BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LANX SPINAL FIXATION SYSTEM

    MDR report key: 4289949 · Received November 26, 2014

    Report

    Report Number
    3004485144-2014-00024
    Event Type
    Injury
    Date Received
    November 26, 2014
    Date of Event
    September 4, 2013
    Report Date
    January 3, 2014
    Manufacturer
    BIOMET SPINE, LLC
    Product Code
    NKB
    PMA / PMN Number
    K120399
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A POST-OPERATIVE PROGRESS REPORT, THE SURGEON NOTED THE FOLLOWING INFO REGARDING THE PATIENT: THE PATIENT HAS PERSISTENT COMPLAINTS OF BILATERAL LOWER EXTREMITY NONDERMATOMAL PAIN, INCLUDING WEAKNESS IN HIS LOWER EXTREMITIES, TROUBLE KEEPING HIS BALANCE, AND DIFFICULTY WALKING. THE SURGEON ALSO NOTED THE FOLLOWING REGARDING THE IMPLANTED DEVICES: "X-RAYS OF THE LUMBAR SPINE WERE OBTAINED WHICH SHOW GOOD POSITIONING OF THE INTERBODY SPACER AS WELL AS PEDICLE SCREWS. THERE IS REALLY NO SUBSIDENCE OR PROBLEM WITH THE SPACER OR PEDICLE SCREWS.. AT THIS POINT, THERE IS NOTHING REALLY WRONG WITH THE FUSION ITSELF". 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 ISSUES TO BIOMET SPINE DURING AN FDA ON-SITE INSPECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769458 LANX SPINAL FIXATION SYSTEM PEDICLE SCREW SPINAL SYSTEM NKB BIOMET SPINE, LLC UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other INTERBODY SPACER| SET SCREWS| PEDICLE SCREW CONSTRUCT CONSISTING OF PEDICLE| SCREWS| ROD