BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHOENIX ANTEGRADE FEMORAL NAIL SYSTEM

    MDR report key: 1912334 · Received December 2, 2010

    Report

    Report Number
    2242816-2010-00176
    Event Type
    Malfunction
    Date Received
    December 2, 2010
    Date of Event
    November 11, 2010
    Report Date
    November 11, 2010
    Manufacturer
    EBI, LLC
    Product Code
    HSB
    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 ON EXTRACTION OF A NAIL TO REPLACE WITH A SMALLER SIZE, CONNECTING BOLT FRACTURED. PATIENT OUTCOME: NO ADVERSE EFFECT REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHOENIX ANTEGRADE FEMORAL NAIL SYSTEM CONNECTING BOLT HSB EBI, LLC 305380

    Patients

    Seq Age Sex Outcome Treatment
    1