BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X-POST

    MDR report key: 2916451 · Received December 19, 2012

    Report

    Report Number
    8031010-2012-00070
    Event Type
    Malfunction
    Date Received
    December 19, 2012
    Report Date
    November 26, 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 INT HIS EVENT, THERE HAS BEEN PREVIOUS REPORT RECEIVED WITHIN THE PAST TWO YEARS INVOLVING POST BREAKAGE THAT RESULTED IN A SERIOUS INJURY. THEREFORE, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR PART 803. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE LOT NUMBER WAS NOT PROVIDED FOR RETAINED-PRODUCT TESTING AND/OR DHR REVIEW.

    Description of Event or Problem · 1

    IN THIS EVENT IT WAS REPORTED THAT A X-POST WAS "FRAYED AT THE APICAL END." THE BROKEN PIECE WAS RETRIEVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1