BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASCENSION DRUJ

    MDR report key: 2156030 · Received July 1, 2011

    Report

    Report Number
    1651501-2011-00053
    Event Type
    Injury
    Date Received
    July 1, 2011
    Date of Event
    June 3, 2011
    Report Date
    July 1, 2011
    Manufacturer
    ASCENSION ORTHOPEDICS, INC.
    Product Code
    KXE
    PMA / PMN Number
    K052137
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITTLE INFO ABOUT THE EVENT HAS BEEN PROVIDED. THE INVESTIGATION IS ONGOING. IF ADD'L INFO IS COLLECTED/DETERMINED, A SUPPLEMENTAL REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT HAD A DRUJ DEVICE REMOVED BECAUSE THE PT WAS EXPERIENCING PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASCENSION DRUJ WRIST JOINT ULNAR (HEMI-WRIST) PROSTHESIS KXE ASCENSION ORTHOPEDICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention