BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CM DRIVE IMPLANT 4.3X10

    MDR report key: 8170690 · Received December 17, 2018

    Report

    Report Number
    3008261720-2018-05908
    Event Type
    Injury
    Date Received
    December 17, 2018
    Date of Event
    September 19, 2018
    Report Date
    December 17, 2018
    Manufacturer
    NEODENT - JJGC S.A.
    Product Code
    DZE
    UDI-DI
    07899878023395
    PMA / PMN Number
    K123022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER: E2015015.

    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 5 MONTHS AFTER THE DENTAL IMPLANT WAS PLACED IN ADA SITE 4 IN THE MOUTH, THE FAILURE WAS EVIDENT AT THE RESTORATION APPOINTMENT. CLINICIAN NOTED THE PATIENT'S MOBILITY. THE IMPLANT WAS REMOVED AND ANOTHER WAS PLACED ON THE DATE OF EVENT. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED PATIENT COMPLICATIONS. (B)(4).

    Description of Event or Problem · 0

    THE CLINICIAN REPORTED THAT 5 MONTHS AFTER THE DENTAL IMPLANT WAS PLACED IN ADA SITE 4 IN THE MOUTH, THE FAILURE WAS EVIDENT AT THE RESTORATION APPOINTMENT. CLINICIAN NOTED THE PATIENT'S MOBILITY. THE IMPLANT WAS REMOVED AND ANOTHER WAS PLACED ON THE DATE OF EVENT. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1010979 CM DRIVE IMPLANT 4.3X10 ENDOSSEOUS DENTAL IMPLANT DZE NEODENT - JJGC S.A. 800237694I 07899878023395

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention IMPLANT PLACEMENT| IMPLANT PLACEMENT| IMPLANT PLACEMENT