BEUDAMED
    FDA Adverse Event Summary report: N

    OSIGRAFT (EPTOTERMIN ALFA)

    MDR report key: 2594037 · Received May 24, 2012

    Report

    Report Number
    1224732-2012-00038
    Date Received
    May 24, 2012
    Report Date
    April 26, 2012
    Manufacturer
    OLYMPUS BIOTECH
    Product Code
    MPY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON 04/26/2012, OLYMPUS BIOTECH PHARMACOVIGILANCE LEARNED OF AN ADVERSE EVENT IN THE LITERATURE: 'RESULTS OF NONUNION TREATMENT WITH BONE MORPHOGENETIC PROTEIN 7 (BMP-7)', A. MOGHADDAM-ALVANDI ET AL, PUBLISHED IN UNFALLCHIRURG, 2012, DOI 10.1007/S00113-011-2100-0. A PT (DEMOGRAPHICS UNK) WHO RECEIVED BMP-7 FOR AN UNSPECIFIED NONUNION EXPERIENCED 'ABSENCE OF BONE CONSOLIDATION' WHICH REQUIRED REVISION SURGERY. THE AUTHORS REPORTED USING BMP-7 "OFF LABEL" IN ALL LONG BONES. NO FURTHER DETAIL WAS PROVIDED WITH REGARD TO SPECIFIC LOCATION OF TREATMENT AS IT PERTAINED TO REPORTED ADVERSE EVENTS. ADDITIONAL INFO HAS BEEN REQUESTED FROM THE AUTHORS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention