BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAYFIELD MODIFIED SKULL CLAMP

    MDR report key: 2190902 · Received July 19, 2011

    Report

    Report Number
    3004608878-2011-00099
    Event Type
    Malfunction
    Date Received
    July 19, 2011
    Report Date
    July 19, 2011
    Manufacturer
    INTEGRA, CINCINNATI
    Product Code
    HBL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SKULL CLAMP HAS TOO MUCH MOVEMENT. THERE WAS PT CONTACT BUT NO PT INJURY OR DEATH WAS ALLEGED. ADD'L CLINICAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAYFIELD MODIFIED SKULL CLAMP SKULL CLAMPS AND HEADREST SYSTEMS HBL INTEGRA, CINCINNATI 109

    Patients

    Seq Age Sex Outcome Treatment
    1