BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSTEOGEN

    MDR report key: 2122175 · Received June 13, 2011

    Report

    Report Number
    2242816-2011-00065
    Event Type
    Injury
    Date Received
    June 13, 2011
    Date of Event
    May 11, 2011
    Report Date
    May 16, 2011
    Manufacturer
    EBI, LLC
    Product Code
    LOE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT COMPLAINED OF PAIN AND SWELLING OF LEG. A REVISION SURGERY WAS CONDUCTED AT WHICH RADIO-OPAQUE MATERIAL WAS FOUND AROUND THE BATTERY OF THE IMPLANTED DEVICE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention