BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKYLINE CAM LOCKING

    MDR report key: 2273111 · Received September 28, 2011

    Report

    Report Number
    2273111
    Event Type
    Malfunction
    Date Received
    September 28, 2011
    Date of Event
    September 21, 2011
    Report Date
    September 28, 2011
    Manufacturer
    DEPUY SPINE
    Product Code
    LRZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US

    Narratives

    Description of Event or Problem · 1

    SCREW DRIVER HEAD BROKE WHILE BEING USED TO IMPLANT CERVICAL SCREW INTO PLATE. ALL PIECES REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SKYLINE CAM LOCKING CAM TIGHTENER SHAFT LRZ DEPUY SPINE * *

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR