BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSIGRAFT (OP-1 IMPLANT OSTEOGENIC PROTEIN 1)

    MDR report key: 1558566 · Received December 9, 2009

    Report

    Report Number
    1224732-2009-00056
    Event Type
    Injury
    Date Received
    December 9, 2009
    Report Date
    November 25, 2009
    Manufacturer
    STRYKER BIOTECH
    Product Code
    MPY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON 11/25/2009, STRYKER PVG REVIEWED AN ARTICLE IN THE LITERATURE OF REPORTS OF NON-UNION AND INFECTION IN PTS WHO RECEIVED RHBMP-7 AS PART OF A STUDY (APPLICATION OF RHBMP-7 AND PLATELET-RICH PLASMA IN THE TREATMENT OF LONG BONE NON-UNIONS: A PROSPECTIVE RANDOMISED CLINICAL STUDY ON 120 PTS), PUBLISHED IN INJURY, INT J CARE INJURED (2008) 39, 1391-1402. THE ARTICLE STATED THAT FOUR PTS WHO RECEIVED RHBMP-7 FAILED TO PROGRESS TO UNION AND SOME PTS EXPERIENCED INFECTIONS (NOS). NO ADD'L DETAILS WERE PROVIDED. FURTHER INFO HAS BEEN REQUESTED FROM THE AUTHORS REGARDING DETAILS OF THESE PTS AND ADVERSE EVENTS EXPERIENCED. THIS INITIAL MDR IS BEING SUBMITTED AS AN AGGREGATE REPORT UNTIL FURTHER INFO IS RECEIVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention