N/A 961-579Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00721902467707), received between Oct 5, 2017 and Oct 29, 2021 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 29, 2021Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED IN A CRANIAL RESECTION. IT WAS REPORTED THAT THE INSTRUMENT WAS DEFECTIVE. IT WAS NOT ALWAYS SEEN DURING THE PROCEDURE. TROUBLESHOOTING WAS NOT ABLE TO BE PERFORMED DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH THE USE OF THE STANDARD PROBE INSTEAD. THE NEXT STEP WAS TO REPLACE THE INSTRUMENT. THERE WAS NO REPORTED DELAY TO THE CASE. NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12721215 ↗
• MalfunctionNov 18, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED OUTSIDE OF A PROCEDURE THAT THE SITE HAD MULTIPLE DAMAGED INSTRUMENTS. THE TRACKER WAS STUCK ON A MEDIUM CLAMP. NO PATIENT WAS PRESENT AT THE TIME OF THE EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 9335016 ↗
• MalfunctionNov 1, 2018Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE OF PROCEDURE. IT WAS REPORTED THAT THE SITE HAD DISCOVERED DAMAGED INSTRUMENTS DURING STERILE PROCESSING. THE WAS NOTED THAT THE PROBES ARE BENT, THE CLAMP SCREW IS STRIPPED AND THE REFERENCE FRAME IS BENT. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Patient Involvement

  MAUDE report 8029099 ↗
• MalfunctionOct 5, 2017Material Deformation; Material Deformation

  A SITE REPRESENTATIVE REPORTED THAT WHILE OUTSIDE OF PROCEDURE THE SCREW HEAD OF THE MEDIUM FIGHTER WAS OUTWORN. THERE WAS NO PATIENT PRESENT AT THE TIME OF THE ISSUE.

  Patient problems: No Patient Involvement

  MAUDE report 6915982 ↗