N/A 9733665Recalls & reported problems
Medtronic Navigation, Inc. · TRAY LID 9733665 NAV VERTEX MAX · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000053529), received between Oct 24, 2017 and Aug 14, 2018 — classified as 2 malfunctions.
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 16, 2026.
Most reported problems
Device problems
- Break1
- Communication or Transmission Problem1
- Device Operates Differently Than Expected1
- Device Stops Intermittently1
Patient problems
- No Consequences Or Impact To Patient1
- No Patient Involvement1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 14, 2018Break; Break
MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE A PROCEDURE. IT WAS REPORTED THAT THE ACTIVE PROBE WAS FRACTURED. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.
Patient problems: No Patient Involvement
MAUDE report 7782355 ↗MalfunctionOct 24, 2017Device Stops Intermittently; Communication or Transmission Problem; Device Operates Differently Than Expected; Device Stops Intermittently; Communication or Transmission Problem; Device Operates Differently Than Expected
A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A CRANIAL RESECTION, THE ROUND TIP ACTIVE PROBE WAS INTERMITTENTLY BEING RECOGNIZED WHEN USED ALONGSIDE THE REFERENCE FRAME. DISCONNECTING THE REFERENCE FRAME AND RECONNECTING IT DID NOT RESTORE FUNCTIONALITY. THE NAVIGATION SYSTEM WAS RESTARTED AND FUNCTIONALITY WAS RESTORED. THE REPORTED ISSUE THEN REOCCURRED AGAIN AND THE NAVIGATION SYSTEM WAS RESTARTED AGAIN TO RESTORE FUNCTIONALITY. THE PROCEDURE WAS THEN COMPLETED WITH THE NAVIGATION SYSTEM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6972815 ↗
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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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