N/A 9730492Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00721902652295), received between Jul 10, 2017 and May 22, 2019 — classified as 7 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 16, 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.

• MalfunctionMay 22, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED OUTSIDE OF A PROCEDURE THAT THE SCREWS OF BOTH TRACKERS (BLUE AND PURPLE) CAN'T BE FIXED. NO PATIENT WAS PRESENT AT THE TIME OF THE EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8632321 ↗
• MalfunctionMar 14, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE A PROCEDURE. IT WAS REPORTED THAT THE VIOLET FIGHTERS FOR THE DRILL GUIDE HAD STRIPPED SCREWS AND NEEDED TO BE REPLACED. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Patient Involvement

  MAUDE report 8422902 ↗
• MalfunctionMar 14, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE A PROCEDURE. IT WAS REPORTED THAT THE VIOLET FIGHTER FOR THE DRILL GUIDE HAD STRIPPED SCREWS AND NEEDED TO BE REPLACED. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Patient Involvement

  MAUDE report 8422881 ↗
• MalfunctionMar 4, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT A SCREW FOR THE TRACKER WAS WORN OUT. THE TRACKER WAS NOT ABLE TO BE FIXED TO THE INSTRUMENT. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS OBSERVED.

  Patient problems: No Patient Involvement

  MAUDE report 8386772 ↗
• MalfunctionSep 17, 2017Material Deformation; Material Deformation

  A HOSPITAL REPRESENTATIVE REPORTED THAT THE TERATRACKER SCREW WAS STRIPPED AND WOULD NO LONGER TIGHTEN DOWN. NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 6871438 ↗
• MalfunctionSep 1, 2017Device Operates Differently Than Expected; Material Deformation; Device Operates Differently Than Expected; Material Deformation

  A SITE REPRESENTATIVE REPORTED THAT, WHILE OUTSIDE OF A PROCEDURE, THE SCREWS ON THE TRACKER WERE WORN. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6839119 ↗
• MalfunctionJul 10, 2017Material Deformation; Material Deformation

  A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE OUTSIDE OF A PROCEDURE, THE SCREW FOR THE TERATRACKER WAS STRIPPED. THE REPORTED ISSUE WAS FOUND OUT OF THE DEMO TRAY. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6699105 ↗