BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRW STEREOTACTIC SYSTEM CRW FRAME

    MDR report key: 19311212 · Received May 13, 2024

    Report

    Report Number
    MW5154811
    Event Type
    Malfunction
    Date Received
    May 13, 2024
    Date of Event
    May 9, 2024
    Report Date
    May 9, 2024
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION
    Product Code
    HAW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ERROR IN CRW INTEGRA DEVICE. WE PERFORMED NUMEROUS PHANTOM TESTS AND HAVE CONCLUDED THAT THE LOCALIZER HAS A MISMATCH OF 0.6MM VERTICAL RELATIVE TO THE BRWLF SPACE. THE BRWLF(BRW LOCALIZER FRAME) GEOMETRY MAY MISMATCH BRAINLAB ELEMENTS DATA AS A CONTRIBUTOR. WE SEE A VERTICAL DIFFERENCE BETWEEN RADIONICS SOFTWARE AND BRAINLAB. THE DATA SUGGESTS THAT EITHER ON MANUFACTURING SIDE OR SOFTWARE SIDE THERE IS AROUND A 0.5MM VERTICAL PROBLEM THAT NEEDS TO BE FIXED ACROSS INTEGRA, BRAINLAB, PHANTOM, PRECISION ARC, AND BRW LOCALIZER FRAME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1547762 CRW STEREOTACTIC SYSTEM CRW FRAME NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW INTEGRA LIFESCIENCES CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO Prefer Not To Disclose Other