BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EBI BONE HEALING SYSTEM

    MDR report key: 829122 · Received March 12, 2007

    Report

    Report Number
    2242816-2007-00010
    Event Type
    Injury
    Date Received
    March 12, 2007
    Date of Event
    January 2, 2007
    Report Date
    March 2, 2007
    Manufacturer
    EBI
    Product Code
    LOF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT WAS REPORTED BY THE PT, NOT A MEDICAL PROVIDER.

    Description of Event or Problem · 1

    PATIENT STATED THE BHS UNIT CAUSED EXCESSIVE BONE GROWTH. PT OUTCOME: DROP FOOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EBI BONE HEALING SYSTEM LOF LOF EBI 2001 633151

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR