BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAINLAB CURVE

    MDR report key: 7609508 · Received June 15, 2018

    Report

    Report Number
    MW5077893
    Event Type
    Malfunction
    Date Received
    June 15, 2018
    Date of Event
    June 8, 2018
    Report Date
    June 14, 2018
    Manufacturer
    BRAINLAB NORTH AMERICA
    Product Code
    HAW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    NAVIGATED CRANIOTOMY FOR RESECTION OF TUMOR USING BRAINLAB CURVE. DEVICE WAS GUIDING PHYSICIAN. LANDMARKS OFF BY 1 TO 1 1/2 INCHES. MULTIPLE SPECIMENS SENT TO LAB BEFORE TUMOR TISSUE IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447189 BRAINLAB CURVE GUIDED SURGICAL NAVIGATION SYSTEM HAW BRAINLAB NORTH AMERICA CURVE

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other