N/A 9734402 (UDI 00763000053819)Recalls & reported problems
Medtronic Navigation, Inc. · PROBE 9734402 LUMBAR · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000053819), received between Sep 14, 2018 and Feb 13, 2025 — classified as 3 malfunctions.
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Material Deformation1
- Mechanical Problem1
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Patient Involvement1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 13, 2025Mechanical Problem; Mechanical Problem
MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE PROBE WAS DAMAGED. IT HAD A CROOKED TIP. THE NEXT STEP WAS TO REPLACE THE INSTRUMENT. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS RECEIVED THAT IT WAS UNKNOWN HOW THE INSTRUMENT GOT DAMAGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21375405 ↗MalfunctionAug 4, 2023Use of Device Problem; Use of Device Problem
MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM OUTSIDE OF PROCEDURE. IT WAS REPORTED THAT A STRAIGHT PROBE LUMBAR NEEDED REPLACEMENT. THERE WAS NO PATIENT PRESENT. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE LUMBAR PROBE WAS BROKEN. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE MOST LIKELY CAUSE OF THE DAMAGED PROBE WAS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17457885 ↗MalfunctionSep 14, 2018Material Deformation; Material Deformation
MEDTRONIC RECEIVED INFORMATION THAT, WHILE OUTSIDE A PROCEDURE, THE STRAIGHT LUMBAR PROBE WAS IDENTIFIED AS BEING BENT. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.
Patient problems: No Patient Involvement
MAUDE report 7877818 ↗
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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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