BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CALAMUS HEATED PLUGGER

    MDR report key: 5411564 · Received February 4, 2016

    Report

    Report Number
    8031010-2016-00002
    Event Type
    Malfunction
    Date Received
    February 4, 2016
    Report Date
    January 5, 2016
    Manufacturer
    DENTSPLY MAILLEFER
    Product Code
    EKR
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THERE HAS BEEN A PREVIOUS REPORT RECEIVED WHERE THIS MALFUNCTION OF A SIMILAR DEVICE RESULTED IN A SERIOUS INJURY. THEREFORE, IT MUST BE PRESUMED THAT RECURRENCE OF THIS MALFUNCTION COULD POSSIBLY CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR REQUIRE MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE SUCH. AS SUCH, THIS EVENT 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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE BROKEN PIECE WAS RETRIEVED FROM THE PATIENT'S MOUTH. MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE TO OBTAIN THE DEVICE FOR EVALUATION. AT THIS TIME, SINCE WE CANNOT TEST THE SAMPLE, WE WILL RECORD AND TRACK THIS LOT # FOR FUTURE TRENDING.

    Description of Event or Problem · 1

    IN THIS EVENT, IT WAS REPORTED THAT A CALAMUS HEATED PLUGGER SEPARATED; EVENT OUTCOME IS UNKNOWN AS OF THIS MDR EVALUATION. HOWEVER, THERE IS NO INDICATION THAT INJURY RESULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69855 CALAMUS HEATED PLUGGER PLUGGER, ROOT CANAL, ENDODONTIC EKR DENTSPLY MAILLEFER NA 3212012

    Patients

    Seq Age Sex Outcome Treatment
    1