BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NORION SKELETAL REPAIR

    MDR report key: 566806 · Received January 7, 2005

    Report

    Report Number
    MW1034355
    Event Type
    Injury
    Date Received
    January 7, 2005
    Date of Event
    August 31, 2004
    Report Date
    January 7, 2005
    Manufacturer
    SYNTHES
    Product Code
    MQV
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SCHATZKER TI FX RIGHT KNEE WITH OPEN REDUCTION & TIBIAL PLATE NORION BONE CEMENT. DEVELOPED SEVERE PAIN & SWELLING IN SURGICAL SITE WITH NO EVIDENCE OF THROMBOPHLEBITIS. NOW A QUESTION OF ALLERGIC RESPONSE TO NORION SR5 BONE VOID FILLER.

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NORION SKELETAL REPAIR SYSTEM BONE VOID FILLER MQV SYNTHES * N576403

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Disability