N/A 9734296Recalls & reported problems
Medtronic Navigation, Inc. · TAP 9734296 3.75 · Class 2
- 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 00613994724113), received between Jan 8, 2021 and Feb 12, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Use of Device 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
- Use of Device Problem2
- Mechanical Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 12, 2025Mechanical Problem; Mechanical Problem
2024-JUL-17 MPXR 00833777, 1203148 (REP, HCP, FOR): MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED INTRA-OPERATIVELY DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THERE WAS TIP DEFORMATION OF THE TAPS. THE OPERATION WAS COMPLETED BY USING A SPAR TAP INSTEAD. NO SURGICAL DELAY. NO KNOWN IMPACT TO PATIENT OUTCOME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21370273 ↗MalfunctionDec 27, 2024Use of Device Problem; Use of Device Problem
MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE TAP WAS DEFORMED. THERE WAS NO SURGICAL DELAY. THERE WAS NO IMPACT ON THE PATIENT'S OUTCOME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21028131 ↗MalfunctionJan 8, 2021Use of Device Problem; Use of Device Problem
MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE TIP OF THE TAP WAS BENT. IT WAS NOTED THAT THE CAUSE OF THE BEND WAS UNKNOWN. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11139708 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.