BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOPRO

    MDR report key: 456509 · Received April 24, 2003

    Report

    Report Number
    1833506-2003-00001
    Event Type
    Malfunction
    Date Received
    April 24, 2003
    Date of Event
    March 1, 2003
    Report Date
    April 24, 2003
    Manufacturer
    BIOPRO, INC.
    Product Code
    MVB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    TIBIAL TRAY CRACKED AT SCREW HOLE. IT IS NOT CERTAIN IF TRAUMA WAS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOPRO 70MM TIBIAL TRAY MVB BIOPRO, INC. NA M049390

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization| R