BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LANX SPINAL FIXATION SYSTEM

    MDR report key: 4172379 · Received October 9, 2014

    Report

    Report Number
    3004485144-2014-00013
    Event Type
    Malfunction
    Date Received
    October 9, 2014
    Date of Event
    August 5, 2014
    Report Date
    September 12, 2014
    Manufacturer
    BIOMET SPINE, LLC
    Product Code
    NKB
    PMA / PMN Number
    K120399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    APPROXIMATELY 28 MONTHS AFTER PEDICLE SCREW INSTALLATION, THE PT TWISTED AND HEARD A POPPING SOUND. A SUBSEQUENT X-RAY REVEALED A BROKEN PEDICLE SCREW. A REVISION IS CURRENTLY SCHEDULED TO REMOVE BROKEN DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636807 LANX SPINAL FIXATION SYSTEM PEDICLE SCREW SPINAL SYSTEM NKB BIOMET SPINE, LLC 7716-6545 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR