BEUDAMED
    FDA Adverse Event Other Summary report: N

    OSIGRAFT (EPTOTERMIN ALFA)

    MDR report key: 2170155 · Received June 28, 2011

    Report

    Report Number
    1224732-2011-00002
    Event Type
    Other
    Date Received
    June 28, 2011
    Report Date
    June 16, 2011
    Manufacturer
    OLYMPUS BIOTECH
    Product Code
    MQV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2011, OLYMPUS PVG LEARNED OF AN ADVERSE EVENT IN THE LITERATURE: DEREGIBUS ET AL, 'NONUNION OF A SACRAL FRACTURE REFRACTORY TO BONE GRAFTING: INTERNAL FIXATION AND OSTEOGENIC PROTEIN-1 (BMP-7) APPLICATION', PUBLISHED IN MUSCULOSKELET SURG, 26-MAY-2011, DOI 10.1007/S12306-011-0131-X. IN THE ARTICLE, THE AUTHORS DESCRIBE A (B)(6), MALE, PT, (DEMOGRAPHICS UNK) WHO UNDERWENT THREE UNSUCCESSFUL PROCEDURES TO REPAIR HIS PELVIS, WHICH HAD BEEN FRACTURED IN A WORK ACCIDENT. THE THREE PROCEDURES, ALL OF WHICH WERE PERFORMED WITHIN THE FIRST NINE MONTHS FOLLOWING THE PT'S ACCIDENT, INVOLVED EITHER BONE GRAFTING AND/OR INTERNAL FIXATION. APPROX NINE MONTHS AFTER THE ACCIDENT, THE PT RECEIVED OSIGRAFT IN CONJUNCTION WITH TWO ILIO-SACRAL SCREWS AS PART OF A FOURTH PROCEDURE TO STABILIZE THE SACRAL FRACTURE. THREE MONTHS AFTER RECEIVING THE OSIGRAFT, THE PT'S PHYSICAL STATUS REPORTEDLY IMPROVED, AND HE WAS ABLE 'TO WALK WITH ONE STICK AND SIT WITH SLIGHT DISCOMFORT'. HOWEVER, THE PT STILL COMPLAINED OF INTERMITTENT SACROILIAC PAIN WHICH WAS CHARACTERIZED AS 'TOLERABLE'. ADD'L INFO HAS BEEN REQUESTED FROM THE AUTHORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OSIGRAFT (EPTOTERMIN ALFA) IMPLANT MQV OLYMPUS BIOTECH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other