BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CM DRIVE IMPLANT 3.5X8

    MDR report key: 7447736 · Received April 20, 2018

    Report

    Report Number
    3008261720-2018-01835
    Event Type
    Injury
    Date Received
    April 20, 2018
    Date of Event
    February 2, 2016
    Report Date
    April 20, 2018
    Manufacturer
    NEODENT - JJGC S.A.
    Product Code
    DZE
    UDI-DI
    07898237569307
    PMA / PMN Number
    K123022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER: E2015015. INSTRADENT USA, INC IS SUBMITTING THE REPORT ON BEHALF OF NEODENT - JJGC. IN TELEPHONE CONTACT, THE DENTIST INFORMED THAT HE DID NOT HAVE INFORMATION ABOUT LOT NUMBER OF THE PRODUCT.

    Description of Event or Problem · 0

    RP 011246 - THE DENTIST REPORTED THAT 4 MONTHS AFTER 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 IV.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290606 CM DRIVE IMPLANT 3.5X8 ENDOSSEOUS DENTAL IMPLANT DZE NEODENT - JJGC S.A. 07898237569307

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention