N/A 9734450Recalls & reported problems
Medtronic Navigation, Inc. · TOOL 9734450 INSERTION / REMOVAL · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00613994804730), received between Nov 13, 2018 and Jul 22, 2020 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Material Integrity Problem” (4 reports).
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
- Material Integrity Problem4
Patient problems
- No Patient Involvement3
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 22, 2020Material Integrity Problem; Material Integrity Problem
MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED IN A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE REMOVAL END OF THE TOOL BROKE OFF COMPLETELY. THIS OCCURRED AT THE END OF THE PROCEDURE WHEN THE NURSE WAS REMOVING THE TRACKER FROM THE TOOL WITH THE REMOVAL/INSERTION TOOL. THERE WAS NO DELAY TO THE PROCEDURE. NO IMPACT ON PATIENT OUTCOME. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE INSTRUMENT WAS NOT DAMAGED INSIDE OF THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10308111 ↗MalfunctionMar 26, 2019Material Integrity Problem; Material Integrity Problem
MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE A PROCEDURE. IT WAS REPORTED THAT THE SITE DAMAGED THE INSERTION/REMOVAL TOOL. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.
Patient problems: No Patient Involvement
MAUDE report 8452960 ↗MalfunctionFeb 13, 2019Material Integrity Problem; Material Integrity Problem
MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE INSERTION/REMOVAL TOOL INSTRUMENT WAS FOUND TO BE DAMAGED IN THE STERILE PROCESSING DEPARTMENT (SPD). THE INSERTION/REMOVAL TOOL WAS REPORTED TO BE CHIPPED/STRIPPED. THERE WAS NO PATIENT PRESENT.
Patient problems: No Patient Involvement
MAUDE report 8334257 ↗MalfunctionNov 13, 2018Material Integrity Problem; Material Integrity Problem
MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE OF PROCEDURE. IT WAS REPORTED THAT THE INSERTION/REMOVAL TOOL WAS DAMAGED. NO PATIENT PRESENT.
Patient problems: No Patient Involvement
MAUDE report 8064802 ↗
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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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