BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LANX SPINAL FIXATION SYSTEM

    MDR report key: 1736778 · Received June 24, 2010

    Report

    Report Number
    3004485144-2010-00009
    Event Type
    Injury
    Date Received
    June 24, 2010
    Date of Event
    March 29, 2010
    Report Date
    March 29, 2010
    Manufacturer
    LANX, INC.
    Product Code
    KWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION PERTAINING TO THE EVENT WAS REQUESTED BUT NOT PROVIDED BY THE INITIAL REPORTER, INCLUDING PATIENT INFORMATION, DEVICE MODEL/LOT NUMBER, AND THE DATE OF THE DEVICE WAS IMPLANTED. BASED ON INFORMATION RECEIVED, IT APPEARS THAT THE PATIENT'S CONDITION CONTRIBUTED TO A NON-FUSION, WHICH AFFECTED THE EFFECTIVENESS OF THE DEVICE. THERE WAS NO DEVICE FAILURE.

    Description of Event or Problem · 1

    A PATIENT UNDERWENT A REVISION SURGERY TO REMOVE A SPINAL FIXATION DEVICE. THE ORIGINAL HARDWARE WAS REMOVED BECAUSE OF A LACK OF BONY FUSION. BASED ON THE INITIAL REPORT, THERE IS NO INFORMATION TO SUGGEST THAT THE IMPLANTED DEVICE MALFUNCTIONED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention