BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAYFIELD INFINITY XR2

    MDR report key: 3823247 · Received May 5, 2014

    Report

    Report Number
    3823247
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 5, 2014
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION
    Product Code
    HBL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN'S ASSISTANT (PA) PLACED PATIENT IN NEW MODEL - TRANSLUCENT MAYFIELD HEADREST- FOR PROCEDURE PRIOR TO ME ENTERING THE ROOM. WHILE PREPPING AND POSITIONING THE PATIENT, THE PA WENT TO START SHAVING THE OPERATIVE SITE ON THE BACK OF THE PATIENT'S NECK. BEFORE SHE EVEN TOUCHED THE PATIENT TO START SHAVING, WE HEARD A "CLICK," SHE GRABBED THE PATIENTS HEAD, AND STARTED LOOKING TO SEE WHAT THE CLICK SOUND HAD BEEN. SHE QUICKLY FOUND OUT THAT THE PLASTIC SCREW THAT HOLDS THE DEVICE TOGETHER HAD BROKEN AND THE PATIENT'S HEAD WAS NO LONGER BEING HELD UP BY THE HEAD REST. WE OBTAINED THE "OLD" MAYFIELD AND RE-POSITIONED THE PATIENT USING THAT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267930 MAYFIELD INFINITY XR2 MAYFIELD SKULL CLAMP HBL INTEGRA LIFESCIENCES CORPORATION A-2079 *

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR