BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LANX SPINAL FIXATION SYSTEM

    MDR report key: 4289983 · Received November 26, 2014

    Report

    Report Number
    3004485144-2014-00019
    Event Type
    Injury
    Date Received
    November 26, 2014
    Date of Event
    January 16, 2013
    Report Date
    January 16, 2013
    Manufacturer
    BIOMET SPINE, LLC.
    Product Code
    NKB
    PMA / PMN Number
    K121316
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE SURGEON ATTEMPTED TO DISTRACT USING A COMPETITOR'S LAMINA SPREADER NEAR THE BASE OF THE SPINOUS PROCESS. THE SPINOUS PROCESS THEN BROKE. THERE ARE NO INDICATIONS THAT A LANX DEVICE CAUSED OR CONTRIBUTED TO THE EVENT. THIS MDR IS BEING SUBMITTED AS A RESULT OF A RETROSPECTIVE COMPLAINT REVIEW CONDUCTED BY BIOMET SPINE. THIS RETROSPECTIVE REVIEW WAS COMPLETED IN RESPONSE TO AN FDA FORM 483 ISSUED TO BIOMET SPINE DURING AN FDA ON-SITE INSPECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769489 LANX SPINAL FIXATION SYSTEM PEDICLE SCREW SPINAL SYSTEM NKB BIOMET SPINE, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention