BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X-POST

    MDR report key: 2804692 · Received October 17, 2012

    Report

    Report Number
    8031010-2012-00068
    Event Type
    Malfunction
    Date Received
    October 17, 2012
    Report Date
    September 18, 2012
    Manufacturer
    DENTSPLY MAILLEFER
    Product Code
    ELR
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE NO SERIOUS INJURY RESULTED IN THIS EVENT, THERE HAS BEEN A PREVIOUS REPORT RECEIVED IN THE PAST TWO YEARS WHERE THIS MALFUNCTION RESULTED IN A SERIOUS INJURY. THEREFORE, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR PART 803. ACTUAL PRODUCT INVOLVED IN THE EVENT IS NOT AVAILABLE AND CANNOT BE ANALYZED BY OUR LAB. A DHR REVIEW WAS CONDUCTED WITH NO DISCREPANCIES NOTED. ADD¿L INFO REGARDING THE PT OUTCOME HAS BEEN REQUESTED AND WILL BE SUBMITTED AS IT BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IN THIS EVENT IT WAS REPORTED THAT AN X-POST SEPARATED IN THE MOUTH OF PT. ONE PIECE IS IN THE CROWN AND THE OTHER ONE IS STILL IN THE TOOTH. OUTCOME OF THE EVENT IS UNK AS OF THIS MDR EVAL, THOUGH THERE IS NO INDICATION THAT A SERIOUS INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 X-POST ELR DENTSPLY MAILLEFER 9285990

    Patients

    Seq Age Sex Outcome Treatment
    1