BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CM TITAMAX EX IMPLANT 4.0X9 MM

    MDR report key: 7829490 · Received August 29, 2018

    Report

    Report Number
    3008261720-2018-03700
    Event Type
    Injury
    Date Received
    August 29, 2018
    Date of Event
    March 15, 2018
    Report Date
    August 29, 2018
    Manufacturer
    NEODENT - JJGC S.A.
    Product Code
    DZE
    UDI-DI
    07898237568843
    PMA / PMN Number
    K101945
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER: E2015015. INSTRADENT USA, INC IS SUBMITTING THE REPORT ON BEHALF OF NEODENT - JJGC. CONSIDERING THE SURGICAL METHODOLOGY, IT WAS SEEN THAT THE DENTIST HAS SELECTED AN IMPLANT DESIGN WHICH IS NOT RECOMMENDED FOR THE PATIENT'S BONE QUALITY. MOREOVER, IT WAS SEEN THAT THE DENTIST HAS USED MORE DRILLS THAN RECOMMENDED TO PERFORM THE IMPLANT INSTALLATION.

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER: E2015015. INSTRADENT USA, INC IS SUBMITTING THE REPORT ON BEHALF OF NEODENT - JJGC. CONSIDERING THE SURGICAL METHODOLOGY, IT WAS SEEN THAT THE DENTIST HAS SELECTED AN IMPLANT DESIGN WHICH IS NOT RECOMMENDED FOR THE PATIENT'S BONE QUALITY. MOREOVER, IT WAS SEEN THAT THE DENTIST HAS USED MORE DRILLS THAN RECOMMENDED TO PERFORM THE IMPLANT INSTALLATION.

    Description of Event or Problem · 0

    (B)(4) ¿ THE DENTIST REPORTED THAT 1 MONTH AFTER DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION 20#, ITS NON-OSSEOINTEGRATION WAS OBSERVED. IN ADDITION, 40 NCM OF PRIMARY STABILITY WAS ACHIEVED AND THE PATIENT PRESENTED INSUFFICIENT BONE QUALITY/QUANTITY (BONE TYPE II).

    Description of Event or Problem · 0

    (B)(4). ¿ THE DENTIST REPORTED THAT 1 MONTH AFTER DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION 20#, ITS NON-OSSEOINTEGRATION WAS OBSERVED. IN ADDITION, 40NCM OF PRIMARY STABILITY WAS ACHIEVED AND THE PATIENT PRESENTED INSUFFICIENT BONE QUALITY/QUANTITY (BONE TYPE II).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670873 CM TITAMAX EX IMPLANT 4.0X9 MM ENDOSSEOUS DENTAL IMPLANT DZE NEODENT - JJGC S.A. 800148931 07898237568843

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention