BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALACOS®

    MDR report key: 17216170 · Received June 28, 2023

    Report

    Report Number
    17216170
    Event Type
    Malfunction
    Date Received
    June 28, 2023
    Date of Event
    May 10, 2023
    Report Date
    June 14, 2023
    Manufacturer
    HERAEUS MEDICAL LLC
    Product Code
    MBB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PALACOS SYSTEM DIDN'T MIX LIQUID AND POWDER TO MAKE CEMENT MIXTURE AND PRODUCT WAS NOT USABLE. PATIENT NOT AFFECTED. ONLY PRODUCT PACKAGING AVAILABLE FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1725687 PALACOS® BONE CEMENT, ANTIBIOTIC MBB HERAEUS MEDICAL LLC MV+G PRO 80 9009331615

    Patients

    Seq Age Sex Outcome Treatment
    1 28105 DA Unknown