N/A 960-556 (UDI 00763000055387)Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00763000055387), received between Feb 6, 2018 and Feb 6, 2026 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (15 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 16, 2026.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 6, 2026Mechanical Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE PASSIVE PLANAR PROBE WAS DAMAGED. THE SITE'S NON-STERILE PASSIVE PLANAR HAD ISSUES BEING SEEN BY THE CAMERA. OTHER INSTRUMENTS TRACKED AS INTENDED. THE MANUFACTURER REPRESENTATIVE (REP) NOTED THAT WHEN COVERING THE TOP SPHERE ON THE INSTRUMENT, IT WAS ABLE TO BE PICKED UP BY THE CAMERA CONSISTENTLY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24279284 ↗
• MalfunctionJan 14, 2026Mechanical Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED INTRA-OPERATIVELY DURING A CRANIAL BIOPSY PROCEDURE. IT WAS REPORTED THAT A PASSIVE PLANAR PROBE USED IN A BIOPSY CASE WAS INTERMITTENTLY DISAPPEARING FROM THE NAVIGATION FIELD. TROUBLESHOOTING STEPS WERE PERFORMED. THE MANUFACTURER REPRESENTATIVE (REP) COVERED INDIVIDUAL SPHERE POSTS ON THE INSTRUMENT AND DETERMINED ONE WAS LIKELY BENT; COVERING IT STABILIZED THE INSTRUMENT'S PROJECTION ON THE SCREEN AND LOWERED THE GEOMETRY ERROR. THE LIKELY CAUSE OF THE ISSUE WAS A BENT INSTRUMENT SPHERE POST. THERE WAS NO SURGICAL DELAY AND NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24068355 ↗
• MalfunctionOct 30, 2025Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE PASSIVE-PLANAR BLUNT PROBE WAS BENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23428478 ↗
• MalfunctionJun 4, 2025Mechanical Problem; Device Sensing Problem; Mechanical Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE REPRESENTATIVE WAS UNABLE TO TRACK THE PASSIVE PLANAR. WHEN THE REPRESENTATIVE COVERED ONE OF THE SPHERES WITH HER HAND, SHE WAS ABLE TO TRACK THE INSTRUMENT. THE REPRESENTATIVE SWAPPED THE SPHERES ON THE INSTRUMENT, BUT THE ISSUE PERSISTED. THE PROBABLE CAUSE WAS NOTED TO BE A BENT POST. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22146559 ↗
• MalfunctionMay 5, 2025No Device Output; Device Sensing Problem; No Device Output; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE NAVIGATION PROBE WAS NOT WORKING PROPERLY. THE PROBE WAS ONLY SHOWING CORRECTLY WHEN IT WAS TURNED DIRECTLY TOWARDS THE CAMERA, ANY SLIGHT MOVEMENT CAUSES BLINKING OF THE INSTRUMENT ON THE NAVIGATION SCREEN. IT COULD BE VERIFIED, BUT REGISTRATION COULD NOT BE DONE WITH IT, SINCE IT BLINKS ALL THE TIME. THEY CHECKED THE BALLS, THEN CHANGED THEM AND CHECKED AGAIN IF THEY WERE CLEAN AND ATTACHED CORRECTLY. AFTER A WHILE THEY BROUGHT ANOTHER PROBE THAT THEY HAVE, AND IT WORKED PERFECTLY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21961344 ↗
• MalfunctionMar 27, 2025Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED DURING A CRANIAL RESECTION PROCEDURE. IT WAS REPORTED THAT THE PASSIVE PLANAR BLUNT WOULD INTERMITTENTLY FLICKER IN THE TRACKING WINDOW. THE PASSIVE PLANAR BLUNT HAD 3 GREEN AND 2 RED SPHERES IN THE SOFTWARE. THE GEOMETRY ERROR WAS 0.9MM, BUT THE USER EVENTUALLY WAS ABLE TO VERIFY THE INSTRUMENT. THERE WAS A LESS THAN ONE HOUR SURGICAL DELAY. THERE WAS NO IMPACT ON PATIENT OUTCOME. TROUBLESHOOTING INCLUDED: - CONFIRMING THE SPHERES WERE DRY, CLEAN, AND FULLY SEATED. - THE MANUFACTURER REPRESENTATIVE (REP) CONFIRMED THE REFERENCE FRAME WAS VISIBLE AND NOT FLICKERING IN THE TRACKING WINDOW. - ANOTHER PASSIVE PLANAR BLUNT WAS ALSO FLICKERING. - REP CHANGED THE SPHERES TO NO EFFECT. - REP SWAPPED OUT THE SYSTEM WITH ANOTHER SYSTEM TO NO EFFECT. - REP CLEANED OFF THE CAMERA LENS TO NO EFFECT. - REP REPOSITIONED THE CAMERA TO NO EFFECT. - MOVING BACKWARD IN THE SOFTWARE DID NOT RESOLVE THE ISSUE. - REBOOTING THE SYSTEM DID NOT RESOLVE THE ISSUE. ADDITIONAL TROUBLESHOOTING INFORMATION WAS RECEIVED. IT WAS REPORTED THAT IN SELF-TEST, IT LOOKED NORMAL. THE CLINICAL SPECIALIST (CS) WAS ABLE TO VERIFY THE NAVIGUS PROBE, T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21713543 ↗
• MalfunctionMar 10, 2025Mechanical Problem; Device Sensing Problem; Mechanical Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE PASSIVE PLANAR PROBE BLUNT WAS NOT VERIFYING BECAUSE ONE FOR THE POSTS IS BENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21569371 ↗
• MalfunctionMar 7, 2025Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE INSTRUMENT PROBE WAS BENT. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21554573 ↗
• MalfunctionFeb 18, 2025Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE PASSIVE PLANAR PROB BLUNT EXCEEDED THE 0.5MM GEOMETRY ERROR AND WOULD NOT VERIFY. NO PATIENT WAS PRESENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21402155 ↗
• MalfunctionFeb 18, 2025Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED DURING A CRANIAL BIOPSY PROCEDURE. IT WAS REPORTED THAT PRE-INCISION THE SITE WAS UNABLE TO REGISTER THE INSTRUMENT. THERE WAS NO REPORTED IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21398569 ↗
• MalfunctionFeb 18, 2025Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE INSTRUMENT WOULD NOT RESPOND TO THE CAMERA SENSOR. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21395328 ↗
• MalfunctionFeb 12, 2025No Device Output; Device Sensing Problem; No Device Output; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE PROBE WAS ONLY SHOWING CORRECTLY WHEN IT WAS TURNED DIRECTLY TOWARDS THE CAMERA, ANY SLIGHT MOVEMENT CAUSED BLINKING OF THE INSTRUMENT ON THE NAVIGATION SCREEN. IT COULD BE VERIFIED, BUT REGISTRATION COULD NOT BE DONE WITH IT, SINCE IT BLINKED ALL THE TIME. THE SITE CHECKED THE BALLS, THEN CHANGED THEM AND CHECKED AGAIN IF THEY WERE CLEAN AND ATTACHED CORRECTLY. AFTER A WHILE THEY BROUGHT ANOTHER PROBE THAT THEY HAD, AND IT WORKED PERFECTLY. THE SITE SAID IT HAD ALREADY HAPPENED ONCE BEFORE WITH THIS PARTICULAR PROBE, THE EXACT SAME SITUATION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21364545 ↗
• MalfunctionDec 10, 2024Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THERE WAS DIFFICULTY VERIFYING AND TRACKING THE PASSIVE PLANAR BLUNT PROBE AND A NAVIGUS PROBE. THE REFERENCE FRAME WAS VISIBLE WITHOUT ISSUE, BUT THE PASSIVE PLANAR PROBE CONTINUED TO HAVE TRACKING DIFFICULTIES, CAUSING CONCERN FOR THE SURGEON REGARDING ITS USE FOR REGISTRATION. TECHNICAL SERVICES SUSPECTED A FAULTY PROBE. TROUBLESHOOTING STEPS INCLUDED CHANGING THE REFLECTIVE SPHERES ON THE INSTRUMENT, WHICH DID NOT RESOLVE THE ISSUE, AND USING A DIFFERENT PASSIVE PLANAR PROBE FROM A SPINE REFERENCING TRAY, WHICH SEEMED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20895907 ↗
• MalfunctionOct 21, 2024Mechanical Problem; Device Sensing Problem; Mechanical Problem; Device Sensing Problem

  ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE INSTRUMENTS SEEMED TO BE IN ROUGH SHAPE AND DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20494176 ↗
• MalfunctionMar 28, 2024Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT TWO PASSIVE PLANAR BLUNT PROBES WERE NOT WORKING. THE TWO PROBES WERE FLASHING ON THE SCREEN DURING NAVIGATION. THE NAVIGATION SYSTEM DID NOT ALWAYS RECOGNIZE THEM. THE SUSPECTED CAUSE WAS THAT IT COULD BE A SLIGHT DEFORMATION OF THE PROBES THAT WERE NOT ABLE TO BE SEEN. MAYBE CAUSED BY MANY MANIPULATION, USAGE, AND STERILIZATION. IT WAS CONFIRMED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19000594 ↗
• MalfunctionJul 26, 2023Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE PASSIVE PLANER PROBE WOULD NOT TRACK. THIS WAS FOUND OUTSIDE OF A CASE. NO PATIENT WAS PRESENT. ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE REPORTED THAT THE TRACKING ISSUE WAS NOT RESOLVED. THE GEOMETRY ERROR WAS LIKELY DUE TO USAGE AND WEAR AND TEAR OVER TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17401173 ↗
• MalfunctionJun 18, 2023Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE. IT WAS REPORTED THAT THE PASSIVE BLUNT PROBE WOULD SHIFT IN AND OUT OF TRACKING. WHEN TOP SPHERE WAS REMOVED, SYSTEM FUNCTIONED AS INTENDED. THERE WAS NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17149539 ↗
• MalfunctionMay 14, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE A PROCEDURE. IT WAS REPORTED THAT THE SITE HAS A DAMAGED PASSIVE PLANAR PROBE. THE INSTRUMENT WAS TESTED AND THE GEOMETRY ERROR WAS AROUND 0.5-0.7. THE INSTRUMENT HAD A HIGH GEOMETRY ERROR AND IT PASSED VERIFICATION DESPITE THE DAMAGE. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Patient Involvement

  MAUDE report 8609443 ↗
• MalfunctionFeb 6, 2018Material Deformation; Output Problem; Material Deformation; Output Problem

  A MEDTRONIC REPRESENTATIVE REPORTED THAT WHILE OUTSIDE OF A PROCEDURE, AN INSTRUMENT ON THE NAVIGATION SYSTEM WAS DAMAGED. THE DRIVER TIP WAS WORN OUT AND COULD NO LONGER SCREW THE CLAMP TIGHTLY. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS OBSERVED.

  Patient problems: No Patient Involvement

  MAUDE report 7246076 ↗