BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IO FIX

    MDR report key: 3596412 · Received January 22, 2014

    Report

    Report Number
    3007289093-2014-00003
    Event Type
    Injury
    Date Received
    January 22, 2014
    Date of Event
    December 23, 2013
    Report Date
    December 23, 2013
    Manufacturer
    EXTREMITY MEDICAL LLC
    Product Code
    HWC
    PMA / PMN Number
    K121349
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IMPLANT WAS REMOVED DUE TO PATIENT NON-UNION OF THE SECOND TARSOMETATARSAL JOINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53443 IO FIX SCREW, FIXATION, BONE HWC EXTREMITY MEDICAL LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention