BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXT HEX ZYGOMATIC IMPL TI 45

    MDR report key: 7087457 · Received December 6, 2017

    Report

    Report Number
    3008261720-2017-06672
    Event Type
    Injury
    Date Received
    December 6, 2017
    Date of Event
    October 25, 2017
    Report Date
    December 6, 2017
    Manufacturer
    NEODENT - JJGC S.A.
    Product Code
    DZE
    UDI-DI
    07898237567303
    PMA / PMN Number
    K141777
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    DENTAL ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER: E2015015. INSTRADENT USA, INC IS SUBMITTING THE REPORT ON BEHALF OF NEODENT - JJGC

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER: E2015015. INSTRADENT USA, INC IS SUBMITTING THE REPORT ON BEHALF OF NEODENT - JJGC THE DENTIST REPORTED THAT IMMEDIATE LOAD WAS PERFORMED.

    Description of Event or Problem · 0

    THE CLINICIAN REPORTED THAT THE IMPLANT WAS PLACED ON (B)(6) 2017 AND WAS REMOVED ON (B)(6) 2017 IN SITE #6 DUE TO LACK OF INTEGRATION. THE BONE QUALITY WAS DETERMINED TO BE TYPE II. IT WAS REPORTED THAT INSUFFICIENT BONE QUALITY/QUANTITY AND A SINUS MEMBRANE PERFORATION COULD HAVE INFLUENCED THE PROBLEM FOUND. THE CLINICIAN ALSO REPORTED THAT, FOLLOWING THE IMPLANT LOSS, THE PATIENT EXPERIENCED FISTULA.

    Description of Event or Problem · 0

    THE CLINICIAN REPORTED THAT THE IMPLANT WAS PLACED ON (B)(6) 2017 AND WAS REMOVED ON (B)(6) 2017 IN SITE #6 DUE TO LACK OF INTEGRATION. THE BONE QUALITY WAS DETERMINED TO BE TYPE II. IT WAS REPORTED THAT INSUFFICIENT BONE QUALITY/QUANTITY AND A SINUS MEMBRANE PERFORATION COULD HAVE INFLUENCED THE PROBLEM FOUND. THE CLINICIAN ALSO REPORTED THAT, FOLLOWING THE IMPLANT LOSS, THE PATIENT EXPERIENCED FISTULA. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    867221 EXT HEX ZYGOMATIC IMPL TI 45 ENDOSSEOUS DENTAL IMPLANT DZE NEODENT - JJGC S.A. 26984 07898237567303

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention LITHIUM AND LEVOTHYROXINE