BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GM HELIX ACQUA IMPLANT,TI,5.0X16

    MDR report key: 7517706 · Received May 16, 2018

    Report

    Report Number
    3008261720-2018-02237
    Event Type
    Injury
    Date Received
    May 16, 2018
    Date of Event
    March 28, 2018
    Report Date
    May 16, 2018
    Manufacturer
    NEODENT - JJGC S.A.
    Product Code
    DZE
    UDI-DI
    07899878025023
    PMA / PMN Number
    K163194
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE CORRECT 510(K) NUMBER (K163194) CANNOT CURRENTLY BE SELECTED IN THE G5 FIELD. IT DEPARTMENT AWARE ((B)(6) 2018). EXEMPTION NUMBER: E2015015.

    Additional Manufacturer Narrative · 0

    THE CORRECT 510(K) NUMBER (K163194) CANNOT CURRENTLY BE SELECTED IN THE FIELD. IT DEPARTMENT AWARE ((B)(6) 2018). EXEMPTION NUMBER: E2015015.

    Description of Event or Problem · 0

    THE CLINICIAN REPORTED THAT ON THE DAY THE IMPLANT WAS PLACED IN ADA SITE 4 IN THE MOUTH, PRIMARY STABILITY WAS NOT ACHIEVED IN TYPE IV BONE AND WAS REMOVED. CLINICIAN REPORTS INSUFFICIENT BONE QUALITY/QUANTITY. THE SITE WAS NOT GRAFTED. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED COMPLICATIONS

    Description of Event or Problem · 0

    THE CLINICIAN REPORTED THAT ON THE DAY THE IMPLANT WAS PLACED IN (B)(6) SITE 4 IN THE MOUTH, PRIMARY STABILITY WAS NOT ACHIEVED IN TYPE IV BONE AND WAS REMOVED. CLINICIAN REPORTS INSUFFICIENT BONE QUALITY/QUANTITY. THE SITE WAS NOT GRAFTED. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED COMPLICATIONS. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362024 GM HELIX ACQUA IMPLANT,TI,5.0X16 ENDOSSEOUS DENTAL IMPLANT DZE NEODENT - JJGC S.A. 121059 07899878025023

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention