BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHADAPT BIOIMPLANT

    MDR report key: 1051113 · Received May 22, 2008

    Report

    Report Number
    3005147058-2008-00002
    Event Type
    Injury
    Date Received
    May 22, 2008
    Date of Event
    June 27, 2007
    Report Date
    May 22, 2008
    Manufacturer
    PEGASUS BIOLOGICS, INC.
    Product Code
    FTM
    PMA / PMN Number
    K043388
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTED BY GENZYME ASSOCIATE MEDICAL DIR, THE PT UNDERWENT IMPLANTATION OF AUTOLOGOUS CULTURED CHONDROCYTES IN 2007. GENZYME COMPANY REP REPORTED, THE PT DEVELOPED SYNOVITIS AFTER CARTICEL IMPLANTATION WHERE THE ORTHOADAPT PRODUCT WAS USED. A "WASH OUT" PROCEDURE WAS PERFORMED ON THE PT. THE CULTURE WAS NEGATIVE. THIS EVENT HAS NOT BEEN CONFIRMED AND IS BEING REPORTED FROM A CONSERVATIVE STANDPOINT. WHEN ADD'L RELEVANT INFO IS RECEIVED A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHADAPT BIOIMPLANT SURGICAL MESH FTM PEGASUS BIOLOGICS, INC. OFX 2500 POR 070104-01R

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other CARTICEL (AUTOLOGOUS CULTURED CHONDROCYTES)| LIVING TISSUE