BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALACOS CEMENT

    MDR report key: 25147886 · Received May 11, 2026

    Report

    Report Number
    MW5187977
    Event Type
    Injury
    Date Received
    May 11, 2026
    Date of Event
    April 8, 2026
    Report Date
    May 1, 2026
    Manufacturer
    HERAEUS MEDICAL LLC
    Product Code
    LOD
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    PLEASE BE ADVISED THAT WHILE INVESTIGATING AN EVENT INVOLVING ONE OF OUR PRODUCTS, (B)(6) NOTED A POTENTIAL ADVERSE EVENT REGARDING A NON-(B)(6) PRODUCT. STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR DIZZINESS. DEVICE RELATED: NO INFORMATION PROVIDED. PROCEDURE RELATED: NO INFORMATION PROVIDED. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611172 PALACOS CEMENT BONE CEMENT LOD HERAEUS MEDICAL LLC 75734326

    Patients

    Seq Age Sex Outcome Treatment
    1