N/A 960-527 (UDI 00673978090023)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00673978090023), received between Feb 6, 2019 and May 14, 2020 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (4 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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 14, 2020Output Problem; Output Problem

  (B)(4) (REP HCP FOR): MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE DRILL GUIDE WAS DEFECTIVE. (B)(6)(REP, FOR): NO NEW INFORMATION. INSTRUMENT IS IN POSSESSION OF THE SITE.

  Patient problems: No Patient Involvement

  MAUDE report 10057292 ↗
• MalfunctionAug 2, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED IN A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT TWO DRILL BITS WERE WOBBLY IN THE DRILL GUIDE. THE REPRESENTATIVE WAS PERFORMING A TEST OF THE DRILL BITS TO SEE IF HE COULD RECREATE THE ISSUE. IT WAS FURTHER NOTED THAT THEY TESTED BOTH 2.4 DRILL BITS OUT OF THE UDG TRAYS. IT WAS CONFIRMED THAT THEY WERE BENT AND WILL NEED A REPLACEMENT FOR BOTH TRAYS. THERE WAS A DELAY TO THE PROCEDURE OF LESS THAN ONE HOUR. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8855833 ↗
• MalfunctionAug 2, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED IN A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT TWO DRILL BITS WERE WOBBLY IN THE DRILL GUIDE. THE REPRESENTATIVE WAS PERFORMING A TEST OF THE DRILL BITS TO SEE IF HE COULD RECREATE THE ISSUE. IT WAS FURTHER NOTED THAT THEY TESTED BOTH 2.4 DRILL BITS OUT OF THE UDG TRAYS. IT WAS CONFIRMED THAT THEY WERE BENT AND WILL NEED A REPLACEMENT FOR BOTH TRAYS. THERE WAS A DELAY TO THE PROCEDURE OF LESS THAN ONE HOUR. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8855822 ↗
• MalfunctionJul 11, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED IN A CERVICAL SPINE PROCEDURE. IT WAS REPORTED THAT THE DRILL BIT BROKE OFF IN C1. THE HEALTH CARE PROFESSIONAL (HCP) WAS ABLE TO REMOVE IT AND THE PATIENT IS FINE. THERE WAS LESS THAN AN HOUR DELAY IN THE PROCEDURE. NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8780734 ↗
• MalfunctionFeb 6, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED IN A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT WHEN UNIVERSAL DRILL GUIDE (UDG) WAS BEING DRILLED THE BIT TIP BROKE OFF. THE HEALTH CARE PROFESSIONAL WAS ABLE TO REMOVE THE BROKEN BIT WITHOUT CAUSING PATIENT INJURY. THE PROCEDURE WAS COMPLETED WITH NAVIGATING USING THE STEALTH MIDAS. THE PROCEDURE WAS DELAYED LESS THAN AN HOUR. NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8312462 ↗