BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHOENIX ANKLE NAIL

    MDR report key: 2444921 · Received February 7, 2012

    Report

    Report Number
    2444921
    Event Type
    Malfunction
    Date Received
    February 7, 2012
    Date of Event
    June 20, 2011
    Report Date
    February 7, 2012
    Manufacturer
    EBI, LLC.
    Product Code
    HSB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US

    Narratives

    Description of Event or Problem · 1

    IN JUNE 2011, FOLLOWING COMPLAINTS OF INCREASED PAIN AND EDEMA OF LEFT ANKLE AFTER A LOT OF WALKING, X-RAY SHOWED A NEW FRACTURE OF THE IM NAIL AND STRESS FRACTURE OF THE TALUS. THE PLAN WAS TO CONTINUE TO LIMIT WEIGHTBEARING, BONE STIMULATOR AND FOLLOW UP LEFT ANKLE X-RAY IN 6 WEEKS.======================MANUFACTURER RESPONSE FOR IM NAIL, (BRAND NOT PROVIDED) (PER SITE REPORTER).======================UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHOENIX ANKLE NAIL IM NAIL HSB EBI, LLC. * 112250

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR