BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GM HELIX ACQUA IMPLANT,TI,4.3X13

    MDR report key: 20822357 · Received December 2, 2024

    Report

    Report Number
    0001222315-2024-003244
    Event Type
    Injury
    Date Received
    December 2, 2024
    Date of Event
    August 1, 2022
    Report Date
    December 2, 2024
    Manufacturer
    JJGC S.A.
    Product Code
    DZE
    UDI-DI
    07899878024965
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    FL, 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 28. DETAILS OF SURGERY: IMPLANT SURFACE NOT COMPLETELY COVERED WITH BONE. ON 2022-08-01, NON-OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH BONE TYPE III. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: PAIN, HYPERSENSITIVITY AND ABSCESS. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333126 GM HELIX ACQUA IMPLANT,TI,4.3X13 ENDOSSEOUS DENTAL IMPLANT DZE JJGC S.A. NEC47 07899878024965

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Male Required Intervention