N/A 9734682Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00763000054298), received between Aug 30, 2018 and Dec 19, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Mechanical Jam” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K171267); 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 19, 2025Mechanical Jam; Mechanical Jam

  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 23857414 ↗
• MalfunctionDec 19, 2025Mechanical Jam; Mechanical 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23857386 ↗
• MalfunctionMar 4, 2025Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THERE WERE MULTIPLE INSTRUMENTS THAT REQUIRED REPLACEMENT. THE ORANGE AND VIOLET INSTRUMENT TRACKER SHOWED THE RETAINING CLIP BROKEN OFF. THE THORACIC PROBE TIP WAS BENT AND NO LONGER ABLE TO BE LOGGED INTO THE SOFTWARE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21516034 ↗
• 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 17065957 ↗
• MalfunctionJan 26, 2021Use of Device Problem; Use of Device Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE VIOLET INSTRUMENT TRACKER WAS DEFECTIVE. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11232607 ↗
• MalfunctionJan 23, 2021Mechanical Jam; Mechanical Jam

  MEDTRONIC RECEIVED INFORMATION REGARDING NAVIGATION AND SPINAL INSTRUMENTS, OUTSIDE OF PROCEDURE. IT WAS REPORTED THAT THE VIOLET IN STRUMENT TRACKER AND TAP GOT STUCK, IT WAS NOT POSSIBLE TO REMOVE THE TAP. NO PATIENT WAS PRESENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11220110 ↗
• MalfunctionOct 16, 2019Mechanical Problem; Material Integrity Problem; Mechanical Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED PRIOR TO A SPINAL PROCEDURE. IT WAS REPORTED THAT THE TRACKERS WERE DAMAGED AND WOULD NOT TRACK. THE MANUFACTURER REPRESENTATIVE REPORTED THAT THE ISSUE HAD OCCURRED ON MULTIPLE OCCASIONS AND SITUATIONS. TROUBLESHOOTING WAS ATTEMPTED, BUT THE ISSUE WAS NOT RESOLVED. THE CAUSE OF NO TRACKING WAS NOT DETERMINED. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 9200167 ↗
• MalfunctionOct 17, 2018Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED THAT INTRA/PERI-OPERATIVELY DURING THE NAVIGATE TASK OF A SACROILIAC AND THORACOLUMBAR PROCEDURE, THE VIOLET NAVIGATED FRAME COMPONENT BECAME STUCK ON A TAP BECAUSE IT WAS DAMAGED. THERE WAS NO DELAY TO CASE. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7973373 ↗
• MalfunctionAug 30, 2018Break; Break

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE VIOLET NAVLOCK WAS DAMAGED. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS OBSERVED.

  Patient problems: No Patient Involvement

  MAUDE report 7832676 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K171267. 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