N/A 960-559Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 00673978090153), received between Jan 4, 2017 and Apr 2, 2025 — classified as 41 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (20 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 25 most recent of 41 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 2, 2025Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE PROBE HAD A SHAPE DEFORMATION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21758425 ↗
• MalfunctionFeb 13, 2025Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE INSTRUMENT TIP WAS BENT. NO PATIENT WAS PRESENT. ADDITIONAL INFORMATION WAS RECEIVED THAT IT WAS SUSPECTED THAT THE PROBE HAD BECOME BENT WHEN THE DIRECTION WAS CHANGED AS THE PROBE WAS INSERTED INTO THE BONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21381685 ↗
• MalfunctionJan 31, 2025Use of Device Problem; Use of Device Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE INSTRUMENT TIP WAS DEFORMED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21288247 ↗
• MalfunctionJan 29, 2025Use of Device Problem; Use of Device Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21269613 ↗
• MalfunctionJan 23, 2025Use of Device Problem; Use of Device Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT BEFORE A CASE IT WAS NOTICED THAT THE PASSIVE PLANAR PROBE HAD A BENT TIP. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS STATED THAT THE LIKELY CAUSE WAS THAT THE SITE DROPPED THE INSTRUMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21218082 ↗
• MalfunctionDec 19, 2023Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE PASSIVE PLANAR PROBE WAS NOT VISIBLE TO THE NAVIGATION SYSTEM DURING THE PROCEDURE. THEY TRIED CHANGING THE SPHERES AND CLEANING THE SPHERES, BUT NOTHING WORKED. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME. THERE WAS A SLIGHT DELAY TO THE PROCEDURE OF ABOUT FIVE MINUTES, BUT THE SURGERY WAS COMPLETED WITHOUT INCIDENT. THE ISSUE WAS LIKELY CAUSED BY A BENT PASSIVE BALL TIP PROBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18358176 ↗
• MalfunctionJun 8, 2022Use of Device Problem; Use of Device Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THE TIP OF A PROBE WAS DEFORMED. IT WAS SUSPECTED THAT THE CAUSE WAS DETERIORATION DUE TO USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14634603 ↗
• MalfunctionDec 28, 2021Imprecision; Imprecision

  DURING THE PROCEDURE, THERE WAS AN ALLEGED INACCURACY OF APPROXIMATELY 2MM DUE TO INSTRUMENT DEFORMATION DURING NAVIGATION. THE PROCEDURE WAS COMPLETED BY THE USE OF BACKUP PRODUCTS. THE INACCURACY WAS ISOLATED TO THE PROBLEM INSTRUMENTS. THE REPORTED ISSUE DID NOT RESULT IN A PROCEDURE DELAY. THERE WAS NO IMPACT ON PATIENT OUTCOME. THE LIKELY CAUSE WAS REPORTED AS INSTRUMENT DETERIORATION OVER TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13102050 ↗
• MalfunctionSep 21, 2021Imprecision; Imprecision

  ADDITIONAL INFORMATION RECEIVED, IT WAS REPORTED THAT THE SURGEON STATED HE DIDN¿T MEASURE THE INACCURACY SO HE COULD NOT TELL THE AMONG FOR SURE BUT HE WOULD GUESSED 2MM- INACCURACY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12507825 ↗
• MalfunctionDec 14, 2020Device Sensing Problem; Material Integrity Problem; Device Sensing Problem; Material Integrity Problem

  MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE SUSPECTED CAUSE OF HOW THE PROBE WAS VERIFIED WAS NOT DETERMINED; IT JUST VERIFIED WITH A SLIGHT DELAY. IT WAS REPORTED THAT THE PROBE WAS NOT MANIPULATED TO PASS VERIFICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11002725 ↗
• MalfunctionSep 30, 2020Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED DURING A PROCEDURE. IT WAS REPORTED THAT THE INSTRUMENT WAS UNABLE TO BE TRACKED. IT IS UNKNOWN IF THERE IS A DELAY IN THE PROCEDURE, AND PATIENT IMPACT IS NOT KNOWN. IT WAS REPORTED THAT ISSUE OCCURRED DURING A POSTERIOR SPINAL FUSION PROCEDURE. THERE WAS NO KNOWN IMPACT ON PATIENT OUTCOME. THE INSTRUMENT STOPPED TRACKING, AND DIFFICULT TO TRACE. CAUSE WAS RELATED TO BENT INSTRUMENT. SITE CHANGED TO ANOTHER INSTRUMENT, AND CONTINUED WITH THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10606978 ↗
• MalfunctionFeb 13, 2020Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE TIP OF THE PASSIVE PLANAR BALL-TIP PROBE WAS BENT. IT WAS NOT CONFIRMED WHETHER OR NOT THE PASSIVE PROBE COULD STILL VERIFY. THERE WAS NO PATIENT INVOLVED WHEN THESE ISSUES WERE DISCOVERED.

  Patient problems: No Patient Involvement

  MAUDE report 9707208 ↗
• MalfunctionDec 26, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED THAT THE PROBE HAD A BENT TIP. IT WAS REPORTED THAT THE PROBE COULD VERIFY IF TWO SPHERES WERE REMOVED OFF THE BENT PORTIONS OF THE PROBE. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED. IT WAS REPORTED THAT THE PROBE WAS PART OF AN EVALUATION SYSTEM AND WAS BENT UPON ARRIVAL.

  Patient problems: No Patient Involvement

  MAUDE report 9519739 ↗
• MalfunctionOct 28, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION THAT, WHILE OUTSIDE OF A PROCEDURE, THE PASSIVE PLANAR PROBE WAS DAMAGED. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Patient Involvement

  MAUDE report 9244311 ↗
• MalfunctionOct 8, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE PASSIVE PLANAR BALL TIP PROBE BECAME DAMAGED DURING THE PROCEDURE. THE PROBE WAS NOT NEEDED TO COMPLETE THE CASE. THERE WAS A SURGICAL DELAY OF LESS THAN 1 HOUR DUE TO THIS ISSUE, AND THERE WAS NO IMPACT ON PATIENT OUTCOME. IT WAS NOTED THAT IT WAS NOT KNOWN HOW THE PROBE WAS DAMAGED OR WHAT CAUSED THE DAMAGE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9165047 ↗
• MalfunctionSep 9, 2019Material Integrity Problem; Material Integrity Problem

  ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE PROBE HAD COME DOWN TO THE STERILE PROCESSING DEPARTMENT FROM THE OR AND IT WAS MARKED AS BENT. THE SITE HAD INITIATED ORDERING A REPLACEMENT PROBE AND IT WAS NOTED THAT THE ROOT CAUSE WAS NOT EXPLAINED TO THE STERILE PROCESSING DEPARTMENT AND WAS ALSO UNKNOWN BY THE OR NEURO COORDINATOR. THE PROBE WAS BENT SO IT WOULD NOT PROPERLY REGISTER. IT WAS NOTED THAT THE PROBE COULD NOT BE REGISTERED WHEN TESTED BY A MANUFACTURING REPRESENTATIVE (REP) AND THAT THE TIP WAS TOO FAR FROM DIVOT. THE PROBE WOULD NOT VERIFY SO IT WAS MARKED FOR REPAIR.

  Patient problems: No Patient Involvement

  MAUDE report 8977078 ↗
• MalfunctionJul 19, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED THAT THE PASSIVE PLANAR PROBE WAS BENT VISIBLY. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PROBE WAS NOT ABLE TO BE VERIFIED AND USED. IT HAD BEEN TAKEN OUT OF THE TRAY AND QUARANTINED AS NOT USABLE. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Patient Involvement

  MAUDE report 8808522 ↗
• MalfunctionJul 15, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE PROBE WAS BENT. NO OTHER DETAILS WERE GATHERED. NO PATIENT WAS PRESENT.

  Patient problems: No Patient Involvement

  MAUDE report 8789501 ↗
• MalfunctionJul 8, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION THAT, WHILE OUTSIDE OF A PROCEDURE, THE PASSIVE PLANAR PROBE TIP WAS VISIBLY BENT. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Patient Involvement

  MAUDE report 8769234 ↗
• MalfunctionJun 19, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM WHILE OUTSIDE OF PROCEDURE. IT WAS REPORTED THAT A BALL PLANAR PROBE WAS BENT. THERE WAS NO PATIENT PRESENT WHEN THE ISSUE OCCURRED.

  Patient problems: No Patient Involvement

  MAUDE report 8710611 ↗
• MalfunctionJun 17, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM WHILE OUTSIDE OF PROCEDURE. IT WAS REPORTED THAT THE TIP OF THE BALL TIP POINTER WAS BENT. THERE WAS NO PATIENT PRESENT WHEN THE ISSUE OCCURRED.

  Patient problems: No Patient Involvement

  MAUDE report 8706223 ↗
• MalfunctionJun 13, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM WHILE OUTSIDE OF PROCEDURE. IT WAS REPORTED THAT THE PASSIVE PLANAR PROBE WAS BENT. THERE WAS NO PATIENT PRESENT WHEN THE ISSUE OCCURRED.

  Patient problems: No Patient Involvement

  MAUDE report 8698460 ↗
• MalfunctionMay 13, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION INSTRUMENT OUTSIDE OF PROCEDURE. IT WAS REPORTED THAT A DAMAGED PASSIVE PLANAR BALL WAS NOTICED PRE-OPERATIVELY WHEN VERIFYING INSTRUMENTS. THE PROBE WAS FLASHING IN THE TRACKING WINDOW AND THE ERROR WAS HOVERING AROUND .47 TO .5. THE CASE WAS DONE USING ANOTHER PROBE FROM ANOTHER TRAY. NO PATIENT WAS PRESENT.

  Patient problems: No Patient Involvement

  MAUDE report 8604936 ↗
• MalfunctionApr 24, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION FROM A MANUFACTURER REPRESENTATIVE (REP) REGARDING A DEVICE BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE PASSIVE PLANAR PROBE'S TIP WAS BENT. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8547421 ↗
• MalfunctionApr 16, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE A PROCEDURE. IT WAS REPORTED THAT THE TIP OF THE PASSIVE PROBE BALL CHIP WAS DEFORMED. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Patient Involvement

  MAUDE report 8520467 ↗