N/A 9734410 (UDI 00763000053796)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00763000053796), received between Sep 22, 2017 and Oct 8, 2020 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Bent” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 8, 2020Use of Device Problem; Use of Device Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT. THE RATCHETING HANDLE WAS FOUND TO BE BROKEN BY THE STERILIZATION DEPARTMENT. THE RATCHET HANDLE WOULD BE REPLACED.

  Patient problems: No Patient Involvement

  MAUDE report 10652031 ↗
• MalfunctionJan 16, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED OUTSIDE OF A PROCEDURE THAT THE EGG HANDLE WAS DAMAGED. NO PATIENT WAS PRESENT AT THE TIME OF THE EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8253650 ↗
• MalfunctionJul 3, 2018Bent; Material Deformation; Bent; Material Deformation

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING OUTSIDE A PROCEDURE. IT WAS REPORTED THAT THE TIP OF THE LUMBAR PROBE DIVISIONS WAS WORN OUT. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Patient Involvement

  MAUDE report 7659018 ↗
• MalfunctionJul 3, 2018Bent; Material Deformation; Bent; Material Deformation

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED FOR A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE LUMBAR PROBE WAS DEFORMED. THERE WAS NO DELAY IN SURGERY AND NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7658961 ↗
• MalfunctionJun 11, 2018Bent; Bent

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE A PROCEDURE. IT WAS REPORTED THAT THE THORACIC PROBE WAS BENT. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Patient Involvement

  MAUDE report 7588889 ↗
• MalfunctionOct 4, 2017Break; Break

  A MEDTRONIC REPRESENTATIVE REPORTED THAT DURING A SPINAL FUSION PROCEDURE THE THORACIC PROBE WAS BROKEN DUE TO PATIENT HAVING A SCLEROTIC BONE. THE PROCEDURE WAS COMPLETED WITH THE USE OF NAVIGATION. THERE WAS NO DELAY TO PROCEDURE. NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6913733 ↗
• MalfunctionSep 26, 2017Material Deformation; Material Deformation

  A SITE REPRESENTATIVE REPORTED THAT, WHILE IN A SPINAL FUSION, THE THORACIC PROBE WAS BENT. THE REPORTED ISSUE WAS FOUND TO HAVE OCCURRED WHILE IN THE PATIENT'S ANATOMY. THERE WAS NO REPORTED DELAY TO THE PROCEDURE DUE TO THIS ISSUE. THERE WAS NO IMPACT ON PATIENT OUTCOME. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6895921 ↗
• MalfunctionSep 22, 2017Bent; Bent

  A MEDTRONIC REPRESENTATIVE REPORTED THAT DURING A SPINAL FUSION PROCEDURE WHILE IN NAVIGATION WHEN USING THE THORACIC PROBE TO START ENTRY POINT IN THE BONE THE TIP OF THE PROBE BENT. THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER PROBE. THE PROCEDURE WAS COMPLETED WITH THE USE OF NAVIGATION. THERE WAS A DELAY OF LESS THAN 1 HOUR. NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6887420 ↗