BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRO ZURICH DISTRACTOR

    MDR report key: 5108228 · Received September 28, 2015

    Report

    Report Number
    9610905-2015-00042
    Event Type
    Injury
    Date Received
    September 28, 2015
    Date of Event
    August 14, 2015
    Report Date
    September 16, 2015
    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

    Additional Manufacturer Narrative · 1

    A TEST WAS PERFORMED TO EVALUATE THE MOVEMENT OF THE DISTRACTOR AND IT WAS CONCLUDED THE DISTRACTOR MOVED PROPERLY WITHOUT ANY COMPLICATIONS. IN ADDITION, THE DEVICE WAS OPTICALLY ASSESSED AND STEREO MICROSCOPICALLY INVESTIGATED IN THE LAB. THE STEREO MICROSCOPIC INVESTIGATION REVEALED A TENSILE CRACK DUE TO STRESS. FURTHER OBSERVATION DETERMINED THERE WERE NO INDICATIONS OF MATERIAL OR MANUFACTURING DEFECTS DISCOVERED. PRODUCT DEVICE HISTORY RECORDS WERE ALSO REVIEWED BASED ON THE LOT NUMBER PROVIDED AND REVEALED NO ABNORMALITIES. THE RESULTS OF THE INVESTIGATION CONCLUDE THAT THE ROOT CAUSE FOR BREAKAGE WAS DUE TO STRESSES PLACED UPON THE DEVICE. IF FURTHER INFORMATION CAN BE GATHERED THAT CAN ADD VALUE TO THE CONTENTS OF THE INVESTIGATED REPORT, AN ADDITIONAL FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE PATIENT WAS CHEWING ON A PIECE OF ICE WHEN THE DISTRACTOR PLATE BROKE OFF FROM THE DISTRACTOR BODY. DR. (B)(6) HAD TO PERFORM A SECONDARY SURGERY IN ORDER TO REMOVE THE BROKEN DISTRACTOR AND REPLACE IT WITH A NEW ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639812 MICRO ZURICH DISTRACTOR BONE PLATE MQN KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG 51-422-25-09 33089587

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Other