BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EBI OSTEOGEN IMPLANTABLE GROWTH STIMULATOR

    MDR report key: 1030809 · Received April 17, 2008

    Report

    Report Number
    2242816-2008-00055
    Event Type
    Malfunction
    Date Received
    April 17, 2008
    Date of Event
    April 7, 2008
    Report Date
    April 14, 2008
    Manufacturer
    EBI
    Product Code
    LOE
    PMA / PMN Number
    P970005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PRE-TEST LIGHT DID NOT WORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EBI OSTEOGEN IMPLANTABLE GROWTH STIMULATOR LOE EBI

    Patients

    Seq Age Sex Outcome Treatment
    1