BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEVEL ONE CMF

    MDR report key: 11854616 · Received May 20, 2021

    Report

    Report Number
    9610905-2021-00036
    Event Type
    Injury
    Date Received
    May 20, 2021
    Date of Event
    April 20, 2021
    Report Date
    April 20, 2021
    Manufacturer
    KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG
    Product Code
    MQN
    UDI-DI
    00888118047915
    PMA / PMN Number
    K032442
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. MDR: 9610905-2021-00026. 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 SCREWS BROKE, POSSIBLY DUE TO THE PATIENT'S NONCOMPLIANCE, AND REQUIRED REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755689 LEVEL ONE CMF SCREW MQN KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG 25-882-13-91 00888118047915

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other