BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CM DRIVE ACQUA IMPLANT 5.0X13 MM

    MDR report key: 7840987 · Received September 3, 2018

    Report

    Report Number
    3008261720-2018-04265
    Event Type
    Injury
    Date Received
    September 3, 2018
    Date of Event
    October 19, 2017
    Report Date
    August 29, 2018
    Manufacturer
    NEODENT - JJGC S.A.
    Product Code
    DZE
    UDI-DI
    07899878016878
    PMA / PMN Number
    K133592
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER: E2015015. INSTRADENT USA, INC IS SUBMITTING THE REPORT ON BEHALF OF NEODENT - JJGC.

    Description of Event or Problem · 0

    RP.013867 ¿ THE DENTIST REPORTED THAT THE DENTAL IMPLANT HAD TO BE REMOVED DUE TO THE FRACTURE OF THE CONNECTION DURING SURGERY INSTALLATION. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681473 CM DRIVE ACQUA IMPLANT 5.0X13 MM ENDOSSEOUS DENTAL IMPLANT DZE NEODENT - JJGC S.A. 800187857I 07899878016878

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention