BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GM HELIX IMPLANT 6.0X8 MM

    MDR report key: 8441475 · Received March 21, 2019

    Report

    Report Number
    3008261720-2019-01246
    Event Type
    Injury
    Date Received
    March 21, 2019
    Date of Event
    November 16, 2018
    Report Date
    March 21, 2019
    Manufacturer
    NEODENT - JJGC S.A.
    Product Code
    DZE
    UDI-DI
    07899878028710
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER: E2015015. INSTRADENT USA, INC IS SUBMITTING THE REPORT ON BEHALF OF NEODENT - JJGC. THE INVESTIGATION OF THE COMPLAINT WAS CARRIED OUT CONSIDERING THE ANALYSIS OF THE INFORMATION GIVEN BY THE DENTIST IN THE GUARANTEE FORM AND VISUAL CONFERENCE OF THE PRODUCT RETURNED BY THE DENTIST. THREE ATTEMPTS OF CONTACT WITH THE DENTIST WERE PERFORMED, IN ORDER TO OBTAIN THE MISSING INFORMATION ABOUT LOT NUMBER, BUT WITHOUT SUCCESS. DUE TO A CONFIGURATION IN THE SYSTEM, IT WAS NOT POSSIBLE TO FILL FIELD G5.PREMARKET ID WITH THE CORRECT IDENTIFICATION: K180536 - NEODENT IMPLANT SYSTEM ¿ GM LINE.

    Description of Event or Problem · 0

    (B)(4) ¿ THE DENTIST REPORTED THAT 2 MONTHS AND 3 DAYS AFTER THE DENTAL IMPLANT WAS INSTALLED IN PATIENT¿S MOUTH, ITS NON- OSSEOINTEGRATION WAS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234521 GM HELIX IMPLANT 6.0X8 MM ENDOSSEOUS DENTAL IMPLANT DZE NEODENT - JJGC S.A. 07899878028710

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention