NavLock 9736060Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00763000123178), received between Mar 13, 2019 and Dec 10, 2024 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (5 reports).

1 other recall cover devices cleared under the same FDA submission (K182104); they may or may not involve this specific model.

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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 10, 2024Mechanical Problem; Device Sensing Problem; Mechanical Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE BLACK TRACKER WAS HAVING ISSUES TRACKING AND APPEARED TO POTENTIALLY BE WARPED. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION RECEIVED INDICATED THE TRACKING ISSUE WAS RESOLVED WHEN A DIFFERENT TRACKER WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20892854 ↗
• MalfunctionJun 5, 2023Imprecision; Use of Device Problem; Imprecision; Use of Device Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THE NAVIGATION WAS MEDIAL AND LATERAL FOR ALL THE INSTRUMENTS BUT ALL SCREWS WERE PLACED ACCURATELY, THE ARM WAS ACCURATE. THEY CHECKED NAVIGATION ACCURACY AND THE SNAPSHOT IMAGE AND ISSUE PERSISTED. THERE WAS NO DELAY AND NO IMPACT TO THE PATIENT OUTCOME. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THEY TESTED THE INSTRUMENTS AND THE NAVLOCKS WERE DAMAGED AND CAUSING THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17066428 ↗
• MalfunctionJan 8, 2021Device Sensing Problem; Device Sensing Problem

  ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE REPORTED THAT THE ISSUE WAS DETERMINED TO BE THE CAMERA. THE CAMERA WAS REPLACED AND THE ISSUE WAS RESOLVED. ALL OF THE INSTRUMENTS WERE TESTED AND FOUND TO BE FUNCTIONING AS DESIGNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11140769 ↗
• MalfunctionJun 5, 2020Imprecision; Imprecision

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE NAVLOCKS WERE SHOWING ~3MM OFF. NO PHYSICAL ISSUES WERE SEEN WITH THE NAVLOCKS. TROUBLESHOOTING INVOLVED TAKING A SNAPSHOT AND CHECKING THE ANATOMY AND DIVET WITH THE PLANAR PROBE. EACH TIME A SNAPSHOT WAS TAKEN, THE OTHERS WOULD SHOWED ON, BUT THE BLUE AND BLACK SHOWED OFF. IT WAS THOUGHT THAT THE PATIENT REFERENCE FRAME BEING LOOSE WAS PART OF THE REASON THEY SHOWED OFF IN THIS CASE, BUT THEY HAVE ALSO HAD SHOWN OFF IN PREVIOUS PROCEDURES. THE PROBLEMS WITH THE NAVLOCKS WAS SPORADIC AND THEY WERE CURRENTLY BEING USED FOR CASES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10123025 ↗
• MalfunctionOct 29, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THE BLACK TRACKER FUSED WITH THE LONG DRILL DURING THE CASE. THE CASE WAS COMPLETED WITH THE BLUE TRACKER. THERE WAS NO PATIENT HARM OR ADDITIONAL COMPLICATIONS REPORTED OR ANTICIPATED AS A RESULT OF THE EVENT. THERE WAS NO PATIENT HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9252665 ↗
• MalfunctionAug 7, 2019Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION FROM A MANUFACTURER REPRESENTATIVE (REP) REGARDING A GUIDANCE DEVICE BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE BLACK NAVLOCK WOULD NOT ALLOW AN INSTRUMENT TO RUN THROUGH IT. THERE WAS NO PATIENT INVOLVED. THERE WERE NO ADDITIONAL COMPLICATIONS REPORTED OR ANTICIPATED AS A RESULT OF THE EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8869627 ↗
• MalfunctionJul 17, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A GUIDANCE DEVICE BEING USED IN A SPINAL PROCEDURE. IT WAS REPORTED THAT THE LONG DRILL HAD VIBRATION AND A CHATTERING NOISE WITH THE BLACK NAVLOCK. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE REPLACEMENT WAS SENT AND THE NO ISSUES HAD OCCURRED. THE SYSTEM WAS PERFORMING AS INTENDED. THERE WAS NO PATIENT HARM. THERE WERE NO ADDITIONAL COMPLICATIONS REPORTED OR ANTICIPATED AS A RESULT OF THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8799978 ↗
• MalfunctionJul 12, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A GUIDANCE DEVICE BEING USED IN A SPINAL PROCEDURE. IT WAS REPORTED THAT BOTH THE BLUE AND BLACK NAVLOCKS WERE STICKING TO THE INSTRUMENTS NOT ALLOWING THEM TO SPIN FREELY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO ADDITIONAL COMPLICATIONS REPORTED OR ANTICIPATED AS A RESULT OF THE EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8785105 ↗
• MalfunctionJul 2, 2019Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A GUIDANCE DEVICE BEING USED IN A SPINAL PROCEDURE. IT WAS REPORTED THAT THE BLACK NAVLOCK GOT STUCK ON THE DRILL BIT. NO PATIENT WAS INVOLVED. THERE WERE NO ADDITIONAL COMPLICATIONS REPORTED OR ANTICIPATED AS A RESULT OF THE EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8753562 ↗
• MalfunctionMar 13, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION THAT, WHILE OUTSIDE OF A PROCEDURE, THE INSTRUMENT TRACKER WAS DAMAGED WHILE NAVIGATING DRILL BITS. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8418284 ↗
• MalfunctionMar 13, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION THAT, WHILE OUTSIDE OF A PROCEDURE, THE INSTRUMENT TRACKER WAS DAMAGED WHILE NAVIGATING DRILL BITS. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8418283 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K182104. One submission often covers many models, so check the product and lot details in each record.

• Z-1693-2020 · Aug 28, 2019 · Terminated
  NavLock Tracker *** Rx Only