N/A 960-556 (UDI 00673978090122)Recalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 00673978090122), received between Feb 28, 2017 and Nov 25, 2025 — classified as 1 injury, 39 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (16 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 40 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 25, 2025Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THERE WAS A DAMAGED PASSIVE PLANAR BLUNT-TIP PROBE. THERE WAS NO PATIENT INVOLVEMENT. THE DAMAGED PROBE WAS NOT BEING USED FOR A CASE, BUT WAS BEING STORED IN AN S8 TO BE USED FOR A NON-STERILE CRANIAL REGISTRATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23646270 ↗
• MalfunctionNov 6, 2025Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS A CRANIAL RESECTION. THE ISSUE OCCURRED INTRA-OPERATIVELY AND CAUSED AN UNDER 5 MINUTE SURGICAL DELAY. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23490494 ↗
• MalfunctionSep 22, 2025Incorrect, Inadequate or Imprecise Result or Readings; Device Sensing Problem; Incorrect, Inadequate or Imprecise Result or Readings; Device Sensing Problem

  AFTER REVIEWING THE INITIAL INFORMATION SUBMITTED, IT WAS DETERMINED THAT THE ADDITIONAL INFORMATION THAT WAS LATER RECEIVED REFUTED THE INITIAL INACCURACY ALLEGATION. THE CAMERA COULD NOT SEE THE INSTRUMENT, AND THERE WAS NO INDICATION THAT IT WAS INTERMITTENT. THUS, THIS EVENT DOES NOT MEET THE REQUIREMENTS FOR REPORTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23111692 ↗
• MalfunctionMar 16, 2025Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM OUTSIDE OF PROCEDURE. IT WAS REPORTED THE PASSIVE PROBE HAD A DEFORMATION DUE TO DETERIORATION. THE TIP WAS DULL. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21615577 ↗
• MalfunctionMar 16, 2025Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE PASSIVE PLANAR PROBE WAS BENT. THE SITE BROUGHT OUT ANOTHER PASSIVE PLANAR PROBE AND WAS ABLE TO NAVIGATE THROUGH THE CASE. THERE WAS A REPORTED DELAY OF LESS THAN ONE HOUR AND NO REPORTED IMPACT TO PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21615563 ↗
• MalfunctionFeb 11, 2025Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE PASSIVE PROBE DID NOT RECOGNIZE AND RESPOND TO THE NAVIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21356686 ↗
• MalfunctionNov 21, 2024Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE CAMERA WAS UNABLE TO SEE THE TOOLS. THERE WAS NO PATIENT INVOLVED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE. IT WAS REPORTED THAT THE MOST LIKELY CAUSE OF THE ISSUE WAS THAT THE INSTRUMENT WAS DAMAGED BY THE CUSTOMER¿S MISUSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20743734 ↗
• MalfunctionNov 27, 2023Mechanical Problem; Device Sensing Problem; Mechanical Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE PASSIVE PLANAR WAS NOT TRACKING DURING A PROCEDURE. IT WAS CONFIRMED THAT ONE OF THE SPHERE POSTS WAS BENT. THE INSTRUMENT WAS ABLE TO NAVIGATE WITH THE SPHERE REMOVED FROM THAT POST. THERE WAS NO IMPACT ON PATIENT OUTCOME AND THE ISSUE CAUSED NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18212230 ↗
• MalfunctionSep 27, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17825138 ↗
• MalfunctionMay 29, 2023Imprecision; Use of Device Problem; Device Sensing Problem; Imprecision; Use of Device Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED FOR A CRANIAL RESECTION PROCEDURE. IT WAS REPORTED THAT MULTIPLE PROBES WERE INTERMITTENTLY UNABLE TO BE TRACKED. SPHERES WERE SWAPPED OUT WITH NEW SPHERES, WITH NO EFFECT. SITE REPORTED ONE PROBE HAD A VISIBLY DAMAGED TIP. WHEN SURGEON COVERED ONE SPHERE, THE INSTRUMENT WOULD TRACK. SITE SWAPPED REFERENCE FRAMES WITH NO EFFECT. SITE WAS ABLE TO PROCEED WITH THE PROCEDURE BY HOLDING THE PROBE AT AN ANGLE TO THE CAMERA. SITE DISPLAYED TRACKING DETAILS AND REPORTED ERROR METRIC OF PROBE, WHEN ONE SPHERE WAS COVERED ERROR, THERE WAS 0.47 MM, WHEN ALL WERE UNCOVERED THE ERROR METRIC JUMPED TO APPROXIMATELY 0.6-0.7 MM AND THE PROBE STOPPED BEING TRACKED. THE SITE COVERED EACH SPHERE ONE AT A TIME, AND THE LOWEST ERROR METRIC ACHIEVED WAS ABOUT 0.47 MM. THE SITE SPUN SPHERES AND MADE SURE THEY WERE SEATED FLUSH WITH POSTS WITH NO EFFECT. THE SITE CONFIRMED THAT THE PROBE WAS IN THE MIDDLE OF THE TRACKING WINDOW. THE SITE CONFIRMED THE ERROR METRIC OF THE PATIENT REFERENCE FRAME WAS ABOUT 0.2 MM. THE SITE BROUGHT IN ANOTHER STERILE TRAY FROM A NEIGHBORING HOSPITAL, AND THE SAME ISSUE OCCURRED WITH THAT PROBE. THIS OCC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17017440 ↗
• MalfunctionApr 18, 2022Imprecision; Device Sensing Problem; Imprecision; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT NAVIGATION WAS INACCURATE DURING A L4-S1 TLIF PROCEDURE. THE SURGEON USED AN OPEN, MIDLINE APPROACH AND A UNILATERAL WORKFLOW STARTING ON THE LEFT SIDE AND THEN MOVING TO THE RIGHT SIDE. NAVIGATION TOOLS WERE PLACED DOWN THE ARM GUIDE AND THEY WERE OFF TRAJECTORY. THE DRILL, TAP AND SCREWS WERE OFF. NAVIGATION WAS OFF BY 3-3.5 MM IN THE AXIAL AND LATERAL VIEWS. THE ACCURACY OF THE SURGICAL ARM WAS CHECKED WITH THE PASSIVE PLANAR PROBE BEING PLACED ON THE DIVOT, AND THE ARM WAS ACCURATE. ANATOMICAL CHECKS WERE ALSO ACCURATE. THE SURGEON CONTINUED TO USE THE GUIDANCE SYSTEM TO PLACE SCREWS. C-ARM IMAGES WERE TAKEN BEFORE AND AFTER PLACEMENT AND THE SCREWS WERE PLACED ACCURATELY. A NEW SNAPSHOT WAS NOT TAKEN UNTIL THE REFERENCE FRAMES WERE SWITCHED FROM THE ROBOTIC REFERENCE FRAME TO THE STEALTH AIR FRAME FOR THE TLIF PORTION DUE TO THE PASSIVE PLANAR LOOKING ACCURATE WHEN TESTING THE DIVOT ON THE ARM GUIDE AS WELL AS WHEN NAV IGATING TO KNOWN ANATOMICAL LANDMARKS. THERE WAS NO PATIENT HARM AND THE PROCEDURE WAS DELAYED LESS THAN AN HOUR. ADDITIONAL INFORMATION RECEIVE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14135772 ↗
• MalfunctionOct 11, 2021Use of Device Problem; Use of Device Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12605958 ↗
• MalfunctionJun 9, 2021Use of Device Problem; Use of Device Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION INSTRUMENT THAT WAS USED OUTSIDE OF PROCEDURE. DURING INSPECTION, IT WAS FOUND THAT THE TIP OF THE INSTRUMENT WAS DEFORMED. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED. ADDITIONAL INFORMATION RECEIVED. THE CAUSE OF THE REPORTED ISSUE WAS NOT KNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11970299 ↗
• MalfunctionNov 6, 2020Device Sensing Problem; Device Sensing Problem

  ADDITIONAL INFORMATION WAS PROVIDED STATING THAT THE CAUSE OF THE DAMAGE IS UNKNOWN. THE PART WAS RECEIVED LIKE THIS FROM STERILE PROCESSING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10801483 ↗
• MalfunctionOct 21, 2020Mechanical Problem; Communication or Transmission Problem; Mechanical Problem; Communication or Transmission Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED THAT THE SITE HAD A PASSIVE PLANAR THAT HAD A BENT POST. THE SPHERE ALWAYS SHOWED RED IN THE SOFTWARE FOR THAT SPECIFIC POST. THIS WAS REPORTED OUTSIDE OF A PROCEDURE. THERE WAS NO PATIENT INVOLVED. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE ISSUE WAS DISCOVERED BEFORE A PROCEDURE. THE SITE USED ANOTHER PASSIVE PLANER PROBE FOR THE PROCEDURE. THE SPHERE ON THE SYSTEM WAS NOT TURNING TO GREEN, OR YELLOW TO TRACK.

  Patient problems: No Patient Involvement

  MAUDE report 10713821 ↗
• MalfunctionOct 5, 2020Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED THAT THE PROBE WAS NOT SEEN BY THE CAMERA. NO PATIENT WAS PRESENT AT THE TIME OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10626554 ↗
• MalfunctionJun 16, 2020Degraded; Degraded

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM THAT WAS USED OUTSIDE OF PROCEDURE. IT WAS REPORTED THAT THE SITE HAS A DAMAGED PASSIVE PLANAR PROBE INSTRUMENT. THE PROBE IS BENT AT THE TIP. NO PATIENT PRESENT. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE SURGEON DISCOVERED THIS PRIOR TO THE PROCEDURE AND THERE WAS NO PATIENT PRESENT. THE CAUSE OF THE DAMAGE WAS UNKNOWN.

  Patient problems: No Patient Involvement

  MAUDE report 10160803 ↗
• 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 9891863 ↗
• MalfunctionFeb 28, 2020Material Integrity Problem; Material Integrity Problem

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

  Patient problems: No Patient Involvement

  MAUDE report 9772206 ↗
• MalfunctionFeb 24, 2020Mechanical Problem; Material Integrity Problem; Mechanical Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED THAT THE PASSIVE PLANAR HAD A BENT POST FOR ONE OF THE SPHERES. WHEN THE SPHERE WAS ON THE POST, THE INSTRUMENT WOULD NOT TRACK DUE TO HIGH GEOMETRY ERROR, HOWEVER, WHEN THE SPHERE WAS REMOVED AND ONLY 4 SPHERES WERE ON THE INSTRUMENT, IT TRACKED FINE VERIFIED WITH NO PROBLEMS. THIS WAS REPORTED OUTSIDE OF A PROCEDURE DURING SET-UP. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 9746594 ↗
• MalfunctionDec 23, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM THAT WAS USED OUTSIDE OF PROCEDURE. IT WAS REPORTED THAT A PASSIVE PLANAR PROBE IS DAMAGED. THERE WAS NO PATIENT PRESENT AT THE TIME OF THE EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 9510787 ↗
• MalfunctionDec 9, 2019Material Integrity Problem; Material Integrity Problem

  (B)(6) 2019 E1,E2 (REP) NEW INFORMATION RECEIVED: THE INSTRUMENT COULD BE VERIFIED HOWEVER WOULD LOSE THE ABILITY TO TRACK DEPENDING ON THE ANGLE OF HOW THE PLANAR PROBE WAS HELD.THIS WAS NOT A DUPLICATE OF CASE (B)(4).THE SITE HAS ORDERED 2 REPLACEMENT PASSIVE PLANAR PROBES TO REPLACE THE DAMAGED PROBE. CAUSE OF DAMAGE WAS UNKNOWN SPECIFICALLY, LOSE THE ABILITY TO TRACK DEPENDING ON THE ANGLE OF HOW THE PLANAR PROBE WAS HELD. THE CLINICAL SPECIALIST CURRENTLY HAVE POSSESSION OF THE INSTRUMENT AND WILL RETURN BY THE END OF THE WEEK.

  Patient problems: No Patient Involvement

  MAUDE report 9441107 ↗
• MalfunctionDec 2, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED FOR A CRANIAL RESECTION PROCEDURE. IT WAS REPORTED TWO DAMAGED PASSIVE PLANAR BLUNT INSTRUMENTS. THIS WAS FOUND DURING A CASE WHEN THE SITE WAS ATTEMPTING TO REGISTER. ON BOTH INSTRUMENTS, THE TOP PRONG WAS BENT SO YOU HAD TO REMOVE A SPHERE TO NAVIGATE. IT WAS NOTED THE DAMAGE WAS VISIBLE. THIS ISSUE WAS DISCOVERED INTRAOPERATIVELY AND CAUSED A 10-MINUTE SURGICAL DELAY. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME. ADDITIONAL INFORMATION WAS RECEIVED STATING BOTH PROBES WERE ABLE TO BE VERIFIED WITH INTERMITTENT TRACKING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9396598 ↗
• MalfunctionNov 11, 2019Material Integrity Problem; Material Integrity Problem

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

  Patient problems: No Patient Involvement

  MAUDE report 9306117 ↗
• MalfunctionNov 8, 2019Output Problem; Output Problem

  MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE PROCEDURE TYPE WAS TUMOR RESECTION. IT WAS REPORTED THAT THE CAUSE OF THE REPORTED ISSUE WAS UNKNOWN; IT WAS REPORTED THAT THEY WERE TRYING TO DETERMINE IF THE PROBE OR THE SPHERES WERE THE ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9296002 ↗