N/A 960-556 (UDI 00763000223069)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00763000223069), received between Jan 3, 2019 and Dec 13, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• MalfunctionDec 13, 2024Mechanical Problem; Device Sensing Problem; Mechanical Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A CRANIAL RESECTION PROCEDURE. IT WAS REPORTED THAT THAT DURING A CASE, THE PASSIVE PLANAR PROBE WAS UNABLE TO BE TRACKED. A MEDTRONIC REPRESENTATIVE (REP) ARRIVED ON SITE AND REPORTED THAT THE TOP LEG OF THE PROBE WAS VISIBLY BENT TO THE LEFT SIDE. WHEN THE INSTRUMENT WAS HELD IN FRONT OF THE CAMERA, THE GEOMETRY ERROR OF THE PROBE WAS 0.8 MM. WHEN THE TOP SPHERE WAS COVERED, THE GEOMETRY ERROR DROPPED TO 0.4 MM AND THE INSTRUMENT COULD BE TRACKED. WHEN COVERING ANY OTHER SPHERE, THE GEOMETRY ERROR REMAINED AT 0.8 MM. THERE WAS A 30 SECOND DELAY. THERE WAS NO IMPACT ON THE PATIENT'S OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20926324 ↗
• MalfunctionSep 11, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ADDITIONAL INFORMATION WAS RECEIVED. THE INACCURACY WAS 2 MM LEFT OF THE EXPECTED TARGET. THE LIKELY CAUSE OF THE ISSUE WAS THERE MIGHT BE SOME ERROR WITH THE PRONGS THAT HOLD THE SPHERES ON THE HANDLE OF THE PROBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17720082 ↗
• MalfunctionNov 21, 2022Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE PASSIVE PLANAR PROBE WOULD NOT VERIFY. AFTER CLOSER INSPECTION THEY NOTICED THAT THE FRAME HAD BEEN BENT. NO PATIENT WAS PRESENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15837265 ↗
• MalfunctionJan 3, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING AN INSTRUMENT THAT WAS USED WITH A NAVIGATION SYSTEM. IT WAS REPORTED OUTSIDE OF A PROCEDURE THAT THE PASSIVE PLANAR BLUNT PROBE WAS BROKEN. THERE WAS NO PATIENT PRESENT.

  Patient problems: No Patient Involvement

  MAUDE report 8214270 ↗