BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EAGLE PLUS SELF TAPPING SCREW 16MM

    MDR report key: 2234134 · Received September 6, 2011

    Report

    Report Number
    1526439-2011-00153
    Event Type
    Malfunction
    Date Received
    September 6, 2011
    Date of Event
    August 11, 2011
    Report Date
    September 6, 2011
    Manufacturer
    DEPUY RAYNHAM
    Product Code
    KWQ
    PMA / PMN Number
    K070994
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PLATE WAS RETURNED WITH ONE BUSHING FREE AND INCLUDED. THERE IS A SCREW WITHIN THE PLATE LOCKED IN THE BUSHING. BASED ON THE DESCRIPTION OF THE EVENT AND THE CONDITION OF THE DEVICE IT APPEARS THAT THE SCREW LOCKED WITHIN THE BUSHING AS IT IS INTENDED TO DO. THERE IS NOTED DAMAGE ON THE THREAD OF THE SCREW AND ON THE BOTTOM OF THE BUSHINGS. THIS INDICATES THAT THE SCREWS WERE BROUGHT INTO CONTACT WITH THE RIM OF THE BUSHING IN AN AGGRESSIVE MANNER WHEN ADVANCING THE SCREWS. VISUAL EXAMINATION INDICATES THAT THE PROBLEM EXPERIENCED WERE LIKELY SURGEON TECHNIQUE RELATED.

    Description of Event or Problem · 1

    CONTACT REPORTED THAT UPON PLACING A SCREW INTO AN CERVICAL PLATE THE BUSHING GOT CAUGHT ON THE SCREW IN A MANNER IN WHICH IT COULD NOT BE ADVANCED OR REMOVED. SURGEON REMOVED THE PLATE AND AS THIS WAS THE ONLY 17MM PLATE IN THE SET HE COMPLETE THE CASE USING A 19MM PLATE. REP CONFIRMED THAT THE ISSUE CAUSED AN EXTENSION OF SURGERY BEYOND 30-MIN. AND AS A RESULT AN MDR IS FILED TO DOCUMENT THIS EVENT. DEVICE 2. SEE ALSO 1526439-2011-00152.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EAGLE PLUS SELF TAPPING SCREW 16MM CERVICAL FIXATION DEVICE KWQ DEPUY RAYNHAM AMF005

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR