Unibody™ FM-4010Recalls & reported problems
Medtronic, Inc. · FIDUCIAL FM-4010 IMAGE 10MM GLOBAL AIMD · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20613994747833), received between Feb 12, 2018 and Feb 12, 2018 — classified as 1 injury.
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 18, 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.
InjuryFeb 12, 2018Break; Break
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED DURING THE PROCEDURE THE FIDUCIAL BROKE IN HALF WHEN BEING UNSCREWED FROM THE SKULL. NO ENVIRONMENTAL OR EXTERNAL FACTORS WERE REPORTED TO HAVE LED OR CONTRIBUTED TO THE ISSUE. THE SECOND HALF WAS REMOVED SURGICALLY FROM THE SKULL. THE ISSUE WAS RESOLVED AND THE PATIENT WAS ALIVE WITHOUT INJURY AT THE TIME OF THE REPORT. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7264316 ↗
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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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