BEUDAMED
    FDA Adverse Event Summary report: N

    ACUMEND K-WIRE

    MDR report key: 1052026 · Received May 15, 2008

    Report

    Report Number
    1052026
    Date Received
    May 15, 2008
    Date of Event
    May 13, 2008
    Report Date
    May 15, 2008
    Manufacturer
    ACUMED, LLC
    Product Code
    HTY
    Report Source
    User Facility report
    Reporter Location
    RI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    K-WIRE BROKE WITHIN ORIF RIGHT ELBOW-PIECES REMOVED BUT TWO SMALL PIN DOT PIECES WERE NOTED ON X-RAY. SURGEON WAS UNABLE TO RETRIEVE THE PIECES. REMAINED IN PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUMEND K-WIRE K-WIRE HTY ACUMED, LLC NOT KNOWN NOT KNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR