BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INBONE TOTAL ANKLE

    MDR report key: 985574 · Received January 24, 2008

    Report

    Report Number
    3005663955-2008-00002
    Event Type
    Injury
    Date Received
    January 24, 2008
    Date of Event
    May 21, 2006
    Report Date
    January 24, 2006
    Manufacturer
    INBONE TECHNOLOGIES
    Product Code
    HSN
    PMA / PMN Number
    K051309
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: PHYSICIAN NOTES AND PATIENT X-RAYS. ADDITIONAL ANKLE IMPLANT COMPONENTS. PART NUMBERS FOR LOT # 2261: 200010-901, 200010-902, 200222-903, 200221-932, 200220-903, 200219-923, 200009-902, AND 200009-901.

    Description of Event or Problem · 1

    PATIENT FELL TWO DAYS AFTER ANKLE SURGERY. THIS RESULTED IN A REVISION SURGERY ONE MONTH LATER TO RE-ALIGN ANKLE IMPLANT. NOTE: ISSUE DISCOVERED DURING 1/23/08 INTERNAL AUDIT OF PATIENT FILES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INBONE TOTAL ANKLE TOTAL ANKLE REPLACEMENT HSN INBONE TECHNOLOGIES 200011-901 2261

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR Hospitalization