BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRO ZURICH DISTRACTOR

    MDR report key: 4936578 · Received July 23, 2015

    Report

    Report Number
    9610905-2015-00035
    Event Type
    Injury
    Date Received
    July 23, 2015
    Date of Event
    July 14, 2015
    Report Date
    July 21, 2015
    Manufacturer
    KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG
    Product Code
    MQN
    PMA / PMN Number
    K010139
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A PHYSICAL 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 MANUFACTURER'S 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 MECHANICAL OVERLOAD PLACED ON THE DEVICE. IF FURTHER INFORMATION IS GATHERED THAT COULD ADD VALUE TO THE CONTENTS OF THE INVESTIGATED REPORT, AN ADDITIONAL FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    TWO WEEKS INTO THE CONSOLIDATION PERIOD, AN X-RAY WAS PERFORMED AND DISCOVERED THE LEFT SIDE SPOT WELD HAD BROKEN OFF THE DISTRACTOR FOOT PLATE. THE BROKEN DISTRACTOR IS SCHEDULED TO BE REPLACED IN A SECONDARY SURGERY ON (B)(6) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479716 MICRO ZURICH DISTRACTOR BONE DISTRACTOR MQN KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG 51-440-30-09 33020830

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO Other