BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEVEL ONE CMF

    MDR report key: 11317862 · Received February 11, 2021

    Report

    Report Number
    9610905-2021-00007
    Event Type
    Injury
    Date Received
    February 11, 2021
    Date of Event
    January 12, 2021
    Report Date
    January 12, 2021
    Manufacturer
    KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG
    Product Code
    JEY
    UDI-DI
    00888118042088
    PMA / PMN Number
    K943347
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    KLS-MARTIN L.P. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG (MANUFACTURER). REFERENCE EXEMPTION NUMBER E2017029. AN INVESTIGATION WAS PERFORMED ON THE BASIS OF COMPLAINT STATISTICS AS NO DEVICE WAS RETURNED FOR EVALUATION. THE FAILURE ROOT CAUSE CANNOT BE DETERMINED DUE TO THE DEVICE NOT BEING RETURNED. IF FURTHER INFORMATION IS OBTAINED THAT MIGHT ADD VALUE TO THE CONTENTS OF THE INVESTIGATION REPORT, AN ADDITIONAL FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT FELL AND THE PLATE BROKE AS A RESULT OF THE FALL AND NECESSITATED REMOVAL OF MULTIPLE PRODUCTS FROM MULTIPLE IMPLANT COMPANIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208937 LEVEL ONE CMF PLATE JEY KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG 25-550-08-91 UNKNOWN 00888118042088

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other