BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CM TITAMAX EX IMPLANT 3.75X15

    MDR report key: 7011120 · Received November 8, 2017

    Report

    Report Number
    3008261720-2017-00242
    Event Type
    Injury
    Date Received
    November 8, 2017
    Date of Event
    July 29, 2015
    Report Date
    August 13, 2015
    Manufacturer
    NEODENT - JJGC S.A.
    Product Code
    DZE
    UDI-DI
    07898237569161
    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 111508 - THE DENTIST REPORTED THAT 2 MONTHS AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION #4 IT WAS VERIFIED ITS NON- OSSEOINTEGRATION. TWENTY-FIVE NCM OF PRIMARY STABILITY WAS ACHIEVED. PATIENT PRESENTED INSUFICIENT BONE QUALITY/QUANTITY (BONE TYPE III).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788978 CM TITAMAX EX IMPLANT 3.75X15 ENDOSSEOUS DENTAL IMPLANT DZE NEODENT - JJGC S.A. 800130445 07898237569161

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention