N/A 9731110Recalls & reported problems
Medtronic Navigation, Inc. · HANDLE 9731110 IMAGE GUIDED · 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 00885074102641), received between Jan 25, 2017 and Jan 25, 2017 — classified as 1 malfunction.
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 16, 2026.
Most reported problems
Device problems
- Mechanical 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.
MalfunctionJan 25, 2017Mechanical Problem; Mechanical Problem
A MEDTRONIC REPRESENTATIVE REPORTED DURING A CASE THAT THE SITE WAS UNABLE TO VERIFY THE OSTEOTOME ON THE UNILATERAL HANDLE. THE SURGEON MANIPULATED THE PART, AGAINST USER INSTRUCTIONS, AND WAS THEN ABLE TO NAVIGATE SUCCESSFULLY. THERE WAS NO IMPACT TO THE PATIENT REPORTED AND A 10 MINUTE DELAY IN THE SURGERY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6276148 ↗
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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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