N/A 9730490 (UDI 00763000055813)Recalls & reported problems
Medtronic Navigation, Inc. · TRACKER 9730490 TERATRACKER GREEN · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000055813), received between Jun 5, 2018 and Jun 5, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Mechanical Problem” (1 report).
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
- Mechanical Problem1
Patient problems
- No Patient Involvement1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 5, 2018Mechanical Problem; Mechanical Problem
MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED THAT PRIOR TO THE START OF A CASE, THE SITE DISCOVERED THE SCREW THAT ATTACHED THE TRACKER TO THE UNIVERSAL DRILL GUIDE (UDG) WAS MISSING. THERE WAS NO PATIENT PRESENT WHEN THE ISSUE WAS DISCOVERED AND THE SITE COMPLETED THE SURGERY USING A DIFFERENT TRACKER. THERE WAS NO REPORTED DELAY TO THE CASE.
Patient problems: No Patient Involvement
MAUDE report 7570453 ↗
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- Stealthstation® S7™ 9733858Medtronic Navigation, Inc. · Neurological stereotaxic Instrument8 deaths984 reports
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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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