BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI MAXLOCK EXTREME

    MDR report key: 4134438 · Received September 23, 2014

    Report

    Report Number
    4134438
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    September 9, 2014
    Report Date
    September 23, 2014
    Manufacturer
    ORTHOHELIX SURGICAL DESIGNS, INC
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ORTHOPEDIC SURGEON WAS USING K-WIRE AND IT BROKE OFF IN THE BONE WHEN HE WENT TO PULL IT OUT. SURGEON FELT IT WOULD DO MORE DAMAGE TO ATTEMPT TO RETRIEVE IT THEREFORE HE LEFT IN THE PATIENT'S BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591354 MINI MAXLOCK EXTREME PIN, FIXATION HRS ORTHOHELIX SURGICAL DESIGNS, INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR