BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LANX SPINAL FIXATION SYSTEM

    MDR report key: 1962855 · Received January 13, 2011

    Report

    Report Number
    3004485144-2011-00003
    Event Type
    Injury
    Date Received
    January 13, 2011
    Date of Event
    December 5, 2010
    Report Date
    December 14, 2010
    Manufacturer
    LANX, INC
    Product Code
    KWP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL METHOD: NO DEVICE RETURNED FOR EVAL. RESULTS: BASED ON REP'S OBSERVATIONS, SURGEON POSSIBLY OVER DISTRACTED WHILE IMPLANTING THE DEVICE. CONCLUSION: NO CONCLUSION COULD BE DRAW FROM THE INFO PROVIDED.

    Description of Event or Problem · 1

    A PT UNDERWENT A REVISION SURGERY TO REMOVE AN INTERSPINOUS FIXATION DEVICE. THE SURGEON IMPLANTED THE DEVICE ON (B)(6) 2010. THE PT WAS REPORTED TO BE DOING WELL THE NEXT DAY, HOWEVER, (B)(6) 2010 THE PT REPORTED HAVING SYMPTOMS OF DISCOMFORT. A POST-OP EVAL DETERMINED THAT THE IMPLANT HAD LOOSENED OR MIGRATED. POST-OP INDICATED THE DEVICE WAS INTACT BUT THE SPINOUS PROCESS WAS FRACTURED. ON (B)(6) 2010, THE IMPLANT WAS REMOVED AND A FORAMINECTOMY WAS PERFORMED. NO ADDITIONAL DEVICES WERE IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LANX SPINAL FIXATION SYSTEM SPINAL FIXATION SYSTEM KWP LANX, INC 6211-0014

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention