BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JDEVOLUTION S

    MDR report key: 23522326 · Received November 11, 2025

    Report

    Report Number
    3013264549-2025-00085
    Event Type
    Injury
    Date Received
    November 11, 2025
    Date of Event
    September 3, 2025
    Report Date
    October 21, 2025
    Manufacturer
    J DENTAL CARE SRL
    Product Code
    DZE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DHR FOR LOT 01-01-24-1925 WAS REVIEWED, AND NO EVIDENCE OF DEFECTS OR NON-CONFORMITIES WAS IDENTIFIED FOR THE PRODUCT UNDER COMPLAINT. THE RESULTS OF THE INVESTIGATION CONFIRM THAT BOTH THE MANUFACTURING AND STERILIZATION PROCESSES ARE IN COMPLIANCE. QUALITY CONTROL PROCEDURES ENSURE THAT BATCHES MEET THE NECESSARY SPECIFICATIONS BEFORE DISTRIBUTION

    Description of Event or Problem · 0

    LACK OF PRIMARY STABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2614917 JDEVOLUTION S JDEVOLUTION S Ø 3.2 L 11.5 DZE J DENTAL CARE SRL 01-01-24-1925

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male