BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEX

    MDR report key: 7946376 · Received October 9, 2018

    Report

    Report Number
    7946376
    Event Type
    Malfunction
    Date Received
    October 9, 2018
    Date of Event
    May 17, 2018
    Report Date
    June 5, 2018
    Manufacturer
    STRYKER TRAUMA SA
    Product Code
    JDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DURING A SURGICAL PROCEDURE REMOVAL EXTERNAL FIXATOR OF THE RIGHT LEG, REMOVAL OF THE FRAME THE TWO ANTERIOR PINS HAD FRACTURED AT THE BONE INTERFACE HALF OF THE PINS WAS STILL REMAINING INSIDE THE FEMUR, BURIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787837 APEX PIN, FIXATION, THREADED JDW STRYKER TRAUMA SA 5017-4-180S L31110

    Patients

    Seq Age Sex Outcome Treatment
    1 23360 DA