BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASCENSION SADDLE PYROCARBON CMC

    MDR report key: 2030691 · Received March 18, 2011

    Report

    Report Number
    1651501-2011-00006
    Event Type
    Injury
    Date Received
    March 18, 2011
    Date of Event
    February 17, 2011
    Report Date
    March 18, 2011
    Manufacturer
    ASCENSION ORTHOPEDICS, INC.
    Product Code
    KYI
    PMA / PMN Number
    K061451
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITTLE INFO HAS BEEN SUPPLIED ON THE EVENT. IF ADDITIONAL INFO IS OBTAINED, A SUPPLEMENT REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    THE SURGEON REPORTED THAT HE HAD TO REVISE A CMC JOINT WITH A NEW IMPLANT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R