BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MANUAL SCREWDRIVER (MEDIUM) 1.2 MM

    MDR report key: 7840993 · Received September 3, 2018

    Report

    Report Number
    3008261720-2018-03960
    Event Type
    Malfunction
    Date Received
    September 3, 2018
    Date of Event
    January 1, 2018
    Report Date
    August 29, 2018
    Manufacturer
    NEODENT - JJGC S.A.
    Product Code
    DZE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER: E2015015. INSTRADENT USA, INC IS SUBMITTING THE REPORT ON BEHALF OF NEODENT - JJGC. THE DEVICE DOES NOT HAVE 510(K) NUMBER BECAUSE IT IS 510 (K) EXEMPT DEVICE. COMMON DEVICE NAME AND PRODUCT CODE (D2) ¿ THE ONLY PRODUCT CODE AVAILABLE ON THE SOFTWARE SYSTEM USED TO EXECUTE THE REPORT BY THE COMPANY IS DZE (WHICH IS FOR ENDOSSEOUS DENTAL IMPLANT). THE CORRECT WOULD BE PRODUCT CODE NDP, WHICH REFERS TO ENDOSSEOUS DENTAL IMPLANT ACCESSORIES AS COMMON DEVICE NAME. THIS IS A PUNCTUAL SITUATION AND WE ARE ALREADY WORKING ON THE UPDATE OF THESE CODES ON THE SOFTWARE SYSTEM OF THE COMPANY. CONSIDERING THE INVESTIGATION OF THE EVENT IT WAS DECIDED THAT A CHANGE IN THE PRODUCTION PROCESS OF THIS DEVICE WOULD BE NECESSARY AS CORRECTIVE ACTION. THIS CHANGE REQUEST WAS ALREADY IMPLEMENTED IN THE COMPANY.

    Description of Event or Problem · 0

    (B)(4). THE DENTIST REPORTED THAT AFTER THE STERILIZATION PROCESS OF THE MANUAL SCREWDRIVER, ITS FRACTURE WAS OBSERVED. THERE WERE NO REPORTED PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681509 MANUAL SCREWDRIVER (MEDIUM) 1.2 MM ENDOSSEOUS DENTAL IMPLANT DZE NEODENT - JJGC S.A. 91919

    Patients

    Seq Age Sex Outcome Treatment
    1 Other