BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQ REVERSE TORQUE DEFINING SCREW KIT

    MDR report key: 18008394 · Received October 25, 2023

    Report

    Report Number
    1038671-2023-02607
    Event Type
    Injury
    Date Received
    October 25, 2023
    Date of Event
    August 23, 2023
    Report Date
    October 25, 2023
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862086518
    PMA / PMN Number
    K063569
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PENDING INVESTIGATION. D10: 320-10-05 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +5 6993379 320-42-00 - 145-DEG PE 42MM HUM LINER +0 S313393.

    Description of Event or Problem · 0

    AS REPORTED, THE PATIENT HAD AN INITIAL RIGHT TSA ON AN (B)(6) 2021. THE PATIENT WAS DISLOCATING AND CAME IN TO SEE THE SURGEON. THE PATIENT WAS REVISED ON (B)(6) 2023 AND THE SCREW WAS FOUND TO BE STRIPPED. THERE WAS NO REPORTED SURGICAL DELAY/PROLONGATION. THE PATIENT OUTCOME IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2140751 EQ REVERSE TORQUE DEFINING SCREW KIT PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC. 10885862086518

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Required Intervention SEE H10