NA 9734734Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000300227), received between May 12, 2023 and Jun 12, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Imprecision” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 12, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THERE WAS AN ALLEGED INACCURACY. DURING A CASE AND WHEN USING THE STRAIGHT THORACIC PROBE, THE SURGEON WOULD ROTATE IT 360 DEGREES AND NAVIGATION SHOULD HAVE STAYED STATIONARY, BUT IT DID NOT. THE SITE ALSO STATED THAT WHEN USING DIFFERENT INSTRUMENTS, IT WOULD NOT STAY ON THE SAME LOCATION ON THE ANATOMY IN THE NAVIGATION SCREEN, EVEN THOUGH THEY WERE ON THE SAME LOCATION IN THE ANATOMY. IT WAS NOTED THAT AN EXAMPLE OF ANOTHER INSTRUMENT USED WAS THE NAVIGATED AMA DRILL IN THE DOWN POSITION. THEY ABORTED THE USE OF NAVIGATION AND WENT TO FLUORO. THERE WAS LESS THAN AN HOUR DELAY TO THE PROCEDURE. THERE WAS NO IMPACT TO PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22198325 ↗
• 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 16924213 ↗

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