N/A 9736428Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000554293), received between Mar 20, 2026 and Mar 20, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Sensing Problem” (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

Recent adverse event reports

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

• MalfunctionMar 20, 2026Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT TRAJECTORY 1 AND 2 INTERMITTENTLY SHOWED BLANK/BLACK. THE REFERENCE FRAME "JUMPED AROUND" ON TRACKING DETAIL. THE MANUFACTURER REPRESENTATIVE (REP) CONFIRMED THAT INSTRUMENTS NOT BEING USED WERE OUT OF VIEW, THAT THERE WERE FINGERPRINTS ON THE RIGHT CAMERA LENS, THAT ONE SPHERE ON THE PATIENT REFERENCE FRAME WAS RED, AND THAT THE SYSTEM WAS CONNECTED TO A BOOM. THE REP MOVED THE CAMERA IN AND OUT, PRESSED SPHERES DOWN WITHOUT USING EXCESSIVE FORCE AS THE SPHERES WERE INDIRECTLY CONNECTED TO THE PATIENT'S SPINE, CLEANED THE CAMERA LENSES, AND CLEANED INSTRUMENTS. THE ISSUE DID NOT REPLICATE WITH ANOTHER PATIENT REFERENCE FRAME AND NO APPARENT ISSUES WERE SEEN IN THE NETWORK DEVICE INTERFACE (NDI) TOOLBOX. THERE WAS NO SURGICAL DELAY. THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24649775 ↗