Navigation Software Cranial 3.0Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04056481138790), received between Jul 21, 2020 and Dec 21, 2020 — classified as 3 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (3 reports).

2 other recalls cover devices cleared under the same FDA submission (K092467); they may or may not involve this specific model.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 21, 2020Use of Device Problem; Use of Device Problem

  A CRANIAL SURGERY FOR A BIOPSY FOR RETRIEVAL OF A DIAGNOSTIC SAMPLE OF A LESION, SUSPECTED LYMPHOMA VS. GLIOMA, LOCATED RIGHT FRONTAL CA. 5CM DEEP IN THE BRAIN, WITH A SIZE OF CA. 15MM, HAS BEEN PERFORMED WITH THE AID OF THE BRAINLAB NAVIGATION VERSION 3.0. THE PRE-OPERATIVE MRI SCAN USED WITH NAVIGATION WAS ACQUIRED 4 DAYS BEFORE THE SURGERY. A TRAJECTORY WAS PLANNED. DURING THE PROCEDURE THE SURGEON: - POSITIONED THE PATIENT IN A SUPINE ORIENTATION IN A NON-BRAINLAB HEAD HOLDER, AND ATTACHED THE UNSTERILE PATIENT REFERENCE ARRAY FOR NAVIGATION TO THE HEAD HOLDER. - PERFORMED THE IMAGE REGISTRATION WITH SURFACE MATCHING, ACQUIRING REGISTRATION POINTS USING THE SOFTOUCH ON THE PATIENT'S SKIN SURFACE TO MATCH THE DISPLAY OF THE NAVIGATION TO THE CURRENT PATIENT ANATOMY. - VERIFIED THE ACCURACY, TOOK FURTHER REGISTRATION POINTS TO IMPROVE, SINCE RESULT WAS STILL NOT SATISFACTORY, PERFORM A SECOND REGISTRATION, VERIFIED THE ACCURACY AS ACCEPTABLE FOR THE SURGERY, AND ACCEPTED THE REGISTRATION TO PROCEED. - DETERMINED THE ENTRY POINT WITH THE NAVIGATED POINTER, AND MARKED IT ON THE PATIENT SKIN. - REMOVED THE UNSTERILE REFERENCE ARRAY, DRAPED THE PATIENT, AND ATTACHED A STERILE REFEREN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11046083 ↗
• InjuryDec 21, 2020Use of Device Problem; Use of Device Problem

  A CRANIAL SURGERY FOR A TUMOR REMOVAL HAS BEEN PERFORMED WITH THE AID OF THE BRAINLAB NAVIGATION VERSION 3.0 (THE DATE OF THE SURGERY IS UNKNOWN, THE BRAINLAB REP. WAS INFORMED BY A DIFFERENT SURGEON VIA EMAIL ON (B)(6) 2020). DURING THE PROCEDURE THE SURGEON COULD NOT FIND THE TUMOR ON THE FIRST ATTEMPT WITH NAVIGATION, THEREFORE TOOK THE PATIENT FROM THE OPERATING TABLE TO PERFORM AN INTRA-OPERATIVE MRI SCAN. THE MRI SHOWED MUCH MORE PERILESIONAL CHANGE THAN EXPECTED, SUSPECTED BY THE SURGEON DUE TO THE INITIAL ATTEMPTS TO FIND THE TUMOR. FROM THE SCAN IT WAS DETERMINED THAT THE LESION WAS CA. 2CM AWAY FROM WHERE THE NAVIGATION HAD INDICATED IT. THE SURGERY CONTINUED WITH NAVIGATION, USING THE INTRA-OPERATIVE MRI SCAN. THE PROCEDURE WAS DELAYED BY MORE THAN 1H DUE TO THIS. THERE WERE AND WILL BE NO FURTHER DETAILS OF THIS SURGERY AND PATIENT PROVIDED BY THE SURGEON TO BRAINLAB. THE SURGEON/HOSPITAL DID NOT REPORT: THAT THERE WOULD HAVE BEEN ANY HARM OR NEGATIVE EFFECT TO THE PATIENT DUE TO THIS ISSUE, NEITHER DUE TO THE PROLONG OF SURGERY/ANESTHESIA OF MORE THAN 1H. THAT THE SURGERY AND TUMOR RESECTION WOULD NOT HAVE BEEN SUCCESSFUL AS INTENDED AT THE END OF THE SURGERY. THAT THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11045944 ↗
• InjuryJul 21, 2020Use of Device Problem; Improper or Incorrect Procedure or Method; Device Handling Problem; Use of Device Problem; Improper or Incorrect Procedure or Method; Device Handling Problem

  A CRANIAL SURGERY (ON (B)(6) 2020) FOR BIOPSY (TO RETRIEVE A DIAGNOSTIC SAMPLE), WITH APPROXIMATED TUMOR VOLUME OF 7.5 CM³, LOCATED APPROX. 6 CM IN DEPTH, WAS PERFORMED WITH THE AID OF THE BRAINLAB NAVIGATION SOFTWARE CRANIAL 3.0. A PRE-OPERATIVE MRI SCAN WAS ACQUIRED 13 DAYS BEFORE THE SURGERY (ON (B)(6) 2020), TO USE WITH NAVIGATION. DURING THE PROCEDURE THE SURGEON: POSITIONED THE PATIENT IN SUPINE ORIENTATION IN A NON-BRAINLAB HEAD HOLDER AND ATTACHED THE UNSTERILE 4-SPHERE STANDARD REFERENCE ARRAY. PLANNED A TRAJECTORY. PERFORMED THE INITIAL PATIENT REGISTRATION ON THE PRE-OPERATIVE MRI (SURFACE MATCHING WITHOUT PRE-REGISTRATION POINTS) USING THE Z-TOUCH, TO MATCH THE DISPLAY OF THE NAVIGATION TO THE CURRENT PATIENT ANATOMY. ADJUSTED THE REFERENCE ARRAY, PERFORMED A 2ND PATIENT REGISTRATION, AND ACCEPTED THE RESULT AFTER VERIFICATION OF REGISTRATION ACCURACY. ALIGNED THE VARIOGUIDE TO THE PLANNED TRAJECTORY AND MADE THE BURR HOLE. - MODIFIED THE ENTRY POINT OF THE PLANNED TRAJECTORY TO MATCH THE EXACT LOCATION OF THE BURR HOLE. REALIGNED THE VARIOGUIDE TO THE ADJUSTED TRAJECTORY. TOOK 3 SAMPLES USING THE BRAINLAB-DISTRIBUTED BIOPSY NEEDLE AND ENDED SURGERY. ACCORDING TO THE HO

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10301320 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K092467. One submission often covers many models, so check the product and lot details in each record.

• Z-0056-2021 · Aug 31, 2020 · Terminated
  Ultrasound Navigation Software 1.0 and Ultrasound Integration Software for Cranial/ENT Navigation 3.0.x and 3.1.x - Product Usage: intended to be an intra-operative image guided l
• Z-0598-2016 · Apr 22, 2013 · Terminated
  Brainlab Cranial Navigation System: An Image Guided Surgery System / Stereotactic. Radiology Departments. The BrainLAB Cranial IGS System is intended to be an intra-operative imag