BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CALSTRUX (TRICALCIUM PHOSPHATE)

    MDR report key: 2893393 · Received October 30, 2007

    Report

    Report Number
    1224732-2005-00045
    Event Type
    Injury
    Date Received
    October 30, 2007
    Date of Event
    January 15, 2005
    Report Date
    October 24, 2007
    Manufacturer
    STRYKER BIOTECH
    Product Code
    MPY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A FEMALE PT DEVELOPED INFLAMMATION WITH SWELLING, INFLAMED SKIN, BLISTERING WITH FIRMNESS IN ARM FOLLOWING IMPLANTATION WITH OP-1 IMPLANT AND CALSTRUX TO TREAT RADIAL SHAFT NONUNION. THE GRAFT MOVED INTO "SUBCUTANEOUS LOCATION." THE PT WAS HOSPITALIZED AND UNDERWENT SURGERY TO REMOVE THE GRAFT. SYMPTOMS CLEARED FOLLOWING REMOVAL OF THE GRAFT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CALSTRUX (TRICALCIUM PHOSPHATE) IMPLANT MPY STRYKER BIOTECH 40015 TUML005

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R