Registration Software Cranial 3.5Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04056481140687), received between Oct 2, 2019 and Oct 2, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Use of Device Problem” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryOct 2, 2019Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Use of Device Problem

  A CRANIAL SURGERY FOR REMOVAL OF AN EPILEPTIC FOCUS IN THE BRAIN WITH POTENTIAL FOCAL CORTICAL DYSPLASIA (FCD), LOCATED RIGHT SIDE TEMPO-PARIETAL IN THE GYRUS SUPRA MARGINALIS, WITH A SIZE OF CA. 2CM, WAS PERFORMED WITH THE AID OF THE BRAINLAB NAVIGATION SOFTWARE CRANIAL 3.5. A PRE-OPERATIVE CT SCAN WAS ACQUIRED CA. 4 MONTHS BEFORE THE SURGERY, TO USE WITH NAVIGATION. FURTHER IMAGE SET(S) WERE FUSED TO THIS CT SCAN USED FOR PATIENT REGISTRATION TO THE NAVIGATION. DURING THE PROCEDURE THE SURGEON: POSITIONED THE PATIENT IN A SUPINE ORIENTATION IN A NON-BRAINLAB HEAD HOLDER. PERFORMED THE INITIAL PATIENT REGISTRATION ON THE PRE-OP CT USING THE Z-TOUCH AND SOFTOUCH ACQUIRING REGISTRATION POINTS ON THE PATIENT'S SKIN TO MATCH THE DISPLAY OF THE NAVIGATION TO THE CURRENT PATIENT ANATOMY. VERIFIED THE ACCURACY OF THE REGISTRATION AND ACCEPTED THE REGISTRATION TO PROCEED. REMOVED THE UNSTERILE NAVIGATION REFERENCE ARRAY AND DRAPED THE PATIENT. ATTACHED A STERILE REFERENCE ARRAY, RE-CHECKED NAVIGATION ACCURACY AT THE TOP OF THE HEAD, IN THE REGION OF THE INTENDED CRANIOTOMY. PLANNED AND PERFORMED THE CRANIOTOMY (OF CA.4 X 4 CM), INCLUDING INITIAL INCISION AND DURA OPENING, WITH THE AID OF

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9144791 ↗

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