BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GM HELIX ACQUA IMPLANT,TI,4.3X13

    MDR report key: 18205279 · Received November 24, 2023

    Report

    Report Number
    0001222315-2023-029303
    Event Type
    Injury
    Date Received
    November 24, 2023
    Date of Event
    August 18, 2022
    Report Date
    November 24, 2023
    Manufacturer
    JJGC S.A.
    Product Code
    DZE
    UDI-DI
    07899878024965
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2022 IN ADA 23. DETAILS OF SURGERY: IMPLANT SURFACE NOT COMPLETELY COVERED WITH BONE. ON 2022-08-18, NON-OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH BONE TYPE III AND FAIR ORAL HYGIENE. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: PERI-IMPLANTITIS, PAIN, SWELLING AND INFLAMMATION. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186785 GM HELIX ACQUA IMPLANT,TI,4.3X13 ENDOSSEOUS DENTAL IMPLANT DZE JJGC S.A. LGR63 07899878024965

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female Required Intervention