N/A 9734402 (UDI 00613994724021)Recalls & reported problems
Medtronic Navigation, Inc. · PROBE 9734402 LUMBAR · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00613994724021), received between Oct 11, 2016 and Jan 28, 2025 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Material Integrity Problem” (2 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Material Integrity Problem2
- Bent1
- Material Deformation1
- Material Twisted/Bent1
- Use of Device Problem1
Patient problems
- No Patient Involvement2
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 28, 2025Use of Device Problem; Use of Device Problem
MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE TIP OF THE INSTRUMENT WAS DEFORMED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21253805 ↗MalfunctionJan 1, 2019Material Integrity Problem; Material Integrity Problem
MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE OF A PROCEDURE. THERE WAS NO PATIENT PRESENT. IT WAS REPORTED THAT THE INSTRUMENTS HAD BEEN DAMAGED.
Patient problems: No Patient Involvement
MAUDE report 8207381 ↗MalfunctionDec 27, 2018Material Integrity Problem; Material Integrity Problem
MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE A PROCEDURE. IT WAS REPORTED THAT THE LUMBAR PROBE WAS DAMAGED. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.
Patient problems: No Patient Involvement
MAUDE report 8201781 ↗MalfunctionMar 14, 2017Bent; Bent
A MEDTRONIC REPRESENTATIVE REPORTED THAT THE LUMBAR PROBE WAS BENT. THERE WAS NO PATIENT IMPACT REPORTED AND THE DELAY IN SURGERY WAS LESS THAN AN HOUR. SURGERY PROCEEDED AS PLANNED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6404182 ↗MalfunctionOct 11, 2016Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent
A MEDTRONIC REPRESENTATIVE REPORTED THAT THE TIP OF THE LUMBAR PROBE WAS FOUND TO BE TWISTED DURING A SPINAL FUSION PROCEDURE. THE INSTRUMENT WAS STILL REPORTEDLY USABLE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH IT. THIS ISSUE DID NOT CAUSE A DELAY AND THE PATIENT WAS NOT IMPACTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6016770 ↗
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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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