N/A 9734437Recalls & reported problems
Medtronic Navigation, Inc. · PROBE 9734437 RIGHT THORACIC TACTILE · Class 2
- 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 00613994759634), received between May 24, 2024 and May 24, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (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.
Reports received per month
Most reported problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings1
- Mechanical Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 24, 2024Mechanical Problem; Incorrect, Inadequate or Imprecise Result or Readings; Mechanical Problem; Incorrect, Inadequate or Imprecise Result or Readings
MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE SURGEON WAS CONCERNED THAT THE LEFT AND RIGHT THORACIC TACTILE PROBES MAY BE BENT. THE INSTRUMENTS VERIFIED AS INTENDED, BUT WHEN IN USE, THE SURGEON WAS CONCERNED IT WAS NOT GIVING A STRAIGHT TRAJECTORY. THE SURGEON PUT PEDICLE MARKERS IN, SPUN THE PATIENT, LOOKED ALONG THE SAME TRAJECTORIES AND CONTINUED WITH SURGERY. THERE WAS NO DELAY IN SURGERY. THERE WAS NO IMPACT ON PATIENT OUTCOME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19392225 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.