N/A 9733817Recalls & reported problems
Medtronic Navigation, Inc. · DILATOR 9733817 NAVIGATED · Class 2
Data updated Oct 13, 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 00613994482617), received between Jun 2, 2017 and Jun 2, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Deformation” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Material Deformation1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 2, 2017Material Deformation; Material Deformation
A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A SPINAL FUSION, THE NAVIGATED DILATOR WAS BENT AND THAT THE SLEEVES WERE NOT GOING OVER EACH OTHER SMOOTHLY. THE SITE ELECTED TO CONTINUE USING THE INSTRUMENT WITHOUT NAVIGATION. NO ADDITIONAL INFORMATION WAS PROVIDED. THERE WAS NO REPORTED DELAY TO THE PROCEDURE DUE TO THIS ISSUE. THERE WAS NO IMPACT ON PATIENT OUTCOME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6608267 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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