BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NORIADE SKELETON REPAIR SYSTEM

    MDR report key: 565663 · Received January 3, 2005

    Report

    Report Number
    MW1034175
    Event Type
    Injury
    Date Received
    January 3, 2005
    Date of Event
    August 31, 2004
    Report Date
    January 3, 2005
    Manufacturer
    SYNTHES
    Product Code
    MQV
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 3/2/05: ADD'L DESCRIPTION OF THE INCIDENT IS CONTAINED IN SECTION B5 OF THE ATTACHED MEDWATCH REPORT# 2939274-2005-03. TO DATE, NO FURTHER INFO HAS BEEN PROVIDED. THE PRODUCT WAS NOT RETURNED; THEREFORE, NO EVAL COULD BE PERFORMED AND NO CONCLUSIONS COULD BE DRAWN. TO DATE, NO FURTHER INFO HAS BEEN PROVIDED.

    Description of Event or Problem · 1

    PT HAD A SURGERY DONE IN 2004 AND SUFFERED BLOOD CLOT, EDEMA, TETANUS AND DRAINAGE FOR SOMETIME. ALSO ITCHING LIKE CRAZY. PMD AND ORTHOPEDIC CONFIRMED ALLERGIC REACTION. PRODUCT IS USED OFF LABEL AND MANUFACTURER WOULD NOT TELL THE CONTENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NORIADE SKELETON REPAIR SYSTEM BONE FILLER MQV SYNTHES UNK N576403

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention