N/A 9733065 (UDI 00643169702912)Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00643169702912), received between Jan 10, 2019 and Apr 6, 2026 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (13 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 6, 2026Material Fragmentation

  ADDITIONAL INFORMATION RECEIVED. THIS ISSUE OCCURRED INTRA-OPERATIVELY AND CAUSED A LESS THAN ONE HOUR DELAY IN THE PROCEDURE. NO KNOWN IMPACT TO PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24794013 ↗
• MalfunctionJan 30, 2025Material Fragmentation; Mechanical Problem; Material Fragmentation; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A CRANIAL BIOPSY PROCEDURE. IT WAS REPORTED THAT 2 OF THE SCREWS IN THE SYSTEM'S BASE SHEARED OFF IN THE PATIENT'S SKULL UPON REMOVAL AT END OF A PROCEDURE. THE SCREW SHANK WAS FLUSHED WITH SKULL SO IT COULD NOT BE REMOVED AND HAVE BEEN LEFT IN THE PATIENT. THE BASE WAS USED IN ACCORDANCE WITH INSTRUCTIONS FOR USE (IFU). SEQUENTIAL TIGHTENING OF SCREWS WAS PERFORMED WITH THE PROVIDED DRIVER. THE SCREWS WERE ADVANCED ONCE ONLY AND BASE WAS NOT REPOSITIONED. THERE WAS NO DELAY TO THE PROCEDURE. UNKNOWN PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21274591 ↗
• MalfunctionAug 14, 2023Output Problem; Output Problem

  ADDITIONAL INFORMATION WAS RECEIVED. THERE WAS A SURGICAL DELAY OF 20 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17540538 ↗
• MalfunctionApr 10, 2023Material Integrity Problem; Device Handling Problem; Material Integrity Problem; Device Handling Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A CRANIAL BIOPSY. IT WAS REPORTED THAT THE SCREW OF THE TRAJECTORY BASE SNAPPED OFF IN SKULL. THERE WAS NO IMPACT ON PATIENT OUTCOME AND THE ISSUE CAUSED NO DELAY. ADDITIONAL INFORMATION WAS RECEIVED, IT WAS REPORTED THAT THE DOCTOR HAD LEFT THE SMALL PIECE THAT HAD BROKEN IN AS HE WAS PLACING A BURR HOLE PLATE THERE AND NOTED THAT IT WOULD BE FINE. THERE WERE NO SCREW REVISIONS AND THE PATIENT HAD AN INCISION MADE AND WAS UNDER ANESTHESIA WHEN THE EVENT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16709129 ↗
• MalfunctionMar 23, 2022Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED DURING A CRANIAL BIOPSY PROCEDURE. IT WAS REPORTED THAT A SCREW ON THE TRAJECTORY GUIDE WAS DAMAGED DURING REMOVAL AND A PORTION REMAINED IN THE SKULL OF THE PATIENT. THERE WAS NO REPORTED DELAY TO THE PROCEDURE DUE TO THIS  ISSUE. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13870442 ↗
• MalfunctionJan 27, 2022Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A CRANIAL BIOPSY PROCEDURE. IT WAS REPORTED THAT DURING A NAVIGUS BIOPSY CASE, WHEN THE SURGEON WAS PLACING THE BASE TWO OF THE SCREW HEADS BROKE OFF. THE SURGEON WAS ABLE TO ATTACH THE BASE WITH DIFFERENT SCREWS AND WERE ABLE TO REMOVE THE BROKEN SCREWS FROM THE PATIENT. THEE WAS NO IMPACT TO THE PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13367551 ↗
• MalfunctionJan 12, 2022Use of Device Problem; Material Integrity Problem; Use of Device Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED IN A CRANIAL BIOPSY. IT WAS REPORTED THAT THE SITE COULD NOT USE THE 2.2 GUIDE FROM THE EXTERNAL BIOPSY KIT BECAUSE IT WAS NOT CANNULATED ALL THE WAY THROUGH SO BIOPSY NEEDLE COULD NOT GO THROUGH. THERE WAS NO DELAY TO THE CASE. NO IMPACT ON PATIENT OUTCOME. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE SITE USED ANOTHER KIT TO COMPLETE THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13237231 ↗
• MalfunctionApr 20, 2021Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION INSTRUMENT USED DURING A CRANIAL BIOPSY PROCEDURE. IT WAS REPORTED THAT WHEN SITE PUT THE BASE FOR THE GUIDE KIT, THE SURGEON PUT A LOT OF PRESSURE ON THE SCREWS WHEN ATTACHING THE BASE. USED AN EXTERNAL STRAIGHT BASE. AT THE END OF THE PROCEDURE, HE BROKE OFF ONE OF THE SCREWS. ABOUT HALF THE SCREW WAS LEFT IN THE PATIENT'S SKULL. SURGEON TRIED TO GRAB THE 1MM THAT WAS STICKING OUT AND BROKE THAT PIECE OFF ALSO. IT WAS ESTIMATED THAT ONLY A COUPLE MM WERE LEFT. THE SURGEON DECIDED TO LEAVE IT BECAUSE IT WAS CLOSE TO THE BURR HOLE AND COVERED IT WITH A BURR HOLE COVER. THERE WAS ABOUT 5 MINUTES DELAY TO THE PROCEDURE. IMPACT ON PATIENT OUTCOME IS NOT KNOWN AT THIS TIME.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 11694418 ↗
• MalfunctionAug 18, 2020Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A CRANIAL BIOPSY PROCEDURE. IT WAS REPORTED THAT A SCREW BROKE OFF UPON REMOVAL OF THE SKULL-MOUNTED BASE. THE HEAD OF THE SCREW BROKE OFF, LEAVING THE BOTTOM, THREADED PORTION OF THE SCREW IN THE SKULL. A BURRHOLE COVER PLATE WAS PLACED ON THE SKULL. UPON CLOSURE, THE PIECE OF THE SCREW REMAINS IN THE PATIENT SKULL. THERE WAS NO DELAY TO THE PROCEDURE. THERE WAS NO REPORTED IMPACT TO PATIENT OUTCOME; THE PATIENT WAS DOING WELL AND REQUIRED NO FURTHER ACTION OR INTERVENTION. IT WAS SUSPECTED THAT THE SCREW WAS OVERTIGHTENED/TORQUED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10422359 ↗
• MalfunctionAug 4, 2020Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED FOR A CRANIAL BIOPSY PROCEDURE. IT WAS REPORTED THAT THE SURGEON WAS ONLY ABLE TO TIGHTEN THE BASE ABOUT TWO THREADS BEFORE THE SCREW BROKE. THE SCREW WAS PART OF THE STRAIGHT BASE IN THE TRAJECTORY BIOPSY KIT. THE SITE MOVED FORWARD WITH THE ANGLED BASE. THE SURGEON WAS ABLE TO REMOVE THE PIECE OF SCREW FROM THE PATIENT. THERE WAS A 10-15 MINUTE DELAY AND NO REPORTED IMPACT TO PATIENT OUTCOME. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED IT WAS NOT NECESSARY TO INCREASE THE SIZE OF THE INITIAL BURR HOLE AND THAT THE SCREW WAS REMOVED WITH A SMALL MATCHSTICK DRILL BIT AT THE SITE OF THE BROKEN SCREW.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10362597 ↗
• MalfunctionMar 13, 2020Material Integrity Problem; Material Integrity Problem

  ADDITIONAL INFORMATION WAS RECEIVED. IT WAS CONFIRMED THAT THE SCREW WAS REMOVED FROM THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9829858 ↗
• MalfunctionOct 4, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED FOR A CRANIAL BIOPSY. IT WAS REPORTED THAT INTRA-OPERATIVELY, THE SURGEON WAS UNABLE TO GET THE STRAIGHT BASE TO ENGAGE WITH THE CLEAR GUIDE STEM. THEY OPENED A SECOND KIT OF A DIFFERENT LOT NUMBER AND HAD THE SAME ISSUE. THE SURGEON SWAPPED TO AN ANGLED BASE PLATE WITH A TWENTY MINUTE DELAY AND NO NEGATIVE IMPACT TO THE PATIENT. THE REST OF THE CASE WENT SMOOTHLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9156112 ↗
• MalfunctionJan 25, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED IN A CRANIAL BIOPSY. IT WAS REPORTED THAT THE GUIDE STEM WOULD NOT POP INTO THE STRAIGHT BASE PROPERLY. THEY COULD FIT IT IN RIGHT, BUT WHENEVER THEY TRIED TO MOVE IT WITH THE NAVIGUS PROBE IN IT, THE GUIDE STEM WOULD POP OUT. THIS OCCURRED EVEN WHEN THE LOCKING RING WAS TIGHTENED COMPLETELY, THEN BARELY UNTIGHTENED. THEY SWITCHED TO AN ANGLED BASE AND CONTINUED WITH THE PROCEDURE. THERE WAS LESS THAN AN HOUR DELAY IN THE PROCEDURE. NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8279105 ↗
• MalfunctionJan 18, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED THAT INTRA/PERI-OPERATIVELY DURING A CRANIAL BIOPSY PROCEDURE, THE NAVIGUS BIOPSY KIT GUIDE STEM WOULD NOT LOCK INTO THE STRAIGHT EXTERNAL BASE. THE SITE OPENED ANOTHER KIT AND THE ISSUE REOCCURRED. THE SITE USED THE ANGLED BASE TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY TO THE PROCEDURE. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8262376 ↗
• MalfunctionJan 18, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED THAT INTRA/PERI-OPERATIVELY DURING A CRANIAL BIOPSY PROCEDURE THE NAVIGUS BIOPSY KIT GUIDE STEM WOULD NOT LOCK INTO THE STRAIGHT EXTERNAL BASE. THE SITE OPENED ANOTHER KIT AND THE ISSUE REOCCURRED. THE SITE USED THE ANGLED BASE TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY TO THE PROCEDURE. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8262365 ↗
• MalfunctionJan 10, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED FOR A CRANIAL BIOPSY. IT WAS REPORTED THAT THE SITE OPENED 2 NAVIGUS BIOPSY KITS AND NEITHER ON WAS ABLE TO LOCK THE GUIDE STEM INTO THE STRAIGHT BASE. ON THE KIT THEY ENDED UP USING AN ANGLED BASE AND THAT RESOLVED THE ISSUE. THERE WAS A REPORTED DELAY OF LESS THAN ONE HOUR AND NO OTHER REPORTED IMPACT TO PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8232774 ↗