BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CM ALVIM IMPLANT3.5X13

    MDR report key: 7924099 · Received October 1, 2018

    Report

    Report Number
    3008261720-2018-04821
    Event Type
    Injury
    Date Received
    October 1, 2018
    Date of Event
    August 15, 2018
    Report Date
    October 1, 2018
    Manufacturer
    NEODENT - JJGC S.A.
    Product Code
    DZE
    UDI-DI
    07898237568737
    PMA / PMN Number
    K101945
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    DENTIST

    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. 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.

    Description of Event or Problem · 0

    THE CLINICIAN REPORTED THAT OVER 5 MONTHS AFTER THE DENTAL IMPLANT WAS PLACED IN ADA SITE 22 IN THE MOUTH, THE IMPLANT DID NOT INTEGRATE IN TYPE II BONE. THE SITE WAS GRAFTED. AN ABUTMENT WAS PLACED. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED PATIENT COMPLICATIONS.

    Description of Event or Problem · 0

    THE CLINICIAN REPORTED THAT OVER 5 MONTHS AFTER THE DENTAL IMPLANT WAS PLACED IN ADA SITE 22 IN THE MOUTH, THE IMPLANT DID NOT INTEGRATE IN TYPE II BONE. THE SITE WAS GRAFTED. AN ABUTMENT WAS PLACED. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED PATIENT COMPLICATIONS. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764818 CM ALVIM IMPLANT3.5X13 ENDOSSEOUS DENTAL IMPLANT DZE NEODENT - JJGC S.A. 800327463 07898237568737

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention ABUTMENT PLACEMENT| ABUTMENT PLACEMENT| ABUTMENT PLACEMENT