BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GM HELIX IMPLANT 6.0X10

    MDR report key: 8438454 · Received March 20, 2019

    Report

    Report Number
    3008261720-2019-01191
    Event Type
    Injury
    Date Received
    March 20, 2019
    Date of Event
    February 7, 2019
    Report Date
    March 20, 2019
    Manufacturer
    NEODENT - JJGC S.A.
    Product Code
    DZE
    UDI-DI
    07899878028727
    PMA / PMN Number
    K180536
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    G5-PREMARKET ID: K180536. EXEMPTION NUMBER: E2015015. INSTRADENT USA, INC IS SUBMITTING THE REPORT ON BEHALF OF NEODENT - JJGC.

    Description of Event or Problem · 0

    THE CLINICIAN REPORTED 3 WEEKS AFTER THE DENTAL IMPLANT WAS PLACED IN ADA SITE 30 IN THE MOUTH, THE IMPLANT DID NOT ACHIEVE OSSEOINTEGRATION IN TYPE III BONE. CLINICIAN NOTED PAIN IN THIS PATIENT WITH EXCELLENT HYGIENE. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED POST-OPERATIVE COMPLICATIONS.

    Description of Event or Problem · 0

    THE CLINICIAN REPORTED 3 WEEKS AFTER THE DENTAL IMPLANT WAS PLACED IN ADA SITE 30 IN THE MOUTH, THE IMPLANT DID NOT ACHIEVE OSSEOINTEGRATION IN TYPE III BONE. CLINICIAN NOTED PAIN IN THIS PATIENT WITH EXCELLENT HYGIENE. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED POST-OPERATIVE COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231848 GM HELIX IMPLANT 6.0X10 ENDOSSEOUS DENTAL IMPLANT DZE NEODENT - JJGC S.A. 800367934 07899878028727

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention