BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAYFIELD ULTRA BASE UNIT

    MDR report key: 2103313 · Received May 17, 2011

    Report

    Report Number
    3004608878-2011-00067
    Event Type
    Malfunction
    Date Received
    May 17, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 17, 2011
    Manufacturer
    INTEGRA, CINCINNATI
    Product Code
    HBL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    A TRIAD SKULL CLAMP WAS REPORTED TO HAVE SLIPPED DURING A POSTERIOR CERVICAL FUSION. THE PT HAD NOT BEEN REPOSITIONED WHEN THE UNIT SLIPPED. THE PT DID NOT INCUR AN INJURY AS A RESULT OF THE SLIPPAGE. MAYFIELD ADULT DISPOSABLE PINS WERE BEING USED AT THE TIME. A STEREOTAXY DEVICE WAS NOT USED DURING THIS PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAYFIELD ULTRA BASE UNIT BASE UNITS AND ADAPTERS HBL INTEGRA, CINCINNATI 049

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR