BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CM DRIVE IMPLANT 4.3X10

    MDR report key: 7338888 · Received March 14, 2018

    Report

    Report Number
    3008261720-2018-01201
    Event Type
    Injury
    Date Received
    March 14, 2018
    Date of Event
    November 2, 2017
    Report Date
    November 9, 2018
    Manufacturer
    NEODENT - JJGC S.A.
    Product Code
    DZE
    UDI-DI
    07898237569260
    PMA / PMN Number
    K123022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    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 USED SEQUENCE OF DRILLS DIFFERENT THAN THE ONES RECOMMENDED FOR THE IMPLANT INSTALLATION

    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 USED SEQUENCE OF DRILLS DIFFERENT THAN THE ONES RECOMMENDED FOR THE IMPLANT INSTALLATION.

    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 USED SEQUENCE OF DRILLS DIFFERENT THAN THE ONES RECOMMENDED FOR THE IMPLANT INSTALLATION.

    Description of Event or Problem · 0

    (B)(4). THE DENTIST REPORTED THAT ALMOST 4 MONTHS AFTER DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION #8, ITS NON-OSSEOINTEGRATION WAS OBSERVED. 35NCM OF PRIMARY STABILITY WAS ACHIEVED. IN ADDITION, THE DENTIST REPORTED THAT THE PROCEDURE OF IMMEDIATE LOAD WAS PERFORMED AND ALSO THE OCCURENCE OF BIOMECHANICAL OVERLOAD.

    Description of Event or Problem · 0

    (B)(4). THE DENTIST REPORTED THAT ALMOST 4 MONTHS AFTER DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION #8, ITS NON-OSSEOINTEGRATION WAS OBSERVED. 35NCM OF PRIMARY STABILITY WAS ACHIEVED. IN ADDITION, THE DENTIST REPORTED THAT THE PROCEDURE OF IMMEDIATE LOAD WAS PERFORMED AND ALSO THE OCCURENCE OF BIOMECHANICAL OVERLOAD.

    Description of Event or Problem · 0

    (B)(4). THE DENTIST REPORTED THAT ALMOST 4 MONTHS AFTER DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION #8, ITS NON-OSSEOINTEGRATION WAS OBSERVED. 35NCM OF PRIMARY STABILITY WAS ACHIEVED. IN ADDITION, THE DENTIST REPORTED THAT THE PROCEDURE OF IMMEDIATE LOAD WAS PERFORMED AND ALSO THE OCCURENCE OF BIOMECHANICAL OVERLOAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181024 CM DRIVE IMPLANT 4.3X10 ENDOSSEOUS DENTAL IMPLANT DZE NEODENT - JJGC S.A. 85836I 07898237569260

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention