BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNTHES USA, INC.

    MDR report key: 778809 · Received September 28, 2006

    Report

    Report Number
    778809
    Event Type
    Malfunction
    Date Received
    September 28, 2006
    Date of Event
    September 20, 2006
    Report Date
    September 28, 2006
    Manufacturer
    SYNTHES USA, INC.
    Product Code
    MNI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON THE FIRST POST-OP VISIT, X-RAYS CLEARLY SHOWED THE CAP AND THE RIGHT LOWER SCREW HAD BEEN DISLODGED FROM THE SCREW HEAD. NO ABNORMALITY IN THE SCREW WAS SEEN AND THE REASON FOR THE MALFUNCTION COULD NOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNTHES USA, INC. SURGICAL HARDWARE, 3-D HEAD MNI SYNTHES USA, INC. 498.571 *

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR NO OTHER THERAPIES