BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEVEL ONE CMF

    MDR report key: 6082918 · Received November 7, 2016

    Report

    Report Number
    9610905-2016-00041
    Event Type
    Injury
    Date Received
    November 7, 2016
    Report Date
    October 26, 2016
    Manufacturer
    KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG
    Product Code
    JEY
    UDI-DI
    00888118039750
    PMA / PMN Number
    K943347
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHODS: VISUAL INSPECTION, STEREO MICROSCOPIC INSPECTION AND PROCESS EVALUATION BASED ON THE LOT NUMBER. RESULTS: TENSILE CRACKS WERE OBSERVED UNDER THE STEREO MICROSCOPE. FURTHER OBSERVATION DETERMINED THERE WERE NO INDICATIONS OF MATERIAL OR MANUFACTURING DEFECTS OBSERVED. THE PRODUCT HISTORY DEVICE RECORDS WERE ALSO REVIEWED BASED ON THE LOT NUMBER PROVIDED, AND NO ABNORMALITIES WERE FOUND. ASSESSMENT CONCLUSION: THE RESULTS OF THE INVESTIGATION CONCLUDE THAT THE ROOT CAUSE FOR BREAKAGES WAS DUE TO MECHANICAL OVERLOAD ON THE DEVICE. IF FURTHER INFORMATION CAN BE GATHERED THAT MIGHT ADD VALUE TO THE CONTENTS OF THE INVESTIGATION REPORT, AN ADDITIONAL FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    TWO PLATES BROKE IN HALF AFTER IMPLANTATION INTO THE PATIENT. PATIENTS FRACTURE DID NOT HEAL. PLATES WERE REMOVED ON (B)(6) 2016 AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    734348 LEVEL ONE CMF PLATE JEY KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG 25-398-31-09 32794064 00888118039750

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other| R