BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALACOS R

    MDR report key: 19515 · Received September 30, 1994

    Report

    Report Number
    1020279-1994-00002
    Event Type
    Malfunction
    Date Received
    September 30, 1994
    Report Date
    September 1, 1994
    Manufacturer
    EM INDUSTRIES, INC.
    Product Code
    LOD
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE MIXING AND PREPARATION OF THE BONE CEMENT RESULTED IN PREMATURE DETERIORATION AND DISRUPTION OF THE CEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALACOS R Implant BONE CEMENT LOD EM INDUSTRIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 *