BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKELETAL DYNAMICS

    MDR report key: 18164916 · Received November 17, 2023

    Report

    Report Number
    3006742481-2023-00016
    Event Type
    Malfunction
    Date Received
    November 17, 2023
    Date of Event
    October 20, 2023
    Report Date
    November 17, 2023
    Manufacturer
    SKELETAL DYNAMICS INC.
    Product Code
    KWI
    UDI-DI
    00841506100043
    PMA / PMN Number
    K172688
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AT THIS TIME WE HAVE BEEN UNABLE TO OBTAIN INFORMATION ABOUT THE PATIENT OR IMPLANT OTHER THAN FLUOROSCOPIC IMAGES.

    Description of Event or Problem · 0

    AN IMPLANTED RADIAL HEAD DISASSOCIATED FROM THE RADIAL STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    880467 SKELETAL DYNAMICS ALIGN RADIAL HEAD SYSTEM KWI SKELETAL DYNAMICS INC. AN2002015 00841506100043

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female