N/A 960-535Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00681490915939), received between Apr 4, 2017 and Apr 21, 2020 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Mechanical 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 18, 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 21, 2020Mechanical Problem; Material Integrity Problem; Mechanical Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED OUTSIDE OF A PROCEDURE THAT THE SITE SAID THEY LOST A WASHER ON ONE OF THE DUAL STARBURST ADAPTERS. NO PATIENT WAS PRESENT AT THE TIME OF THE EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 9982554 ↗
• MalfunctionMar 19, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED FOR A CRANIAL RESECTION PROCEDURE. THE ISSUE OCCURRED PRE-OPERATIVELY AND CAUSED NO DELAY TO THE SURGERY. IT WAS REPORTED THAT THE DUAL STARBURST ATTACHMENT COULD NOT BE FITTED IN WELL. THE SCREW HOLE OF THE ATTACHMENT COULD NOT BE FITTED IN WELL. THE SURGERY WAS COMPLETED WITH NAVIGATION/IMAGING SYSTEM AND BACK UP PRODUCTS. THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8431865 ↗
• MalfunctionAug 4, 2017Mechanical Problem; Device Operates Differently Than Expected; Material Deformation; Mechanical Problem; Device Operates Differently Than Expected; Material Deformation

  A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A LASER INDUCED THERMAL THERAPY (LITT) PROCEDURE, IT WAS FOUND THAT THE DOUBLE STAR ADAPTER TEETH WERE WORN OUT AND CAUSING MOVEMENT. THE SITE REPLACED THE ADAPTER AND RE-REGISTERED THE PATIENT AND THEN WAS ABLE TO PROCEED WITH THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF 30 MINUTES DUE TO THIS ISSUE. THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6767908 ↗
• MalfunctionApr 4, 2017Mechanical Problem; Device Operates Differently Than Expected; Mechanical Problem; Device Operates Differently Than Expected

  A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE OUTSIDE OF A PROCEDURE, THE TEETH ON THE DOUBLE STAR ADAPTER WERE WORN. NO ADDITIONAL INFORMATION WAS PROVIDED. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Patient Involvement

  MAUDE report 6456894 ↗