BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GM HELIX IMPLANT,TI,4.3X13

    MDR report key: 18598004 · Received January 29, 2024

    Report

    Report Number
    0001222315-2024-002203
    Event Type
    Injury
    Date Received
    January 29, 2024
    Date of Event
    October 5, 2023
    Report Date
    January 29, 2024
    Manufacturer
    JJGC S.A.
    Product Code
    DZE
    UDI-DI
    07899878024224
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CO, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2023 IN ADA 12. ON 2023-10-05, NON-OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. THERE WERE NO REPORTED PATIENT INJURIES OR COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1649580 GM HELIX IMPLANT,TI,4.3X13 ENDOSSEOUS DENTAL IMPLANT DZE JJGC S.A. XNG93 07899878024224

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Male Required Intervention