N/A 9733825 (UDI 00763000053468)Recalls & reported problems
Medtronic Navigation, Inc. · MOUNT ASSY, 9733825, REPEATABLE - iOi · Class 2
Data updated Oct 18, 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 00763000053468), received between Dec 12, 2019 and Dec 12, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Integrity 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 18, 2026.
Most reported problems
Device problems
- Material Integrity Problem1
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.
MalfunctionDec 12, 2019Material Integrity Problem; Material Integrity Problem
MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED FOR AN OPTICAL TUMOR RESECTION PROCEDURE. IT WAS REPORTED THAT THE SITE WAS HAVING ISSUES WITH THE REFERENCE FRAME NOT PROPERLY MOUNTING WITH IN THE MOUNT WHICH WAS CAUSING THE FRAME TO BE VERY LOOSE. A TECH NOTICED THE ISSUE DURING PROCEDURE. THEY NOTED THAT THE REFERENCE FRAME APPEARED TO BE LOOSE IN ITS MOUNT. THE SURGEON STATED THAT NAVIGATION APPEARED ACCURATE AND PROCEEDED WITH THE SURGERY USING NAVIGATION. AFTER THE SURGERY THE THREADS SEEMED TO HAVE BACK OUT OF THE MOUNT SUCH THAT IT WAS SLIGHTLY ELEVATED AND PREVENT THE FRAME FROM FULLY SEATING. THERE WAS A LESS THAN 5 MINUTE DELAY AND NO REPORTED IMPACT TO PATIENT OUTCOME.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9459125 ↗
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
- StealthStation S8 Platform 9735665Medtronic Navigation, Inc. · Neurological stereotaxic Instrument2 deaths1,542 reports
- Fusion™ ENT Image Guidance System 9733560XOMMedtronic Navigation, Inc. · Neurological stereotaxic Instrument1,316 reports
- Stealthstation® S7™ 9733858Medtronic Navigation, Inc. · Neurological stereotaxic Instrument8 deaths984 reports
- Stealthstation® S7™ 9733858Medtronic Navigation, Inc. · Neurological stereotaxic Instrument1 death695 reports
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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