BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLAV FRAC PLT,CENTRAL THIRD,LFT,SS

    MDR report key: 10547374 · Received September 17, 2020

    Report

    Report Number
    1220246-2020-02178
    Event Type
    Injury
    Date Received
    September 17, 2020
    Date of Event
    September 3, 2020
    Report Date
    September 17, 2020
    Manufacturer
    ARTHREX, INC.
    Product Code
    HRS
    UDI-DI
    00888867027442
    PMA / PMN Number
    K143139
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT'S LEGAL REPRESENTATIVE THAT THE PATIENT HAD AN ARTHREX AR-2653CL CLAVICLE PLATE (LOT 6791442) IMPLANTED. ON OR AROUND (B)(6) 2019 THE PATIENT NOTICED PAIN, REDNESS AND A LUMP INHER CLAVICLE. SHE PROCEEDED TO THE EMERGENCY ROOM WHERE X-RAYS WERE TAKEN DEMONSTRATING THE PLATE HAD BROKEN. THE PLATE WAS SUBSEQUENTLY SURGICALLY REMOVED ON OR AROUND (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1011627 CLAV FRAC PLT,CENTRAL THIRD,LFT,SS PLATE, FIXATION, BONE HRS ARTHREX, INC. CLAV FRAC PLT,CENTRAL THIRD,LFT,SS 6791442 00888867027442

    Patients

    Seq Age Sex Outcome Treatment
    1 Other