Navigation Software Cranial 3.5Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04056481140663), received between Oct 10, 2019 and May 18, 2023 — classified as 7 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (6 reports).

2 other recalls cover devices cleared under the same FDA submission (K092467, K192703); 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMay 18, 2023Use 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 CRANIOTOMY FOR RESECTION AND TISSUE VERIFICATION OF AN OCCIPITAL PARASAGITTAL LESION IN THE BRAIN FOR THE MEDICAL INDICATION OF EPILEPSY WAS PERFORMED WITH THE AID OF THE DISPLAY BY THE BRAINLAB NAVIGATION SW CRANIAL 3.5. A PRE-OPERATIVE MRI WAS ACQUIRED SIX DAYS PRIOR TO THE SURGERY FOR USE WITH NAVIGATION. DURING THE PROCEDURE THE SURGEON: POSITIONED THE PATIENT PRONE IN A NON-BRAINLAB HEAD HOLDER, AND ATTACHED THE NAVIGATION REFERENCE ARRAY TO THE HEAD HOLDER. PERFORMED THE INITIAL PATIENT REGISTRATION ON THE PREOPERATIVE MRI ACQUIRING REGISTRATION POINTS ON THE PATIENT'S SKIN TO MATCH THE DISPLAY OF THE NAVIGATION TO THE CURRENT PATIENT ANATOMY: THE FIRST ATTEMPT RESULTED IN NO MATCH; THE REGISTRATION WAS REPEATED A SECOND TIME AND WAS SUCCESSFUL, AND THE ACCURACY WAS VERIFIED. THE SURGEON DETECTED A 1.5MM DEVIATION BUT CONSIDERED IT WITHIN THE CLINICAL EXPECTATIONS FOR THIS PROCEDURE, AND THE REGISTRATION WAS ACCEPTED TO PROCEED. REMOVED THE UNSTERILE PATIENT REFERENCE ARRAY, DRAPED THE PATIENT, AND ATTACHED THE STERILE PATIENT REFERENCE ARRAY TO THE HEAD HOLDER. VERIFIED THE ACCURACY OF NAVIGATION WITH THE POINTER AT THE REGION OF INTEREST AND DETERMINED THERE WAS NO CHANGE

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 16953346 ↗
• InjuryMay 17, 2023Use 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 TO PERFORM A METASTASIS RESECTION AND HISTOPATHOLOGICAL VERIFICATION OF A SUPERFICIAL LESION IN THE FRONTAL LOBE, WAS PERFORMED WITH THE AID OF THE DISPLAY BY THE BRAINLAB NAVIGATION SOFTWARE CRANIAL 3.5. A PRE-OPERATIVE MRI WAS ACQUIRED ONE DAY PRIOR TO THE SURGERY FOR USE WITH NAVIGATION. DURING THE PROCEDURE THE SURGEON: POSITIONED THE PATIENT SUPINE IN A NON-BRAINLAB HEAD HOLDER, AND ATTACHED THE NAVIGATION REFERENCE ARRAY TO THE HEAD HOLDER. PERFORMED THE INITIAL PATIENT REGISTRATION ON THE PREOPERATIVE MRI ACQUIRING REGISTRATION POINTS ON THE PATIENT'S SKIN TO MATCH THE DISPLAY OF THE NAVIGATION TO THE CURRENT PATIENT ANATOMY AND VERIFIED THE ACCURACY OF THE REGISTRATION: THERE WAS A 2MM DEVIATION DETECTED, BUT THIS WAS WITHIN THE SURGEON'S CLINICAL EXPECTATIONS FOR THIS PROCEDURE, AND ACCEPTED THE REGISTRATION TO PROCEED. REMOVED THE UNSTERILE PATIENT REFERENCE ARRAY, DRAPED THE PATIENT, AND ATTACHED THE STERILE PATIENT REFERENCE ARRAY TO THE HEAD HOLDER. VERIFIED THE ACCURACY OF NAVIGATION WITH THE POINTER AT THE REGION OF INTEREST ONLY AND DETERMINED THERE WAS NO CHANGE IN THE ACCURACY, AND IT WAS STILL WITHIN THE SURGEON'S CLINICAL EXPECTATIONS FOR THIS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16948659 ↗
• InjuryMay 9, 2023Use 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 TO REMOVE A TUMOR (MENINGIOMA) IN THE FRONTAL LOBE OF THE BRAIN WAS PERFORMED WITH THE AID OF THE DISPLAY BY THE BRAINLAB NAVIGATION SOFTWARE CRANIAL 3.5. A PREOPERATIVE MRI WAS ACQUIRED 8 DAYS PRIOR TO THE SURGERY, FOR USE WITH NAVIGATION. DURING THE PROCEDURE THE SURGEON: POSITIONED THE PATIENT SUPINE IN A NON-BRAINLAB HEAD HOLDER, AND ATTACHED THE NAVIGATION REFERENCE ARRAY TO THE HEAD HOLDER. PERFORMED THE INITIAL PATIENT REGISTRATION ON THE PREOPERATIVE MRI ACQUIRING REGISTRATION POINTS ON THE PATIENT'S SKIN TO MATCH THE DISPLAY OF THE NAVIGATION TO THE CURRENT PATIENT ANATOMY: THE FIRST ATTEMPT WAS UNSUCCESSFUL, AND THE SOFTWARE RETURNED NO MATCH FOUND. PERFORMED THE REGISTRATION A SECOND TIME, WHICH WAS SUCCESSFUL, AND THE ACCURACY OF THE REGISTRATION WAS VERIFIED AND ACCEPTED BY THE SURGEON TO PROCEED. REMOVED THE UNSTERILE PATIENT REFERENCE ARRAY, DRAPED THE PATIENT, AND ATTACHED THE STERILE PATIENT REFERENCE ARRAY TO THE HEAD HOLDER. VERIFIED THE ACCURACY OF NAVIGATION WITH THE POINTER AT THE REGION OF INTEREST ONLY AND DEEMED IT TO BE VERY GOOD TO PROCEED. PLANNED THE INCISION AND CRANIOTOMY LOCATION USING THE NAVIGATED POINTER AND MARKED IT ON THE PATI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16895701 ↗
• InjuryNov 17, 2021Use of Device Problem; Use of Device Problem

  A CRANIAL SURGERY FOR TUMOR RESECTION, A MENINGIOMA LOCATED CA. 4CM DEEP IN THE BRAIN INTRAVENTRICULAR LEFT CARREFOUR, WITH A SIZE OF CA. 5CM, HAS BEEN PERFORMED WITH THE AID OF THE BRAINLAB NAVIGATION SW CRANIAL 3.5. A PRE-OPERATIVE MRI SCAN ACQUIRED 17 DAYS BEFORE THE SURGERY WAS USED TO REFERENCE THE NAVIGATION DISPLAY TO. DURING THE PROCEDURE THE SURGEON: POSITIONED THE PATIENT IN A PRONE ORIENTATION IN A NON-BRAINLAB HEAD HOLDER, AND ATTACHED THE PATIENT REFERENCE ARRAY FOR NAVIGATION TO THE HEAD HOLDER. PERFORMED THE INITIAL PATIENT REGISTRATION ON THE PRE-OP MRI ACQUIRING REGISTRATION POINTS ON THE PATIENT'S SKIN WITH THE SOFTOUCH POINTER TO MATCH THE DISPLAY OF THE NAVIGATION TO THE CURRENT PATIENT ANATOMY. VERIFIED THE ACCURACY, AND ACCEPTED THE REGISTRATION TO PROCEED. DETERMINED THE ENTRY POINT INTO THE HEAD WITH THE NAVIGATED POINTER AND MARKED IT ON THE SKIN. DRAPED THE PATIENT AND EXCHANGED THE REFERENCE ARRAY TO A STERILE ONE. VERIFIED THE MARKED ENTRY POINT WITH THE POINTER AND PERFORMED THE INCISION AT THE MARKED LOCATION. CREATED THE KEY HOLE (BONE FLAP) OF CA. 3CM IN THE SKULL AT THE SAME-SIZED SKIN INCISION. USED A (NON-BRAINLAB) MICROSCOPE CALIBRATED TO NAVIGAT

  Patient problems: Hyporesponsive to stimuli

  MAUDE report 12827380 ↗
• InjuryJul 8, 2021Improper or Incorrect Procedure or Method; Device Handling Problem; Improper or Incorrect Procedure or Method; Device Handling Problem

  A SURGERY FOR PLACEMENT OF A RIGHT VENTRICULOPERITONEAL (VP) SHUNT WAS PERFORMED WITH THE AID OF THE DISPLAY BY THE (B)(4). DURING THE PROCEDURE THE SURGEON: PLANNED A TRAJECTORY WITHIN THE BRAINLAB SOFTWARE AND LOADED THE (PRE-CALIBRATED) GEOMETRY OF THE BRAINLAB DISPOSABLE STYLET INTO THE NAVIGATION SOFTWARE. POSITIONED THE PATIENT IN A SUPINE ORIENTATION IN A NON-BRAINLAB HEAD HOLDER. PERFORMED THE INITIAL PATIENT REGISTRATION ON THE PREOPERATIVE MRI ACQUIRING REGISTRATION POINTS ON THE PATIENT'S SKIN TO MATCH THE DISPLAY OF THE NAVIGATION TO THE CURRENT PATIENT ANATOMY, AND VERIFIED AND ACCEPTED THE ACCURACY OF THE REGISTRATION TO PROCEED. REMOVED THE UNSTERILE NAVIGATION REFERENCE ARRAY, DRAPED THE PATIENT, AND ATTACHED THE STERILE REFERENCE ARRAY. CREATED THE BONE FLAP AND BURR HOLE TO ACCOMMODATE THE SHUNT, AND OPENED THE DURA. UPDATED THE ENTRY POINT OF THE PLANNED TRAJECTORY INTRAOPERATIVELY USING THE BRAINLAB POINTER TO BETTER ALIGN TO THE RIGHT VENTRICLE. USED THE NAVIGATED BRAINLAB STYLET TO PLACE A CATHETER IN THE RIGHT VENTRICLE, BUT NO CEREBROSPINAL FLUID (CSF) WAS RETURNED. A COUPLE FURTHER ATTEMPTS IN THE SAME MANNER WERE ALSO UNSUCCESSFUL. USED THE NAVIGATED BRAIN

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Paresis

  MAUDE report 12134767 ↗
• InjuryMay 26, 2021Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  A CRANIAL SURGERY FOR BILATERAL RESPONSIVE NEUROSTIMULATION (RNS) ELECTRODE LEAD PLACEMENTS FOR TREATMENT OF SEIZURES, AT A DEPTH OF APPROX. 86 MM FROM A FRONTO-ORBITAL APPROACH, HAS BEEN PERFORMED WITH THE AID OF THE BRAINLAB NAVIGATION SOFTWARE CRANIAL 3.1.3 (ON (B)(6) 2021). TRAJECTORIES HAD BEEN PLANNED PRE-OPERATIVELY ON AN MRI SCAN (ACQUIRED 3, 5 WEEKS PRIOR TO THE SURGERY). DURING THE PROCEDURE THE SURGEON: POSITIONED THE PATIENT IN A SUPINE ORIENTATION IN A NON-BRAINLAB HEAD HOLDER ON THE OR TABLE. FIXATED FIDUCIAL MARKERS (TEN BONE SCREWS AND SEVEN ADHESIVE DONUT MARKERS) AROUND THE PATIENT HEAD AND ACQUIRED A CT SCAN. PERFORMED THE INITIAL PATIENT REGISTRATION ON THE CT ACQUIRING PLANNED REGISTRATION POINTS ON THE FIDUCIAL MARKERS (ON BONE FIDUCIALS AS WELL AS ON ADHESIVE DONUT MARKERS) USING THE BRAINLAB POINTER, TO MATCH THE DISPLAY OF THE NAVIGATION TO THE CURRENT PATIENT ANATOMY. VERIFIED THE ACCURACY OF THE REGISTRATION AND ACCEPTED THE REGISTRATION TO PROCEED (DESPITE RECOGNIZING SOME DEVIATION AT SELECTED BONE SCREWS). MARKED A SKIN INCISION ENTRY POINT USING NAVIGATION. DRAPED THE PATIENT AND EXCHANGED THE UNSTERILE REFERENCE ARRAY FOR A STERILE ONE. PERFORMED AN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11884857 ↗
• InjuryOct 10, 2019Use of Device Problem; Use of Device Problem

  A CRANIAL SURGERY FOR A DIAGNOSTIC BIOPSY OF A LESION IN THE BRAIN, LOCATED CA. 39 MM DEEP IN THE LEFT PARIETAL LOBE HAS BEEN PERFORMED WITH THE AID OF THE BRAINLAB NAVIGATION (USING THE REGISTRATION SOFTWARE CRANIAL V.3.5 TO REGISTER THE PATIENT TO THE NAVIGATION). A PRE-OPERATIVE CT SCAN WAS ACQUIRED CA. 4 DAYS BEFORE THE SURGERY, TO USE WITH NAVIGATION. TO THIS CT SCAN USED FOR PATIENT REGISTRATION TO THE NAVIGATION, FUSED WAS A FURTHER MRI DATASET ACQUIRED CA. 3 WEEKS BEFORE THE SURGERY. A TRAJECTORY WAS PLANNED. DURING THE PROCEDURE THE SURGEON: POSITIONED THE PATIENT IN A SUPINE ORIENTATION WITH HEAD SIDEWAYS IN A NON-BRAINLAB HEAD HOLDER, AND ATTACHED THE UNSTERILE NAVIGATION REFERENCE ARRAY TO THE HEAD HOLDER USING THE VARIO REFERENCE ARM. PERFORMED THE IMAGE REGISTRATION WITH SURFACE MATCHING WITH ACQUIRING REGISTRATION POINTS - USING THE Z-TOUCH AND THE POINTER ON THE PATIENT'S SKIN SURFACE TO MATCH THE DISPLAY OF THE NAVIGATION TO THE CURRENT PATIENT ANATOMY. VERIFIED THE ACCURACY OF THE PATIENT REGISTRATION TO NAVIGATION, DETERMINED THE RESULT AS GOOD, AND ACCEPTED THE REGISTRATION TO PROCEED. REMOVED THE UNSTERILE NAVIGATION REFERENCE ARRAY AND DRAPED THE PATIENT. ATTA

  Patient problems: Hematoma

  MAUDE report 9174154 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K092467, K192703. 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