N/A 9734906Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000209551), received between Jan 7, 2019 and May 24, 2019 — 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.

• MalfunctionMay 24, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED FOR A SACROILIAC AND THORACOLUMBAR PROCEDURE. THE ISSUE OCCURRED INTRAOPERATIVELY DURING THE NAVIGATE TASK AND CAUSED NO DELAY TO THE SURGERY. IT WAS REPORTED THAT THE NAVLOCK WAS DAMAGED DURING THE CASE. THEY WERE MALLETTING THE HANDLE AND ONE OF THE CLIPS BEGAN TO POP OUT. THEY WERE ABLE TO HIT IT BACK INTO PLACE. THE SURGERY WAS COMPLETED WITH NAVIGATION AND THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8641683 ↗
• MalfunctionJan 7, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED OUTSIDE OF A PROCEDURE THAT THE NAVLOCK AND PROBE WERE DAMAGED DURING STERILE PROCESSING DEPARTMENT (SPD). NO PATIENT WAS PRESENT AT THE TIME OF THE EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8223925 ↗