BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEVEL ONE CMF

    MDR report key: 10983739 · Received December 10, 2020

    Report

    Report Number
    9610905-2020-00138
    Event Type
    Injury
    Date Received
    December 10, 2020
    Date of Event
    November 24, 2020
    Report Date
    November 24, 2020
    Manufacturer
    KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG
    Product Code
    HRS
    PMA / PMN Number
    K971297
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    KLS-MARTIN L.P. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF KARL LEIBINGER MEDIZINTECHNIK (B)(4) (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. POSSIBLE STOCK NUMBERS: 25-876-05-91. 25-878-05-91. 25-878-04-91.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SCREWS PULLED FROM THE BONE. THEY WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1451906 LEVEL ONE CMF SCREW HRS KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG SEE H10 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 10 MO Other