N/A 9734403 (UDI 00763000053802)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00763000053802), received between Oct 4, 2017 and Jun 20, 2025 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 20, 2025Mechanical Problem; Incorrect, Inadequate or Imprecise Result or Readings; Mechanical Problem; Incorrect, Inadequate or Imprecise Result or Readings

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE TIP OF THE INSTRUMENT WAS BENT AND THEY WERE WORRIED THAT THE ACCURACY OF THE INSTRUMENT WOULD BE OFF SO THEY DID NOT USE THE INSTRUMENT. THEY HAD ANOTHER INSTRUMENT AVAILABLE AND USED THAT SO THERE WERE NO ISSUES WITH THE PATIENT OR THE SURGERY. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE INSTRUMENT WAS TESTED AND VERIFIED WITH THE MEDTRONIC IMAGING SYSTEM BECAUSE THE LENGTH WAS THE SAME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22298798 ↗
• MalfunctionJan 25, 2025Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM OUTSIDE OF PROCEDURE. IT WAS REPORTED THAT A PURCHASE ORDER WAS RECEIVED VIA EMAIL THAT INDICATED A THORACIC PROBE NEEDED TO BE REPAIRED. THERE WAS NO PATIENT PRESENCE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED. THE INSTRUMENT WAS BENT. ADDITIONAL INFORMATION WAS RECEIVED. THE MOST LIKELY / SUSPECTED CAUSE OF THE EVENT WAS UNKNOWN. THE SITE TRIED VERIFYING THE INSTRUMENT PRIOR TO A CASE AND IT WAS NOT SUCCESSFUL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21236860 ↗
• MalfunctionJan 25, 2025Use of Device Problem; Use of Device Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM OUTSIDE OF PROCEDURE. IT WAS REPORTED THAT A PURCHASE ORDER WAS RECEIVED VIA EMAIL THAT INDICATED A THORACIC PROBE NEEDED TO BE REPAIRED. THERE WAS NO PATIENT PRESENCE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED. THE INSTRUMENT WAS BENT. ADDITIONAL INFORMATION WAS RECEIVED. THE MOST LIKELY / SUSPECTED CAUSE OF THE EVENT WAS UNKNOWN. THE SITE TRIED VERIFYING THE INSTRUMENT PRIOR TO A CASE AND IT WAS NOT SUCCESSFUL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21236859 ↗
• MalfunctionDec 27, 2024Use of Device Problem; Use of Device Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE THORACIC PROBE WAS DAMAGED. NO ADDITIONAL INFORMATION AVAILABLE AT TIME OF CALL. NO PATIENT WAS PRESENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21026555 ↗
• MalfunctionOct 10, 2023Material Fragmentation; Material Fragmentation

  THE PROCEDURE TYPE WAS A POSTERIOR LUMBAR FUSION. THERE WAS NO DELAY TO THE PROCEDURE. NO REPORTED IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17904244 ↗
• MalfunctionNov 18, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED OUTSIDE OF A PROCEDURE THAT THE SITE HAD MULTIPLE DAMAGED INSTRUMENTS. THE PROBE HAD A TWISTED TIP. NO PATIENT WAS PRESENT AT THE TIME OF THE EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 9335086 ↗
• MalfunctionOct 11, 2019Material Integrity Problem; Material Integrity Problem

  ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT GENERAL USE CONTRIBUTED TO THE DAMAGE TO THE PROBES AND THAT THEY WERE VISUALLY BENT. THE SITE DID NOT TRY TO VERIFY THEM SINCE THEY DID NOT WANT TO USE BENT INSTRUMENTS WHEN NAVIGATING.

  Patient problems: No Patient Involvement

  MAUDE report 9180192 ↗
• MalfunctionJan 18, 2019Material Integrity Problem; Material Integrity Problem

  FOLLOW-UP WITH THE MANUFACTURER REPRESENTATIVE (REP) DETERMINED THAT THE PROBE DID NOT PASS VERIFICATION AFTER IT WAS BENT AND THE PROBE WAS DISPOSED OF SO THE DEVICE COULD NOT BE ANALYZED. THE REP ALSO APPEARED TO INDICATE THAT A DIFFERENT PROBE WAS NOT USED FOR THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8260185 ↗
• MalfunctionSep 19, 2018Material Twisted/Bent; Material Twisted/Bent

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM EVENT HAVING OCCURRED OUTSIDE OF PROCEDURE. IT WAS REPORTED THAT THE SITE HAD TWO BENT THORACIC PROBES THAT NEEDED TO BE REPLACED. IT WAS UNKNOWN WHETHER OR NOT THE PROBES WOULD HAVE VERIFIED AS THE SITE DISPOSED OF THE PROBES OR LOST THEM PRIOR TO ANALYSIS. NO PATIENT PRESENT.

  Patient problems: No Patient Involvement

  MAUDE report 7891085 ↗
• MalfunctionSep 18, 2018Material Deformation; Material Deformation

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED FOR AN ORTHO PROCEDURE. IT WAS REPORTED THAT THE THORACIC PROBE WAS BENT/DAMAGED AGAINST THE OLD AND HARD BONE OF THE PATIENT. THERE WAS NO IMPACT TO PATIENT. THERE WAS NO REPORTED DELAY TO THE PROCEDURE DUE TO THIS ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7886220 ↗
• MalfunctionSep 13, 2018Material Deformation; Material Deformation

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE RATCHETING HANDLE WAS DAMAGED. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS OBSERVED.

  Patient problems: No Patient Involvement

  MAUDE report 7872863 ↗
• MalfunctionAug 30, 2018Material Deformation; Material Deformation

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED OUTSIDE OF A PROCEDURE PRIOR TO A CASE THAT THE THORACIC PROBE WAS BENT. THERE WAS NO PATIENT PRESENT.

  Patient problems: No Patient Involvement

  MAUDE report 7834431 ↗
• MalfunctionOct 4, 2017Break; Break

  A MEDTRONIC REPRESENTATIVE REPORTED THAT DURING A SPINAL FUSION PROCEDURE WHILE NAVIGATING, A LUMBAR PROBE BROKE AS THE PATIENT HAD A VERY 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 6913791 ↗