BEUDAMED
    FDA Adverse Event Other Summary report: N

    CRW PRECISION ARC SYSTEM

    MDR report key: 4240490 · Received October 31, 2014

    Report

    Report Number
    1222895-2014-00030
    Event Type
    Other
    Date Received
    October 31, 2014
    Report Date
    October 9, 2014
    Manufacturer
    INTEGRA BURLINGTON MA, INC.
    Product Code
    HAW
    PMA / PMN Number
    K944463
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    PRECISION ARC TRUNION RING SEIZED AND FROZEN. THE PATIENT WAS SUBJECTED TO AN ADDITIONAL 90 MINUTES OF ANESTHESIA. NO PATIENT INJURY REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT TO DATE, NO NEW INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    700293 CRW PRECISION ARC SYSTEM STEREOTAXY HAW INTEGRA BURLINGTON MA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other