BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GM HELIX IMPLANT 3.5X10

    MDR report key: 7652740 · Received June 29, 2018

    Report

    Report Number
    3008261720-2018-02921
    Event Type
    Injury
    Date Received
    June 29, 2018
    Date of Event
    March 5, 2018
    Report Date
    June 29, 2018
    Manufacturer
    NEODENT - JJGC S.A.
    Product Code
    DZE
    UDI-DI
    07899878024156
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER: E2015015. INSTRADENT USA, INC IS SUBMITTING THE REPORT ON BEHALF OF NEODENT - JJGC. THE PREMARKET ID IS K163194. THIS NUMBER CORRESPOND TO A NEW DEVICE, WHICH HAS NOT BEEN UPDATED IN THE SOFTWARE SYSTEM USED TO SEND THE REPORT TO FDA, BECAUSE OF THAT THE G5 FIELD IS EMPTY. IN ADDITION, WE ARE ALREADY WORKING ON THE UPDATE OF THIS CODE ON THE SOFTWARE SYSTEM OF THE COMPANY.

    Description of Event or Problem · 0

    (B)(4)¿ THE DENTIST REPORTED THAT 4 MONTHS AFTER DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION 4#, ITS NON-OSSEOINTEGRATION WAS OBSERVED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494792 GM HELIX IMPLANT 3.5X10 ENDOSSEOUS DENTAL IMPLANT DZE NEODENT - JJGC S.A. 800308309 07899878024156

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention