BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASCENSION MCP DISTAL IMPLANT

    MDR report key: 1618277 · Received February 25, 2010

    Report

    Report Number
    1651501-2010-00005
    Event Type
    Injury
    Date Received
    February 25, 2010
    Date of Event
    January 12, 2010
    Report Date
    February 25, 2010
    Manufacturer
    ASCENSION ORTHOPEDICS, INC.
    Product Code
    NEG
    PMA / PMN Number
    P000057
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING RECORDS WERE REVIEWED. NOTHING WAS IDENTIFIED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE EXPLANTED DEVICE WAS NOT RETURNED FOR EVALUATION AND ADDITIONAL INFO WAS UNK OR NOT PROVIDED. NO CONCLUSION COULD BE DRAWN ON THE INFO THAT WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS EXPERIENCING JOINT PAIN AND SOME SUBLUXATION WITH HER IMPLANT. IT WAS LATER DETERMINED THAT A FRACTURE OF THE IMPLANT OCCURRED. REVISION SURGERY WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASCENSION MCP DISTAL IMPLANT FINGER PYROLYTIC CARBON PROSTHESIS NEG ASCENSION ORTHOPEDICS, INC. MCP-100-30D 09-1991

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization