BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLOBUS MEDICAL TRANSITION

    MDR report key: 3020830 · Received March 19, 2013

    Report

    Report Number
    MW5029463
    Event Type
    Injury
    Date Received
    March 19, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 19, 2013
    Manufacturer
    GLOBUS MEDICAL
    Product Code
    NQP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT IS (B)(6) FEMALE WITH LIFE LIMITING LOW BACK PAIN, HISTORY OF MULTIPLE LUMBAR SPINE PROCEDURES. PT REPORTED L4-S1 POSTERIOR SPINE FUSION 20 YEARS PRIOR. ALSO REPORTED L3-L4 POSTERIOR SPINE FUSION WITH L2-L3 STABILIZATION IN 2010 IN FT COLLINS, CO. PT STATED NO RELIEF FROM THAT PROCEDURE. SURGERY PERFORMED (B)(6) 2013 WHICH DEMONSTRATED "OBVIOUS GROSS LOOSENING OF THE RIGHT L2 AND BILATERAL L4 PEDICLE SCREWS. PRIOR TO COMPLETE IMPLANT REMOVAL, THERE WAS NOTED TO BE GROSS MOTION BETWEEN L3 AND L4. HOWEVER, THAT WAS HARD TO ASSESS DUE TO THE LOOSE SCREWS AT L4." SURGERY (B)(6) 2013 INCLUDED L2-L4 HARDWARE REMOVAL WITH EXPLORATION OF POSTERIOR SPINE FUSION, L3 - L4 BILATERAL POSTEROLATERAL FUSION, T10 - L3 BILATERAL POSTERIOR SPINE FUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114494 GLOBUS MEDICAL TRANSITION L2 - L4 HARDWARE NQP GLOBUS MEDICAL TRANSITION UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention