N/A 9730491 (UDI 00763000055820)Recalls & reported problems
Medtronic Navigation, Inc. · TRACKER 9730491 TERATRACKER GOLD · 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 00763000055820), received between Jul 3, 2018 and Jul 3, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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
- Break1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 3, 2018Break; Break
MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED FOR A SACROILIAC AND THORACOLUMBAR PROCEDURE. THE ISSUE OCCURRED INTRAOPERATIVELY AND CAUSED NO DELAY TO THE SURGERY. IT WAS REPORTED THAT WHILE AN ILIAC BONE FRAME WAS SET UP, FIXATION OF THE REFERENCE FRAME FIXATOR WAS LOOSE. THE PRODUCT WAS DISCARDED AT THE SITE. THE SURGERY WAS COMPLETED WITH NAVIGATION AND THERE WAS NO IMPACT ON PATIENT OUTCOME.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7659167 ↗
Other Neurological stereotaxic Instrument devices
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- StealthStation S8 Platform 9735665Medtronic Navigation, Inc. · Neurological stereotaxic Instrument1 death1,896 reports
- StealthStation S8 9735669Medtronic Navigation, Inc. · Neurological stereotaxic Instrument1,831 reports
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- Fusion™ ENT Image Guidance System 9733560XOMMedtronic Navigation, Inc. · Neurological stereotaxic Instrument1,316 reports
- 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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