N/A 9734683Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00763000076634), received between Sep 9, 2020 and Jul 28, 2026 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (4 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

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.

• MalfunctionJul 28, 2026Incorrect, Inadequate or Imprecise Result or Readings

  A separate, different tracker was used to complete the case. The issue observed was with an orange tracker, and a gray tracker was used to complete case. When replicating the issue, the same tracker was used.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50061051 ↗
• MalfunctionFeb 7, 2025Mechanical Jam; Mechanical Jam

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT INSTRUMENTS WERE STUCK WITHIN TRACKERS. IT WAS IMPOSSIBLE TO CLIP THE TRACKER ON OR TO REMOVE IT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21334191 ↗
• MalfunctionDec 30, 2024Use of Device Problem; Use of Device Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THERE WAS A DEFECTIVE INSTRUMENT DUE TO DAMAGE. THE PROBABLE CAUSE WAS USE OF THE INSTRUMENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21043400 ↗
• InjuryOct 13, 2021Material 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 HEALTH CARE PROFESSIONAL (HCP) WAS ACCESSING THE PEDICURE WITH THE THORACIC PROBE AND IT BROKE OFF IN THE PATIENT¿S VERTEBRAL BODY. THE HCP WAS HAMMERING ON THE NAVLOCK WHEN IT BROKE. THERE WAS NO REPORTED IMPACT TO THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE TIP OF THE PROBE REMAINED IN THE PEDICLE OF THE PATIENT ANATOMY. THE TIP COULD NOT BE REMOVED BECAUSE IT WOULD HAVE CAUSED MORE DAMAGE.

  Patient problems: Device Embedded In Tissue or Plaque; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12624206 ↗
• MalfunctionMay 19, 2021Use of Device Problem; Use of Device Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE INSTRUMENTS WERE DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11849001 ↗
• MalfunctionJan 23, 2021Mechanical Jam; Mechanical Jam

  MEDTRONIC RECEIVED INFORMATION REGARDING NAVIGATION AND SPINAL INSTRUMENTS, OUTSIDE OF PROCEDURE. IT WAS REPORTED THAT THE ORANGE INSTRUMENT TRACKER WAS DAMAGED. IT WAS REPORTED THAT THE INSTRUMENT 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 11220178 ↗
• MalfunctionJan 8, 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 ORANGE INSTRUMENT TRACKER WAS DEFECTIVE. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11140351 ↗
• MalfunctionSep 9, 2020Use of Device Problem; Use of Device Problem

  MEDTRONIC RECEIVED INFORMATION THAT, WHILE OUTSIDE OF A PROCEDURE, THE ORANGE INSTRUMENT TRACKER USED ALONGSIDE THE NAVIGATION SYSTEM WAS DEFECTIVE. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Patient Involvement

  MAUDE report 10511307 ↗

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