BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHOENIX ANKLE ARTHRODESIS IMPLANTS

    MDR report key: 1922602 · Received December 13, 2010

    Report

    Report Number
    2242816-2010-00186
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    October 8, 2010
    Report Date
    December 8, 2010
    Manufacturer
    EBI, LLC
    Product Code
    HSB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE IFU, "POSSIBLE ADVERSE EFFECTS" INCLUDE:"NONUNION OR DELAYED UNION, WHICH MAY LEAD TO BREAKAGE OF THE IMPLANT"."BENDING OR FRACTURE OF THE IMPLANT".

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A NAIL FRACTURED APPROXIMATELY 7 MONTHS POST-OP. FRACTURED NAIL WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHOENIX ANKLE ARTHRODESIS IMPLANTS 11X150MM NAIL HSB EBI, LLC 866520

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention