BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CM DRIVE ACQUA IMPLANT 4.3X10

    MDR report key: 7523205 · Received May 17, 2018

    Report

    Report Number
    3008261720-2018-02261
    Event Type
    Injury
    Date Received
    May 17, 2018
    Date of Event
    January 20, 2018
    Report Date
    May 17, 2018
    Manufacturer
    NEODENT - JJGC S.A.
    Product Code
    DZE
    UDI-DI
    07899878016892
    PMA / PMN Number
    K133592
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER: E2015015. INSTRADENT USA, INC IS SUBMITTING THE REPORT ON BEHALF OF NEODENT - JJGC. AFTER THE EVALUATION WAS NOTICED THAT THE ITEM RECEIVED IS DIFFERENT FROM THE ITEM REPORTED ON GUARANTEE FORM BY THE DENTIST. THEREFORE, THE LOT NUMBER WAS NOT CONSIDERED.

    Description of Event or Problem · 0

    RP 011856 - THE DENTIST REPORTED THAT AFTER 8 MONTHS DENTAL IMPLANT WAS INSTALLED IN PATIENT¿S MOUTH, ITS NON-OSSEOINTEGRATION WAS OBSERVED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365459 CM DRIVE ACQUA IMPLANT 4.3X10 ENDOSSEOUS DENTAL IMPLANT DZE NEODENT - JJGC S.A. 07899878016892

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention