N/A 9733457 (UDI 00763000121198)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00763000121198), received between Apr 9, 2019 and Mar 6, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (8 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 6, 2026Material Fragmentation

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT PROBE PEDICEL BROKE ON THE FIRST USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24533185 ↗
• MalfunctionSep 18, 2025Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE INSTRUMENT WAS RETURNED AFTER THE LOANER PERIOD AND IT WAS FOUND TO BE DEFORMED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23085706 ↗
• MalfunctionAug 25, 2025Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT BENDING OF THE TIP OF THE INSTRUMENT WAS CONFIRMED DURING PRE-USAGE PREPARATION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22890711 ↗
• MalfunctionAug 25, 2025Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED INTRA-OPERATIVELY DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE TIP OF THE INSTRUMENT DEFORMED DURING USE IN A SCOLIOSIS OPERATION. IT WAS BELIEVED THAT THE INSTRUMENT WAS USED IN A HARD PART OF THE BONE. THE OPERATION WAS COMPLETED BY USING ANOTHER INSTRUMENT. NO KNOWN IMPACT TO PATIENT OUTCOME. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22890090 ↗
• MalfunctionAug 6, 2025Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED OUTSIDE OF A PROCEDURE THAT THE PROBE, WHICH WAS RETURNED DUE TO THE END OF THE LOAN PERIOD, WAS FOUND TO HAVE A DEFORMED TIP DURING THE ACCEPTANCE INSPECTION. NO PATIENT WAS PRESENT AT THE TIME OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22730181 ↗
• MalfunctionAug 5, 2025Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED OUTSIDE OF A PROCEDURE THAT THREE TRACKERS HAD POOR ATTACHMENT TO THE PASSIVE MARKERS. THE DRIVER HAD A SCREW INSTALLATION FAILURE. THE PROBE HAD A TIP DEFORMATION. NO PATIENT WAS PRESENT AT THE TIME OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22718481 ↗
• MalfunctionJul 29, 2025Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THERE WAS DEFORMATION OF THE TIP OF THE CERVICAL PROBE. IT WAS NOTED THAT THE PROBABLE CAUSE OF THE ISSUE WAS THAT THE DEVICE WAS USED IN A HARD PART OF THE BONE AND BENT. THE OPERATION WAS COMPLETED BY USING A DIFFERENT INSTRUMENT. THIS ISSUE CAUSED NO SURGICAL DELAY. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22648060 ↗
• MalfunctionJul 17, 2025Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED FOR A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THERE WAS A DEFORMATION OF CERVICAL PROBE TIP. IT IS UNKNOWN HOW THIS OCCURRED. THERE WAS NO REPORTED IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22534795 ↗
• MalfunctionFeb 3, 2025Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE 2.25 MILLIMETER (MM) PEDICLE PROBE WAS BENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21291537 ↗
• MalfunctionApr 9, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE A PROCEDURE. IT WAS REPORTED THAT THE CERVICAL PROBE TIP WAS BENT. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Patient Involvement

  MAUDE report 8497001 ↗