N/A 961-581Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00721902467684), received between Dec 12, 2016 and May 22, 2024 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 22, 2024Material Fragmentation; Mechanical Problem; Device Sensing Problem; Material Fragmentation; Mechanical Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT WHEN THE USER TRIED TO REMOVE IT FROM THE INSTRUMENT, THE SCREW PORTION BROKE AND WAS DIFFICULT TO REMOVE. THERE WAS NO REPORTED DELAY TO THE PROCEDURE DUE TO THIS ISSUE. THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19373829 ↗
• MalfunctionOct 6, 2022Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE TRACKER WAS NOT DETECTED BY THE NAVIGATION SYSTEM. THE NEXT STEP WAS FOR THE INSTRUMENT TO BE REPLACED. NO PATIENT WAS PRESENT AT THE TIME OF THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS CLARIFIED THAT THE INSTRUMENT WAS UNABLE TO BE DETECTED BY THE SYSTEM SO IT WAS NOT POSS IBLE TO START THE CALIBRATION PROCESS TO BE ABLE TO USE THE INSTRUMENT. IT WAS CLARIFIED THAT THE CAMERA NEEDS TO DETECT THE INSTRUMENT IN ORDER TO START THE CALIBRATION PROCESS. AFTER THIS, THIS USER CAN THEN VERIFY THE INSTRUMENT. NO TROUBLESHOOTING WAS PERFORMED AT THE TIME OF THE ISSUE. ANOTHER TRACKER WAS USED TO PERFORM THE CALIBRATION PROCESS. THE PROBABLE CAUSE OF THE REPORTED ISSUE WAS THIS TYPE OF PROBLEM IS LINKED TO THE SHAPE OF THE INSTRUMENT. MAYBE THERE WAS A LITTLE CHANGE IN THE SHAPE OF THE TOOL AND THIS CREATED A MODIFICATION TO THE GEOMETRY OF THE TOOL MAKING IMPOSSIBLE TO THE CAMERA RECOGNIZE THE INSTRUMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15553539 ↗
• MalfunctionFeb 3, 2020Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED IN A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE SITE WAS HAVING ISSUES CALIBRATING THE BLACK SURETRAK BEFORE A CASE. THEY STATED IT WOULD PROMPT THEM TO DO CALIBRATION, BUT AFTER THAT THEY WERE NOT ABLE TO COMPLETE ANY OF THE STEPS. THE MANUFACTURER REPRESENTATIVE WAS GOING TO CHECKOUT THE SURETRAK AND VERIFY THE GEOMETRY ERROR WAS WITHIN TOLERANCE. THE PATIENT WAS STILL IN THERE ROOM AT THE TIME OF THE EVENT. THERE WAS LESS THAN AN HOUR DELAY IN THE CASE. NO IMPACT ON PATIENT OUTCOME. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE PROCEDURE WAS ABLE TO CONTINUE THE CASE BY ATTACHING THE BLACK PASSIVE SURETRAK TO THE INSTRUMENT AND IT PROCEEDED TO CALIBRATE. THEY CHECKED THE GEOMETRY ERROR AND IT SHOWED .7 WHILE ATTEMPTING TO CALIBRATE. THE ISSUE WAS CAUSED BY A HIGH GEOMETRY ERROR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9660398 ↗
• MalfunctionSep 28, 2018Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING 4 DAMAGED INSTRUMENTS. IT WAS UNKNOWN IF THEY COULD BE VERIFIED OR NOT. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS FOUND.

  Patient problems: No Patient Involvement

  MAUDE report 7918324 ↗
• MalfunctionSep 28, 2017Material Deformation; Material Deformation

  A SITE REPRESENTATIVE REPORTED THAT WHILE OUTSIDE OF PROCEDURE THE SCREW HEAD OF THE LARGE FIGHTER WAS OUTWORN. THERE WAS NO PATIENT PRESENT AT THE TIME OF THE ISSUE.

  Patient problems: No Patient Involvement

  MAUDE report 6902577 ↗
• MalfunctionSep 7, 2017Material Deformation; Material Deformation

  A SITE REPRESENTATIVE REPORTED THAT, WHILE OUTSIDE OF A PROCEDURE, THE SCREW ON THE CLAMP WAS WORN AND WOULD NOT FUNCTION AS DESIGNED. IT WAS REPORTED THAT THE ISSUE WAS DISCOVERED IN THE SITE'S STERILE PROCESSING DEPARTMENT (SPD). THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6849712 ↗
• MalfunctionJul 18, 2017Material Deformation; Material Deformation

  A SITE REPRESENTATIVE REPORTED THAT, WHILE OUTSIDE OF A PROCEDURE, THE SCREW ON THE SURETRAK WAS WORN. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6721199 ↗
• MalfunctionJul 13, 2017Imprecision; Imprecision

  A SITE REPRESENTATIVE REPORTED THAT, WHILE IN A DESE L4-L5 TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF), THE SURETRAK BEING USED WAS REPORTED TO HAVE DIFFICULTIES NAVIGATING. AN IMPRECISION WAS REPORTED TO BE IN THE RANGE OF 5MM WHEN USING THE SURETRAK AS OPPOSED TO ANY OTHER INSTRUMENTS INTRODUCED INTO THE SURGICAL FIELD. ASIDE FROM THE SURETRAK, THE PROCEDURE CONTINUED AS INTENDED. THERE WAS NO REPORTED DELAY TO THE PROCEDURE DUE TO THIS ISSUE. THERE WAS NO IMPACT ON PATIENT OUTCOME. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6710849 ↗
• MalfunctionDec 12, 2016Break; Material Deformation; Break; Material Deformation

  A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A SPINE PROCEDURE, THE SITE'S SURETRAK2 LARGE PASSIVE TRACKER WAS DAMAGED. A SPHERE POST CAME OFF OF THE INSTRUMENT. NO FURTHER DETAILS REGARDING THE DAMAGE, OR HOW IT OCCURRED, WERE PROVIDED. A SECOND SURETRAK2 TRACKER WAS BROUGHT IN AND USED TO CONTINUE THE PROCEDURE. THE SURGEON COMPLETED THE PROCEDURE WITH THE USE OF THE NAVIGATION SYSTEM. THERE WAS NO DELAY OF THERAPY. THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6167776 ↗