BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GM HELIX ACQUA IMPLANT,TI,3.5X13

    MDR report key: 12190114 · Received July 19, 2021

    Report

    Report Number
    0001222315-2021-11720
    Event Type
    Injury
    Date Received
    July 19, 2021
    Date of Event
    June 3, 2021
    Report Date
    July 19, 2021
    Manufacturer
    JJGC S.A.
    Product Code
    DZE
    UDI-DI
    07899878024910
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    IN, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2021-11 IN ADA 7. ON (B)(6) 2021, NON-OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: PAIN. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1090035 GM HELIX ACQUA IMPLANT,TI,3.5X13 ENDOSSEOUS DENTAL IMPLANT DZE JJGC S.A. 140.946 ZF602 07899878024910

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention