N/A 960-539 (UDI 00763000055578)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00763000055578), received between Nov 29, 2018 and Apr 4, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Output Problem” (3 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 4, 2022Use of Device Problem; Output Problem; Use of Device Problem; Output Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THERE WAS A DEFECTIVE BIOPSY GUIDE.  NO PATIENT WAS PRESENT WHEN THE ISSUE WAS IDENTIFIED. ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE INDICATED IT WAS IMPOSSIBLE TO LOCK THE BIOPSY GUIDE. THE REPORTED ISSUE WAS THOUGHT TO BE RELATED TO NORMAL USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14001985 ↗
• MalfunctionMay 7, 2019Output Problem; Output Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT IT COULD BE CONFIRM THROUGH THE NEURO COORDINATOR AND NS REP THAT THIS WOULD NOT TIGHTEN. IT WAS UNKNOWN HOW IT WAS DAMAGED. THE SITE BELIEVED IT WAS THROUGH NORMAL WEAR AND TEAR.

  Patient problems: No Patient Involvement

  MAUDE report 8586283 ↗
• MalfunctionJan 3, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED FOR A CRANIAL BIOPSY PROCEDURE. THE ISSUE OCCURRED INTRAOPERATIVELY AND DELAYED THE SURGERY BY 5 MINUTES. IT WAS REPORTED THAT THE SITE HAD A DAMAGED PRECISION AIMING DEVICE AND THE WING WOULD NOT TIGHTEN. THE SURGERY WAS COMPLETED BY OBTAINING A NEW ARTICULATING ARM TRAY AND THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8214314 ↗
• MalfunctionNov 29, 2018Output Problem; Output Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. DURING A CRANIAL BIOPSY PROCEDURE IT WAS REPORTED THAT THE LOCK ON THE BIOPSY GUIDE WAS LOOSE. THERE WAS NO DELAY TO THE PROCEDURE. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8114661 ↗