N/A 960-553Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00673978090108), received between Mar 15, 2017 and Mar 16, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 16, 2025Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT SIX INSTRUMENTS WERE DEFORMED DUE TO A PROBLEM DURING STERILIZATION. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT IT WAS UNKNOWN WHETHER THE STERILIZATION PROBLEM WAS DUE TO THE INSTRUMENTS DESIGN OR DUE TO THE WRONG STERILIZATION PROCEDURE BEING PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21615572 ↗
• MalfunctionFeb 3, 2025Mechanical Problem; Mechanical Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21290793 ↗
• MalfunctionDec 7, 2020Imprecision; Imprecision

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THERE WAS TIP DEFORMATION ON THE PASSIVE PLANAR PROBE. THE PROCEDURE WAS COMPLETED USING THE PROBE. THERE WAS NO DELAY AND NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10961019 ↗
• MalfunctionSep 25, 2019Mechanical Problem; Material Integrity Problem; Mechanical Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED THAT DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE THAT THE SPHERES WERE NOT BEING TRACKED WHEN FIVE PASSIVE MARKERS WERE ATTACHED TO THE PASSIVE PROBE. THE ISSUE WAS NOT RESOLVED EVEN THOUGH THE PASSIVE MARKERS WERE REPLACED WITH NEW ONES. THE PROCEDURE WAS COMPLETED BY REPLACING THE PASSIVE PROBE WITH BALL CHIP PROBE. 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 9118771 ↗
• MalfunctionJan 2, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE OF PROCEDURE. IT WAS REPORTED THAT THE TIP OF THE SHARP PLANAR PASSIVE PROBE WAS BENT. NO PATIENT PRESENT.

  Patient problems: No Patient Involvement

  MAUDE report 8210156 ↗
• MalfunctionMar 24, 2017Material Deformation; Material Deformation

  A MEDTRONIC REPRESENTATIVE REPORTED THAT DURING A SPINAL FUSION PROCEDURE THE TIP OF THE PASSIVE PLANAR SHARP WAS DISCOVERED TO BE BENT. IT WAS UNKNOWN IF THE INSTRUMENT WAS BENT WHILE IN USE OR DURING INSTRUMENT VERIFICATION. THERE WAS NO DELAY OR IMPACT TO THE OUTCOME OF THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6433912 ↗
• MalfunctionMar 15, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  A MEDTRONIC REPRESENTATIVE REPORTED THAT THE PASSIVE PLANAR SHARP WAS BENT. THE INSTRUMENT VERIFIED PROPERLY BUT THE SURGEON BELIEVED THAT IT WAS BENT. THE SURGEON CONTINUED TO USE THE BENT PROBE. IT WAS OBSERVED THAT THERE WAS A SLIGHT INACCURACY OF A COUPLE OF MM. THERE WAS NO PATIENT IMPACT REPORTED AND THE DELAY IN SURGERY WAS LESS THAN AN HOUR. SURGERY PROCEEDED AS PLANNED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6408121 ↗