BEUDAMED
    FDA Adverse Event Other Summary report: N

    ASCENSION MCP

    MDR report key: 1329092 · Received February 27, 2009

    Report

    Report Number
    1651501-2009-00012
    Event Type
    Other
    Date Received
    February 27, 2009
    Report Date
    February 27, 2009
    Manufacturer
    ASCENSION ORTHOPEDICS, INC.
    Product Code
    KYJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. LOT TRACE DEMONSTRATED THAT THE DEVICE MET ALL APPLICABLE MANUFACTURING SPECIFICATIONS.

    Description of Event or Problem · 1

    SURGEON REPORTED A FRACTURE IN THE DISTAL COMPONENT IN POST-OP X-RAY. REVISION SURGERY HAS NOT BEEN PERFORMED TO DATE; NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASCENSION MCP TOTAL FINGER JOINT IMPLANT KYJ ASCENSION ORTHOPEDICS, INC. MCP-100 (DISTAL) 06-0831

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other