BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUGRIP CMC IMPLANT

    MDR report key: 2092876 · Received May 11, 2011

    Report

    Report Number
    1651501-2011-00040
    Event Type
    Injury
    Date Received
    May 11, 2011
    Date of Event
    April 11, 2011
    Report Date
    May 11, 2011
    Manufacturer
    ASCENSION ORTHOPEDICS, INC.
    Product Code
    KYI
    PMA / PMN Number
    K041451
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS ONGOING TO OBTAIN ADDITIONAL INFORMATION ABOUT THE EVENT. A REVISION SURGERY HAS NOT BEEN REPORTED BUT MAY BE AN OPTION. X-RAYS WERE PROVIDED FOR ANALYSIS. THE X-RAYS APPEAR TO SHOW LYSIS AND LOOSENING. IF ADDITIONAL INFORMATION IS OBTAINED, A SUPPLEMENT REPORT WILL BE SUBMITTED AS APPROPRIATE.

    Description of Event or Problem · 1

    REPORTED THAT THE NUGRIP IMPLANT WAS CAUSING ISSUES FOR A PATIENT AFTER BEING IMPLANTED. FROM THE INFORMATION COLLECTED TO DATE THE EVENT APPEARS TO HAVE SOME TRAPEZIAL CYSTS AND SOME LOOSING IS EVIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUGRIP CMC IMPLANT WRIST JOINT CARPAL TRAPEZIUM PROSTHESIS KYI ASCENSION ORTHOPEDICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention