N/A 9730489Recalls & reported problems
Medtronic Navigation, Inc. · TRACKER 9730489 TERATRACKER BLUE · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00721902652264), received between May 20, 2019 and May 22, 2019 — classified as 2 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Material Integrity Problem2
Patient problems
- No Patient Involvement2
Recent adverse event reports
The 2 most recent of 2 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 8632313 ↗MalfunctionMay 20, 2019Material Integrity Problem; Material Integrity Problem
MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION WHILE OUTSIDE OF PROCEDURE. IT WAS REPORTED THAT THE TACTILE PROBE TRACKER HAD A MISSING PIN. THERE WAS NO PATIENT WHEN THE ISSUE OCCURRED.
Patient problems: No Patient Involvement
MAUDE report 8624062 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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