

  MAUDE report 22169031 ↗
• MalfunctionMay 7, 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 L5 RIGHT SCREW DEVIATED BY 3 CENTIMETERS (CM) AND WENT DIRECTLY INTO THE DISC SPACE, WHICH WAS NOT PLANNED. TWO FACET DEFECTS WERE PERFORMED PRIOR TO PLACING THE SCREWS. REDIRECTING WAS PERFORMED AS TROUBLESHOOTING BUT THE ISSUE REMAINED. THE SURGEON PROCEEDED FREEHANDEDLY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21979884 ↗
• MalfunctionMay 5, 2025Unintended Collision; Incorrect, Inadequate or Imprecise Result or Readings; Use of Device Problem; Unintended Collision; 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 WHEN SENDING THE ARM TO A TRAJECTORY, THE ARM HIT THE REFERENCE FRAME AND THEREFORE CAUSED THEM TO LOSE ACCURACY. THE ARM HIT THE FRAME DESPITE THE FRAME BEING WITHIN THE 3DEFINED AREA. THE NAVIGATION WAS ABORTED, AS SURGEON BYPASSED THE ISSUE BY HAND-PLACING SCREWS. THERE WAS NO PATIENT HARM AND THE PROCEDURE WAS DELAYED BY 30 MINUTES. ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE REPORTED THAT THE 3DEFINE SCAN DID NOT PICK UP THE DRAPE COVERING THE REFERENCE FRAME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21960422 ↗
• MalfunctionApr 23, 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 AN L5-S1 TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) SPINAL FUSION PROCEDURE USING COMPUTED TOMOGRAPHY-TO-FLUORO REGISTRATION, BOTH L5 SCREWS WERE SIGNIFICANTLY LOWER THAN THE PLANNED TRAJECTORY. THE SURGEON BEGAN AT S1 (LEFT) AND THEN MOVED TO L5 (LEFT), WHERE AN X-RAY CONFIRMED THE SCREW WAS POSITIONED LOWER THAN PLANNED BUT STILL ACCEPTABLE. HOWEVER, UPON TRANSITIONING TO L5 (RIGHT), ANOTHER X-RAY REVEALED THE SCREW WAS SIGNIFICANTLY LOWER THAN PLANNED AND NOT ACCEPTABLE. A MEDTRONIC IMAGING SPIN CONFIRMED BOTH L5 SCREWS WERE PLACED TOO LOW. DUE TO LIMITED REMAINING PEDICLE, SCREW PLACEMENT AT L5 WAS NO LONGER VIABLE. CONSEQUENTLY, THE SURGEON PERFORMED A FUSION FROM L4 TO S1 INSTEAD OF THE ORIGINALLY PLANNED L5-S1. THE GUIDANCE SYSTEM WAS USED AT L4, AND CORRECT SCREW PLACEMENT WAS CONFIRMED AT THAT LEVEL. 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 TRAJECTORIES WERE DEVIATED BETWEEN 4 AND 7 MILLIMETERS (MM) CAUDAL OF THE PLAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21892298 ↗
• 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, USING THE GUIDE WIRE SYSTEM. IT WAS REPORTED THAT AN ALLEGED INACCURACY OCCURRED. THE THIRD PEDICLE SCREW OUT OF FOUR APPEARED LOW DESPITE ACHIEVING ALL GREEN ON REGISTRATION. WHEN THE TRAJECTORY WAS RE-TRIED WITH A REDUCTION TUBE, THE SCREW STILL APPEARED LOW. CONSEQUENTLY, THE SURGEON DECIDED NOT TO PLACE SCREWS ON THE RIGHT SIDE, OPTING TO ONLY INSERT SCREWS ON THE LEFT SIDE. IT WAS ALSO NOTED THAT THE PEDICLE SEEMED TO HAVE SHIFTED ON THE RIGHT SIDE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT BOTH THE SURGEON AND MANUFACTURER REPRESENTATIVE DID NOT A SHIFT UPON VERIFICATION. ONCE THE PEDICLE WAS DRILLED UPON, THE X-RAY IMAGING REVEALED THE SCREW WAS LOW IN THE PEDICLE. THE SURGEON ELECTED TO SKIP PLACEMENT OF SCREWS ON THE RIGHT SIDE AND JUST DO A UNILATERAL SCREW PLACEMENT ON THE LEFT SIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21881890 ↗
• MalfunctionMar 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 L5 SCREWS DEVIATED SLIGHTLY FROM THE PLANNED TRAJECTORY AND THE S1 DRILLING TRAJECTORY DID NOT FOLLOW THE PLANNED PATH, GOING INTO THE PROMONTORY. THE SURGEON NOTED AN UNUSUAL SOUND DURING DRILLING AT S1, PROMPTING A LATERAL X-RAY, WHICH CONFIRMED THE DEVIATION. THE POSITION OF THE RED MARKER WAS NEVER ADJUSTED, AND THE STAR MARKER WAS NOT DETECTED IN THE MEDTRONIC IMAGING SYSTEM DUE TO THE PRESENCE OF THE TOWER IN L4 AND L5. TWO TITANIUM CAGES WERE INSERTED DURING "STAGE 1," AND THE SAME COMPUTED TOMOGRAPHY SCAN WAS USED FOR THE L4-S1 PERCUTANEOUS PROCEDURE DURING "STAGE 2." THE SITE SWITCHED TO AN MEDTRONIC IMAGING SYSTEM SCAN TO PLAN FOR INSERTING THE LAST TWO SCREWS AND EVENTUALLY REMOVED THE GUIDANCE SYSTEM, OPTING TO USE THE NAVIGATION SYSTEM INSTEAD, NECESSITATING ANOTHER MEDTRONIC IMAGING SCAN. THIS RESULTED IN A 1 HOUR AND 30-MINUTE DELAY TO THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21719252 ↗
• MalfunctionFeb 19, 2025Imprecision; Imprecision

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THE SYSTEM WAS CONTINUING TO SHOW INSTRUMENTS INACCURATELY. THE INSTRUMENTS WERE ON PLAN, BUT DEEP BY ABOUT 3MM. THE SITE RETOOK A SNAPSHOT AND THE ISSUE DID NOT RESOLVE. THE PASSIVE PLANAR PROBE IN THE ARM GUIDE DIVOT ALSO SHOWED OFF. THE ISSUE WAS OCCURRING WITH TWO DIFFERENT SNAPSHOT TRACKERS. THE SUSPECTED OR MOST LIKELY CAUSE WAS THE SNAPSHOT TRACKERS. THEY COMPLETED THE CASE WITH THE GUIDANCE SYSTEM; THE TRAJECTORIES WERE STILL CORRECT; THE NAVIGATION INSTRUMENTS WERE JUST SHOWING DEEPER INTO THE BONE THAN THEY ACTUALLY WERE. THE SITE PLACED THE PASSIVE PLANAR PROBE INTO THE DIVOT ON THE ARM GUIDE AND IT SHOWED THAT IT WAS ABOVE THE DIVOT. THEY SENT TO SNAPSHOT AND TOOK ANOTHER SNAPSHOT, AND THE PASSIVE PLANAR PROBE WAS STILL SHOWING ABOVE THE DIVOT. THERE WAS NO PATIENT HARM AND THE PROCEDURE WAS NOT DELAYED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21410750 ↗
• MalfunctionFeb 19, 2025Imprecision; Imprecision

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT DURING A ONE LEVEL CASE, TWO SCREWS WERE MORE MEDIAL THAN THE CT TO FLUORO PLAN. THE MANUFACTURER REPRESENTATIVE SUSPECTED USER ERROR WITH SOFT TISSUE PRESSURE. THE USE OF THE GUIDANCE SYSTEM WAS ABORTED. TWO SCREWS WERE REMOVED AND FLUORO WAS USED TO CONTINUE WITH THE CASE. 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 21410317 ↗
• MalfunctionFeb 18, 2025Imprecision; Imprecision

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT UPON THE FINAL SPIN L4 ONE SCREW WAS LATERAL AND THE THREADS OF THE SCREW WERE OUTSIDE OF THE VERTEBRAL BODY. THE SURGEON DID NOT REPOSITION THE SCREW, HOWEVER IT BREACHED, AND THE SPIN DID NOT REFLECT TRAJECTORY OF THE SCREW OR NAVIGATION. THERE WAS NO DELAY OR IMPACT ON PATIENT OUTCOME. ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE REPORTED THAT THE CAUSE OF THE DEVIATION WAS NOT DETERMINED. THE DRILL WAS USED TO POTENTIALLY ELIMINATE SKIVING AND THERE WAS NO SOFT TISSUE PRESSURE PRESENT DUE TO THE PERCUTANEOUS NATURE OF THE TOOLS. THE DEVIATION WAS LESS THAN 3.5 MM. THE SURGEON DETERMINED THAT THE DEVIATION WAS CLINICALLY ACCEPTABLE AND NO REVISION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21403841 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K203005. One submission often covers many models, so check the product and lot details in each record.

• Z-0101-2024 · Sep 5, 2023 · Open, Classified
  MAZOR X robotic guidance system, Model TPL0059, with software versions 4.2.2 or 5.0.1