BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OP-1 IMPLANT (OSTEOGENIC PROTEIN 1)

    MDR report key: 1220396 · Received November 5, 2008

    Report

    Report Number
    1224732-2008-00031
    Event Type
    Injury
    Date Received
    November 5, 2008
    Date of Event
    October 1, 2008
    Report Date
    November 3, 2008
    Manufacturer
    STRYKER BIOTECH
    Product Code
    MPY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN 2008, STRYKER BIOTECH RECEIVED A REPORT OF AN ADVERSE EVENT IN A PT WHO RECEIVED ONE UNIT OF OP-1 IMPLANT AS PART OF A NAIL EXCHANGE FOR A NON-UNION OF THE LEFT PROXIMAL FEMUR IN 2008. THE PT WAS READMITTED TO THE HOSPITAL IN 2008, FOR AN IRRIGATION AND DEBRIDEMENT AT WHICH TIME THE PHYSICIAN NOTED BUILDUP OF FLUID AT THE OPERATIVE SITE. THE PHYSICIAN STATED THAT HE BELIEVES THE EDEMA MAY BE RELATED TO THE OP-1 IMPLANT. FURTHER INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OP-1 IMPLANT (OSTEOGENIC PROTEIN 1) IMPLANT MPY STRYKER BIOTECH NA FC0801003

    Patients

    Seq Age Sex Outcome Treatment
    1 Other