BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CM DRIVE IMPLANT 5.0X10 MM

    MDR report key: 7829919 · Received August 29, 2018

    Report

    Report Number
    3008261720-2018-04140
    Event Type
    Injury
    Date Received
    August 29, 2018
    Date of Event
    January 1, 2018
    Report Date
    August 29, 2018
    Manufacturer
    NEODENT - JJGC S.A.
    Product Code
    DZE
    UDI-DI
    07898237569239
    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 LESS DRILLS THAN RECOMMENDED TO PERFORM 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 LESS DRILLS THAN RECOMMENDED TO PERFORM THE IMPLANT INSTALLATION.

    Description of Event or Problem · 0

    (B)(4). ¿ THE DENTIST REPORTED THAT AFTER DENTAL IMPLANT WAS INSTALLED IN PATIENT¿S MOUTH, ITS NON-OSSEOINTEGRATION WAS OBSERVED. IN ADDITION, THE PATIENT PRESENTED BONE TYPE IV.

    Description of Event or Problem · 0

    (B)(4). THE DENTIST REPORTED THAT AFTER DENTAL IMPLANT WAS INSTALLED IN PATIENT¿S MOUTH, ITS NON-OSSEOINTEGRATION WAS OBSERVED. IN ADDITION, THE PATIENT PRESENTED BONE TYPE IV.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671597 CM DRIVE IMPLANT 5.0X10 MM ENDOSSEOUS DENTAL IMPLANT DZE NEODENT - JJGC S.A. 58313I 07898237569239

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention