N/A 9733065 (UDI 00613994157119)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00613994157119), received between Jun 4, 2019 and Jul 22, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Integrity 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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 22, 2019Output Problem; Output Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED THAT INTRA/PERI-OPERATIVELY DURING THE NAVIGATE TASK OF A CRANIAL BIOPSY PROCEDURE, THE BIOPSY KIT WAS DAMAGED. THE CLEAR TUBE WOULD NOT ¿SNAP¿ INTO THE GREY EXTERNAL PART THAT IS SECURED TO THE SKULL WHICH ENABLES THE TRAJECTORY TO BE LOCKED, AND BIOPSY TAKEN. THE SITE USED THE ANGLED FIXATION PIECE AND WERE ABLE TO SUCCESSFULLY GET THE BIOPSY. THERE WAS NO DELAY TO THE PROCEDURE AND THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8813585 ↗
• MalfunctionJun 4, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED IN A CRANIAL BIOPSY. IT WAS REPORTED THAT WHILE THE HEALTH CARE PROFESSION (HCP) WAS UNSCREWING THE NAVIGUS BASE, ONE OF THE SCREWS SHEARED OFF IN THE SKULL. THE HCP WAS ABLE TO DRILL IT OUT. 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 8667458 ↗