BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GM DRIVE ACQUA IMPLANT 5.0X11.5

    MDR report key: 8053152 · Received November 8, 2018

    Report

    Report Number
    3008261720-2018-05426
    Event Type
    Injury
    Date Received
    November 8, 2018
    Date of Event
    October 25, 2018
    Report Date
    January 14, 2019
    Manufacturer
    NEODENT - JJGC S.A.
    Product Code
    DZE
    UDI-DI
    07899878025177
    PMA / PMN Number
    K163194
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

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

    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 1.5 MONTHS AFTER THE DENTAL IMPLANT AND ABUTMENT WERE PLACED IN ADA SITE 20 IN THE MOUTH, THE IMPLANT DID NOT INTEGRATE IN TYPE IV BONE. THE SITE WAS GRAFTED. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED PATIENT COMPLICATIONS.

    Description of Event or Problem · 0

    THE CLINICIAN REPORTED THAT 1.5 MONTHS AFTER THE DENTAL IMPLANT AND ABUTMENT WERE PLACED IN ADA SITE 20 IN THE MOUTH, THE IMPLANT DID NOT INTEGRATE IN TYPE IV BONE. THE SITE WAS GRAFTED. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED PATIENT COMPLICATIONS.

    Description of Event or Problem · 0

    THE CLINICIAN REPORTED THAT 1.5 MONTHS AFTER THE DENTAL IMPLANT AND ABUTMENT WERE PLACED IN ADA SITE 20 IN THE MOUTH, THE IMPLANT DID NOT INTEGRATE IN TYPE IV BONE. THE SITE WAS GRAFTED. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED PATIENT COMPLICATIONS. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    889794 GM DRIVE ACQUA IMPLANT 5.0X11.5 ENDOSSEOUS DENTAL IMPLANT DZE NEODENT - JJGC S.A. 126119 07899878025177

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention ABUTMENT REMOVAL| ABUTMENT REMOVAL| ABUTMENT REMOVAL| ABUTMENT REMOVAL