N/A 963-776 (UDI 00673978963358)Recalls & reported problems
Medtronic Navigation, Inc. · INST 963-776 CANNULA, 2.9 MM DIAMETER · Class 2
Data updated Oct 18, 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 00673978963358), received between Apr 1, 2019 and Apr 1, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Integrity 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
- Material Integrity 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.
MalfunctionApr 1, 2019Material Integrity Problem; Material Integrity Problem
MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED FOR A PROCEDURE. IT WAS REPORTED THAT DURING THE CLEANING AFTER THE PROCEDURE, IT WAS NOTED THAT THE GUIDE WIRE COULD NOT BE REMOVED FROM THE DRILL GUIDE AND THE SITE WAS REQUESTING REPAIR. THE PROCEDURE HAD BEEN COMPLETED AND THERE WAS NO REPORTED IMPACT TO THE PATIENT OUTCOME. THERE WAS NO REPORTED SURGICAL DELAY DUE TO THIS ISSUE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8471968 ↗
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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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