Mazor X System TPL0059-07Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 07290109184098), received between Feb 18, 2022 and Jan 30, 2026 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (6 reports).

2 FDA recall records name this device's identifier, 2 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Dec 10, 2025Open, Classified

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

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

2. 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 ↗

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 30, 2026Incorrect, Inadequate or Imprecise Result or Readings; Communication or Transmission Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THERE WAS AN ISSUE DURING SURGERY. THE SURGERY UTILIZED A SCAN AND PLAN WORKFLOW. THE MANUFACTURER REPRESENTATIVE PERFORMED A SCAN AND PREPARED TO PLAN THE REST OF THE CASE. HOWEVER, THE ANESTHESIOLOGIST ACCIDENTALLY MOVED THE PATIENT DURING THIS TIME. IT WAS REALIZED THAT THE SCAN HAD A PORTION OF L2 CUT OFF. SINCE THE PATIENT HAD BEEN MOVED AND PART OF L2 WAS CUT, IT WAS DECIDED THAT A 2ND SHOT WAS NEEDED. THE REPRESENTATIVE MOVED THE STAR MARKER NORTH A FEW METERS AND TOOK THE SHOT, WHICH SUCCESSFULLY FOUND THE STAR MARKER. THE REPRESENTATIVE INSERTED THEIR USB, BUT THE SYSTEM DID NOT GIVE THEM THE OPTION TO LOAD A NEW SCAN. THE MANUFACTURER WENT TO THE 3DEFINE SCREEN, BUT THERE WAS NO POPULATED SCAN. THE REPRESENTATIVE THEN WENT TO THE MOUNTING SCREEN AND THE SYSTEM PROMPTED THEM WITH A MESSAGE ASKING IF THEY WISHED TO REMOUNT. THE REPRESENTATIVE SELECTED NO AND MOVED FORWARD. IT THEN ALLOWED THEM TO IMPORT THE 2ND EXAM. THE STAR MARKER ON THIS 2ND EXAM WAS SUCCESSFULLY DETECTED, SO THE REPRESENTATIVE PLANNED THE REST OF THE CASE. HOWEVER, WHEN THE ARM WAS SENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24223143 ↗
• MalfunctionJul 22, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ADDITIONAL INFORMATION WAS RECEIVED. IT WAS CLARIFIED THAT THAT THERE WAS A MISUNDERSTANDING WHEN THE CASE WAS ORIGINALLY CALLED IN AND THAT THE CAGE BETWEEN L5-S1 WAS NOT FLIPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22569295 ↗
• InjuryJul 2, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE PATIENT HAD SHOWN SOME IMPROVEMENT SINCE THE SURGERY. THE SUSPECTED CAUSE WAS A PATIENT SHIFT DUE TO LEANING WHILE DRILLING, LEADING TO THE SKIVE.

  Patient problems: Muscle Weakness/Atrophy; Nervous System Injury

  MAUDE report 22387097 ↗
• MalfunctionMay 5, 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 L3-L5 CASE, THE RIGHT SCREW ON L4 DEVIATED 2.5MM LOWER THAN THE PLAN. THE SITE DID A MANUAL ADJUSTMENT AT THE SEGMENTATION LINE AND GOT ALL GREEN VALUES. THERE WAS NO SHIFT. THE SITE USED A C-ARM TO CHECK THE LATERAL VIEW OF THE SCREW. THERE WAS NO PATIENT HARM AND THE PROCEDURE WAS DELAYED BY 15 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21961629 ↗
• MalfunctionApr 21, 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 SURGEON WAS USING A CT TO FLOURO WORKFLOW, MOVING FROM S1 TO L4. THE MANUFACTURER REPRESENTATIVE NOTED THAT ALL SCREWS WERE GREEN. ALL SCREWS WERE ACCURATE AND INSERTED WITHOUT ISSUE UP UNTIL LEFT L4. THE SURGEON INSERTED LEFT L4, BUT NOTED THAT THE INSERT FELT OFF. THE SITE TOOK A SPIN OF THE PATIENT, AND THE SPIN REVEALED THAT LEFT L4 HAD SKIVED. THE SURGEON REMOVED THE SCREW AND REINSERTED VIA NAVIGATION. HOWEVER, THE SURGEON NOTED THAT THE SCREW IN NAVIGATION LOOKED OFF, BUT STILL IN THE ORIGINAL HOLE. THE SECOND SCREW WAS INSERTED AND THE SURGEON FELT SATISFIED. THE ORIGINAL SCAN OCCURRED WHILE THE PATIENT WAS ANGLED. THERE WAS NO PATIENT HARM AND THE PROCEDURE WAS DELAYED LESS THAN ONE HOUR. ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE REPORTED THAT THE DEVIATION WAS LESS THAN 3.5MM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21874699 ↗
• MalfunctionFeb 5, 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 T11-S2 POSTERIOR SPINAL REVISION CASE OF A UNILATERAL FUSION. PLANNING WAS COMPLETED PRIOR TO THE PROCEDURE AND THE SURGEON REQUESTED TO HUB THE PLANNED SCREWS. REGISTRATION WAS DONE USING THE CT-FLUORO METHOD. A COUPLE ADDITIONAL OBLIQUE IMAGES WERE NEEDED ON BOTH SECTIONS IN ORDER TO GET GOOD REGISTRATION. REGISTRATION WAS APPROVED BY THE SURGEON. THE SURGEON COMPLETED A LANDMARK AND NAVIGATION ACCURACY CHECK. TWO SEGMENTS WERE COMPLETED. THE PROXIMAL SEGMENT FROM T11-L3 WAS DONE FIRST WITH A SPINOUS PROCESS CLAMP CONNECTED TO A BONE MOUNT BRIDGE AS THE PLATFORM. THE DISTAL SECTION FROM L4 TO S2 WAS COMPLETED WITH BILATERAL SCHANZ PINS AND SCHANZ ARMS. SCREW PLACEMENT WAS COMPLETED WITHOUT ISSUE, BUT THE MANUFACTURER REPRESENTATIVE DID NOTICE THAT DRILLING WAS COMPLETED WITHOUT PULLING THE CANNULA UP FROM THE BONE PRIOR TO THE DRILL MAKING CONTACT. A POST-OP SPIN WAS COMPLETED AND LEFT L1 HAD A LATERAL BREACH OF 5 MM, L2 RIGHT AND LEFT HAD LATERAL BREACHES OF 5 MM AND LEFT L5 HAD A MEDIAL BREACH OF 2 MM. THE SURGEON DECIDED TO ABORT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21313432 ↗
• MalfunctionFeb 5, 2025Imprecision; Imprecision

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THERE WERE DEVIATIONS DURING THE PROCEDURE. THE SURGICAL SYSTEM WAS MOUNTED TO THE PATIENT USING TWO SCHANZ ARMS CONNECTED TO THE PSIS. THE PROCEDURE WAS SPLIT INTO ONE SEGMENT FROM T10-L2 AND A SECOND SEGMENT FROM L3-S2. THE SURGEON STARTED AT T10 ON THE LEFT SIDE, COMPLETED THE LEFT SIDE, AND THE MOVED TO THE RIGHT SIDE. THE LEFT T10, LEFT T11, LEFT L5 AND RIGHT S2AI SCREWS WERE DEVIATED MEDIALLY 2-3 MM DUE TO SKIVING. THE DEVIATIONS WERE IDENTIFIED DURING A POST-OP SPIN. THE REPRESENTATIVE NOTED THAT THE PATIENT HAD SMALL PEDICLES. THERE WAS NO PATIENT HARM AND THE PROCEDURE WAS DELAYED LESS THAN AN HOUR. ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE REPORTED THAT A 10 POINT ACCURACY AND BUILT IN SELF (BIST) TESTS WERE PERFORMED PRIOR TO THE PROCEDURE. A DIVOT CHECK WAS DONE DURING THE FIRST REGISTRATION AND WAS ACCURATE. THE SURGEON DID NOT PERFORM AN ACCURACY CHECK DURING THE SECOND SEGMENT. THE REPRESENTATIVE SUSPECTED THE DEVIATION MAY BE CAUSED BY DOUBLE SCHANZ ARM AND PSIS PIN FOR THE MOUNT AND NOT TAPPING AFTER PILOT HOLE DRILLING. THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21313049 ↗
• MalfunctionJan 28, 2025Imprecision; Imprecision

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT ALL FOUR SCREWS THAT WERE PLACED WERE OFF. THE SURGEON FELT ACCURATE WHILE EVERYTHING WAS PLACED, AND THEN CONFIRMATION SCANS SHOWED THAT THE SCREWS IN L4 WERE LOWER THAN PLANNED AND THE SCREWS IN L5 WERE TO THE RIGHT OF PLAN. IT WAS UNKNOWN BY HOW MUCH. L4 AND L5 WERE PLACED USING A PERC PIN. FLUORO WAS USED TO REPLACE THE SCREWS. THERE WAS NO PATIENT HARM AND THE PROCEDURE WAS DELAYED BY 30 TO 60 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21256741 ↗
• MalfunctionDec 22, 2023Mechanical Problem; Incorrect, Inadequate or Imprecise Result or Readings; Mechanical Problem; Incorrect, Inadequate or Imprecise Result or Readings

  ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE REPORTED THAT A FAULTY SURGICAL ARM WAS USED DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18383765 ↗
• MalfunctionOct 19, 2022Imprecision; Unintended Collision; Imprecision; Unintended Collision

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT WHILE IN A CASE THE SURGEON WAS PERFORMING A OPEN PROCEDURE L3-S1. PLACING COMPETITIVE GUIDEWIRES AND ALL THE WIRES WERE DETERMINED TO BE OFF (10 WIRES). THE MNAUFACTURER REPRESENTATIVE THOUGHT ROUGHLY 3-5MM OFF. L2, L3, AND L4 WERE ALL LOW. L5 AND S1 MEDIAL ON RIGHT, LATERAL ON LEFT. THE INACCURACIES WERE INCONSISTENT BETWEEN OPERATING LEVELS. THE SURGEON TOOK C-ARM SHOTS AFTER PLACING GUIDEWIRES AND THAT IS WHEN IT WAS DETERMINED THAT ALL WIRES WERE INACCURATE. AT THIS POINT THEY PULLED THE WIRES AND WENT TO FLOURO. DURING THE CASE MANUFACTURER REPRESENTATIVE STATED WHEN THEY SENT THE ARM, IT HIT TRAJECTORY, HE USED THE DOWN ARROW TO LOWER THE ARM CLOSER TO PATIENT. HE DID THAT TO BRING TRAJECTORY CLOSER. AS HE WATCHED SOME OF THOSE MOTIONS FROM THE SIDE HE THINKS YOU CAN SEE THE ARM SHAKE JUST A LITTLE BIT. ENOUGH FOR HIM TO CATCH IT (NO CANULA IN ARM GUIDE). AFTER THE CASE, THE MANUFACTURER REPRESENTATIVE PUT THE SYSTEM IN DEMO MODE, SENT THE ARM TO TRAJECTORY, DROPPED POINTER (FROM DOOR BIST TEST) IN GUIDE TO MARK WHERE IT HIT THE TABLE. HE THEN PULLED OUT, LOW

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15634435 ↗
• MalfunctionFeb 18, 2022Imprecision; Imprecision

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THE GUIDANCE SYSTEM WAS INACCURATE DURING A T5-T9 FUSION CASE WITH A FRACTURE AT T7. REGISTRATION WAS COMPLETED AND LOOKED GOOD WITH THE SURGICAL SYSTEM MOUNTED TO T8. BEFORE DRILLING AND PLACING THE K-WIRE, THE SURGEON SENT THE SURGICAL ARM TO RIGHT T5. THE SURGEON DETERMINED THAT THE SURGICAL ARM WAS 2-3 MM MEDIAL AND LOW WHEN CHECKED WITH FLUORO. THE MOUNT WAS MOVED TO T6 IN CASE THE FRACTURE WAS CAUSING INSTABILITY AND THE PATIENT WAS RE-REGISTERED. THE SURGEON SENT THE SURGICAL ARM TO LEFT T5 AND IT WAS ACCURATE. A K-WIRE WAS PLACED AND THE SURGEON MOVED TO RIGHT T5, BUT IT WAS STILL INACCURATE. FLOURO WAS DONE TO CHECK THE PLACEMENT OF LEFT T5 AND IT WAS A LITTLE MEDIAL. THE SAME SURGICAL ARM INACCURACY WAS SEEN AT ALL OF THE LEVELS. THE SURGEON DECIDED TO ABORT THE USE OF THE GUIDANCE SYSTEM AND COMPLETE THE PROCEDURE FREEHAND. THERE WAS NO PATIENT HARM AND THE PROCEDURE WAS DELAYED MORE THAN AN HOUR. AFTER THE PROCEDURE, AN ADVANCED ACCURACY TEST WAS DONE AND THE SURGICAL ARM FAILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13556036 ↗