BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CM ALVIM ACQUA IMPLANT 4.3X8 MM

    MDR report key: 7829978 · Received August 29, 2018

    Report

    Report Number
    3008261720-2018-04175
    Event Type
    Injury
    Date Received
    August 29, 2018
    Date of Event
    March 12, 2018
    Report Date
    August 29, 2018
    Manufacturer
    NEODENT - JJGC S.A.
    Product Code
    DZE
    UDI-DI
    07899878016601
    PMA / PMN Number
    K150199
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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.

    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

    (B)(4). THE DENTIST REPORTED THAT 3 MONTHS AFTER DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION 14#, ITS NON-OSSEOINTEGRATION WAS OBSERVED. 30NCM OF PRIMARY STABILITY WAS ACHIEVED AND THE PATIENT PRESENTED BONE TYPE II.

    Description of Event or Problem · 0

    (B)(4). THE DENTIST REPORTED THAT 3 MONTHS AFTER DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION 14#, ITS NON-OSSEOINTEGRATION WAS OBSERVED. IN ADDITION, 30NCM OF PRIMARY STABILITY WAS ACHIEVED AND THE PATIENT PRESENTED BONE TYPE II.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671602 CM ALVIM ACQUA IMPLANT 4.3X8 MM ENDOSSEOUS DENTAL IMPLANT DZE NEODENT - JJGC S.A. 800312871 07899878016601

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention