N/A 9734403 (UDI 00613994724014)Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00613994724014), received between Sep 27, 2016 and Nov 4, 2025 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (9 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 4, 2025Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT A PRODUCT THAT WAS RETURNED AFTER THE END OF THE LOAN PERIOD (TIP DEFORMATION, LOANER RETURN, NO ALLEGATION OF MALFUNCTION) WAS FOUND TO HAVE AN ISSUE DURING THE ACCEPTANCE INSPECTION. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT DEFORMATION MAY HAVE OCCURRED DUE TO EXCESSIVE LOAD DURING USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23465816 ↗
• MalfunctionMar 24, 2021Use of Device Problem; Use of Device Problem

  MEDTRONIC RECEIVED INFORMATION FROM A MANUFACTURER REPRESENTATIVE REGARDING A NAVIGATION SYSTEM OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THERE WERE SEVERAL DAMAGED INSTRUMENTS. THERE WAS A TWISTED TIP, AND A PIECE BROKEN OFF. THE RATCHETING EGG HANDLE HAD THE TOP MISSING OFF OF HANDLE. A NAVLOCK WAS NOT VERIFY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11564358 ↗
• MalfunctionFeb 3, 2020Material Integrity Problem; Material Integrity Problem

  ADDITIONAL INFORMATION WAS RECEIVED STATING THE PROBE WAS NOT ABLE TO BE VERIFIED.

  Patient problems: No Patient Involvement

  MAUDE report 9659599 ↗
• MalfunctionOct 8, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE OF PROCEDURE. IT WAS REPORTED THAT THE DEVICE WAS FOUND IN A HOSPITAL BOX LABELED ¿DAMAGED¿ IN THE STERILE PROCESSING DEPARTMENT AT THE FACILITY. THE BOX CONTAINED SEVERAL USED INSTRUMENTS. THERE WAS NO FURTHER CONTEXT ABLE TO BE PROVIDED BY THE INITIAL REPORTER. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Patient Involvement

  MAUDE report 9167900 ↗
• MalfunctionSep 13, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED THAT THE SITE HAD THREE INSTRUMENTS THAT WERE BENT AND TWISTED. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Patient Involvement

  MAUDE report 9049925 ↗
• MalfunctionSep 13, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED THAT THE SITE HAD THREE INSTRUMENTS THAT WERE BENT AND TWISTED. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Patient Involvement

  MAUDE report 9049904 ↗
• MalfunctionJul 24, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING NAVIGATION INSTRUMENTS OUTSIDE OF PROCEDURE. IT WAS REPORTED THAT THE PROBE WAS BENT, THE CLAMP WAS STRIPPED, AND THE RATCHETING HANDLE HAD NO CAP. NO PATIENT WAS PRESENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE PROBE WAS ABLE TO BE VERIFIED.

  Patient problems: No Patient Involvement

  MAUDE report 8821942 ↗
• MalfunctionMar 1, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THERE WAS AN ISSUE WITH ONE OF THE SITE'S NAVLOCK. THE INSTRUMENT WAS NOT ACCEPTING ANY INSTRUMENTS AND ALSO DAMAGED TWO OTHER INSTRUMENTS. IT LEFT GROOVES IN THE METAL WHICH PREVENTS THEM FROM SLIDING INTO THE SHAFT CORRECTLY.

  Patient problems: No Patient Involvement

  MAUDE report 8384023 ↗
• MalfunctionNov 1, 2018Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE OF PROCEDURE. IT WAS REPORTED THAT THE SITE HAD DISCOVERED DAMAGED INSTRUMENTS DURING STERILE PROCESSING. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Patient Involvement

  MAUDE report 8028660 ↗
• MalfunctionNov 1, 2018Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE OF PROCEDURE. IT WAS REPORTED THAT THE SITE HAD DISCOVERED DAMAGED INSTRUMENTS DURING STERILE PROCESSING. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Patient Involvement

  MAUDE report 8028632 ↗
• MalfunctionSep 27, 2018Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING 4 DAMAGED INSTRUMENTS. IT WAS UNKNOWN IF THEY COULD BE VERIFIED OR NOT. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS FOUND.

  Patient problems: No Patient Involvement

  MAUDE report 7916698 ↗
• MalfunctionJun 13, 2018Positioning Problem; Positioning Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A TRANSFORAMINAL LUMBAR INTER-BODY FUSION (TILF). IT WAS REPORTED THAT WHEN THE SITE NAVIGATED ON THE IMAGING SYSTEM, NAVIGATION WAS 2MM OFF THE SKIN IN THE SAGITTAL VIEW. THIS EVENT OCCURRED INTRA/PERIOPERATIVELY WITH LESS THAN ONE HOUR DELAY TO SURGICAL TIME. THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7597787 ↗
• MalfunctionJun 9, 2017Bent; Bent

  A MEDTRONIC REPRESENTATIVE REPORTED THAT DURING A SPINAL FUSION PROCEDURE WITH NAVIGATION SYSTEM A NAVLOCK THORACIC PROBE WAS FOUND TO HAVE BENT TIP. THERE WAS NO DELAY TO THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH THE USE OF NAVIGATION SYSTEM. NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6630225 ↗
• MalfunctionDec 8, 2016Bent; Material Deformation; Bent; Material Deformation

  A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A SPINE PROCEDURE, THE SITE'S THORACIC PROBE TIP WAS BENT. NO FURTHER DETAILS REGARDING THIS DAMAGE, OR SPECIFICALLY WHEN IT OCCURRED, WERE PROVIDED. THE SURGEON OPTED TO CONTINUE AND COMPLETED THE PROCEDURE WITH THE USE OF THE NAVIGATION SYSTEM. DELAY IN THERAPY WAS 10 MINUTES. THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6155481 ↗
• MalfunctionSep 27, 2016Bent; Material Deformation; Bent; Material Deformation

  A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A POSTERIOR SPINAL FUSION PROCEDURE, THE SITE'S THORACIC PROBE WAS BENT. NO FURTHER DETAILS REGARDING THE DAMAGE, OR HOW IT OCCURRED, WERE PROVIDED. THE SURGEON OPTED TO CONTINUE AND COMPLETED THE PROCEDURE WITH THE USE OF THE NAVIGATION SYSTEM. THERE WAS NO DELAY OF THERAPY. THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5982095 ↗