BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CM ALVIM IMPLANT 3.5X10

    MDR report key: 7011110 · Received November 8, 2017

    Report

    Report Number
    3008261720-2017-00213
    Event Type
    Injury
    Date Received
    November 8, 2017
    Date of Event
    May 19, 2014
    Report Date
    August 5, 2015
    Manufacturer
    NEODENT - JJGC S.A.
    Product Code
    DZE
    UDI-DI
    07898237569055
    PMA / PMN Number
    K101945
    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

    OS 111345 - THE DENTIST REPORTED THAT 2 DAYS AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION #8 IT WAS VERIFIED ITS NON- OSSEOINTEGRATION . 70 NCM OF PRIMARY STABILITY WAS ACHIEVED AND IMMEDIATE LOAD WAS NOT EXECUTED. PATIENT PRESENTED BONE TYPE III. BONE OVERHEATING HAPPENED DURING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788970 CM ALVIM IMPLANT 3.5X10 ENDOSSEOUS DENTAL IMPLANT DZE NEODENT - JJGC S.A. 07898237569055

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention