N/A 9733658Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00613994386021), received between Dec 5, 2016 and Jul 30, 2018 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 30, 2018Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED FOR A CRANIAL RESECTION PROCEDURE. IT WAS REPORTED THAT THE CRANIAL FRAME AND PASSIVE PLANAR BLUNT INSTRUMENTS WERE FLICKERING CONTINUOUSLY. THE SURGEON WAS ABLE TO REGISTER THE PATIENT, BUT THE FLICKERING CONTINUED. TRACKING VIEW SHOWED THE CAMERA WAS POSITIONED TOO CLOSE IN THE FIELD OF VIEW. THE SITE RE-POSITIONED THE CAMERA, BUT THIS DID NOT RESOLVE THE ISSUE. CHANGING OUT SPHERES DID NOT HELP. THE SITE COVERED UP EACH CRANIAL FRAME SPHERE AND DISCOVERED ONE THAT WHEN COVERED HELPED THE FLICKERING A LITTLE BIT. IT WAS RECOMMENDED THAT THE SITE REPLACE THE SPHERE OR NOT USE THAT PARTICULAR SPHERE ON THE FRAME. REMOVING THE SPHERE DID NOT HELP AND THE INSTRUMENT AND FRAME CONTINUED TO FLICKER. THEY PUT A NEW SPHERE ON THE FRAME AND THE SYSTEM STILL FLICKERED. TOWARDS THE END OF THE CASE THE CAMERA CONTINUED TO TRACK WITHOUT FLICKERING. DELAY TO SURGERY 15 MINUTES. NO PATIENT IMPACT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7731747 ↗
• MalfunctionFeb 7, 2018Application Interface Becomes Non-Functional Or Program Exits Abnormally; Device Operates Differently Than Expected; Application Interface Becomes Non-Functional Or Program Exits Abnormally; Device Operates Differently Than Expected

  A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A CRANIAL BIOPSY, THE NAVIGATION SYSTEM EXITED THE APPLICATION SOFTWARE WITHOUT PROMPT FROM THE USER. IT WAS REPORTED THAT PRIOR TO THE PROCEDURE PREP, THE NAVIGATION SYSTEM FUNCTIONED AS DESIGNED. PRIOR TO THE PATIENT BEING INTUBATED, THE APPLICATION SOFTWARE EXITED WITHOUT PROMPT FROM THE USER AND THE SURGEON OPTED TO DISCONTINUE WITH THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. THERE WAS NO KNOWN IMPACT ON PATIENT OUTCOME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7248794 ↗
• InjuryMay 12, 2017Imprecision; Imprecision

  A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A CRANIAL PROCEDURE, THE SURGEON ALLEGED AN INACCURACY OCCURRED. THE SURGEON ALLEGED THE INACCURACY WAS APPROXIMATELY 3 CENTIMETERS, OCCURRING WHEN CREATING A POSTERIOR BONE FLAP. THE PHYSICIAN ASSISTANT (PA) PERFORMED TWO TRACER REGISTRATIONS AND THEY WERE HAPPY WITH THE SECOND RESULT. WHEN NAVIGATING TO THE POSTERIOR TUMOR, A BONE FLAP WAS MADE, HOWEVER, THEN THEY COULD NOT ACCESS THE POSTERIOR PART OF THE TUMOR SO THE FLAP WAS ENLARGED AND THE SURGEON ALLEGED A NAVIGATION INACCURACY. THE SURGEON COMPLETED THE PROCEDURE WITH THE USE OF THE NAVIGATION SYSTEM. THERE WAS NO DELAY OF THERAPY.

  Patient problems: Iatrogenic Source; Injury

  MAUDE report 6564247 ↗
• MalfunctionFeb 14, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  A MEDTRONIC REPRESENTATIVE REPORTED THAT DURING A CRANIAL CASE WHEN THE SYSTEM WAS BOOTING UP, THE CAMERA WOULD CONTINUE BEEPING AND WOULD NOT CONNECT TO THE SYSTEM. REBOOTING THE SYSTEM DID NOT RESOLVE THE ISSUE. THE MDT REP REMOVED ALL OF THE COMMUNICATION/POWER CABLES AND RESEATED AND REBOOTED AGAIN WHICH DID NOT RESOLVE THE ISSUE. THE CASE WAS COMPLETED WITHOUT NAVIGATION. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF LESS THAN 1 HOUR DUE TO THIS ISSUE. THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6330718 ↗
• MalfunctionDec 28, 2016Imprecision; Device Operates Differently Than Expected; Imprecision; Device Operates Differently Than Expected

  A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A CRANIAL RESECTION, THE SURGEON FELT INACCURATE DURING THE PROCEDURE AT TIMES. THE REPRESENTATIVE REPORTED THAT THE SURGEON CONTINUED TO USE THE NAVIGATION SYSTEM WHILE ALSO HAVING AN ULTRASOUND PRESENT FOR ADDITIONAL USE. NO ADDITIONAL INFORMATION WAS PROVIDED. THERE WAS NO REPORTED DELAY TO THE PROCEDURE DUE TO THIS ISSUE. THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6210205 ↗
• MalfunctionDec 5, 2016Imprecision; Imprecision

  A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A CRANIAL RESECTION PROCEDURE, THE SURGEON ALLEGED AN INACCURACY OCCURRED. THE INACCURACY WAS ALLEGED TO BE 1 CENTIMETER POSTERIOR WITHIN MACH CRANIAL SOFTWARE AND WAS NOTED ONCE THE PATIENT WAS STERILE. THE MEDTRONIC REPRESENTATIVE NOTED THE PATIENT HAD LOOSE SKIN AND THE SKIN WAS MANIPULATED ON 3D MODEL FROM HEADPHONES DURING MR. SURGICAL ENTRY POINT WAS NEAR EAR. NO FURTHER DETAILS REGARDING THIS ISSUE WERE PROVIDED. 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 6145741 ↗