BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    W2.0MM IMF SCREW SELF-DRILLING 12MM

    MDR report key: 2841365 · Received October 23, 2012

    Report

    Report Number
    2520274-2012-02454
    Event Type
    Malfunction
    Date Received
    October 23, 2012
    Date of Event
    September 25, 2012
    Report Date
    September 25, 2012
    Product Code
    DZL
    PMA / PMN Number
    K010527
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SCREW IS BROKE AT THE THREADS JUST BELOW THE HEAD. ONLY ONE FULL REVOLUTION OF THE THREAD REMAINS. VISUAL EXAMINATION IS CONSISTENT WITH THE COMPLAINT. ALTHOUGH THERE ARE THREADS PRESENT THERE ARE NOT ENOUGH REMAINING THREADS TO MEASURE THE THREAD PROFILE, MAJOR DIAMETER AND MINOR DIAMETER WITH CONFIDENCE. A NITON GUN WAS USED TO MEASURE TYPE MATERIAL, PASSED SPECIFICATIONS.

    Description of Event or Problem · 1

    DURING A PROCEDURE, SURGEON WAS USING IMF SCREWS AND CERCLAGE WIRE TO WIRE THE PT'S JAW. WHILE INSERTING THE SCREW, THE SCREW BROKE. TIP OF SCREW COULD NOT BE RETRIEVED AND REMAINS IMPLANTED IN THE PT. SURGEON WAS ABLE TO USE ANOTHER SCREW TO COMPLETE PROCEDURE WITH NO FURTHER PROBLEM. IT WAS NOTED THERE WAS NO HARM TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 W2.0MM IMF SCREW SELF-DRILLING 12MM IMF SCREW SELF-DRILLING DZL

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR WIRE| SCREW