BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LANX SPINAL FIXATION SYSTEM

    MDR report key: 3890782 · Received June 4, 2014

    Report

    Report Number
    3004485144-2014-00006
    Event Type
    Injury
    Date Received
    June 4, 2014
    Date of Event
    April 28, 2014
    Report Date
    May 6, 2014
    Manufacturer
    BIOMET SPINE LLC
    Product Code
    NKB
    PMA / PMN Number
    K120399
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    A REVISION SURGERY WAS PERFORMED TO ADDRESS TWO BROKEN PEDICLE SCREWS AT S1, PAIN, AND PSEUDOARTHROSIS APPROXIMATELY 5 YEARS AFTER INSTALLATION. PER REPORTER, THE PATIENT WAS LIFTING A HEAVY BOX WHEN SHE HEARD A POP AND BEGAN TO FEEL PAIN IN HER LOWER BACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327483 LANX SPINAL FIXATION SYSTEM PEDICLE SCEW SPINAL SYSTEM NKB BIOMET SPINE LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention 7703-1600 SET SCREWS