BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CM DRIVE IMPLANT 3.5X8

    MDR report key: 7013145 · Received November 9, 2017

    Report

    Report Number
    3008261720-2017-00796
    Event Type
    Injury
    Date Received
    November 9, 2017
    Date of Event
    October 30, 2015
    Report Date
    November 6, 2015
    Manufacturer
    NEODENT - JJGC S.A.
    Product Code
    DZE
    UDI-DI
    07898237569307
    PMA / PMN Number
    K123022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    DENTIST

    Narratives

    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

    RP.000408 - THE DENTIST REPORTED THAT 5 MONTHS AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION#9 IT WAS VERIFIED ITS NON- OSSEOINTEGRATION. THIRTY NCM OF PRIMARY STABILITY WAS ACHIEVED AND IMMEDIATE LOAD WAS NOT PERFORMED. PATIENT PRESENTED BONE TYPE III, FENESTRATION HAS OCCURRED DURING SURGERY AND BONE GRAFT WAS EXECUTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    793814 CM DRIVE IMPLANT 3.5X8 ENDOSSEOUS DENTAL IMPLANT DZE NEODENT - JJGC S.A. 800182161 07898237569307

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention