BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CM ALVIM IMPLANT 5.0X13

    MDR report key: 7346894 · Received March 16, 2018

    Report

    Report Number
    3008261720-2018-01271
    Event Type
    Injury
    Date Received
    March 16, 2018
    Date of Event
    July 3, 2017
    Report Date
    March 16, 2018
    Manufacturer
    NEODENT - JJGC S.A.
    Product Code
    DZE
    UDI-DI
    07898237569024
    PMA / PMN Number
    K101945
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    EXEMPTION NUMBER: (B)(4). INSTRADENT USA, INC IS SUBMITTING THE REPORTON BEHALF OF NEODENT - JJGC. IN TELEPHONE CONTACT, THE DENTIST INFORMEDTHAT HE DID NOT HAVE INFORMATION ABOUT LOT NUMBER OF THE PRODUCT.CONSIDERING THE SURGICAL METHODOLOGY, THE DENTIST REPORTED THAT THEIMPLANT WAS IMMEDIATELY INSTALLED IN AN ALVEOLUS WITH SIGNS OF INJURY/INFECTION. IT WAS ALSO SEEN THAT THE DENTIST HAS USED MORE DRILLS THANRECOMMENDED TO PERFORM THE IMPLANT INSTALLATION.

    Description of Event or Problem · 1

    RP 010871 ¿ THE DENTIST REPORTED THAT 1 MONTH AFTER DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION #8, ITS NON-OSSEOINTEGRATION WAS OBSERVED. IN ADDITION, 60NCM OF PRIMARY STABILITY WAS ACHIEVED, THE PATIENT PRESENTED BONE TYPE III, THE PROCEDURES OF IMMEDIATE IMPLANT AND IMMEDIATE LOAD WERE PERFORMED AND BONE GRAFT WAS EXECUTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188218 CM ALVIM IMPLANT 5.0X13 ENDOSSEOUS DENTAL IMPLANT DZE NEODENT - JJGC S.A. 07898237569024

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention