NA 9734683Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00763000300265), received between May 12, 2023 and Jul 7, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 7, 2025Material Fragmentation; Mechanical Problem; Material Fragmentation; Mechanical Problem

  IT WAS REPORTED THAT IT GOT DEFORMED DURING PROBING. THE ISSUE WAS DISCOVERED DURING USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22419202 ↗
• MalfunctionFeb 26, 2025Use of Device Problem; Use of Device Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE POST OF THE INSTRUMENT TRACKER WITH A SPHERE ATTACHED TO IT FELL OFF MID-CASE. THE REPORTED CAUSE OF THE EVENT WAS THAT THE INSTRUMENT WAS BEING USED FOR NAVIGATION OF A THORACIC PROBE AND POST OF TRACKER FELL OFF DURING USE. THERE WAS NO PHYSICAL IMPACT TO THE TRACKER WHEN THIS OCCURRED. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF LESS THAN 1 HOUR DUE TO THIS ISSUE. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21471460 ↗
• MalfunctionAug 27, 2024Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT WHEN THEY WERE USING THE TRACKERS THE SPHERES WERE FLICKERING IN AND OUT WHILE NAVIGATING. BOTH THE ORANGE AND GRAY TRACKER, AND BOTH HAD A GEOMETRY ERROR OF .49MM. THE PURPLE AND PASSIVE PLANAR PROBE WERE WORKING AS EXPECTED. THE REPRESENTATIVE RAN A STATUS CHECK ON THE CAMERA AND EVERYTHING WAS WORKING AS EXPECTED. THERE WAS NO REPORTED DELAY AND NO REPORTED IMPACT TO PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20077533 ↗
• MalfunctionMay 12, 2023Imprecision; Imprecision

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT WHEN TRAINING USING THE NAVIGATION THE MANUFACTURER REPRESENTATIVE FOUND THE TRACKER ASSEMBLED ON THE TAP OR DRIVER WERE NOT ACCURATE BECAUSE THE EXTENSION LINE AND TOOLS DISPLAYED ON SCREEN WERE NOT ALONG THE CENTER OF THE TRAJECTORY. THE BLUE AND BLACK TRACKER WERE GOOD THOUGH. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16924203 ↗

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