BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GM HELIX IMPLANT,TI,4.3X11.5

    MDR report key: 22914575 · Received August 28, 2025

    Report

    Report Number
    0001222315-2025-002414
    Event Type
    Injury
    Date Received
    August 28, 2025
    Date of Event
    May 30, 2025
    Report Date
    August 28, 2025
    Manufacturer
    JJGC S.A.
    Product Code
    DZE
    UDI-DI
    07899878024217
    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 2025-07-10 IN ADA 11. ON 2025-07-10, NON-OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: PAIN AND MOBILITY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1697958 GM HELIX IMPLANT,TI,4.3X11.5 ENDOSSEOUS DENTAL IMPLANT DZE JJGC S.A. TTR94 07899878024217

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention