BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIX ANCHOR DRILLS ROOT FACER

    MDR report key: 8139182 · Received December 6, 2018

    Report

    Report Number
    8031010-2018-00145
    Event Type
    Malfunction
    Date Received
    December 6, 2018
    Report Date
    February 4, 2019
    Manufacturer
    DENTSPLY MAILLEFER
    Product Code
    DZP
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    THE BROKEN INSTRUMENT WAS NOT RETURNED AND CANNOT BE ANALYZED. A BATCH NUMBER WAS PROVIDED HOWEVER THIS NUMBER HAS NO CORRESPONDING IN OUR SYSTEM. THE RIGHT BATCH NUMBER IS UNKNOWN, NO DHR REVIEW CAN BE DONE. ROOT CAUSES ARE NOT IDENTIFIED. WE WILL TRACK THIS KIND OF EVENT AND MONITOR THE TREND.

    Additional Manufacturer Narrative · 1

    AS A RESULT OF THIS MALFUNCTION, THE POTENTIAL FOR SURGICAL INTERVENTION EXISTS TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE OR PERMANENT IMPAIRMENT OF A BODY FUNCTION AS EVIDENCED BY PREVIOUS REPORTED EVENTS WITH SIMILAR FILES. THIS EVENT, THEREFORE, IS REPORTABLE PER 21CFR PART 803. THE DEVICE IS AVAILABLE FOR EVALUATION, THOUGH HAS NOT BEEN RETURNED AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

    Description of Event or Problem · 1

    IN THIS EVENT IT WAS REPORTED THAT A ROOT FACER RADIX ANKER SEPARATED DURING TREATMENT. THE TIP REMAINED IN THE ROOT CANAL. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    980085 RADIX ANCHOR DRILLS ROOT FACER INSTRUMENT, DIAMOND, DENTAL DZP DENTSPLY MAILLEFER NA 200069

    Patients

    Seq Age Sex Outcome Treatment
    1