BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEVEL ONE THORACIC

    MDR report key: 19916973 · Received August 6, 2024

    Report

    Report Number
    9610905-2024-00052
    Event Type
    Injury
    Date Received
    August 6, 2024
    Report Date
    July 9, 2024
    Manufacturer
    KLS MARTIN SE & CO. KG
    Product Code
    HRS
    UDI-DI
    10888118101928
    PMA / PMN Number
    K153482
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE MATERIAL NUMBER NOR LOT NUMBER WAS IDENTIFIED THEREFORE COMPLAINT RATE, REVIEW OF DEVICE HISTORY RECORDS AND RISK FILE WAS NOT POSSIBLE. THE ROOT CAUSE FOR THE FAILURE CANNOT BE DETERMINED SINCE NEITHER MATERIAL NUMBER NOR LOT NUMBER WERE PROVIDED, AND THE DEVICE WAS NOT 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 MATERIAL NUMBER IDENTIFIED (B)(4).

    Description of Event or Problem · 0

    THORACIC SCREWS BECAME SLIGHTLY LOOSENED FROM MULTIPLE BONES IN THE SAME LOCATION DUE TO UNKNOWN REASONS. THEY WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1771274 LEVEL ONE THORACIC SCREW HRS KLS MARTIN SE & CO. KG SEE H11 UNKNOWN 10888118101928

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other