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N/A 9734907 (UDI 00643169091047)Recalls & reported problems

Medtronic Navigation, Inc. · TRACKER KIT 9734907 NavLock UNIV ORANGE · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169091047), received between Oct 3, 2016 and Oct 3, 2016 — classified as 1 malfunction.

The most frequently reported specific device problem is “Imprecision” (1 report).

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

Device problems

  • Imprecision1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionOct 3, 2016Imprecision; Imprecision

    A SITE REPRESENTATIVE ALLEGED THAT WHILE IN A SPINAL FUSION PROCEDURE, NAVIGATION USING THEIR NAVLOCK UNIVERSAL ORANGE TRACKER WAS INACCURATE. NO SPECIFIC MEASUREMENT, OR DIRECTION, OF THE ALLEGED INACCURACY WAS PROVIDED. NO FURTHER DETAILS REGARDING THIS ISSUE, OR SPECIFICALLY WHEN IT OCCURRED, WERE PROVIDED. THE SURGEON COMPLETED THE PROCEDURE WITH THE USE OF THE NAVIGATION SYSTEM. THERE WAS NO DELAY OF THERAPY. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 5993335 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.