BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC SIGMARP STB TB IN 4 10.0

    MDR report key: 1020297 · Received March 25, 2008

    Report

    Report Number
    1818910-2008-00875
    Event Type
    Injury
    Date Received
    March 25, 2008
    Date of Event
    February 24, 2008
    Report Date
    February 24, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, DEPUY-CORK
    Product Code
    NJL
    PMA / PMN Number
    PMA074
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 REVISED TO ADDRESS INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFC SIGMARP STB TB IN 4 10.0 87NJL NJL DEPUY ORTHOPAEDICS, DEPUY-CORK NA 2185056

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention