BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WS TITAMAX IMPLANT 4.0X5

    MDR report key: 7840989 · Received September 3, 2018

    Report

    Report Number
    3008261720-2018-03073
    Event Type
    Injury
    Date Received
    September 3, 2018
    Date of Event
    May 25, 2018
    Report Date
    August 29, 2018
    Manufacturer
    NEODENT - JJGC S.A.
    Product Code
    DZE
    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. THE DEVICE DOES NOT HAVE A 510 (K), BUT WAS ONCE IMPROPERLY SOLD IN US AND IS BEING REPORTED SINCE THERE STILL ARE 2 UNITS INSTALLED IN PATIENTS.

    Description of Event or Problem · 0

    RP.012759¿ THE DENTIST REPORTED THAT 4 YEARS AND 6 MONTHS AFTER DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION 30#, ITS LOSS OF OSSEOINTEGRATION WAS OBSERVED. SIXTY NCM OF PRIMARY STABILITY WAS ACHIEVED, THE PATIENT PRESENTED BONE TYPE II AND BIOMECHANICAL OVERLOAD HAS OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681469 WS TITAMAX IMPLANT 4.0X5 ENDOSSEOUS DENTAL IMPLANT DZE NEODENT - JJGC S.A. 800089176

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention