BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROPEX

    MDR report key: 1840918 · Received September 17, 2010

    Report

    Report Number
    8031010-2010-00121
    Event Type
    Injury
    Date Received
    September 17, 2010
    Report Date
    August 19, 2010
    Manufacturer
    DENTSPLY MAILLEFER
    Product Code
    LQY
    PMA / PMN Number
    K992233
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    BECAUSE EVAL OF THE UNIT INVOLVED IS NOT COMPLETE AS OF THIS REPORT AND SINCE AN INCORRECT MEASUREMENT READING ON AN APEX LOCATOR 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 EVAL, THOUGH RESULTS ARE NOT AVAILABLE AS OF THIS REPORT.

    Description of Event or Problem · 1

    IN THIS EVENT IT WAS REPORTED THAT A PROPEX APEX LOCATOR GAVE INCORRECT MEASUREMENTS, POSSIBLY CAUSING OVER-INSTRUMENTATION RESULTING IN DAMAGE TO PTS' APICAL FORAMEN. AS A RESULT, THE PTS WERE TREATED IN AN UNDISCLOSED MANNER TO ADDRESS THEIR DAMAGED APICAL FORAMEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROPEX LQY DENTSPLY MAILLEFER 0841168

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention