BEUDAMED
    FDA Adverse Event Other Summary report: N

    ASI

    MDR report key: 843777 · Received April 26, 2007

    Report

    Report Number
    2030833-2007-00007
    Event Type
    Other
    Date Received
    April 26, 2007
    Date of Event
    March 28, 2007
    Report Date
    April 26, 2007
    Manufacturer
    NEXA ORTHOPEDICS, INC.
    Product Code
    MJW
    PMA / PMN Number
    K032902
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    X-RAY REVEALED ANGLED SUBTALAR IMPLANT (ASI) MIGRATED FROM ORIGINAL IMPLANTED POSITION. SURGEON ELECTED TO REMOVE ORIGINAL IMPLANT AND REPLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASI ANGLED SUBTALAR IMPLANT MJW NEXA ORTHOPEDICS, INC. ASI-MD K07826

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other| R