NavLock 9733734 (UDI 00763000054465)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00763000054465), received between Sep 12, 2018 and Mar 3, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (5 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 3, 2025Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SITE HAD 2 INSTRUMENTS THAT WERE DEFECTIVE. THE TRACKER WAS NOT SEEN BY THE POSITIONER. THE RATCHETING STRAIGHT HANDLE HAD A WORN HANDLE. THE CAUSE OF THE DAMAGE WAS LIKELY WEAR AND TEAR FROM USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21507120 ↗
• MalfunctionNov 7, 2021Material Integrity Problem; Material Integrity Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12760548 ↗
• MalfunctionFeb 20, 2020Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED IN A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE RATCHET HANDLE BROKE. THERE WAS NO DELAY TO THE CASE. NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9733951 ↗
• MalfunctionMar 5, 2019Material Integrity Problem; Material Integrity Problem

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

  Patient problems: No Patient Involvement

  MAUDE report 8392391 ↗
• MalfunctionJan 22, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING AN INSTRUMENT BEING USED WITH A NAVIGATION SYSTEM. IT WAS REPORTED OUTSIDE OF A PROCEDURE THAT THE SITE'S RATCHETING HANDLE WAS DAMAGED. THIS WAS DISCOVERED AFTER IT WAS STERILIZED, THERE WAS NO PATIENT PRESENT.

  Patient problems: No Patient Involvement

  MAUDE report 8267058 ↗
• MalfunctionOct 4, 2018Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED FOR A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE TOP OF THE RATCHET HANDLE BROKE. ISSUE RESOLVED WITH INSTRUMENT REPLACEMENT. THERE WAS NO REPORTED DELAY TO THE PROCEDURE DUE TO THIS ISSUE. THERE WAS NO IMPACT TO PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7934849 ↗
• MalfunctionSep 20, 2018Break; Break

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

  Patient problems: No Patient Involvement

  MAUDE report 7895768 ↗
• MalfunctionSep 18, 2018Material Deformation; Material Deformation

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM OUTSIDE OF PROCEDURE. IT WAS REPORTED THAT THE HEAD OF THE DRIVER WAS DEFECTIVE AND NEEDED TO BE REPLACED.

  Patient problems: No Patient Involvement

  MAUDE report 7885818 ↗
• MalfunctionSep 12, 2018Material Deformation; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT WHILE USING THE SYSTEM FOR A PROCEDURE, THE NAVLOCK HANDLE WAS MALFUNCTIONING. THERE WAS NO REPORTED DELAY TO THE PROCEDURE DUE TO THIS ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7869391 ↗