NavLock 9734734 (UDI 00763000054489)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00763000054489), received between Feb 28, 2020 and Feb 12, 2026 — classified as 5 malfunctions.

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

• MalfunctionFeb 12, 2026Mechanical Jam

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A CERVICAL SPINE PROCEDURE. IT WAS REPORTED THAT THE USER INSERTED THE INFINITY DRILL BIT INTO THE NAVLOCK TRACKER VIOLET AND CREATED A PILOT HOLE, BUT IT STOPPED ROTATING. ATTACHED IT TO ANOTHER NAVLOCK TRACKER, BUT IT BECAME STUCK AGAIN. THERE WAS NO SURGICAL DELAY. THERE WAS NO IMPACT ON PATIENT OUTCOME. IT WAS REPORTED THAT ALL 4 COLORS HAD SLIGHT SCRATCHES ON THE INTERNAL SIDE WHICH COULD NOT BE CAPTURED IN AN IMAGE. ALL NAVLOCKS TRACKERS WERE DIFFICULT TO ATTACH OR REMOVE, ESPECIALLY THE GREY ONE WAS HARD AND WAS MOST LIKELY STUCK AS IT CANNOT BE REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24324953 ↗
• MalfunctionDec 19, 2025Failure to Advance; Mechanical Jam; Failure to Advance; Mechanical Jam

  MEDTRONIC RECEIVED INFORMATION REGARDING AN AUTOMATED TRAJECTORY GUIDANCE UNIT BEING USED IN A CERVICAL SPINE PROCEDURE. THE INFINITY DRILL BIT WAS INSERTED INTO THE TRACKER AND A PILOT HOLE WAS CREATED, BUT ROTATION CEASED. THE BIT WAS ATTACHED TO ANOTHER TRACKER, BUT IT BECAME STUCK AGAIN. THERE WAS NO REPORTED DELAY TO THE CASE. NO REPORTED IMPACT TO THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT POWERED INSTRUMENTS WERE NOT USED. THE INSTRUMENT WAS NOT ABLE TO BE ROTATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23848671 ↗
• MalfunctionNov 19, 2025Mechanical Problem; Mechanical Jam; Mechanical Problem; Mechanical Jam

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A CERVICAL SPINE PROCEDURE. IT WAS REPORTED THAT THE TRACKER COULD NOT BE CONNECTED TO THE SPINAL TAP DRIVER. EVEN IF THE CONNECTION WAS MADE, THE DEVICE WAS INTERFERING AND THE TRACKER COULD NOT ROTATE. IT WAS REPORTED THAT BEFORE INSERTING THE 5TH SCREW, AND ATTEMPT WAS MADE TO CREATE A PILOT HOLE USING THE TAP AND THE TRACKER, BUT THE BONE WAS TOO HARD, AND PROGRESS COULD NOT BE MADE. UPON INSPECTION OUTSIDE OF THE SURGICAL FIELD, IT WAS FOUND THAT THE TAP AND TRACKER WERE STUCK TOGETHER, THERE WERE NO PROBLEMS UP TO THE 4TH SCREW. AFTER SURGERY, THE ADHESION WAS RELEASED, AND AN ATTEMPT WAS MADE TO INSERT EACH INTO OTHER TAPS AND TRACKERS. HOWEVER, ASSEMBLY WAS NOT POSSIBLE FOR BOTH. THERE WAS NO IMPACT TO PATIENT'S OUTCOME AND SURGICAL DELAY WAS LESS THAN ONE-HOUR. ADDITIONAL INFORMATION WAS RECEIVED. THE NAVIGATION AND IMAGING SYSTEM WERE USED AS TROUBLESHOOTING. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE SURGERY CONTINUED WITH A DIFFERENT NAVAL BLOCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23598149 ↗
• MalfunctionNov 22, 2024Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE GREEN TRACKER COULD NOT BE SEEN BY THE CAMERA, THE ORANGE TRACKER HAD A BROKEN MOUNTING CLAMP, AND THE PROBE HAD A BENT TIP. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20756781 ↗
• MalfunctionFeb 28, 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 A NON-MEDTRONIC DRIVER BECAME STUCK ONTO THE GREEN NAVLOCK TRACKER. THE HEALTH CARE PROFESSIONAL WAS ABLE TO PROCEED WITHOUT IT. THERE WAS NO DELAY IN THE PROCEDURE. NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Patient Involvement

  MAUDE report 9770226 ↗