BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROPEX

    MDR report key: 2220085 · Received August 12, 2011

    Report

    Report Number
    8031010-2011-00119
    Event Type
    Malfunction
    Date Received
    August 12, 2011
    Report Date
    July 20, 2011
    Manufacturer
    DENTSPLY MAILLEFER
    Product Code
    LQY
    PMA / PMN Number
    K992233
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE THERE IS APPARENTLY NO REPORT OF INJURY IN THIS EVENT, THERE HAS BEEN A PREVIOUS REPORT RECEIVED WITHIN THE PAST TWO YEARS INVOLVING THIS MALFUNCTION THAT RESULTED IN A SERIOUS INJURY. THEREFORE, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR PART 803. THIS EVENT WILL BE REVEALED, AS APPROPRIATE, IF FURTHER INFO BECOMES AVAILABLE. ADDITIONAL INFO REGARDING THE PT OUTCOME HAS BEEN REQUESTED. ADDITIONAL INFO WILL BE SUBMITTED AS IT BECOMES AVAILABLE. THE DEVICE IS AVAILABLE FOR EVAL, THOUGH RESULTS ARE NOT AVAILABLE AS OF THIS REPORT. EVAL RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

    Description of Event or Problem · 1

    IN THIS EVENT IT WAS REPORTED THAT A PROPEX II APEX LOCATOR PROVIDED INCORRECT MEASUREMENTS; OUTCOME OF THIS EVENT IS UNK AS OF THIS MDR EVAL. HOWEVER, THERE IS NO INDICATION THAT INJURY RESULTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1