BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APTIS DRUJ

    MDR report key: 17269994 · Received July 6, 2023

    Report

    Report Number
    3004521401-2023-00001
    Event Type
    Injury
    Date Received
    July 6, 2023
    Date of Event
    April 9, 2023
    Report Date
    July 6, 2023
    Manufacturer
    APTIS MEDICAL
    Product Code
    KXE
    PMA / PMN Number
    K053119
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    WE ARE STILL INVESTIGATING THE CAUSE OF THE ISSUE. THE SURGEON HAS INDICATED HE MAY HAVE IMPLANTED THE STEM INCORRECTLY. BUT WE ARE WAITING FOR EXPLATATION DATE AND DECISION AS TO WHETHER THE FACILITY WILL SEND US THE EXPLANTED STEM FOR REVIEW WHICH WAS REQUESTED ON (B)(6) 2023.

    Description of Event or Problem · 0

    WHILE AT WORK, THE PATIENT WAS USING HIS HAND TO LAY BRICKS WHEN HE FELT HIS WRIST "GIVE OUT". EVER SINCE THEN HE CAN DISLOCATE THE ULNAR STEM AND REDUCE IT MANUALLY. AT THIS POINT IT STAYS DORSALLY DISLOCATED UNLESS HE KEEPS IT MANUALLY REDUCED OR WRAPPED UP TIGHTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418158 APTIS DRUJ APTIS DRUJ KXE APTIS MEDICAL DRUJ-IS160 9449782

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Required Intervention