BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GM HELIX IMPLANT 6.0X8

    MDR report key: 8705520 · Received June 17, 2019

    Report

    Report Number
    3008261720-2019-02736
    Event Type
    Injury
    Date Received
    June 17, 2019
    Date of Event
    May 17, 2019
    Report Date
    June 17, 2019
    Manufacturer
    NEODENT - JJGC S.A.
    Product Code
    DZE
    UDI-DI
    07899878028710
    PMA / PMN Number
    K180536
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL PATIENT CODE: 1932/INFLAMMATION. EXEMPTION NUMBER: E2015015. INSTRADENT USA, INC IS SUBMITTING THE REPORT ON BEHALF OF NEODENT - JJGC. THE INFORMATION PROVIDED IN THIS REPORT WAS BASED ON INFORMATION GIVENBY THE DENTIST IN NEODENT¿S PRODUCTS WARRANTY FORM THAT WAS RECORDED IN THE SYSTEM THAT IS USED BY BOTH THE MANUFACTURER AND THE SUBSIDIARY. THE ORIGINAL COMPLAINT AND THE PRODUCT WERE RECEIVED BY THE SUBSIDIARY AND DID NOT ARRIVE IN THE MANUFACTURER YET. WHEN THIS HAPPENS, A NEW EVALUATION OF THE COMPLAINT WILL BE CARRIED OUT AND, IF NECESSARY, A NEW FOLLOW-UP REPORT WILL BE SEND.

    Additional Manufacturer Narrative · 0

    THE 510(K) NUMBER IS 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 THAT 1 MONTH AFTER THE DENTAL IMPLANT WAS PLACED IN ADA SITE 14 IN THE PATIENT'S MOUTH, THE IMPLANT DID NOT ACHIEVE OSSEOINTEGRATION IN TYPE II BONE. THE CLINICIAN NOTED CHRONIC PAIN, INFLAMMATION AND AN INFECTION IN THIS PATIENT WITH GOOD 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 THAT 1 MONTH AFTER THE DENTAL IMPLANT WAS PLACED IN ADA SITE 14 IN THE PATIENT'S MOUTH, THE IMPLANT DID NOT ACHIEVE OSSEOINTEGRATION IN TYPE II BONE. THE CLINICIAN NOTED CHRONIC PAIN, INFLAMMATION AND AN INFECTION IN THIS PATIENT WITH GOOD 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
    498046 GM HELIX IMPLANT 6.0X8 ENDOSSEOUS DENTAL IMPLANT DZE NEODENT - JJGC S.A. 800367856 07899878028710

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention