N/A 9733825 (UDI 00613994428387)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 00613994428387), received between Mar 26, 2019 and Mar 26, 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 Patient Involvement1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 26, 2019Material Integrity Problem; Material Integrity Problem
MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED OUTSIDE OF A PROCEDURE THAT THE IOI MOUNT WAS DAMAGED. IT IS UNKNOWN HOW IT BECAME DAMAGED. NO PATIENT WAS PRESENT AT THE TIME OF THE EVENT. FOLLOW-UP WITH THE MANUFACTURER REPRESENTATIVE (REP) DETERMINED THAT THE MOUNT WAS NOT USABLE AND WAS FOUND IN SPD. THE REP THOUGHT THAT THE SCREW WAS BROKEN AND THAT WAS THE EXTENT OF THE DAMAGE. THE ISSUE OCCURRED OUTSIDE OF A PROCEDURE.
Patient problems: No Patient Involvement
MAUDE report 8452153 ↗
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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- 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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