BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GM HELIX ACQUA IMPLANT 4.3X16

    MDR report key: 8367863 · Received February 25, 2019

    Report

    Report Number
    3008261720-2019-00668
    Event Type
    Injury
    Date Received
    February 25, 2019
    Date of Event
    January 29, 2019
    Report Date
    February 25, 2019
    Manufacturer
    NEODENT JJGC S.A.
    Product Code
    DZE
    UDI-DI
    07899878024972
    PMA / PMN Number
    K163194
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER: E2015015. INSTRADENT USA, INC IS SUBMITTING THE REPORT ON BEHALF OF NEODENT - JJGC. CONSIDERING THE SURGICAL METHODOLOGY, THE DENTIST REPORTED THAT THE IMPLANT WAS IMMEDIATELY INSTALLED IN AN ALVEOLUS WITH SIGNS OF INJURY/ INFECTION. THE INVESTIGATION OF THE COMPLAINT WAS CARRIED OUT CONSIDERING THE ANALYSIS OF THE INFORMATION GIVEN BY THE DENTIST IN THE GUARANTEE FORM, VISUAL CONFERENCE OF THE PRODUCT RETURNED BY THE DENTIST AND THE EVALUATION OF RELEVANT PRODUCTION RECORDS.

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER: E2015015. INSTRADENT USA, INC IS SUBMITTING THE REPORT ON BEHALF OF NEODENT - JJGC.

    Description of Event or Problem · 0

    THE CLINICIAN REPORTED THAT 8.5 MONTHS AFTER THE DENTAL IMPLANT WAS PLACED IN ADA SITE 13 OF THE PATIENT'S MOUTH, THE IMPLANT HAD NOT ACHIEVED OSSEOINTEGRATION IN TYPE III BONE. THE CLINICIAN REPORTED THAT INSUFFICIENT BONE QUALITY AND QUANTITY COULD HAVE INFLUENCED THE EVENT. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THE PATIENT REPORTED PAIN AFTER THE EVENT, NO ADDITIONAL COMPLICATIONS WERE REPORTED. (B)(4).

    Description of Event or Problem · 0

    THE CLINICIAN REPORTED THAT 8.5 MONTHS AFTER THE DENTAL IMPLANT WAS PLACED IN ADA SITE 13 OF THE PATIENT'S MOUTH, THE IMPLANT HAD NOT ACHIEVED OSSEOINTEGRATION IN TYPE III BONE. THE CLINICIAN REPORTED THAT INSUFFICIENT BONE QUALITY AND QUANTITY COULD HAVE INFLUENCED THE EVENT. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THE PATIENT REPORTED PAIN AFTER THE EVENT, NO ADDITIONAL COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    160185 GM HELIX ACQUA IMPLANT 4.3X16 ENDOSSEOUS DENTAL IMPLANT DZE NEODENT JJGC S.A. 800336000 07899878024972

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CREOS BONE GRAFT| CREOS BONE GRAFT| CREOS BONE GRAFT