BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JDEVOLUTION PLUS

    MDR report key: 22307207 · Received June 23, 2025

    Report

    Report Number
    3013264549-2025-00003
    Event Type
    Injury
    Date Received
    June 23, 2025
    Date of Event
    October 17, 2024
    Report Date
    February 18, 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 01-27-22-13223 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

    DURING SURGERY, THE IMPLANT DID NOT INTEGRATE INTO POSITION 22. FOUND LACK OF PRIMARY STABILITY DURING THE HEALING PERIOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    927916 JDEVOLUTION PLUS JDEVOLUTION PLUS Ø 3.7 L 10 DZE J DENTAL CARE SRL 01-27-22-13223

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male