BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VEPTR-II IMPLANTS

    MDR report key: 1250489 · Received November 25, 2008

    Report

    Report Number
    MW5009104
    Event Type
    Injury
    Date Received
    November 25, 2008
    Date of Event
    October 8, 2008
    Report Date
    November 25, 2008
    Manufacturer
    SYNTHES, INC.
    Product Code
    MDI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    DE, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    COMPLETE DISENGAGEMENT OF VEPTR-II IMPLANTS: LEFT PROXIMAL RIB CRADLE DEVICE AND DISTRACTION LOCKING CLIP. PT REQUIRED SURGERY FOR REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VEPTR-II IMPLANTS DISTRACTION LOCK AND CRADLE DEVICE MDI SYNTHES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Disability