BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAYFIELD MODIFIED SKULL CLAMP

    MDR report key: 1982774 · Received January 6, 2011

    Report

    Report Number
    3004608878-2011-00002
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Report Date
    January 6, 2011
    Manufacturer
    INTEGRA-OHIO, INC
    Product Code
    HBL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SINGLE PIN PRESSURE GAUGE FAILED. IT WAS NOT KNOWN IF THERE WAS ANY PT INJURY. ADD'L CLINICAL INFO HAS BEEN REQUESTED, HOWEVER, NO FURTHER INFO HAS BEEN PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1