BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CM DRIVE IMPLANT 3.5X13 MM

    MDR report key: 7883192 · Received September 17, 2018

    Report

    Report Number
    3008261720-2018-04592
    Event Type
    Injury
    Date Received
    September 17, 2018
    Date of Event
    August 18, 2018
    Report Date
    September 17, 2018
    Manufacturer
    NEODENT - JJGC S.A.
    Product Code
    DZE
    UDI-DI
    07898237569215
    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 COMPLAINANT INFORMED THAT THE INFORMATION ABOUT LOT NUMBER OF THE PRODUCT WAS NOT AVAILABLE.

    Description of Event or Problem · 0

    RP.014284 ¿ THE DENTIST INFORMED THAT DENTAL IMPLANT HAD TO BE REMOVED AFTER 30 DAYS BECAUSE IT HAD DISPLACED INTO MAXILLARY SINUS. THE INSTALLATION REGION WAS 12#, 30 NCM OF PRIMARY STABILITY WAS ACHIEVED, THE PATIENT PRESENTED BONE TYPE III, IMMEDIATE IMPLANT PROCEDURE WAS PERFORMED AND THE PERFORATION OF THE SINUS MEMBRANE HAS OCCURRED DURING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724006 CM DRIVE IMPLANT 3.5X13 MM ENDOSSEOUS DENTAL IMPLANT DZE NEODENT - JJGC S.A. 07898237569215

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention