BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CM DRIVE ACQUA IMPL TI 3.5X10

    MDR report key: 7086611 · Received December 6, 2017

    Report

    Report Number
    3008261720-2017-06670
    Event Type
    Injury
    Date Received
    December 6, 2017
    Date of Event
    October 26, 2017
    Report Date
    December 6, 2017
    Manufacturer
    NEODENT - JJGC S.A.
    Product Code
    DZE
    UDI-DI
    07899878016830
    PMA / PMN Number
    K133592
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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. AFTER THE EVALUATION WAS NOTICED THAT THE DENTIST REPORTED THAT THE IMPLANT WAS IMMEDIATELY INSTALLED IN AN ALVEOLUS WITH SIGNS OF INJURY/ INFECTION. IN ADDITION, HE USED THE PROCEDURE OF IMMEDIATE LOAD. CONSIDERING THE SURGICAL METHODOLOGY, IT WAS SEEN THAT THE DENTIST HAS USED LESS DRILLS THAN RECOMMENDED TO PERFORM THE IMPLANT INSTALLATION.

    Description of Event or Problem · 0

    THE CLINICIAN REPORTED THAT EIGHT MONTHS AFTER THE DENTAL IMPLANT AND ABUTMENT WERE PLACED IN ADA SITE 4, OSSEOINTEGRATION WAS STILL NOT OBTAINED. CLINICIAN DID NOT PERFORM AN IMMEDIATE PLACEMENT NOR WAS THERE EVIDENCE OF FENESTRATION. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED POST-OPERATIVE COMPLICATIONS.

    Description of Event or Problem · 0

    THE CLINICIAN REPORTED THAT EIGHT MONTHS AFTER THE DENTAL IMPLANT AND ABUTMENT WERE PLACED IN ADA SITE 4, OSSEOINTEGRATION WAS STILL NOT OBTAINED. CLINICIAN DID NOT PERFORM AN IMMEDIATE PLACEMENT NOR WAS THERE EVIDENCE OF FENESTRATION. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED POST-OPERATIVE COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    867791 CM DRIVE ACQUA IMPL TI 3.5X10 ENDOSSEOUS DENTAL IMPLANT DZE NEODENT - JJGC S.A. 48588I 07899878016830

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Required Intervention ABUTMENT| ABUTMENT| ABUTMENT