BEUDAMED
    FDA Adverse Event Other Summary report: N

    INBONE TOTAL ANKLE REPLACEMENT

    MDR report key: 932424 · Received October 24, 2007

    Report

    Report Number
    3005663955-2007-00004
    Event Type
    Other
    Date Received
    October 24, 2007
    Date of Event
    May 23, 2007
    Report Date
    October 24, 2007
    Manufacturer
    INBONE TECHNOLOGIES
    Product Code
    HSN
    PMA / PMN Number
    K051023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: REVIEWED IFU AND DETERMINED WAS ADEQUATE. VERIFIED MFG STERILIZATION OF ANKLE IMPLANT COMPONENTS. ANKLE IMPLANT COMPONENT LIST: P/N 200010-902 LOT 2261, P/N 200009-901 LOT 2261, P/N 200222-903 LOT 2261, P/N 200222-903 LOT: 2261, P/N 200221-932 LOT 10065, P/N 200220-903 LOT 10012, P/N 200347-902 LOT 10093.

    Description of Event or Problem · 1

    ANKLE PROSTHESIS REMOVED FROM PATIENT DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INBONE TOTAL ANKLE REPLACEMENT TOTAL ANKLE HSN INBONE TECHNOLOGIES NA 10022

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR Hospitalization