BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOU

    MDR report key: 4961330 · Received July 30, 2015

    Report

    Report Number
    1935627-2015-00001
    Event Type
    Malfunction
    Date Received
    July 30, 2015
    Date of Event
    November 15, 2013
    Report Date
    July 29, 2015
    Manufacturer
    CORELINK, LLC
    Product Code
    KWQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO FURTHER INFORMATION COULD BE OBTAINED ON THE USE OR THE SCENARIO IN HOW THIS OCCURRED.

    Description of Event or Problem · 1

    SALES REP CALLED, STATING THE TIP OF A THREADED FIXATION PIN BROKE OFF IN THE PATIENT'S BONE. WHILE TRYING TO EXTRACT THE PIN THAT WAS HOLDING THE LUMBAR PLATE IN PLACE, THE TIP BROKE UNDER THE PLATE. THE SURGEON DETERMINED TO LEAVE THE BROKEN TIP IN THE BONE AS NOT TO DISRUPT THE POSITION OF THE PLATE. THE PRODUCT WAS NOT ABLE TO BE OBTAINED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498735 ZOU ANTERIOR LUMBAR FIXATION PIN - THREADED KWQ CORELINK, LLC 6010-101

    Patients

    Seq Age Sex Outcome Treatment
    1