BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGMA STAB XLK INS 2.5 8MM

    MDR report key: 1153046 · Received September 5, 2008

    Report

    Report Number
    1818910-2008-03860
    Event Type
    Injury
    Date Received
    September 5, 2008
    Date of Event
    August 8, 2008
    Report Date
    August 8, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, DEPUY CORK
    Product Code
    JWH
    PMA / PMN Number
    K040166
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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

    THE PATIENT WAS REVISED BECAUSE OF INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGMA STAB XLK INS 2.5 8MM 87JWH JWH DEPUY ORTHOPAEDICS, DEPUY CORK NA 2436384

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention