N/A 9733066Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169702929), received between Jan 10, 2019 and Feb 13, 2020 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Material Integrity 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 13, 2020Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM USED DURING A CRANIAL BIOPSY. IT WAS REPORTED THAT WHEN REMOVING THE "NAVIGUS" BASE FROM THE SKULL, A PIECE OF THE SCREW SNAPPED OFF INTO THE SKULL. THE SURGEON WAS ABLE TO BRING IN A SMALL DRILL TO REMOVE IT. THERE WAS NO DELAY AND NO IMPACT TO THE PATIENT AT THE TIME OF THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9708077 ↗
• InjuryMar 29, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED FOR A CRANIAL BIOPSY PROCEDURE. IT WAS REPORTED THAT ONE OF THE THREE 1.6MM X 8MM SCREWS FROM THE BIOPSY KIT WAS BEING REMOVED FROM THE PATIENT, AND WHILE DOING SO THE SURGEON NOTED THAT THE HEAD OF THE SCREW SHEARED OFF. THE SURGEON DECIDED TO LEAVE THE STEM OF THE SCREW IN THE PATIENT¿S SKULL AND COVERED IT WITH THE BURR-HOLE COVER AS THEY INTENDED TO DO SO. THERE WAS NO DELAY TO THE CASE. IT WAS NOTED THAT THE SURGEON DESCRIBES USING THE DEVICE AS ROUTINE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8467016 ↗
• MalfunctionJan 10, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED IN A CRANIAL RESECTION. IT WAS REPORTED THAT THE SCREW BROKE WHEN USING THE BASE. THE HEALTH CARE PROFESSIONAL RETRIEVED THE BROKEN PART FROM THE PATIENT. THERE WAS LESS THAN AN HOUR DELAY IN THE PROCEDURE. NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8236481 ↗