BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 1062935 · Received June 19, 2008

    Report

    Report Number
    1030489-2008-00289
    Event Type
    Injury
    Date Received
    June 19, 2008
    Date of Event
    January 28, 2008
    Report Date
    May 21, 2008
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC.
    Product Code
    MPW
    PMA / PMN Number
    P000054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCTS FROM MULTIPLE MFRS WERE IMPLANTED DURING THE PROCEDURE. ALTHOUGH IT IS UNK IF ANY OF THE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES. NEITHER THE DEVICE NOR FILMS OR APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MFR FOR EVAL. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT UNDERWENT SURGICAL TREATMENT OF A LEFT ULNAR NON-UNION USING RHBMP-2/ACS AND A 2-HOLE PLATE. THE PT REPORTEDLY DEVELOPED SURGERY SITE SWELLING/EDEMA EARLY IN THE POST-OP PERIOD THAT RESULTED IN COMPARTMENT SYNDROME. THE SURGEON REPORTEDLY PERFORMED A FASCIECTOMY FOUR DAYS POST-OP, DURING WHICH HE NOTED THAT THE LOCAL MUSCLE "LOOKED BAD." THE PT IS NOW APPROX FIVE MONTHS POST-INTERVENTION AND REPORTEDLY CONTINUES TO HAVE "SEVERE" CONTRACTURES OF THE LEFT FOREARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSE BONE GRAFT INFUSE BONE GRAFT MPW MEDTRONIC SOFAMOR DANEK USA, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Required Intervention