BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GM HELIX ACQUA IMPLANT 6.0X10

    MDR report key: 8428019 · Received March 18, 2019

    Report

    Report Number
    3008261720-2019-01173
    Event Type
    Injury
    Date Received
    March 18, 2019
    Date of Event
    January 31, 2019
    Report Date
    March 18, 2019
    Manufacturer
    NEODENT - JJGC S.A.
    Product Code
    DZE
    UDI-DI
    07899878028765
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    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 GIVEN BY 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.

    Description of Event or Problem · 0

    THE CLINICIAN REPORTED 1 MONTH AFTER THE DENTAL IMPLANT WAS PLACED IN ADA SITE 2 IN THE MOUTH, THE IMPLANT DID NOT ACHIEVE OSSEOINTEGRATION IN TYPE II BONE. CLINICIAN NOTED THE PATIENT'S INFECTION. 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 AND 3 DAYS AFTER THE DENTAL IMPLANT AND ABUTMENT WERE PLACED IN ADA SITE 12 IN THE MOUTH, THE IMPLANT DID NOT ACHIEVE OSSEOINTEGRATION. THE PATIENT PRESENTED BONE TYPE II. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222783 GM HELIX ACQUA IMPLANT 6.0X10 ENDOSSEOUS DENTAL IMPLANT DZE NEODENT - JJGC S.A. 800356483 07899878028765

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention HEALING ABUTMENT PLACEMENT| HEALING ABUTMENT PLACEMENT| HEALING ABUTMENT PLACEMENT