N/A 9734590 (UDI 00763000054403)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00763000054403), received between Sep 4, 2019 and Dec 19, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 19, 2025Mechanical Jam; Mechanical Jam

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A CERVICAL SPINE PROCEDURE. IT WAS REPORTED THAT THE USER INSERTED THE INFINITY DRILL BIT INTO THE NAVLOCK TRACKER VIOLET AND CREATED A PILOT HOLE, BUT IT STOPPED ROTATING. ATTACHED IT TO ANOTHER NAVLOCK TRACKER, BUT IT BECAME STUCK AGAIN. THERE WAS NO SURGICAL DELAY. THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23857460 ↗
• MalfunctionDec 30, 2024Use of Device Problem; Use of Device Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THERE WAS A DEFECTIVE INSTRUMENT DUE TO DAMAGE. THE PROBABLE CAUSE WAS USE OF THE INSTRUMENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21043392 ↗
• MalfunctionAug 27, 2024Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT WHEN THEY WERE USING THE TRACKERS THE SPHERES WERE FLICKERING IN AND OUT WHILE NAVIGATING. BOTH THE ORANGE AND GRAY TRACKER, AND BOTH HAD A GEOMETRY ERROR OF .49MM. THE PURPLE AND PASSIVE PLANAR PROBE WERE WORKING AS EXPECTED. THE REPRESENTATIVE RAN A STATUS CHECK ON THE CAMERA AND EVERYTHING WAS WORKING AS EXPECTED.  THERE WAS NO REPORTED DELAY AND NO REPORTED IMPACT TO PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20077298 ↗
• MalfunctionJun 5, 2023Imprecision; 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 NAVIGATION WAS MEDIAL AND LATERAL FOR ALL THE INSTRUMENTS BUT ALL SCREWS WERE PLACED ACCURATELY, THE ARM WAS ACCURATE. THEY CHECKED NAVIGATION ACCURACY AND THE SNAPSHOT IMAGE AND ISSUE PERSISTED. THERE WAS NO DELAY AND NO IMPACT TO THE PATIENT OUTCOME. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THEY TESTED THE INSTRUMENTS AND THE NAVLOCKS WERE DAMAGED AND CAUSING THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17063207 ↗
• MalfunctionJan 11, 2021Use of Device Problem; Use of Device Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED OUTSIDE OF A PROCEDURE THAT THE GREY INSTRUMENT TRACKER WAS DEFECTIVE. NO PATIENT WAS PRESENT AT THE TIME OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11149008 ↗
• MalfunctionFeb 17, 2020Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING AN UNKNOWN SYSTEM USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE GREY TRACKER WAS BREAKING. IT WAS REPORTED THAT THE ATTACHMENT TABS BROKE. THERE WAS NO PATIENT IMPACT AT THE TIME OF THE EVENT. IT WAS REPORTED THAT THE CAUSE WAS LIKELY DUE TO IT BEING HIT REPEATEDLY WITH A MALLET TO DRIVE THE PROBE INTO THE PEDICLES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9717057 ↗
• MalfunctionSep 4, 2019Imprecision; Imprecision

  ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE INDICATED THERE WAS NO IMPACT TO THE PATIENT OUTCOME. THE TRACKERS WERE NOT BE RETURNED AS THE ACCOUNT WANTED TO KEEP THEM. THE MANUFACTURER REPRESENTATIVE TESTED THE TRACKERS AT THE ACCOUNT AND RETURNED THEM TO THE HOSPITAL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8962123 ↗