BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRANIAL SCREW PLUSDRIVE

    MDR report key: 1831761 · Received September 9, 2010

    Report

    Report Number
    1831761
    Event Type
    Malfunction
    Date Received
    September 9, 2010
    Date of Event
    September 3, 2010
    Report Date
    September 9, 2010
    Manufacturer
    SYNTHES
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WITH BONE FLAP IN PLACE AND WHILE SCREWS WERE BEING PUT IN (1) 4MM SCREW POPPED OUT OF THE SCREWDRIVER AND WAS UNABLE TO BE FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRANIAL SCREW PLUSDRIVE SCREW HWC SYNTHES * *

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR