BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FACILITY IMPLANT 12.0

    MDR report key: 7430755 · Received April 13, 2018

    Report

    Report Number
    3008261720-2018-01718
    Event Type
    Injury
    Date Received
    April 13, 2018
    Date of Event
    January 27, 2018
    Report Date
    April 13, 2018
    Manufacturer
    NEODENT - JJGC S.A.
    Product Code
    DZE
    UDI-DI
    07898237569512
    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 REPORTON BEHALF OF NEODENT - JJGC.

    Description of Event or Problem · 0

    RP 011142 - THE DENTIST REPORTED THAT 3 MONTHS AFTER DENTAL IMPLANT WAS INSTALLED IN PATIENT¿S MOUTH, ITS NON-OSSEOINTEGRATION WAS OBSERVED. IN ADDITION, 20NCM OF PRIMARY STABILITY WAS ACHIEVED AND THE PATIENT PRESENTED BONE TYPE II.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271116 FACILITY IMPLANT 12.0 ENDOSSEOUS DENTAL IMPLANT DZE NEODENT - JJGC S.A. 800311118 07898237569512

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention