BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GM HELIX IMPLANT 4.3X13

    MDR report key: 7574694 · Received June 6, 2018

    Report

    Report Number
    3008261720-2018-02507
    Event Type
    Injury
    Date Received
    June 6, 2018
    Date of Event
    May 9, 2018
    Report Date
    June 6, 2018
    Manufacturer
    NEODENT - JJGC S.A.
    Product Code
    DZE
    UDI-DI
    07899878024224
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER: E2015015. THE PREMARKET ID IS K163194.

    Description of Event or Problem · 0

    (B)(4) - THE DENTIST REPORTED THAT 1 MONTH AFTER DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION 6#, ITS NON-OSSEOINTEGRATION WAS OBSERVED. IN ADDITION, FENESTRATION OCCURRED DURING SURGERY, BONE GRAFT WAS EXECUTED, IMMEDIATE LOAD WAS PERFORMED AND TRAUMA OVER THE IMPLANT HAS HAPPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416165 GM HELIX IMPLANT 4.3X13 ENDOSSEOUS DENTAL IMPLANT DZE NEODENT - JJGC S.A. 800306298 07899878024224

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention