N/A 9734062Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00613994665928), received between Nov 15, 2018 and Jul 7, 2022 — classified as 10 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 7, 2022Connection Problem; Connection Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE CAMERA FOR THE NAVIGATION SYSTEM, NIU, AND BOOM MONITOR WAS REMOVED, AS WELL AS THE CABLING PULLED FOR RENOVATION OF THE OPERATING ROOM.  IT WAS NOTED THAT THE SYSTEM WOULD BE REINSTALLED ONCE THE RENOVATION WAS COMPLETE.  IT WAS FURTHER REPORTED THAT THERE WAS NO CAMERA CONNECTION.  UPON RE-INSTALLING THE SYSTEM, THE CAMERA WOULD NOT CONNECT AND IT HAD NO LIGHTS ON.  THE NEXT STEP WAS TO REPLACE THE CABLES FROM THE SYSTEM CONTROL UNIT (SCU) TO THE POSITIONING SENSOR UNIT (PSU).  NO PATIENT WAS PRESENT WHEN THE ISSUE WAS IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14951693 ↗
• MalfunctionAug 3, 2021Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE CAMERA WAS SHOWING AN AMBER LIGHT, BUT STILL FUNCTIONING. THIS WAS DISCOVERED PRIOR TO A CASE WITH NO PATIENT PRESENT. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE CAMERA WOULD BE REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12269697 ↗
• MalfunctionMar 24, 2021Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE EXACT CAUSE WAS UNKNOWN, BUT THAT IT WAS AN ISSUE WITH THE CAMERA AND LOCALIZER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11561852 ↗
• MalfunctionAug 17, 2020Connection Problem; Connection Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED THAT THE LOCALIZER WAS INTERMITTENTLY DISCONNECTING. IT WAS NOTED THAT THE CAMERA HAD BEEN REPLACED AND NO DAMAGE WAS NOTICED ON THE CAMERA CABLES. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Patient Involvement

  MAUDE report 10413877 ↗
• MalfunctionMar 9, 2020Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM THAT WAS USED DURING A CRANIAL RESECTION PROCEDURE. IT WAS REPORTED THAT THE LOCALIZER WAS DISCONNECTED. THE LOCALIZER WAS WORKING AND THEN THE SITE TOOK AN IMRI WITH "IMRIS" AND MERGED IT WITH THE SCAN IN THE SOFTWARE. THE MANUFACTURER REPRESENTATIVE REBOOTED THE SYSTEM AND THE NETWORK INTERFACE UNIT (NIU) IN THE ROOM, BUT THIS DID NOT RESOLVE THE ISSUE. AT THIS POINT THE SURGEON HAD RESECTED ENOUGH TUMOR THAT HE WAS COMFORTABLE ABORTING NAVIGATION AND PROCEEDING WITH THE CASE. THERE WAS NO KNOWN IMPACT ON THE PATIENT. THERE WAS A REPORTED DELAY OF LESS THAN ONE HOUR DUE TO THIS ISSUE. IT WAS CONFIRMED THAT THE SYSTEM IS FUNCTIONING AS INTENDED AFTER PRESSING THE RESET BUTTON ON THE BACK OF THE NIU.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9806660 ↗
• MalfunctionJun 13, 2019Human-Device Interface Problem; Human-Device Interface Problem

  ADDITIONAL INFORMATION WAS RECEIVED STATING THE REPORTED EVENT OCCURRED DURING AN ANTERIOR CERVICAL DISCECTOMY AND FUSION PROCEDURE AND DID NOT CAUSE ANY SURGICAL DELAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8695618 ↗
• MalfunctionMay 7, 2019Output Problem; Output Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE OF PROCEDURE. IT WAS REPORTED THAT THE CAMERA WAS CYCLING. THE NDI TOOLBOX CONFIGURATION WAS SHOWING THAT THE FIRMWARE WAS INCOMPATIBLE. THE REPRESENTATIVE REPLACED THE TRANSCEIVER IN THE NUI AND WAS ABLE TO RUN THE INSTALLER. THE ISSUE WAS THEN RESOLVED. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Patient Involvement

  MAUDE report 8586566 ↗
• MalfunctionApr 19, 2019Human-Device Interface Problem; Human-Device Interface Problem

  MEDTRONIC RECEIVED INFORMATION FROM A MANUFACTURER REPRESENTATIVE (REP) REGARDING A NAVIGATION SYSTEM OUTSIDE OF A PROCEDURE. THE REP INDICATED THAT THE CAMERA FAULT LIGHT WAS FLASHING AND THE SYSTEM DISPLAYED LOCALIZER DISCONNECTED. THE SITE CONTINUED THE CASE WITH A DIFFERENT SYSTEM AND NO PATIENT WAS PRESENT AT THE TIME OF THE ISSUE. THE REP CONTINUED TROUBLESHOOTING AND WHEN THE NDI TOOLBOX WAS CHECKED AND IT WAS UNABLE TO CONNECT TO THE PSU. THE REP PUSHED THE RESTART SWITCH ON THE BACK OF THE NIU WITH NO CHANGE AND THE USB VIEW WAS CHECK AND THE I/O HUB WAS FOUND TO BE MISSING. ON THE TRANSCEIVER IN THE RACK THE POWER LIGHTS WERE MISSING ON THE OPT LINK AND THE USB LINK. WHEN THE REP WAS MOVING THE RACK TO OPEN THE SIDE PANEL THEY SAW DISCONNECTED CABLES. THE REP WAS UNSURE IF THE ACCIDENTALLY DISCONNECTED THE CABLES DURING THE MOVE OR IF THEY WERE ALREADY DISCONNECTED. THE REP LATER TRIED CHANGING THE CAMERA FROM THE SYSTEM TO ANOTHER SYSTEM AND THE NEW SYSTEM ALSO DID NOT FUNCTION SUGGESTING THE ISSUE WAS WITH THE CAMERA SO A NEW CAMERA WAS SHIPPED.

  Patient problems: No Patient Involvement

  MAUDE report 8533011 ↗
• MalfunctionJan 30, 2019Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED FOR A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT PRE-OPERATIVELY, THE SYSTEM DISPLAYED "LOCALIZER NOT CONNECTED". THE SYSTEM WAS RESTARTED FOUR TIMES WITHOUT RESOLVE. THE SITE USED A DIFFERENT NAVIGATION SYSTEM TO CONTINUE THE CASE. THERE WAS NO REPORTED IMPACT TO PATIENT OUTCOME AND THERE WAS NO SURGICAL DELAY.

  Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 8290087 ↗
• MalfunctionNov 15, 2018Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED INTRA/PERI-OPERATIVELY OF A CRANIAL RESECTION PROCEDURE. IT WAS REPORTED THAT THE SYSTEM EXITED. THEY WERE NAVIGATING AND PART WAY THROUGH IT EXITED TO A BOOT TEXT SCREEN. THE SITE CONFIRMED THAT IT EVENTUALLY SWITCHED BACK TO THE REGISTER TASK WITHOUT BEING TOUCHED. THE SITE WAS ABLE TO PROCEED. THERE WAS A LESS THAN 1-HOUR DELAY TO THE PROCEDURE AND NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8074666 ↗