BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GM HELIX ACQUA IMPLANT,TI,3.5X13

    MDR report key: 15989297 · Received December 15, 2022

    Report

    Report Number
    0001222315-2022-027525
    Event Type
    Injury
    Date Received
    December 15, 2022
    Date of Event
    September 27, 2022
    Report Date
    December 15, 2022
    Manufacturer
    JJGC S.A.
    Product Code
    DZE
    UDI-DI
    07899878024910
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MD, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED 2022-08-18 IN ADA 23. ON (B)(6) 2022, 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
    1757900 GM HELIX ACQUA IMPLANT,TI,3.5X13 ENDOSSEOUS DENTAL IMPLANT DZE JJGC S.A. 140.946 KWY87 07899878024910

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention