BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EBI OSTEOGEN IMPLANTABLE GROWTH STIMULATOR

    MDR report key: 1091007 · Received August 5, 2008

    Report

    Report Number
    2242816-2008-00110
    Event Type
    Malfunction
    Date Received
    August 5, 2008
    Date of Event
    July 29, 2008
    Report Date
    August 5, 2008
    Manufacturer
    EBI, L.P.
    Product Code
    LOE
    PMA / PMN Number
    P790005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE'S PRE-OPERATIVE TEST INDICATOR INDICATED THAT THE DEVICE WAS INACTIVE AND SHOULD NOT BE USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EBI OSTEOGEN IMPLANTABLE GROWTH STIMULATOR STIMULATOR, INVASIVE BONE GROWTH LOE EBI, L.P.

    Patients

    Seq Age Sex Outcome Treatment
    1