BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CM DRIVE IMPLANT 4.3X10

    MDR report key: 7029254 · Received November 14, 2017

    Report

    Report Number
    3008261720-2017-04937
    Event Type
    Injury
    Date Received
    November 14, 2017
    Date of Event
    February 24, 2017
    Report Date
    January 22, 2018
    Manufacturer
    NEODENT - JJGC S.A.
    Product Code
    DZE
    UDI-DI
    07898237568812
    PMA / PMN Number
    K123022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER: E2015015. INSTRADENT USA, INC IS SUBMITTING THE REPORT ON BEHALF OF NEODENT - JJGC. AFTER THE EVALUATION WAS NOTICED THAT THE ITEM RECEIVED IS DIFFERENT FROM THE ITEM REPORTED. THIS FOLLOW UP CORRECTS THAT INFORMATION.

    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

    (B)(4). THE CLINICIAN REPORTS THAT 5 MONTHS AFTER THE DENTAL IMPLANT WAS PLACED NON-OSSEOINTEGRATION WAS OBSERVED. THERE WERE NO REPORTED PATIENT INJURIES OR COMPLICATIONS.

    Description of Event or Problem · 0

    (B)(4). THE CLINICIAN REPORTS THAT 5 MONTHS AFTER THE DENTAL IMPLANT WAS PLACED NON-OSSEOINTEGRATION WAS OBSERVED. THERE WERE NO REPORTED PATIENT INJURIES OR COMPLICATIONS.

    Description of Event or Problem · 0

    THE CLINICIAN REPORTS THAT 5 MONTHS AFTER THE DENTAL IMPLANT WAS PLACED NON-OSSEOINTEGRATION WAS OBSERVED. THE DEVICE WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTGATION. THERE WERE NO REPORTED PATIENT INJURIES OR COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    809162 CM DRIVE IMPLANT 4.3X10 ENDOSSEOUS DENTAL IMPLANT DZE NEODENT - JJGC S.A. 32655I 07898237568812

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention