N/A 9733886Recalls & reported problems
Medtronic Navigation, Inc. · FRAME 9733886 SMALL ACTIVE HC · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169545601), received between Mar 1, 2017 and Sep 27, 2022 — classified as 3 malfunctions.
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 18, 2026.
Most reported problems
Device problems
- Mechanical Problem1
- Output Problem1
- Use of Device Problem1
Patient problems
- No Known Impact Or Consequence To Patient2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 27, 2022Use of Device Problem; Use of Device Problem
MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE ACTIVE FRAME HAD LED DEPLETION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15491139 ↗MalfunctionJun 1, 2019Output Problem; Output Problem
MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM EVENT HAVING OCCURRED INTRA-OPERATIVELY OF A PROCEDURE. IT WAS REPORTED THAT THE LED SMALL ACTIVE REFERENCE FRAME HAD A RECOGNITION FAILURE DURING THE CASE. IT WAS STATED THEY WERE ABLE TO COMPLETE THE CASE WITH NAVIGATION. NO FURTHER INFORMATION REGARDING THE PROCEDURE PROVIDED. NO REPORTED IMPACT TO PATIENT AND LESS THAN AN HOUR OF DELAY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8661246 ↗MalfunctionMar 1, 2017Mechanical Problem; Mechanical Problem
A MEDTRONIC REPRESENTATIVE REPORTED THAT THE CONNECTOR TO THE REFERENCE FRAME WAS BROKEN. THIS WAS NOTICED DURING A SPINAL FUSION CASE. THE CASE CONTINUED USING ANOTHER FRAME. THERE WAS NO PATIENT IMPACT REPORTED AND THE DELAY IN SURGERY WAS LESS THAN AN HOUR. SURGERY PROCEEDED AS PLANNED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6370246 ↗
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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