BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LANX SPINAL FIXATION SYSTEM

    MDR report key: 1320998 · Received February 19, 2009

    Report

    Report Number
    3004485144-2009-00003
    Event Type
    Injury
    Date Received
    February 19, 2009
    Date of Event
    December 17, 2008
    Report Date
    January 19, 2008
    Manufacturer
    LANX, INC.
    Product Code
    KWP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER REPEATED REQUESTS, LANX HAS NOT BEEN PROVIDED WITH SUFFICIENT INFORMATION TO ASSIST WITH DETERMINING A CAUSE FOR THIS INFECTION OR FRACTURED SPINOUS PROCESS. A CONCLUSION FOR THE EVENT CANNOT BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    A REVISION SURGERY WAS PERFORMED APPROX SIX WEEKS POST-OP TO REMOVE SPINAL IMPLANTS BECAUSE OF AN INFECTION. DURING THE SURGERY, THE SURGEON DISCOVERED THAT THE PT'S SPINOUS PROCESS WAS FRACTURED. LANX HAS NOT BEEN ABLE TO OBTAIN INFORMATION AS TO HOW OR WHEN THE FRACTURE OCCURRED. THERE HAS BEEN NO INFORMATION PROVIDED TO SUGGEST THAT THE IMPLANTED DEVICE MALFUNCTIONED OR OTHERWISE DID NOT PERFORM AS INTENDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention