BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.0MM TI CANN COMPRESSION HEADLESS SCREW- LT- 44MM

    MDR report key: 17622804 · Received August 25, 2023

    Report

    Report Number
    3012966183-2023-00016
    Event Type
    Malfunction
    Date Received
    August 25, 2023
    Report Date
    August 25, 2023
    Manufacturer
    TYBER MEDICAL
    Product Code
    HWC
    UDI-DI
    00819917024418
    PMA / PMN Number
    K133842
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 4.0MM CCHS SCREW WAS IMPLANTED 7 WEEKS AGO IN A PATIENTS GREATER TOE AND THE SCREW RECENTLY BROKE. THE PATIENT CANNOT RECALL ANY TRAUMA, TRIP/FALL OR ANY OTHER MOVEMENT THAT WOULD HAVE CAUSED THE SCREW TO BREAK. THE SURGEONS NAME IS (B)(6), DPM. THIS COMPLAINT INVOLVES ONE(1) DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2083603 4.0MM TI CANN COMPRESSION HEADLESS SCREW- LT- 44MM SCREW HWC TYBER MEDICAL 04.334.444 00819917024418

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female Other