N/A 961-337Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00721902467783), received between Feb 28, 2017 and May 23, 2025 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 23, 2025Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A CRANIAL RESECTION PROCEDURE. IT WAS REPORTED THAT DURING A CRANIAL RESECTION PROCEDURE, THE PASSIVE PLANAR AND SMALL PASSIVE CRANIAL FRAME INTERMITTENTLY FAILED TO TRACK WHEN ANGLING THE PASSIVE PLANAR. THE SITE ATTEMPTED TO RESOLVE THE ISSUE BY SWAPPING NAVIGATION SYSTEMS, BUT THIS DID NOT LEAD TO A RESOLUTION. SUBSEQUENTLY, THE FRAME AND POINTER WERE SWAPPED, ALLOWING THE PROCEDURE TO CONTINUE. THE MANUFACTURER REPRESENTATIVE ATTEMPTED NAVIGATION OUTSIDE OF SURGERY AND ENCOUNTERED THE SAME TRACKING ISSUE WHEN ANGLING THE PROBE. IT WAS VERIFIED THAT THERE WAS NO GEOMETRY ERROR EXCEEDING THE LIMIT FOR ANY PARTICULAR SPHERE WHEN COVERING UP ONE SPHERE AT A TIME ON BOTH INSTRUMENTS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT AND SURGICAL DELAY WAS 10-MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22081305 ↗
• MalfunctionFeb 6, 2023Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SMALL PASSIVE CRANIAL REFERENCE FRAME AND PASSIVE PLANAR BLUNT PROBE WERE NOT RECOGNIZED DUE TO STERILIZATION WEAR. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE PROBE VERIFIED, BUT WITH EXTREME DIFFICULTY AFTER TRYING DIFFERENT ANGULATIONS. AFTER SEVERAL ATTEMPTS ON THE CRANIAL REFERENCE FRAME DIVOT AND NOT TRACKED AFTERWARDS. IT WAS VERIFIED THAT THE INSTRUMENTS WERE ADDED TO THE PROCEDURE IN USE. THE CAMERA WAS WORKING CORRECTLY, AND THE STATUS LEDS DID NOT INDICATE ANY FAULTS. THE OTHER CRANIAL REFERENCE FRAME AND PROBE WERE VERIFIED AND TRACKED SUCCESSFULLY. THE CAMERA WAS REPOSITIONED SO THAT DISTANCE INDICATORS FELL TO THE CENTER OF THE BAR. THEY CHECKED THE CORRECT INSERTION OF SPHERES, CLEANED AND DRIED THE SPHERES, AND THEN REPLACED THE SPHERES. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE REPORTED ISSUE OCCURRED INTRAOPERATIVELY DURING A TUMOR RESECTION PROCEDURE. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF ALMOST TWENTY MINUTES DUE TO THIS ISSUE. THERE WAS NO REPORTED IMPACT ON PATI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16308671 ↗
• MalfunctionFeb 6, 2023Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SMALL PASSIVE CRANIAL REFERENCE FRAME AND PASSIVE PLANAR BLUNT PROBE WERE NOT RECOGNIZED DUE TO STERILIZATION WEAR. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE PROBE VERIFIED, BUT WITH EXTREME DIFFICULTY AFTER TRYING DIFFERENT ANGULATIONS. AFTER SEVERAL ATTEMPTS ON THE CRANIAL REFERENCE FRAME DIVOT AND NOT TRACKED AFTERWARDS. IT WAS VERIFIED THAT THE INSTRUMENTS WERE ADDED TO THE PROCEDURE IN USE. THE CAMERA WAS WORKING CORRECTLY, AND THE STATUS LEDS DID NOT INDICATE ANY FAULTS. THE OTHER CRANIAL REFERENCE FRAME AND PROBE WERE VERIFIED AND TRACKED SUCCESSFULLY. THE CAMERA WAS REPOSITIONED SO THAT DISTANCE INDICATORS FELL TO THE CENTER OF THE BAR. THEY CHECKED THE CORRECT INSERTION OF SPHERES, CLEANED AND DRIED THE SPHERES, AND THEN REPLACED THE SPHERES. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE REPORTED ISSUE OCCURRED INTRAOPERATIVELY DURING A TUMOR RESECTION PROCEDURE. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF ALMOST TWENTY MINUTES DUE TO THIS ISSUE. THERE WAS NO REPORTED IMPACT ON PATI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16308554 ↗
• MalfunctionMar 9, 2021Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE. IT WAS REPORTED THAT DURING A CRANIAL RESECTION PROCEDURE WHERE THE INSTRUMENTS STOPPED TACKING. SPHERES WERE CHANGED WITHOUT RESOLUTION. SURGEON PROCEEDED WITH NAVIGATION, EVEN THOUGH IT WAS "SPOTTY" THROUGHOUT THE REMAINDER OF THE CASE. PATIENT PRESENT. 20 MIN DELAY. THE REP CALLED IN TO DO TROUBLESHOOTING ON THIS CASE. THEY CHECKED THE GEOMETRY ERROR OF THE REFERENCE FRAME AND IT WAS AT .5 - WHERE THE TOLERANCE OF TRACKING CUTS OFF. THEY COVERED INDIVIDUAL SPHERES AND FOUND THAT WHEN COVERING THE LOWER RIGHT ONE THE GEOMETRY ERROR DROPPED TO. 1. THE PROBES THEY HAD AND OTHER REFERENCE FRAME ALL TRACKED WITHOUT ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11446917 ↗
• MalfunctionMar 27, 2020Human-Device Interface Problem; Material Integrity Problem; Human-Device Interface Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM THAT WAS USED OUTSIDE OF PROCEDURE. THE SITE HAD ISSUES WITH TRACKING. THE PASSIVE TRACKING SPHERES WERE CHANGED WITHOUT RESOLUTION. IT WAS NOTED SOME OF THE POSTS ON THE INSTRUMENTS WERE BENT, WHICH THREW OFF THE GEOMETRY ERROR. NO PATIENT PRESENT.

  Patient problems: No Patient Involvement

  MAUDE report 9891859 ↗
• MalfunctionOct 17, 2018Human-Device Interface Problem; Human-Device Interface Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED THAT DURING THE VERIFY TASK OF A CERVICAL SPINE PROCEDURE, ONE OF THE SPHERE POSTS WERE BENT ON THE CRANIAL REFERENCE FRAME AND CAUSING TRACKING ISSUES. THE SITE REPLACED THE CRANIAL FRAME WITH A NEW REFERENCE FRAME AND THERE WERE NO ISSUES TRACKING. THIS CAUSED A 5 MINUTE DELAY TO SURGERY. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7974872 ↗
• MalfunctionOct 16, 2018Human-Device Interface Problem; Human-Device Interface Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED THAT DURING A CRANIAL RESECTION PROCEDURE DURING REGISTRATION, THE REGISTRATION FRAME WOULD STOP TRACKING RANDOMLY AND THEY WOULD MOVE IT SLIGHTLY AND TRACKING WOULD RESUME. THEY SWAPPED OUT THE SPHERES AND STILL THE SAME BEHAVIOR WOULD OCCUR. AFTER FINISHING REGISTRATION, THEY SWITCHED TO ANOTHER ONE AND THIS ONE TRACKED WITHOUT ANY ISSUE. THE SITE ALSO HAD ANOTHER REFERENCE FRAME THAT THEY TRIED TO USE AS WELL AND THIS ONE TRACKED WITHOUT ANY ISSUE AS WELL. THEY RESUMED THE CASE USING THE TWO GOOD REFERENCE FRAMES. THERE WAS A DELAY TO THE PROCEDURE OF LESS THAN ONE HOUR. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7971896 ↗
• InjuryFeb 28, 2017Mechanical Problem; Mechanical Problem

  A MEDTRONIC REPRESENTATIVE REPORTED THAT WHILE THE SURGEON WAS PERFORMING A TRACER REGISTRATION WITH THE PATIENT PRONE THE SYSTEM WAS ACCURATE. THE SITE DRAPED THE PATIENT AND PUT ON A STERILE FRAME. THE SURGEON ATTEMPTED TO ALIGN THE TRAJECTORY AND THE ORIGINAL BURR-HOLE WAS NOT SUFFICIENT SO THE BURR-HOLE WAS MOVED. THE SURGEON LOCKED THE TRAJECTORY AND SET THE DEPTH ON THE BIOPSY NEEDLE. WHEN THE BIOPSY NEEDLE WAS INSERTED IT HIT CEREBROSPINAL FLUID (CSF) FLUID. AFTER UN-DRAPING THE PATIENT THE SITE PUT ON THE REFERENCE FRAME AND NOTICED A 1 CM INACCURACY. IT WAS NOTED THAT THE TRACER PATTERN WAS FOCUSED ON THE PREDOMINATELY ON THE FOREHEAD. THERE WAS NO IMPACT FROM THE CSF LEAK TO THE PATIENT. THE SURGEON WAS ABLE TO CONTROL THE LEAK. THE DELAY IN SURGERY WAS AN HOUR. THE SURGERY WAS DISCONTINUED AND THE BIOPSY WAS NOT COMPLETED. THE PATIENT WAS RESCHEDULED FOR A SECOND SURGERY. THE DELAY IN SURGERY WAS AN HOUR.

  Patient problems: Cerebrospinal Fluid Leakage; Iatrogenic Source; Injury; Therapeutic Response, Decreased

  MAUDE report 6365229 ↗