BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LANX SPINAL FIXATION SYSTEM

    MDR report key: 4173153 · Received October 10, 2014

    Report

    Report Number
    3004485144-2014-00012
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    September 16, 2014
    Report Date
    September 17, 2014
    Manufacturer
    BIOMET SPINE, LLC
    Product Code
    NKB
    PMA / PMN Number
    K120399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    DURING A REVISION SURGERY TO ADDRESS DISEASE PROGRESSION AT THE ADJACENT LEVEL, THE TULIPS OF TWO PREVIOUSLY IMPLANTED PEDICLE SCREWS WERE FOUND BROKEN WHILE THE TULIP OF A THIRD PEDICLE SCREW BROKE OFF THE SCREW SHAFT DURING ATTEMPTED REMOVAL. THE SURGEON WAS ABLE TO REMOVE THE SCREW SHAFT THAT WAS IMPLANTED AT THE L4 LEVEL, BUT WAS NOT ABLE TO REMOVE EITHER SHAFT AT THE L5 LEVEL; BOTH OF THOSE SCREW SHAFTS REMAIN IN THE PATIENT. FUSION WAS PRESENT AT THE ORIGINALLY INSTRUMENTED L4-L5 LEVEL. THE ORIGINAL SURGERY WAS PERFORMED APPROXIMATELY 7 YEARS AGO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643281 LANX SPINAL FIXATION SYSTEM PEDICLE SCREW SPINAL SYSTEM NKB BIOMET SPINE, LLC 7716-6545 LX-1583

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR