BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEVEL ONE THORACIC

    MDR report key: 10898979 · Received November 24, 2020

    Report

    Report Number
    9610905-2020-00128
    Event Type
    Injury
    Date Received
    November 24, 2020
    Date of Event
    November 3, 2020
    Report Date
    November 3, 2020
    Manufacturer
    KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG
    Product Code
    HRS
    UDI-DI
    00888118101419
    PMA / PMN Number
    K153482
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 1

    KLS-MARTIN L.P. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG (MANUFACTURER). REFERENCE EXEMPTION NUMBER E2017029.

    Description of Event or Problem · 1

    IT WAS REPORTED A PLATE BROKE. THE PLATE IS NOT EXPECTED TO BE REMOVED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1359548 LEVEL ONE THORACIC PLATE HRS KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG 24-015-27-71 33355008 00888118101419

    Patients

    Seq Age Sex Outcome Treatment
    1