BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK DEPUY ANKLE SCREW

    MDR report key: 1403905 · Received June 16, 2009

    Report

    Report Number
    1818910-2009-03240
    Event Type
    Injury
    Date Received
    June 16, 2009
    Date of Event
    May 27, 2009
    Report Date
    May 27, 2009
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    KXC
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION WAS NOT POSSIBLE, AS THE PRODUCT WAS NOT RETURNED. THE INVESTIGATION WAS LIMITED TO REVIEW OF THE INFORMATION PROVIDED, AS THE PART AND LOT NUMBER REQUIRED TO REVIEW THE DEVICE HISTORY RECORDS WAS NOT PROVIDED. PROVIDED INFORMATION STATES THE PATIENT WAS REVISED BECAUSE A SCREW WAS TOO LONG. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    THE PATIENT WAS REVISED BECAUSE THE SCREW WAS TOO LONG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK DEPUY ANKLE SCREW TOTAL ANKLE PROSTHESIS KXC DEPUY ORTHOPAEDICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention