BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCP CERVICAL PLATE

    MDR report key: 662848 · Received January 9, 2006

    Report

    Report Number
    3004435519-2005-00002
    Event Type
    Malfunction
    Date Received
    January 9, 2006
    Date of Event
    November 17, 2005
    Report Date
    December 28, 2005
    Manufacturer
    VERTEBRON, INC.
    Product Code
    JDN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING POST OP X-RAYS A SCP RING BACKED OUT FROM PLATE SCREW INTERFACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCP CERVICAL PLATE SPINAL IMPLANT JDN VERTEBRON, INC. 121-0244 *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN