BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JDEVOLUTION PLUS

    MDR report key: 24262304 · Received February 4, 2026

    Report

    Report Number
    3013264549-2026-00002
    Event Type
    Injury
    Date Received
    February 4, 2026
    Date of Event
    September 29, 2025
    Report Date
    January 5, 2026
    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 01-22-24-1925 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

    FAILURE OF OSSEOININTEGRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321164 JDEVOLUTION PLUS JDEVOLUTION PLUS Ø 3.7 L 10 DZE J DENTAL CARE SRL 01-22-24-1925

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male