BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRO ZURICH DISTRACTOR

    MDR report key: 3113642 · Received May 9, 2013

    Report

    Report Number
    9610905-2013-00022
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    February 11, 2013
    Report Date
    April 23, 2013
    Manufacturer
    KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG
    Product Code
    MQN
    PMA / PMN Number
    K010139
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE SURGEON BECAME AWARE OF ISSUES WITH THE PATIENT'S HEALING. THE DEVICES WERE FOUND TO BE BROKEN UPON REMOVAL, ON (B)(6) 2013. THE SURGEON CONSIDERED THAT AN UNK EXTERNAL EVENT OCCURRED THAT CAUSED/CONTRIBUTED TO THE BREAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202699 MICRO ZURICH DISTRACTOR MQN KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG 51-424-30

    Patients

    Seq Age Sex Outcome Treatment
    1 16 MO Other