BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CM DRIVE IMPLANT 4.3X16 MM

    MDR report key: 7843280 · Received September 4, 2018

    Report

    Report Number
    3008261720-2018-04391
    Event Type
    Injury
    Date Received
    September 4, 2018
    Date of Event
    April 18, 2018
    Report Date
    September 4, 2018
    Manufacturer
    NEODENT - JJGC S.A.
    Product Code
    DZE
    UDI-DI
    07898237568775
    PMA / PMN Number
    K123022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    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.014086¿ THE DENTIST REPORTED THAT 1 MONTH AFTER DENTAL IMPLANT WAS INSTALLED IN PATIENT¿S MOUTH, ITS NON-OSSEOINTEGRATION WAS OBSERVED. FIFTY 0NCM OF PRIMARY STABILITY WAS ACHIEVED, THE PATIENT PRESENTED INSUFFICIENT BONE QUALITY/QUANTITY (BONE TYPE I) AND IMMEDIATE IMPLANT PROCEDURE WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    685475 CM DRIVE IMPLANT 4.3X16 MM ENDOSSEOUS DENTAL IMPLANT DZE NEODENT - JJGC S.A. 800301127I 07898237568775

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention