BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXACTECH BIOLOGICS

    MDR report key: 646777 · Received November 7, 2005

    Report

    Report Number
    646777
    Event Type
    Malfunction
    Date Received
    November 7, 2005
    Date of Event
    October 14, 2005
    Report Date
    November 2, 2005
    Manufacturer
    REGENERATION TECHNOLOGIES, INC.
    Product Code
    NUN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TISSUE PRODUCT RECALL RECEIVED FROM EXACTECH R/T A TISSUE PRODUCT MANUFACTURED BY REGENERATION TECHNOLOGIES, INC. THIS PRODUCT WAS USED ON THE ABOVE PT. DURING HER SURGERY ON 8/22/2005. THE RECALL IS DUE TO POTENTIALLY FALSE OR INACCURATE INFORMATION REGARDING THE DONOR SCREENING AND INFORMED CONSENT RECORD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXACTECH BIOLOGICS OPTE FORM DISC 5 X 45MM NUN REGENERATION TECHNOLOGIES, INC. 002545FZ 101031695

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other