BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LANX SPINAL FIXATION SYSTEM

    MDR report key: 3763727 · Received April 3, 2014

    Report

    Report Number
    3004485144-2014-00003
    Event Type
    Injury
    Date Received
    April 3, 2014
    Date of Event
    January 9, 2014
    Report Date
    April 3, 2014
    Manufacturer
    LANX, INC.
    Product Code
    MNI
    PMA / PMN Number
    071877
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT LABELING INCLUDES A CONTRAINDICATION FOR MORBID OBESITY. IT INDICATES THAT AN OVERWEIGHT OR OBESE PATIENT CAN PRODUCE LOADS ON THE SPINAL SYSTEM, WHICH LEAD TO FAILURE OF THE FIXATION OF THE DEVICE OR FAILURE OF THE DEVICE ITSELF. IT ALSO LISTS NON-UNION OR DELAYED UNION, PSEUDARTHROSIS, PAIN, AND SECOND SURGERY AS POSSIBLE COMPLICATIONS TO THE PROCEDURE.

    Description of Event or Problem · 1

    ON (B)(6) 2011, A PATIENT RECEIVED TWO LANX INTERSPINOUS PROCESS DEVICES TO ADDRESS CHRONIC LOWER BACK PAIN. IN (B)(6) 2013, THE PATIENT EXPERIENCED LOWER BACK PAIN AGAIN, AND THEREFORE, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2014. DURING THIS SURGERY, BOTH LANX INTERSPINOUS PROCESS DEVICES WERE REMOVED AND REPLACED WITH A TRADITIONAL PEDICLE SCREW CONSTRUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200421 LANX SPINAL FIXATION SYSTEM INTERSPINOUS PROCESS SPINAL SYSTEM MNI LANX, INC. 6201-0010/6251-0010

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention