BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CM DRIVE IMPLANT 3.5X8

    MDR report key: 8201678 · Received December 27, 2018

    Report

    Report Number
    3008261720-2018-06106
    Event Type
    Injury
    Date Received
    December 27, 2018
    Date of Event
    December 8, 2017
    Report Date
    December 28, 2018
    Manufacturer
    NEODENT - JJGC S.A.
    Product Code
    DZE
    UDI-DI
    07898237569208
    PMA / PMN Number
    K123022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UY
    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. FOLLOW-UP CREATED TO CORRECT THE INFORMATIONS ABOUT THE REPORTED DENTAL IMPLANT.

    Description of Event or Problem · 0

    (B)(4). THE DENTIST REPORTED THAT 3 MONTHS AFTER THE DENTAL IMPLANT WAS INSTALLED IN PATIENT¿S MOUTH, ITS NON-OSSEOINTEGRATION WAS OBSERVED. IN ADDITION, 20NCM OF PRIMARY STABILITY WAS ACHIEVED AND THE PATIENT PRESENTED BONE TYPE III.

    Description of Event or Problem · 0

    (B)(4). THE DENTIST REPORTED THAT 3 MONTHS AFTER THE DENTAL IMPLANT WAS INSTALLED IN PATIENT¿S MOUTH, ITS NON-OSSEOINTEGRATION WAS OBSERVED. IN ADDITION, 20NCM OF PRIMARY STABILITY WAS ACHIEVED AND THE PATIENT PRESENTED BONE TYPE III.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1039376 CM DRIVE IMPLANT 3.5X8 ENDOSSEOUS DENTAL IMPLANT DZE NEODENT - JJGC S.A. 16882I 07898237569208

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention