Stealthstation® S7™ 9733857 (UDI 00613994450951)Recalls & reported problems

Summary

The FDA's MAUDE database contains 87 adverse event reports that list this exact device (DI 00613994450951), received between Jul 3, 2018 and Feb 9, 2022 — classified as 2 injuries, 85 malfunctions.

The most frequently reported specific device problem is “Human-Device Interface Problem” (20 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 87 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 9, 2022Imprecision; Imprecision

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A SPINAL PROCEDURE. DURING A PROCEDURE (L4-L5 FIXATION), AFTER THE INITIAL IMAGE ACQUISITION, A SCREW WAS INSERTED USING BOTH THE NAVIGATION AND A C-ARM.  AFTER INSERTING FOUR SCREWS, ONCE SCREW WAS DETERMINED TO BE MISALIGNED IN THE C-ARM IMAGE. IT WAS CONFIRMED ALL FOUR PLACED SCREWS WERE MISALIGNED WITH A CONFIRMATION IMAGE ACQUISITION FROM THE IMAGING SYSTEM. AFTER REMOVING THE FOUR SCREWS, THEY WERE REINSERTED. THE PATIENT'S VITALS AND OTHER CONDITIONS DID NOT CHANGE. THE REPORTED ISSUE RESULTED IN A PROCEDURE DELAY OF LESS THAN ONE HOUR. THE PROCEDURE WAS COMPLETED WITH CONTINUED USE OF THE IMAGING SYSTEM. THERE WAS NO PATIENT INVOLVEMENT. AFTER THE PROCEDURE, THE ACCURACY WAS CHECKED WITH THE IMAGING AND NAVIGATION SYSTEMS. NO MIGRATION COULD BE CONFIRMED IN A TEST SCAN USING THE BONE MODEL. AFTER THE EVENT, THE PROCEDURE WAS PERFORMED AND THE BEHAVIOR WAS NOT REPRODUCED. THERE WAS NO PROBLEM WITH DEVICE ACCURACY. THE PATIENT'S BONE WAS REPORTED TO BE HARD AND IT WAS HIT WITH A HAMMER WHEN THE SCREW WAS IMPLANTED AND THE REFERENCE WAS MISALIGNED. IT WAS POSSIBLE THE ERROR OCCURRED AND THE SCREW WA

  Patient problems: Unspecified Tissue Injury

  MAUDE report 13501757 ↗
• MalfunctionJan 10, 2022Imprecision; Imprecision

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED IN A CRANIAL BIOPSY PROCEDURE. IT WAS REPORTED THAT THE HEALTH CARE PROFESSIONAL (HCP) DID A BIOPSY WITH A BIOPSY NEEDLE. THE HCP MISSED THE TUMOR BECAUSE OF THE ALLEGED INACCURACY OF THE GUIDANCE SCREEN. THE REPRESENTATION OF THE NEEDLE ON THE SCREEN GAVE THE WRONG DEPTH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13205159 ↗
• MalfunctionMay 27, 2021Communication or Transmission Problem; Communication or Transmission Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT WHILE ATTEMPTING TO ACQUIRE PATIENT IMAGES WITH A NON-MEDTRONIC IMAGING SYSTEM, IT WAS NOT POSSIBLE TO TRANSFER IMAGES. THE PATIENT NAME AND DATE SHOWED UP ON THE NAVIGATION SYSTEM BUT NO IMAGES APPEARED TO BE PRESENT. THEY ATTEMPTED TO MANUALLY PUSH TO THE NAVIGATION SYSTEM WITH THE SAME RESULT. THE ETHERNET CABLE WAS SWITCHED WITH NO CHANGE. ON THE THIRD ATTEMPT TO MANUALLY TRANSFER, THE SYSTEM GAVE THE MESSAGE "TRANSFER ERROR PLEASE VERIFY CORRECT SCAN WAS SENT". THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11893741 ↗
• MalfunctionMar 15, 2021Display or Visual Feedback Problem; Display or Visual Feedback Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED OUTSIDE OF A PROCEDURE THAT "NO INPUT DETECTED" WAS SEEN ON BOTH MONITORS. A REBOOT WAS ABLE TO RESOLVE THE ISSUE. WHEN THE SYSTEM WAS CHECKED LATER, THE MANUFACTURER REPRESENTATIVE WENT INTO CRANIAL, CLICKED STANDARD PROFILE, AND IT WENT TO A BLUE SCREEN WHERE THE MANUFACTURER LOGO WAS SEEN (CRANIAL APPLICATION BUT NO GRAPHIC USER INTERFACE SEEN). THE BLACK LOGO SCREEN WAS NOT SEEN AS IT NORMALLY IS WHEN THE SYSTEM IS TURNED ON. A HARD SHUTDOWN AND RESTART WAS DONE WHICH SEEMED TO RESOLVE THE ISSUE. THE SUSPECTED CAUSE OF THE ISSUE IS THAT THE COMPUTER IS FAILING INTERMITTENTLY. THERE WAS NO PATIENT INVOLVEMENT. BASED ON SOFTWARE ANALYSIS COMPLETED (B)(6) 2021, THIS EVENT WAS REASSESSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11490286 ↗
• MalfunctionAug 7, 2020Display or Visual Feedback Problem; Display or Visual Feedback Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED IN A CRANIAL RESECTION. IT WAS REPORTED THAT THERE WAS A NOISE COMING FROM THE SURGEON MONITOR, BUT NOTHING WAS DISPLAYED ON THE MONITOR SCREEN. IN THE INITIAL REPORT FROM THE MEDICAL ENGINEER (ME), IT WAS STILL UNKNOWN WHETHER THE CAUSE OF THE ISSUE WAS THE MONITOR OR THE CABLE. HOWEVER, THE CABLE WAS REPLACED WITHIN ONE YEAR. FOR THE TIME BEING, OUTPUT WAS PERFORMED FROM THE VGA TERMINAL OF THE IO PANEL TO ANOTHER MONITOR. THERE WAS NO DELAY TO THE PROCEDURE. NO IMPACT ON PATIENT OUTCOME. ON 2020-AUG-07 IT WAS REPORTED THAT AT THE BEGINNING OF THE PROCEDURE, ALTHOUGH SOMETIMES THERE IS STATIC ON IT, IT WAS ABLE TO BE USED. BUT IT SUDDENLY TURNED BLACK AND WASN'T ABLE TO USE IT IN THE MIDDLE OF THE PROCEDURE. ALTHOUGH THE STAFF PLUGGED OUT AND IN TO RESOLVE THE ISSUE, IT WASN'T RESOLVED THEN. THE MONITOR WAS NOT ABLE TO BE USED IN THE MIDDLE OF THE PROCEDURE AND THERE WASN'T ANOTHER MONITOR ON THE SYSTEM WHEN THE ISSUE OCCURRED SO ANOTHER MONITOR WAS CARRIED IN AND REPLACED. THE MONITOR DID NOT LOSE FUNCTIONALITY WHEN THE NOISE WAS OCCURRING; NO ABNORMAL SOUND WAS REPORTED. THE NOISE THAT WAS DESCRIBED MEANS S

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10380142 ↗
• MalfunctionJul 20, 2020Communication or Transmission Problem; Application Program Freezes or Fails to Launch; Communication or Transmission Problem; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT. THE SITE INDICATED A "RED CROSS" AFTER TRANSFERRING A DATASET VIA NETWORK OR CD-R. THE "ERROR IN DATABASE" MESSAGE WAS OBSERVED ON THE SYSTEM. THE SYSTEM COMPUTER WOULD BE REPLACED.

  Patient problems: No Patient Involvement

  MAUDE report 10295657 ↗
• MalfunctionJul 9, 2020Human-Device Interface Problem; Human-Device Interface Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED OUTSIDE OF A PROCEDURE THAT THE OPTICAL SYSTEM WAS NOT WORKING. NO PATIENT WAS PRESENT AT THE TIME OF THE EVENT. NO FURTHER INFORMATION WAS RECEIVED.

  Patient problems: No Patient Involvement

  MAUDE report 10252970 ↗
• MalfunctionJun 3, 2020Imprecision; Mechanics Altered; Imprecision; Mechanics Altered

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A CRANIAL PROCEDURE. IT WAS REPORTED THAT THERE WAS INACCURACY OF 10 MM OFF THE SKULL. THE MANUFACTURER REPRESENTATIVE BELIEVED IT WAS DUE TO THE VERTEK ARM MOVING WHILE THE PATIENT WAS BEING DRAPED. THE SURGEON COMPLETED THE PROCEDURE WITHOUT NAVIGATION. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10114407 ↗
• MalfunctionApr 10, 2020Human-Device Interface Problem; Human-Device Interface Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING AN NAVIGATION SYSTEM BEING USED FOR A CRANIAL RESECTION PROCEDURE. DURING PREPARATION, AN "X" WAS DISPLAYED ON THE CAMERA AND ALL INDICATORS DID NOT ILLUMINATE. THE CAMERA DETAILS STATED THE "LOCALIZER WAS NOT CONNECTED". SINCE THE LAMP OF THE SENSOR CONTROL UNIT (SCU) WAS NOT ILLUMINATED, THE SCU WAS REPLACED AND THE ISSUE RESOLVED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9948953 ↗
• MalfunctionMar 11, 2020Material Integrity Problem; Output Problem; Material Integrity Problem; Output Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE CAMERA CONNECTION WAS LOOSE. THE PASSIVE FRAME WAS TEMPORARILY NOT VISIBLE.

  Patient problems: No Patient Involvement

  MAUDE report 9819411 ↗
• MalfunctionDec 20, 2019Computer Software Problem; Computer Software Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED FOR A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT INTRA-OPERATIVELY, THE SITE HAD ISSUES WITH THE SCREW SIZE STAYING THE SAME. IT WAS KNOWN THAT THEY WERE LOOKING AT A 60 MILLIMETER SCREW AND THEY WERE TRYING TO GET A 40 MILLIMETER SCREW BUT THE SOFTWARE WOULD ONLY SHOW THE 60 MILLIMETER SCREW. THE PROCEDURE WAS COMPLETED USING THE NAVIGATION SYSTEM AND THERE WAS NO REPORTED IMPACT TO PATIENT OUTCOME. IT WAS UNKNOWN IF THERE WAS ANY DELAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9504110 ↗
• MalfunctionDec 20, 2019Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED FOR CRANIAL RESECTION. IT WAS REPORTED THAT INTRA-OPERATIVELY, BEFORE REGISTRATION, THE SITE HAD BEEN UNABLE TO TRACK INSTRUMENTS. THE SITE WAS ABLE TO CLICK AROUND IN THE SOFTWARE, BUT NOT ABLE TO TRACK ANY INSTRUMENTS. THE SITE BROUGHT IN A DIFFERENT NAVIGATION SYSTEM TO PROCEED. THE PROCEDURE WAS COMPLETED AND THERE WAS NO REPORTED IMPACT TO PATIENT OUTCOME. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF LESS THAN ONE HOUR DUE TO THIS ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9503736 ↗
• MalfunctionOct 29, 2019Human-Device Interface Problem; Human-Device Interface Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED FOR A CRANIAL RESECTION PROCEDURE. THE REGISTRATION WAS DELETED AFTER CHANGING PROCEDURES. AFTER SUCCESSFULLY REGISTERING THE PATIENT, THE SITE REVERTED TO THE PROCEDURE SCREEN AND CHANGED FROM A TUMOR RESECTION PROCEDURE TO A BIOPSY PROCEDURE. THE PROCEDURE WAS COMPLETED BY ABORTING NAVIGATION. THE ISSUE RESULTED IN LESS THAN ONE HOUR PROCEDURE DELAY. THERE WAS NO IMPACT ON PATIENT OUTCOME. NO COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9249970 ↗
• InjuryOct 15, 2019Imprecision; Imprecision

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED THAT AFTER A SACROILIAC AND THORACOLUMBAR PROCEDURE IT WAS DISCOVERED THAT A SCREW HAD ALLEGEDLY BEEN MISPLACED. A WAKE-UP TEST WAS PERFORMED AND THE PATIENT WAS SAID TO HAVE LOST SENSATION IN HER LEGS. THERE WAS NO DELAY TO THE PROCEDURE REPORTED.

  Patient problems: Tissue Damage

  MAUDE report 9190183 ↗
• MalfunctionSep 30, 2019Human-Device Interface Problem; Human-Device Interface Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE. IT WAS REPORTED THAT THE CAMERA DID NOT WORK. THE CAMERA FAILED TO START. THERE WAS NO PATIENT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 9137778 ↗
• MalfunctionSep 26, 2019Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED FOR A CRANIAL RESECTION PROCEDURE. IT WAS REPORTED THAT INTRA-OPERATIVELY, THE SYSTEM WAS GETTING A SR MANAGER FAILURE WHEN LAUNCHING THE SOFTWARE. IT WAS NOT POSSIBLE TO GET INTO CRANIAL AFTER MULTIPLE FORCE SHUTDOWN ATTEMPTS. IT WAS POSSIBLE TO GET INTO ADMINISTRATOR WITHOUT ISSUE. AN ATTEMPT WAS MADE TO UNINSTALL AND RE INSTALL THE SOFTWARE BUT THE ISSUE CONTINUED TO OCCUR. IT WAS STILL NOT POSSIBLE TO LAUNCH CRANIAL. THE SITE USED A DIFFERENT NAVIGATION SYSTEM TO COMPLETE THE CASE. THE PROCEDURE WAS COMPLETED USING THE NAVIGATION SYSTEM AND THERE WAS NO REPORTED IMPACT TO PATIENT OUTCOME. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF LESS THAN ONE HOUR DUE TO THIS ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9123631 ↗
• MalfunctionSep 23, 2019Output Problem; Output Problem

  MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE SITE HAD CHANGED THE SURGEON MONITORS BACK AND FORTH SINCE THE REPORTED ISSUE SO IT WAS UNKNOWN WHICH MONITOR WAS FLICKERING. THE PROBLEM WAS NO LONGER AN ISSUE. THE SITE WAS UNAWARE OF THE CAUSE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9104997 ↗
• MalfunctionJul 30, 2019Output Problem; Output Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE ISSUE DID NOT OCCUR DURING SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8841712 ↗
• MalfunctionJul 25, 2019Environmental Compatibility Problem; Environmental Compatibility Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE. IT WAS REPORTED THAT INTERMITTENTLY THE SYSTEM SHUT DOWN WHEN THE CUSTOMER USED THE AXIEM SYSTEM AND OPTICAL CAMERA. IT WAS STATED THAT THE SYSTEM WAS PLUGGED IN TO A KNOWN FUNCTIONAL ELECTRICAL OUTLET WHEN THE SYSTEM SHUT DOWN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8825875 ↗
• MalfunctionJul 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT ELECTROMAGNETIC GENERATOR AND FOOT SWITCH WERE NOT WORKING WELL.

  Patient problems: No Patient Involvement

  MAUDE report 8823200 ↗
• MalfunctionJun 20, 2019Computer Software Problem; Computer Software Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED IN A CERVICAL SPINE PROCEDURE. IT WAS REPORTED THAT THE IMAGE WAS CENTERED IN TRAJECTORY1, TRAJECTORY2, AND AXIAL; BUT IN THE SAGITTAL VIEW THE IMAGE SHIFTED TO THE TOP LEFT POINT WHEN THE SCREW PROJECTION COULD NOT BE SEEN ON THE C2. WHEN THE SURGEON BRINGS IN THE PASSIVE PLANAR PROBE THE IMAGE IN THE SAGITTAL VIEW STAYS SHIFTED AND THE CROSSHAIRS MOVE TO THE TOP LEFT AS WELL. WHEN THE HEALTH CARE PROFESSIONAL (HCP) PUSHED THE RE-CENTER BUTTON IT RESOLVED THE ISSUE MOMENTARILY. THE HCP COULD MOVE THE IMAGE IN THE SAGITTAL VIEW TO RE-CENTER IT. THE SURGEON SET THE CROSSHAIR SETTINGS AS STATIONARY. THE SURGEON STATED THAT WHEN THE PROCEDURE WAS PLANNED THE SAGITTAL VIEW WAS SHIFTED AS WELL. THERE WAS NO DELAY TO THE PROCEDURE. NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8719987 ↗
• MalfunctionJun 20, 2019Human-Device Interface Problem; Human-Device Interface Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM WHILE OUTSIDE OF PROCEDURE. IT WAS REPORTED THAT THE NAVIGATION SYSTEM WAS NOT RECOGNIZING THE EMITTER. THERE WAS NO PATIENT PRESENT WHEN THE ISSUE OCCURRED.

  Patient problems: No Patient Involvement

  MAUDE report 8717446 ↗
• MalfunctionJun 18, 2019Human-Device Interface Problem; Human-Device Interface Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED OUTSIDE OF A PROCEDURE THAT DURING A SITE VISIT, THE SITE TOLD THE MANUFACTURER REPRESENTATIVE THAT THEY ARE HAVING PROBLEMS WITH MOUNTING THE UNIVERSAL SERIAL BUS (USB) STICK. SO THE PATIENT DATA COULD NOT LOAD FROM USB TO THE SYSTEM. NO PATIENT WAS PRESENT AT THE TIME OF THE EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8707607 ↗
• MalfunctionJun 10, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM WHILE OUTSIDE OF PROCEDURE. IT WAS REPORTED THAT THE AXIEM CABLE COVER WAS FOUND BROKEN DURING INSPECTION. THERE WAS NO PATIENT PRESENT WHEN THE ISSUE OCCURRED.

  Patient problems: No Patient Involvement

  MAUDE report 8685641 ↗
• MalfunctionJun 10, 2019Human-Device Interface Problem; Output Problem; Human-Device Interface Problem; Output Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF PROCEDURE. IT WAS REPORTED THAT DURING SETUP, THEY DROPPED THEIR EMITTER AND IT BEGAN HAVING ISSUES TRACKING INSTRUMENTS. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Patient Involvement

  MAUDE report 8684060 ↗