BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRANIAL NAVIGATION 4.1

    MDR report key: 24755894 · Received April 1, 2026

    Report

    Report Number
    8043933-2026-00019
    Event Type
    Injury
    Date Received
    April 1, 2026
    Date of Event
    March 3, 2026
    Report Date
    May 21, 2026
    Manufacturer
    BRAINLAB SE
    Product Code
    HAW
    UDI-DI
    04056481143848
    PMA / PMN Number
    K223288
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B2, H1: A RISK TO THE PATIENT'S HEALTH COULD NOT BE EXCLUDED FOR THESE SPECIFIC CIRCUMSTANCES, SINCE A TUMOR RESECTION WAS PERFORMED IN A DIFFERENT LOCATION IN THE BRAIN THAN ANTICIPATED WITH THE BRAINLAB NAVIGATION INVOLVED, ALTHOUGH ACCORDING TO THE LIMITED INFORMATION RECEIVED FROM THE HOSPITAL/SURGEON: -NO HARM OR NEGATIVE CLINICAL EFFECTS TO THE PATIENT WERE REPORTED AS A RESULT OF THE NAVIGATION DEVIATION/DISCONTINUATION. -THE SURGERY WAS COMPLETED WITHOUT NAVIGATION, AND NO REMEDIAL ACTIONS WERE REPORTED. H6, H7: A COMPREHENSIVE INVESTIGATION BY BRAINLAB REGARDING THIS SPECIFIC EVENT IS CURRENTLY ONGOING AND FINAL CONCLUSIONS ARE PENDING. BRAINLAB PLANS TO ISSUE A FOLLOW-UP REPORT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    A CRANIAL SURGERY FOR TUMOR RESECTION OF A LEFT TEMPORAL LOBE LESION (APROX.40 MM DEEP WITH A SIZE OF CA. 41 × 41 MM) WAS PERFORMED WITH THE AID OF BRAINLAB CRANIAL NAVIGATION 4.1 INTRAOPERATIVELY, A NAVIGATION INACCURACY WAS IDENTIFIED AT THE REGION OF INTEREST. IN RESPONSE, USE OF THE NAVIGATION SYSTEM WAS DISCONTINUED FOR THE REMAINDER OF THE PROCEDURE. THE RESECTION WAS SUBSEQUENTLY COMPLETED WITHOUT THE AID OF NAVIGATION. ACCORDING TO THE LIMITED INFORMATION RECEIVED FROM THE HOSPITAL/SURGEON: -NO HARM OR NEGATIVE CLINICAL EFFECTS TO THE PATIENT WERE REPORTED AS A RESULT OF THE NAVIGATION DEVIATION/DISCONTINUATION. -THE SURGERY WAS COMPLETED WITHOUT NAVIGATION, AND NO REMEDIAL ACTIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545754 CRANIAL NAVIGATION 4.1 IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC, PRODUCT CODE: HAW HAW BRAINLAB SE 26615-03A 04056481143848

    Patients

    Seq Age Sex Outcome Treatment
    1