BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONE CEMENT

    MDR report key: 17529001 · Received August 12, 2023

    Report

    Report Number
    MW5135930
    Event Type
    Malfunction
    Date Received
    August 12, 2023
    Report Date
    June 27, 2022
    Manufacturer
    TECRES S.P.A.
    Product Code
    LOD
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    THE LEAKAGE OF BONE CEMENT OCCURRED IN 1 CASE (1/81) DURING RPKP SURGERY AND 2 CASES (2/131) DURING FPKP SURGERY. ALL 3 CASES WERE EITHER AT THE DISK SPACE OR AT ANTERIOR/LATERAL VERTEBRAE. THESE 3 PATIENTS WERE ASYMPTOMATIC AFTER SURGERY AND DURING FOLLOW-UP PERIOD. (B)(4). 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
    2116988 BONE CEMENT BONE CEMENT LOD TECRES S.P.A. CEMEX RX

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown