BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GM HELIX ACQUA IMPLANT,TI,3.5X13

    MDR report key: 14194733 · Received April 25, 2022

    Report

    Report Number
    0001222315-2022-08210
    Event Type
    Injury
    Date Received
    April 25, 2022
    Date of Event
    February 21, 2022
    Report Date
    April 25, 2022
    Manufacturer
    JJGC S.A.
    Product Code
    DZE
    UDI-DI
    07899878024910
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    TN, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER REPORTED 2 IMPLANTS ON THE SAME GUARANTEE FORM; PRODUCT WILL BE KEPT WITH FILE (B)(4) AS IT WAS RETURNED IN 1 STERILE POUCH. PLEASE SEE FILE # (B)(4) FOR LINE ITEM 1- JR.

    Description of Event or Problem · 0

    THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2021 IN ADA 13. ON (B)(6) 2022, LOSS OF OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH BONE TYPE III AND FAIR ORAL HYGIENE. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: MOBILITY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183234 GM HELIX ACQUA IMPLANT,TI,3.5X13 ENDOSSEOUS DENTAL IMPLANT DZE JJGC S.A. 140.946 GJF59 07899878024910

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Required Intervention