BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GM HELIX IMPLANT,TI,4.3X11.5

    MDR report key: 14735691 · Received June 17, 2022

    Report

    Report Number
    0001222315-2022-12939
    Event Type
    Injury
    Date Received
    June 17, 2022
    Date of Event
    November 11, 2021
    Report Date
    June 17, 2022
    Manufacturer
    JJGC S.A.
    Product Code
    DZE
    UDI-DI
    07899878024217
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    UT, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2021 IN ADA 13. ON 2021-11-11, NON-OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH BONE TYPE III. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: INFECTION, PERI-IMPLANTITIS, PAIN AND MOBILITY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202230 GM HELIX IMPLANT,TI,4.3X11.5 ENDOSSEOUS DENTAL IMPLANT DZE JJGC S.A. 109.950 EEZ21 07899878024217

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Required Intervention