BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LANX SPINAL FIXATION SYSTEM

    MDR report key: 4575387 · Received March 3, 2015

    Report

    Report Number
    3004485144-2015-00001
    Event Type
    Injury
    Date Received
    March 3, 2015
    Date of Event
    January 28, 2015
    Report Date
    February 2, 2015
    Manufacturer
    BIOMET SPINE LLC
    Product Code
    NKB
    PMA / PMN Number
    K120399
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY WAS PERFORMED APPROXIMATELY THREE YEARS AFTER THE INITIAL LUMBAR FUSION PROCEDURE TO ADDRESS A PATIENT INJURY INVOLVING PAIN AND TETHERING OF THE SPINAL CORD. THERE WAS NO REPORTED FAILURE OF THE IMPLANTED DEVICE ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146057 LANX SPINAL FIXATION SYSTEM PEDICLE SCREW SPINAL SYSTEM, NKB, KWP, MNH, MNI NKB BIOMET SPINE LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention