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N/A 9734303Recalls & reported problems

Medtronic Navigation, Inc. · TAP 9734303 7.5 · 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 00613994724045), received between Jun 9, 2023 and Jun 9, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Use of Device Problem” (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.

Most reported problems

Device problems

  • Use of Device 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.

  • MalfunctionJun 9, 2023Use of Device Problem; Use of Device Problem

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT DURING INSPECTION, IT WAS CONFIRMED THAT THERE WAS A DEFORMATION IN THE HOLLOW PART OF THE TIP OF THE 7.5 MM TAP. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE MOSTLY CAUSE WAS PRESUMED TO BE DUE TO THE HARDNESS OF THE BONES.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17098128 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.