BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GM HELIX IMPLANT,TI,3.5X13

    MDR report key: 18216194 · Received November 28, 2023

    Report

    Report Number
    0001222315-2023-029632
    Event Type
    Injury
    Date Received
    November 28, 2023
    Date of Event
    August 22, 2022
    Report Date
    November 27, 2023
    Manufacturer
    JJGC S.A.
    Product Code
    DZE
    UDI-DI
    07899878024170
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, 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 9. DETAILS OF SURGERY: IMPLANT SURFACE NOT COMPLETELY COVERED WITH BONE. ON 2022-08-22, LOSS OF OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH INADEQUATE BONE QUALITY/QUANTITY. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. THERE WERE NO PATIENT OPERATIVE OR POST-OPERATIVE COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1545209 GM HELIX IMPLANT,TI,3.5X13 ENDOSSEOUS DENTAL IMPLANT DZE JJGC S.A. GNJ86 07899878024170

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Male Required Intervention