N/A 960-521Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00673978089904), received between Jun 2, 2017 and Apr 24, 2023 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (5 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 24, 2023Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE INNER AND OUTER CYLINDERS HAD CONNECTION FAILURE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16795724 ↗
• MalfunctionApr 13, 2022Imprecision; Imprecision

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THE SURGEON USED THE UDG INSTRUMENT AND 3MM DRILL BIT TO MAKE A PILOT HOLE. THE SURGEON THEN CHECKED THE DRILL HOLE WITH THE PASSIVE PLANAR AND IT WAS 1MM OFF CRANIALLY. THE PROCEDURE WAS CONTINUED WITH CAUTION. THERE WAS NO DELAY AND NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14105216 ↗
• MalfunctionMar 14, 2022Use of Device Problem; Use of Device Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE UC DRILL GUIDE (UDG) WAS DAMAGED, AND THE TRACKER WAS UNABLE TO BE SEATED.  NO PATIENT WAS PRESENT WHEN THE ISSUE WAS IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13760573 ↗
• MalfunctionOct 7, 2021Output Problem; Output Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE DEPTH GUIDE SLIPPED AND THE DRILL WENT DEEPER THAN EXPECTED. THERE WAS NO PATIENT PRESENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12590337 ↗
• MalfunctionJun 20, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE. IT WAS REPORTED THAT THE NAVIGATED DRILL GUIDE WAS DAMAGED. THIS WAS FOUND OUTSIDE OF SURGERY. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 8720808 ↗
• MalfunctionJun 12, 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 SCREW THREAD WAS DAMAGED. THERE WAS NO DELAY TO THE PROCEDURE. NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8691345 ↗
• MalfunctionJun 4, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION THAT, WHILE OUTSIDE OF A PROCEDURE, THE UNIVERSAL DRILL GUIDE (UDG) WAS DAMAGED. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Patient Involvement

  MAUDE report 8669196 ↗
• MalfunctionJan 17, 2019Imprecision; Material Integrity Problem; Imprecision; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING DEVICE BEING USED OUTSIDE A PROCEDURE. THE ISSUE OCCURRED DURING INSTRUMENT VERIFICATION OF THE TRACKER AND THE DRILL GUIDE. IT WAS REPORTED THAT THE TWO DEVICES WERE NOT COMPLETELY COMPATIBLE. THE PRODUCT WAS NOT COMPLETELY MATCHED TO THE NAKED EYE, NOT TO MENTION THE SCREW FIXATION, SO IT WOULD BE INACCURATE. THERE WAS A PROBLEM WITH THE PRODUCT PROCESS, THE HANDLE AND THE TRACKER COULD NOT BE COMPLETELY MATCHED, SO IT COULD NOT BE FIXED WITH SCREWS. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Patient Involvement

  MAUDE report 8258982 ↗
• MalfunctionDec 23, 2018Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE OF A PROCEDURE. THERE WAS NO PATIENT PRESENT. IT WAS REPORTED THAT AN ISSUE WAS FOUND WITH THE UNIVERSAL DRILL GUIDE UDG OUTSIDE OF SURGERY. IT WAS REPORTED THAT IT WAS DIFFICULT TO INSERT THE CANNULAS INTO THE OPENING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8193165 ↗
• MalfunctionSep 20, 2018Break; Break

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED THAT THE UNIVERSAL DRILL GUIDE HAD ¿COME APART¿. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Patient Involvement

  MAUDE report 7895916 ↗
• MalfunctionJun 19, 2018Material Deformation; Material Deformation

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE OF PROCEDURE. IT WAS REPORTED THAT THE UNIVERSAL DRILL GUIDE (UDG), WHERE YOU INSERT THE DRILL GUIDE, WAS FOUND TO BE STRIPPED. NO PATIENT WAS PRESENT.

  Patient problems: No Patient Involvement

  MAUDE report 7614135 ↗
• MalfunctionDec 10, 2017Material Deformation; Material Deformation

  A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE OUTSIDE OF A PROCEDURE, THE UNIVERSAL DRILL GUIDE WOULD NOT TIGHTEN SUFFICIENTLY. IT WAS NOTED THAT THE INTERNAL PORTION FOR THE SCREW WAS STRIPPED. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 7102686 ↗
• MalfunctionJun 2, 2017Material Deformation; Material Deformation

  A SITE REPRESENTATIVE REPORTED THAT, WHILE OUTSIDE OF A PROCEDURE, THE UNIVERSAL DRILL GUIDE WAS STRIPPED. NO ADDITIONAL INFORMATION WAS PROVIDED. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Patient Involvement

  MAUDE report 6608304 ↗