BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEVEL ONE THORACIC

    MDR report key: 9280326 · Received November 5, 2019

    Report

    Report Number
    9610905-2019-00201
    Event Type
    Injury
    Date Received
    November 5, 2019
    Date of Event
    September 23, 2019
    Report Date
    October 18, 2019
    Manufacturer
    KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG
    Product Code
    HRS
    PMA / PMN Number
    K153482
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). 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. BASED ON THE INFORMATION PROVIDED THE MOST LIKELY ROOT CAUSED DUE TO PATIENT CONDITION. 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 # - 24-023-09-91 LOT #: 101316; 24-023-11-91 LOT #: 101416; 24-023-13-91 LOT #: 101516; 24-023-15-91 LOT #: 101616.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRODUCT WAS REMOVED DUE TO PATIENT CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1072126 LEVEL ONE THORACIC SCREW HRS KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG SEE H10 SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other