NA 9734060 (UDI 00643169486645)Recalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 00643169486645), received between Oct 14, 2016 and Sep 24, 2024 — classified as 3 injuries, 39 malfunctions.

The most frequently reported specific device problem is “Application Program Freezes or Fails to Launch” (10 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 25 most recent of 42 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2024Display or Visual Feedback Problem; Application Program Freezes or Fails to Launch; Display or Visual Feedback Problem; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT DURING THE PRE-OP [PHASE], THE MEDTRONIC NAVIGATION SYSTEM DID NOT [INITIATE] UPON ACTIVATING THE "ON" SWITCH. THE DISPLAY SHOWED A NO SIGNAL MESSAGE AND THERE WAS NO VISUAL ON THE CENTRAL PROCESSING UNIT (CPU) LAPTOP. THERE WAS TROUBLESHOOTING PRESENT, THE SYSTEM WAS REBOOTED TWICE AND THE SYSTEM THEN [INITIATED] PROPERLY. THERE WAS NO PATIENT INVOLVEMENT OR PRESENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20291688 ↗
• MalfunctionSep 3, 2024Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT WHEN TURNING ON THE SYSTEM, THE SYSTEM DID NOT BOOT UP. THERE WAS TROUBLESHOOTING PRESENT. THE SYSTEM AS TURNED OFF AND ON AND UNPLUGGED AND THE SYSTEM INITIATED PROPERLY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20128529 ↗
• MalfunctionFeb 21, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT UPON TURNING ON THE SYSTEM, ONE OF THE 5 DISPLAYS/MONITORS BEGAN INTERMITTENTLY TURNING OFF AND ON. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18749043 ↗
• MalfunctionJan 19, 2024Unexpected Shutdown; Unexpected Shutdown

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM USED FOR A TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF). IT WAS REPORTED THAT AFTER A FEW MINUTES FROM TURNING ON, THE SYSTEM WENT DOWN. AFTER THE 3D SPIN, THE SYSTEM WENT DOWN AND BEFORE THE SURGEON BEGUN IT WENT OFF AGAIN. THE SYSTEM BLACKED OUT. THE SITE SHUTDOWN THE SYSTEM A FEW TIMES AND CONTINUED WITH THE SURGERY. THE ISSUE OCCURRED PRE-OPERATIVELY. THERE WAS LESS THAN AN HOUR DELAY IN SURGERY. THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18543940 ↗
• MalfunctionOct 18, 2023Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A CRANIAL RESECTION PROCEDURE. IT WAS REPORTED THAT THE SYSTEM BECAME UNRESPONSIVE. THE SITE REBOOTED THE COMPUTER AND THE ISSUE WAS RESOLVED. THERE WAS NO IMPACT ON PATIENT OUTCOME AND THE ISSUE CAUSED A LESS THAN 5 MINUTE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17958869 ↗
• MalfunctionSep 27, 2023Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED IN AN UNKNOWN PROCEDURE. IT WAS REPORTED THAT DURING A CASE THE SYSTEM WAS UNRESPONSIVE. THERE WAS NO FURTHER INFO PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17825905 ↗
• MalfunctionJul 19, 2023Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED DURING A CRANIAL RESECTION PROCEDURE. IT WAS REPORTED THAT THE SYSTEM BECAME UNRESPONSIVE DURING A CASE. THE SITE REBOOTED, AND WENT BACK INTO THE NAVIGATION SCREEN, BUT THE SYSTEM BECAME UNRESPONSIVE AGAIN. THE SECOND TIME THEY REBOOTED AND WENT INTO NAVIGATION A THIRD TIME WHICH ALLOWED FOR THEM TO COMPLETE THE CASE. THE TOTAL DELAY WAS APPROXIMATELY 30 MIN. THERE WAS NO IMPACT ON PATIENT OUTCOME. FOR TROUBLESHOOTING, IT WAS CONFIRMED THAT THERE WERE ABOUT 3 PATIENT EXAMS ON THE SYSTEM AT ONE POINT AND THE SITE WAS ADAMANT ON DELETING PATIENT EXAMS ABOUT A WEEK AFTER THE CASE. IT WAS NOTED THAT THE CURRENT CASE HAD FIVE SCANS MERGED INTO THE EXAM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17350728 ↗
• MalfunctionJun 30, 2023Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED DURING A CRANIAL BIOPSY PROCEDURE. IT WAS REPORTED THAT AFTER THE SITE HAD FINISHED MERGING IMAGES, THE MONITOR CHANGED TO A "SPLASH SCREEN" AND LOG OUTS, AND WOULD NOT CHANGE. THE SITE REBOOTED THE SYSTEM AND WERE ABLE TO CONTINUE WITH THE SURGERY. TECHNICAL SERVICES (TS) RECOMMENDED UNINSTALLING AND REINSTALLING THE CRANIAL SOFTWARE. THIS OCCURRED INTRAOPERATIVELY, AND THERE WAS A SURGICAL DELAY OF LESS THAN ONE HOUR. THERE WAS NO REPORTED IMPACT TO PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17243153 ↗
• InjuryJun 23, 2023Imprecision; Imprecision

  ADDITIONAL INFORMATION WAS RECEIVED. THE PATIENT WAS REINTERVENED THE NEXT DAY, AND IN COMMUNICATION WITH THE SURGEON, THE PATIENT APPEARED TO NOT HAVE ANY POST OP ISSUES. THE PATIENT PRESENTED MOVEMENT IN ALL 4 EXTREMITIES. NO METRIC NUMBER OF INACCURACY WAS INFORMED BY THE SURGEON.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 17191071 ↗
• MalfunctionJun 16, 2023Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT WHILE HAMMERING/CHECKING FOR IMPLANT SIZE WITH A TRIAL, THE IMPACTED AREA OF THE TRACKER WAS BROKEN. NO BROKEN PIECES FELL INSIDE OF THE PATIENT NOR DID IT NEGATIVELY AFFECT THE OUTCOME OF THE SURGERY. THERE WAS NO REPORTED DELAY TO THE PROCEDURE. THERE WAS NO REPORTED IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17143065 ↗
• MalfunctionDec 21, 2022Connection Problem; Application Program Freezes or Fails to Launch; Connection Problem; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE ELECTROMAGNETIC NAVIGATION INTERFACE UNIT BOX WAS HAVING COMMUNICATION ISSUES. IT WAS NOT RECOGNIZED ON THE SYSTEM, AND IT SAID THERE WAS A COMMUNICATION ERROR. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16022965 ↗
• MalfunctionAug 26, 2022Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE LOCALIZER DISCONNECTED FOR THIS SYSTEM. IT WAS NOTED THAT IT WAS THE FIRST TIME SYSTEM HAS BEEN BOOTED UP AFTER 3 YEARS. THERE WERE ALSO TWO LIGHTS ON THE CAMERA, THERE WAS ONE LEFT BLINKING GREEN LED AND A  SOLID RIGHT LED. THERE WAS NO PATIENT INVOLVED. TROUBLESHOOTING DETERMINED THAT THERE WERE LOW TEMPERATURES FOR THE STATE OF THE CAMERA FROM A PREVIEW OF THE NDI TOOLBOX UTILITY AND THERE WAS ALSO A VOLTAGE ISSUE FOUND FOR THE EVENT LOGS. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15300770 ↗
• MalfunctionMar 9, 2021Connection Problem; Application Program Freezes or Fails to Launch; Connection Problem; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE ELECTROMAGNETIC NAVIGATION INTERFACE UNIT WAS NOT COMMUNICATING WITH THE NAVIGATION SYSTEM. IT WAS REPORTED THAT THE CONNECTION DISPLAYED WITH AN ORANGE LINE TO THE NAVIGATION SYSTEM AND THAT THE INTERFACE UNIT SHOWED AN ERROR CODE. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11445678 ↗
• MalfunctionMar 3, 2021Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  CAUSE OF THE ISSUE WAS REPORTED TO BE COMPUTER DAMAGE. ISSUE WAS RESOLVED AFTER A REPLACEMENT OF THE COMPUTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11404098 ↗
• MalfunctionAug 16, 2019Mechanical Problem; Mechanical Problem

  THE LOT NUMBER THAT IS ASSOCIATED TO THE PART IN THIS CASE IS N06738311.

  Patient problems: No Patient Involvement

  MAUDE report 8903365 ↗
• MalfunctionJun 24, 2019Human-Device Interface Problem; Temperature Problem; Human-Device Interface Problem; Temperature Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE. IT WAS REPORTED THAT WHEN SETTING UP THE SYSTEM, THE AXIEM BOX BOOTED TO A FAULT LIGHT AFTER BEING CONNECTED TO THE NAVIGATION SYSTEM. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS OBSERVED. A MEDTRONIC REPRESENTATIVE (REP) LATER REPORTED THAT HE WAS ON SITE AND NOTED THAT THE AXIEM CONTROLLER CONTINUED TO SHOW THE FAULT LIGHT AFTER BEING POWERED ON FOR A COUPLE OF MINUTES. UPON FURTHER REVIEW OF THE EMITTER DETAILS, THE REP SAW THAT THE DETAILS SHOWED "HIGH TEMPERATURE" ERRORS. THE REP WAS ABLE TO CONFIRM THAT THE FAILURE WAS WITH THE CONTROLLER AND NOT THE EMITTER AS HE WAS ABLE TO BORROW A SECONDARY AXIEM CONTROLLER TO USE IT WITH THE ORIGINAL EMITTER AND IT DID NOT HAVE AN ISSUE.

  Patient problems: No Patient Involvement

  MAUDE report 8728767 ↗
• InjuryJun 17, 2019Imprecision; Imprecision

  MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE PATIENT HAD A SECOND AND SUCCESSFUL PROCEDURE TEN DAYS AFTER THE REPORTED EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8704073 ↗
• MalfunctionJun 15, 2019Environmental Compatibility Problem; Environmental Compatibility Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED THAT WHEN THE EQUIPMENT STARTED, NONE OF THE SCREENS SHOWED ANYTHING. THEY STAYED SHOWING "DVI SEARCHING" AND THERE WAS NO SIGNAL COMING FROM THE BLACK BOX. THERE WERE MONITORS WITH FIBER CONNECTIONS AND DVI CONNECTIONS BUT NONE WAS RECEIVING IMAGE. THE MONITOR THAT STAYED INSIDE THE BLACK BOX DIDN'T RECEIVED SIGNAL AS WELL. IT WAS SUSPECTED THAT THE PROBLEM WAS THE OPTICAL TRANSCEIVER BUT THE DVI'S MONITORS WERE NOT WORKING AS WELL. BECAUSE OF THIS, IT WAS SUSPECTED THAT THE PROBLEM COULD BE THE COMPUTER OR AT THE FIRST DVI SPLITTER. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED. TECHNICAL SERVICES (TS) REQUESTED THAT THE DVI SPLITTER, MULTIOUT POWER SUPPLY, AND COMPUTER OUTPUTS BE CHECKED. AN UPDATE WAS PROVIDED THAT THE MULTIOUT POWER SUPPLY WAS OK. IT WAS REPORTED THAT THE PROBLEM WAS THE COMPUTER; IT COULD NOT STAY ON. WHEN THE SYSTEM WAS STARTED, THE COMPUTER STARTED AND STAYED ON FOR LESS THAN FIVE SECOND AND THEN REBOOTED. IT WAS NOTED THAT AFTER SOME SECOND, IT REBOOTED AGAIN AND AGAIN. THE COMPUTER OF THE SYSTEM WAS REPLACED, AND THE ISSUE RESOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 8702276 ↗
• MalfunctionMay 28, 2019Human-Device Interface Problem; Human-Device Interface Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING NAVIGATION SYSTEM WHILE OUTSIDE OF PROCEDURE. IT WAS REPORTED THAT THE SITE HAD AN ISSUE WHERE THE SOFTWARE WAS DISPLAYING THAT THE CAMERA WAS NOT CONNECTED AND ALL THE TOOL CARDS WERE DISPLAYED AS RED. THE SYSTEM HAD NO TRACKING ISSUES DURING A CASE PERFORMED IN THE MORNING. REPRESENTATIVE REPORTED THAT THE OPERATING ROOM (OR) EXPERIENCED AN ELECTRIC SURGE. REPRESENTATIVE WAS UNABLE TO CONFIRM IF THE CAMERA DISPLAYED AS DISCONNECTED BEFORE OR AFTER THE SURGE. THE NDI TOOL BOX CONFIGURATION UTILITY WAS CHECKED ON FOR THE POSITIONING SENSOR UNIT (PSU) WHICH INDICATED NO FAILURES. THE EVENT LOGS ALSO DID NOT SHOW ANY ERRORS. REPRESENTATIVE CONFIRMED THAT UNPLUGGING THE SYSTEM FROM THE WALL AND REPLUGGING IT FIXED THE ISSUE. THE NAVIGATION SYSTEM WAS ACTIVELY TRACKING AN INSTRUMENT. THERE WAS NO PATIENT PRESENT WHEN THE ISSUE OCCURRED.

  Patient problems: No Patient Involvement

  MAUDE report 8648068 ↗
• MalfunctionNov 16, 2018Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED THAT DURING THE NAVIGATE TASK OF A CRANIAL BIOPSY PROCEDURE, THE SYSTEM WAS ON THE REGISTER SCREEN AND WAS UNRESPONSIVE. THEY REBOOTED AND WERE ABLE TO PROCEED WITH THE CASE, HOWEVER PART WAY THROUGH THE CASE THE SYSTEM EXITED TO A BLACK BOOT TEXT SCREEN AND BECAME UNRESPONSIVE. AFTER 10 MINUTES THEY HARD BOOTED THE SYSTEM AND WERE ABLE TO COMPLETE THE CASE. 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 8079526 ↗
• MalfunctionJul 17, 2018Computer Software Problem; Computer Software Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SYSTEM WAS HAVING A POWER CYCLING ISSUE. WHEN THE SYSTEM WAS BOOTING UP THE COMPANY SPLASH SCREEN WAS REPEATEDLY SHOWING UP.

  Patient problems: No Patient Involvement

  MAUDE report 7694606 ↗
• MalfunctionJul 11, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED FOR A CRANIAL RESECTION PROCEDURE. IT WAS REPORTED THAT THE LOCALIZER OF THE SYSTEM DISCONNECTED AND CYCLED POWER 4 TIMES. TURNING THE BOOM POWER SWITCH OFF AND ON SEEMED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT IMPACT REPORTED AND A DELAY TO SURGERY OF LESS THAN ONE HOUR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7679413 ↗
• InjuryJan 10, 2018Imprecision; Device Operates Differently Than Expected; Imprecision; Device Operates Differently Than Expected

  A MEDTRONIC REPRESENTATIVE REPORTED THAT WHILE IN A CRANIAL RESECTION PROCEDURE AN ALLEGED INACCURACY OCCURRED WITH THE NAVIGATION SYSTEM. AFTER REGISTERING AND CHECKING ACCURACY, THE SURGEON FELT THAT THEY WERE ACCURATE AND CONTINUED WITH A TUMOR RESECTION. HOWEVER, FOLLOWING THE RESECTION, THE SURGEON TOOK AN IMRI SCAN WHICH THEY MERGED WITH THE PRE-OP MR AND THEY SAW THAT THE TUMOR WAS STILL VISIBLE IN THE INTRAOPERATIVE MAGNETIC RESONANCE IMAGING (IMRI) SCAN AND NONE OF IT HAD BEEN REMOVED. THE SURGEON THEN CHECKED THE ACCURACY ON THE IMRI AND IT WAS ACCURATE. THE AREA RESECTED WAS REPORTED TO BE VERY CLOSE TO THE ACTUAL LOCATION OF THE TUMOR BUT WAS AT LEAST 5MM OFF. THE SITE THEN TOOK A SMALL SAMPLE AND DECIDED TO CLOSE AND WILL TAKE AN IMAGE ON A FOLLOWING DAY. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF LESS THAN 1 HOUR DUE TO THIS ISSUE AND THE PATIENT WAS AFFECTED AS A RESULT.

  Patient problems: Brain Injury; Iatrogenic Source; Tissue Damage

  MAUDE report 7180784 ↗
• MalfunctionJan 8, 2018No Display/Image; Display or Visual Feedback Problem; Device Operates Differently Than Expected; No Display/Image; Display or Visual Feedback Problem; Device Operates Differently Than Expected

  A MEDTRONIC REPRESENTATIVE REPORTED THAT WHILE IN A PROCEDURE THE TOUCH SCREEN MONITOR ON THE NAVIGATION SYSTEM SHOWED "SEARCHING FOR DVI CONNECTION". THE MONITOR IS NOT FUNCTIONING. THE SITE USED THE OTHER MONITORS AND PROCEEDED WITH THE CASE. THERE WAS NO DELAY TO THE PROCEDURE AS A RESULT OF THIS ISSUE AND NO IMPACT ON THE PATIENT OUTCOME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7172031 ↗
• MalfunctionDec 27, 2017No Display/Image; Device Operates Differently Than Expected; No Display/Image; Device Operates Differently Than Expected

  A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE OUTSIDE OF A PROCEDURE, THE IMAGING SYSTEM DISPLAYED THAT THE TOUCHSCREEN WAS SEARCHING FOR A DVI CONNECTION. THE CONFIGURATION OF THE FIBER OPTIC CABLE WAS MANUALLY ADJUSTED TO DIFFERENT PORTS ON THE NAVIGATION SYSTEM TO RESTORE FUNCTIONALITY. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 7147472 ↗