BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GM HELIX IMPLANT,TI,5.0X8

    MDR report key: 18401805 · Received December 27, 2023

    Report

    Report Number
    0001222315-2023-031926
    Event Type
    Injury
    Date Received
    December 27, 2023
    Date of Event
    October 23, 2023
    Report Date
    August 26, 2024
    Manufacturer
    JJGC S.A.
    Product Code
    DZE
    UDI-DI
    07899878024248
    PMA / PMN Number
    K163194
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MO, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NON-FATAL SERIOUS INJURY OR DEVICE MALFUNCTION STORED DUE TO COVID 19 PANDEMIC IN ACCORDANCE WITH FDA GUIDANCE "POSTMARKETING ADVERSE EVENT REPORTING FOR MEDICAL PRODUCTS AND DIETARY SUPPLEMENTS DURING A PANDEMIC" PUBLISHED MAY 2020.

    Description of Event or Problem · 0

    THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2023 IN ADA 3. ON 2023-10-23, LOSS OF OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH BONE TYPE III. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: PAIN AND MOBILITY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 0

    THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2023 IN ADA 3. ON 2023-10-23, LOSS OF OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH BONE TYPE III. 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
    2307626 GM HELIX IMPLANT,TI,5.0X8 ENDOSSEOUS DENTAL IMPLANT DZE JJGC S.A. RLN02 07899878024248

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Required Intervention