BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GM DRIVE ACQUA IMPLANT 4.3X11.5

    MDR report key: 8554481 · Received April 26, 2019

    Report

    Report Number
    3008261720-2019-01741
    Event Type
    Injury
    Date Received
    April 26, 2019
    Date of Event
    January 31, 2019
    Report Date
    April 26, 2019
    Manufacturer
    NEODENT - JJGC S.A.
    Product Code
    DZE
    UDI-DI
    07899878025115
    PMA / PMN Number
    K163194
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL PATIENT CODES (F10): 1994/PAIN AND 2091/SWELLING. EXEMPTION NUMBER: E2015015. INSTRADENT USA, INC IS SUBMITTING THE REPORT ON BEHALF OF NEODENT - JJGC.

    Additional Manufacturer Narrative · 0

    ADDITIONAL PATIENT CODES (F10): 1994/PAIN 2091/SWELLING 1888/BLEEDING. EXEMPTION NUMBER: E2015015. INSTRADENT USA, INC IS SUBMITTING THE REPORT ON BEHALF OF NEODENT - JJGC. THE INFORMATION PROVIDED IN THIS REPORT WAS BASED ON INFORMATION GIVEN BY THE DENTIST IN NEODENT¿S PRODUCTS WARRANTY FORM THAT WAS RECORDED IN THE SYSTEM THAT IS USED BY BOTH THE MANUFACTURER AND THE SUBSIDIARY. THE ORIGINAL COMPLAINT AND THE PRODUCT WERE RECEIVED BY THE SUBSIDIARY AND DID NOT ARRIVE IN THE MANUFACTURER YET. WHEN THIS HAPPENS, A NEW EVALUATION OF THE COMPLAINT WILL BE CARRIED OUT AND, IF NECESSARY, A NEW FOLLOW-UP REPORT WILL BE SEND.

    Description of Event or Problem · 0

    THE CLINICIAN REPORTED THAT 2.5 MONTHS AFTER THE DENTAL IMPLANT WAS PLACED IN ADA SITE 7 IN THE PATIENT'S MOUTH, THE IMPLANT DID NOT ACHIEVE OSSEOINTEGRATION IN TYPE III BONE. THE CLINICIAN NOTED THE PATIENT'S INFECTION, FISTULA, PAIN, BLEEDING AND SWELLING. THE SITE WAS GRAFTED. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED POST-OPERATIVE COMPLICATIONS.

    Description of Event or Problem · 0

    THE CLINICIAN REPORTED THAT 2.5 MONTHS AFTER THE DENTAL IMPLANT WAS PLACED IN ADA SITE 7 IN THE PATIENT'S MOUTH, THE IMPLANT DID NOT ACHIEVE OSSEOINTEGRATION IN TYPE III BONE. THE CLINICIAN NOTED THE PATIENT'S INFECTION, FISTULA, PAIN, BLEEDING AND SWELLING. THE SITE WAS GRAFTED. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED POST-OPERATIVE COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348644 GM DRIVE ACQUA IMPLANT 4.3X11.5 ENDOSSEOUS DENTAL IMPLANT DZE NEODENT - JJGC S.A. 800349376 07899878025115

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention BONE GRAFT, ABUTMENT PLACEMENT| BONE GRAFT, ABUTMENT PLACEMENT| BONE GRAFT, ABUTMENT PLACEMENT