BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MANUAL SCREWDRIVER (LONG) 1.2 MM

    MDR report key: 8165003 · Received December 14, 2018

    Report

    Report Number
    3008261720-2018-05762
    Event Type
    Malfunction
    Date Received
    December 14, 2018
    Date of Event
    January 1, 2017
    Report Date
    December 7, 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. IN TELEPHONE CONTACT, THE COMPLAINANT INFORMED THAT THE INFORMATION ABOUT LOT NUMBER OF THE PRODUCT WAS NOT AVAILABLE.

    Description of Event or Problem · 0

    (B)(4). THE DENTIST REPORTED THE FRACTURE OF THE MANUAL SCREWDRIVER. THERE WERE NO REPORTED PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1003476 MANUAL SCREWDRIVER (LONG) 1.2 MM ENDOSSEOUS DENTAL IMPLANT DZE NEODENT - JJGC S.A.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other