BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUMMIT DUOFIX TAP SZ7 STD OFF

    MDR report key: 1180154 · Received September 26, 2008

    Report

    Report Number
    1818910-2008-04221
    Event Type
    Injury
    Date Received
    September 26, 2008
    Date of Event
    August 29, 2008
    Report Date
    August 29, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LPH
    PMA / PMN Number
    K011489
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    PT WAS REVISED TO ADDRESS INFECTION, ADVERSE REACTION SINCE ORIGINAL IMPLANT OF DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUMMIT DUOFIX TAP SZ7 STD OFF 87LPH LPH DEPUY ORTHOPAEDICS, INC. NA AW6CN1

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention