BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LANX ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 2590254 · Received May 24, 2012

    Report

    Report Number
    3004485144-2012-00020
    Event Type
    Malfunction
    Date Received
    May 24, 2012
    Date of Event
    February 22, 2012
    Report Date
    May 23, 2012
    Manufacturer
    LANX, INC
    Product Code
    KWQ
    PMA / PMN Number
    K090316
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: NO TESTING METHODS PERFORMED (RELATED IMPLANTS WERE NOT RETURNED TO MFR). RESULTS: NO RESULTS AVAILABLE SINCE NO EVAL PERFORMED (RELATED DEVICE WAS NOT RETURNED TO MFR). CONCLUSIONS: FAILURE TO FOLLOW INSTRUCTIONS (PLATE NOT BENT TO FIT PT ANATOMY).

    Description of Event or Problem · 1

    A 3-LEVEL ANTERIOR CERVICAL PLATE WAS IMPLANTED AT LEVELS C4-C7. THE TWO LOCKING CAPS AT C7 HAVE MIGRATED OUT OF THEIR ORIGINALLY IMPLANTED POSITION. ONE OF THESE LOCKING CAPS AT C7 HAS PARTIALLY DISENGAGED FROM THE CERVICAL PLATE. THE OTHER OF THESE LOCKING CAPS AT C7 HAS FULLY DISENGAGED FROM THE CERVICAL PLATE AND REMAINS IN CLOSE PROXIMITY TO THE CONSTRUCT. THE CERVICAL PLATE WAS NOT BENT TO FIT THE PT'S ANATOMY. THE PT IS NOT EXPERIENCING ANY PAIN AS A RESULT OF THIS EVENT. THE SURGEON DOES NOT PLAN ON REMOVING THE LOCKING CAPS FROM THE PT AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LANX ANTERIOR CERVICAL PLATE SYSTEM ANTERIOR CERVICAL PLATE SYSTEM KWQ LANX, INC

    Patients

    Seq Age Sex Outcome Treatment
    1