N/A 9734436Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000121228), received between Dec 5, 2019 and Aug 9, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Integrity 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.

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.

• MalfunctionAug 9, 2023Imprecision; Material Integrity Problem; Imprecision; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE PEDICAL PROBE WAS BENT AND INACCURATE. IT WAS INACCURATE BY 2 MILLIMETERS LATERAL. ANOTHER PROBE WAS USED TO FINISH THE CASE. THERE WAS LESS THAN ONE HOUR DELAY TO THE CASE. NO REPORTED IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17491459 ↗
• MalfunctionDec 5, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED THAT THE SITE FOUND THAT THE INSTRUMENT TIP WAS BENT WHILE CLEANING THE IT. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Patient Involvement

  MAUDE report 9416631 ↗