BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKYLINE CAM LOCKING

    MDR report key: 2303795 · Received October 19, 2011

    Report

    Report Number
    2303795
    Event Type
    Malfunction
    Date Received
    October 19, 2011
    Date of Event
    October 13, 2011
    Report Date
    October 19, 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

    CAM LOCK TIGHTENER OF THE DEPUY SKYLINE PLATING SYSTEM BROKE WHILE IN USE. ALL PIECES WERE ACCOUNTED FOR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR