BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCP CERVICAL PLATE

    MDR report key: 723356 · Received June 2, 2006

    Report

    Report Number
    3004435519-2006-00001
    Event Type
    Malfunction
    Date Received
    June 2, 2006
    Date of Event
    May 2, 2006
    Report Date
    June 2, 2006
    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 REVIEW OF 4-MONTH POST-OP X-RAYS IT WAS SEEN THAT 5 SCP CERVICAL SCREWS HAD PULLED THROUGH THE BOTTOM OF THE SCP CERVICAL PLATE. AS A RESULT A REVISION PROCEDURE WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCP CERVICAL PLATE SPINAL IMPLANT JDN VERTEBRON, INC. 121-0247 DT0904A

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN