NavLock 9736061Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00763000123185), received between Apr 3, 2019 and Nov 18, 2025 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (3 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Aug 28, 2019Class IITerminated

   Product was incorrectly assembled which could affect navigation accuracy of the device.

   Z-1693-2020 · Root cause: Employee error · Recall details · FDA record ↗

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.

• MalfunctionNov 18, 2025Mechanical Jam; Mechanical Jam

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THE BLUE GUIDANCE SYSTEM NAVLOCK ATTACHMENTS DID NOT SPIN FREELY WHEN A TAP AND A DRIVER WERE INSERTED INTRAOPERATIVELY. THE ISSUE WAS IDENTIFIED DURING THE NAVIGATION TASK AND RESULTED IN LESS THAN ONE HOUR OF EXTENDED SURGICAL TIME. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE ATTACHMENTS DID NOT SPIN FREELY WHEN ATTACHED TO A POWERED DRILL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23578403 ↗
• 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 17065985 ↗
• MalfunctionApr 26, 2022Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THE BLUE NAVLOCK TRACKER WOULD NOT TRACK DURING THE PROCEDURE. THE SPHERES ON THE TRACKER WERE CHANGED AND THE INSTRUMENT WOULD VERIFY, BUT IT WAS NOT SEEN IN TRACKING VIEW IN THE NAVIGATION. THE SURGEON MOVED FORWARD WITH THE CASE BY USING THE BLACK TRACKER AND SWITCHING BETWEEN THE TAP AND DRIVER. THERE WAS NO PATIENT HARM AND THE COMPLAINT WAS DELAYED LESS THAN AN HOUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14207308 ↗
• MalfunctionJan 8, 2021Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE INSTRUMENTATION TRAYS WERE DAMAGED AND THE INSTRUMENTS FAILED TRACKING DURING PREVENTATIVE MAINTENANCE. THE TRAJECTORY ERROR RANGED BETWEEN 0.554 AND 0.976 WHICH WAS ABOVE THE MAXIMUM AMOUNT ALLOWED. TROUBLESHOOTING INVOLVED TRYING DIFFERENT SPHERES, TRYING DIFFERENT NAVLOCK TRACKERS AND SNAPSHOT TRACKER, USING LONG AND SHORT TOOLS, ADJUSTING THE MOUNTED POSITION OF THE SURGICAL SYSTEM, HARD RESTARTS OF THE GUIDANCE SYSTEM AND TRYING DIFFERENT SURGICAL ARMS. THE STEALTH CAMERA WAS VIEWING ALL OF THE SPHERES WELL DURING TESTING. THE MOST PROBABLE CAUSE WAS NOTED TO BE THE WASHING AND CLEANING BY THE STERILE PROCESSING DEPARTMENT. THE INSTRUMENTS WERE IN ROUGH CONDITION AND THE EDGES. THE EDGES OF THE TRACKERS WERE CHIPPED AND THE PAINT WAS FADED. THE TRACKERS WERE DIFFICULT TO DETECT DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11140839 ↗
• MalfunctionSep 5, 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 HE BLUE NAVLOCK WAS NOT LOCKING WITH THE DRILL BIT. 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 8966735 ↗
• 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 8785078 ↗
• MalfunctionApr 3, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED FOR A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THE DRILL BIT DOES NOT FIT EASILY INTO THE BLUE TRACKER. IT WAS NOTED MARRING COULD BE SEEN ON THE SHAFT OF THE BIT. THIS ISSUE OCCURRED INTRAOPERATIVELY AND CAUSED A LESS THAN ONE-HOUR SURGICAL DELAY. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME. ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE REPORTED THE DRILL BIT AND TRACKER WERE LOCKED UP. THE MANUFACTURER REPRESENTATIVE WAS NOT ABLE TO DETERMINE HOW LOCKED UP THE DEVICES WERE SINCE THEY WERE STILL IN THE STERILE FIELD. ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE REPORTED THAT THE SURGEON WAS USING THE BLUE TRACKER WITH THE A DRILL AND THE BIT STARTED BINDING UP ON THE TRACKER WHICH CAUSED THE TRACKER TO NOT SPIN FREELY. THE INSTRUMENTS WERE REMOVED FROM THE PATIENT AND A MALLET WAS USED TO SEPARATE THE BIT FROM THE TRACKER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8480431 ↗
• MalfunctionApr 3, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE TO TREAT A DEFORMITY. IT WAS REPORTED THAT THE DRILL BIT DID NOT FIT EASILY INTO THE BLUE TRACKER, THE DRILL BIT STARTED TO BIND AND WAS NOT SPIN FREELY WITH THE BLUE TRACKER WHEN DRILLING THROUGH THE ARM GUIDE, AND THERE WAS MARRING ON THE SHAFT OF THE DRILL BIT. THE DRILL AND THE BIT WITH THE TRACKER WAS REMOVED FROM THE PATIENT AND THEN MANUALLY SEPARATED USING A MALLET. THE DRILL BIT WAS ABLE TO BE USED WITH THE BLACK TRACKER, BUT THERE WAS MORE FRICTION BETWEEN THE DRILL BIT AND TRACK THAN NORMAL. THE TRACKER WAS TRIED WITH OTHER DRILL BITS AND THE ISSUE DID NOT OCCUR. THE MANUFACTURER REPRESENTATIVE THOUGHT THERE WAS SOME DAMAGE/MARRING ON THE INSIDE OF THE CANNULA OF THE TRACKER, BUT NOT ENOUGH TO AFFECT OTHER INSTRUMENTS. THE MANUFACTURER REPRESENTATIVE ALSO STATED THAT IF THE DRILL WAS NOT COMPLETELY COAXIAL WHILE DRILLING, THE TRACKER WOULD BIND UP. SCREWS WERE BEING IMPLANTED AT C4 TO T12 AND THE DEVICES WERE PREPARED ACCORDING TO LABELING. THERE WAS NO PATIENT HARM, NO DELAY IN THE PROCEDURE FOR MORE THAN AN HOUR AND NO ADDITIONAL ACTIONS WERE REQUIRED AS A RESULT OF THE EV

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8480100 ↗