BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE - 20MM

    MDR report key: 1854588 · Received September 9, 2010

    Report

    Report Number
    1530901-2010-00073
    Event Type
    Malfunction
    Date Received
    September 9, 2010
    Report Date
    September 9, 2010
    Manufacturer
    THEKEN SPINE
    Product Code
    KWQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A RETROSPECTIVE QA REVIEW DETERMINED THAT THIS COMPLAINT SHOULD BE REPORTABLE. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE COMPLAINT LOG SHOWS THAT THIS IS THE FIRST RECORDED COMPLAINT OF SPRING ARM DAMAGE CAUSED BY THE DRILL GUIDE (OR ANY INSTRUMENTATION). DUE TO THE FACT THAT THE VARIABLE ANGLE DRILL GUIDE IS SEATED IN THE SPHERICAL CUTOUT FOR THE SCREW HEAD IN ORDER TO PROPERLY ALIGN WITH THE PLATE, IT IS REQUIRED TO MOVE THE SPRING ARM TO THE SIDE, BUT THIS SHOULD NOT DAMAGE THE ARM. IF ON THE OTHER HAND, THE PLATE WAS DAMAGED PRIOR TO THE SURGERY, THE CAUSE & LOCATION OF THE DAMAGE IS UNKNOWN & IS NOT LIKELY TO BE TRACEABLE. THIS IS AN ISOLATED INCIDENT. THIS IS THE FIRST RECORDED INCIDENT WHERE THE INSTRUMENTATION MAY HAVE DAMAGED THE PART. NO CORRECTIVE OR PREVENTIVE ACTION IS REQUIRED. INTEGRA CONSIDERS THIS COMPLAINT INVESTIGATION CLOSED. FUTURE INCIDENTS OF THIS NATURE WILL BE DOCUMENTED FOR RECURRENCE AND TRENDING PURPOSES.

    Description of Event or Problem · 1

    THE DISTRIBUTOR REPORTED THAT THE SURGEON PUT THE PLATE IN PLACE AND ATTEMPTED TO USE THE DRILL GUIDE TO DRILL THE FIRST HOLE. THE DISTRIBUTOR IMMEDIATELY NOTICED THAT THE INTEGRAL RETAINING ARM ON THE PLATE WAS BENT AND INTERFERING WITH THE DRILL GUIDE. THE PLATE WAS THEN REMOVED AND ANOTHER ONE WAS USED WHICH FUNCTIONED PROPERLY. THE REPORTED STATED THAT SURGERY TIME WAS ONLY MINIMALLY EXTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLATE - 20MM MANTARAY KWQ THEKEN SPINE

    Patients

    Seq Age Sex Outcome Treatment
    1