BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CM DRIVE IMPLANT 4.3X8

    MDR report key: 7012987 · Received November 9, 2017

    Report

    Report Number
    3008261720-2017-00662
    Event Type
    Injury
    Date Received
    November 9, 2017
    Date of Event
    September 22, 2015
    Report Date
    October 14, 2015
    Manufacturer
    NEODENT - JJGC S.A.
    Product Code
    DZE
    UDI-DI
    07898237569277
    PMA / PMN Number
    K123022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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.000171 - THE DENTIST REPORTED THAT 3 MONTHS AFTER THE DENTAL IMPLANT WAS INSTALLED IN PATIENT'S MOUTH IT WAS VERIFIED ITS NON-OSSEOINTEGRATION. THE PATIENT PRESENTED BONE TYPE I.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    793208 CM DRIVE IMPLANT 4.3X8 ENDOSSEOUS DENTAL IMPLANT DZE NEODENT - JJGC S.A. 800115805 07898237569277

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention