NA 6000-005-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04546540245038), received between Jun 6, 2017 and May 14, 2024 — classified as 5 malfunctions.

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

• MalfunctionMay 14, 2024Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE UNIVERSAL TRACKER WAS INACCURATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19310957 ↗
• MalfunctionDec 18, 2018Break; Break

  IT WAS REPORTED THAT DURING TESTING CONDUCTED AT THE MANUFACTURER FACILITY IT WAS OBSERVED THAT THE BATTERY HOLDER AND SENSOR COVERS ARE BROKEN OFF. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING TESTING AT THE MANUFACTURER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8176001 ↗
• MalfunctionSep 25, 2018Break; Break

  IT WAS REPORTED THAT DURING TESTING CONDUCTED AT THE MANUFACTURER FACILITY IT WAS OBSERVED THAT THE BATTERY HOLDER IS BROKEN OFF. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING TESTING AT THE MANUFACTURER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7905787 ↗
• MalfunctionAug 14, 2018Break; Break

  IT WAS REPORTED THAT DURING TESTING CONDUCTED AT THE MANUFACTURER FACILITY IT WAS OBSERVED THAT THE BATTERY HOLDER IS BROKEN OFF. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING TESTING AT THE MANUFACTURER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7782568 ↗
• MalfunctionJun 6, 2017Imprecision; Imprecision

  DURING A SPINAL FUSION PROCEDURE AT THE USER FACILITY THE DEVICE WAS TRACKING INACCURATELY, APPROXIMATELY 4 CM TO THE LEFT, RESULTING IN THE USE OF AN UNKNOWN NON-NAVIGATED SCREW TO COMPLETE THE PROCEDURE. THE INITIAL REPORTER ADVISED THAT THERE WAS NO IMPACT TO THE PATIENT OR CLINICALLY SIGNIFICANT DELAYS ASSOCIATED WITH THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6615280 ↗