NA 9734590Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000300401), received between Jan 24, 2025 and Apr 20, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Mechanical Jam” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K171267); 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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 20, 2026Material Fragmentation

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED PRIOR TO A PROCEDURE. IT WAS REPORTED THAT THE POST OF THE GREY TRACKER BROKE DURING SETUP. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24933075 ↗
• MalfunctionMar 6, 2026Mechanical Jam

  ADDITIONAL INFORMATION AS RECEIVED. IT WAS REPORTED THAT THE ISSUE WAS LIKELY CAUSED DUE TO PROLONGED USE THE INSTRUMENTS WITH NORMAL WEAR AND TEAR OF PARTS. THIS COULD NOT BE CONFIRMED AS MULTIPLE NEW INSTRUMENTS HAD PREVIOUSLY STOPPED WORKING AFTER BEING USED IN ONLY 1 OR 2 CASES. THE MANUFACTURING REPRESENTATIVE (REP) BELIEVED THAT THERE WAS SOMETHING WITH A DISPOSABLE 2.4 DRILL BIT BEING THE MAIN CAUSE OR CONTRIBUTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24531568 ↗
• MalfunctionJan 24, 2025Mechanical Jam; Mechanical Jam

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM USED IN A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE GREY TRACKER DID NOT ROTATE AND COULD NOT BE REMOVED. AFTER TAPPING WITH A HAMMER, THE TRACKER WAS THEN REMOVED. THE OPERATION WAS PERFORMED BY USING ANOTHER COLORED TRACKER. NO HEALTH DAMAGE. THERE WAS A SURGICAL DELAY OF LESS THAN 1 HOUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21232263 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K171267. One submission often covers many models, so check the product and lot details in each record.

• Z-1693-2020 · Aug 28, 2019 · Terminated
  NavLock Tracker *** Rx Only