N/A 9734404 (UDI 00613994736055)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00613994736055), received between Mar 16, 2017 and Dec 10, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Bent” (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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 10, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING NAVIGATION INSTRUMENTS, OUTSIDE OF PROCEDURE. IT WAS REPORTED THAT THE GRAY TRACKER AND AN AWL ARE DAMAGED AND NEED TO BE REPLACED. NO PATIENT WAS PRESENT.

  Patient problems: No Patient Involvement

  MAUDE report 9444840 ↗
• MalfunctionMar 16, 2017Bent; Bent

  A MEDTRONIC REPRESENTATIVE REPORTED THAT WHILE IN A SPINAL FUSION PROCEDURE, THEY DISCOVERED A BENT TIP ON THE AWL TIP INSTRUMENT. THERE WAS NO REPORTED DELAY TO THE PROCEDURE DUE TO THIS ISSUE. THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6409787 ↗