BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRAFTJACKET ACELLULAR PERIOSTEUM REPL. SCAFFOLD

    MDR report key: 483308 · Received September 11, 2003

    Report

    Report Number
    1043534-2003-00071
    Event Type
    Injury
    Date Received
    September 11, 2003
    Date of Event
    July 10, 2003
    Report Date
    July 14, 2003
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    LMO
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ALLEGEDLY PT WAS A "REDO CUFF". SIX WEEKS POST-OP PT HAD A "HUGE COLLECTION OF PURULENT MATERIAL" THAT WAS EVACUATED. GRAFT JACKET COVER PATCH WAS LOOSE AND DIDN'T SEEM INCORPORATED INTO THE CUFF BELOW IT. CULTURE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GRAFTJACKET ACELLULAR PERIOSTEUM REPL. SCAFFOLD BIOLOGIC COMPONENT LMO WRIGHT MEDICAL TECHNOLOGY, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Required Intervention