BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X-SMART

    MDR report key: 2443483 · Received January 20, 2012

    Report

    Report Number
    8031010-2011-00156
    Event Type
    Malfunction
    Date Received
    January 20, 2012
    Report Date
    December 21, 2011
    Manufacturer
    DENTSPLY MAILLERFER
    Product Code
    EKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CY
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BECAUSE EVAL OF THE UNIT INVOLVED IS NOT COMPLETE AS OF THIS REPORT AND SINCE THIS ISSUE COULD CAUSE OR CONTRIBUTE TO SEPARATION OF A FILE WHICH COULD NECESSITATE MEDICAL/SURGICAL INTERVENTION TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE OR PERMANENT IMPAIRMENT OF A BODY FUNCTION, IT MUST BE PRESUMED THAT THE DEVICE MALFUNCTIONED AND THAT THE MALFUNCTION WOULD BE LIKELY TO CAUSE/CONTRIBUTE TO A SERIOUS INJURY SHOULD IT RECUR. AS SUCH, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR PART 803. THE DEVICE IS AVAILABLE FOR EVALUATION, THOUGH RESULTS ARE NOT AVAILABLE AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED WHEN THEY BECOME AVAILABLE.

    Description of Event or Problem · 1

    IN THIS EVENT IT WAS REPORTED THAT AN X-SMART ENDO MOTOR DID NOT AUTO-REVERSE. EVENT OUTCOME IS UNK AS OF THIS MDR EVALUATION. HOWEVER, THERE IS NO INDICATION THAT INJURY RESULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 X-SMART EKX DENTSPLY MAILLERFER

    Patients

    Seq Age Sex Outcome Treatment
    1