BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CM DRIVE ACQUA IMPLANT 3.5X13

    MDR report key: 7629479 · Received June 22, 2018

    Report

    Report Number
    3008261720-2018-02718
    Event Type
    Injury
    Date Received
    June 22, 2018
    Date of Event
    February 3, 2018
    Report Date
    June 22, 2018
    Manufacturer
    NEODENT - JJGC S.A.
    Product Code
    DZE
    UDI-DI
    07899878016847
    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. IN TELEPHONE CONTACT, THE DENTIST INFORMED THAT HE DID NOT HAVE INFORMATION ABOUT LOT NUMBER OF THE PRODUCT.

    Description of Event or Problem · 0

    RP 012370 - THE DENTIST REPORTED THAT 3 MONTHS AFTER 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
    473210 CM DRIVE ACQUA IMPLANT 3.5X13 ENDOSSEOUS DENTAL IMPLANT DZE NEODENT - JJGC S.A. 07899878016847

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention