BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT DEVICE (RHBMP-2)

    MDR report key: 3080390 · Received April 23, 2013

    Report

    Report Number
    MW5029927
    Event Type
    Injury
    Date Received
    April 23, 2013
    Date of Event
    May 5, 2010
    Report Date
    March 31, 2013
    Manufacturer
    MEDTRONIC INC
    Product Code
    NEK
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    HETEROTROPIC BONE GROWTH WITH LEFT LEG RADICULITIS AND LEFT FOOT NUMBNESS. MODERATE LEFT FORAMINAL STENOSIS DUE TO HETEROTOPIC BONE EXTENDING FROM THE POSTERIOR MARGIN OF THE DISC TO THE FACET JOINT. PROCEDURE: OPEN EXPLORATION OF HARDWARE WITH NO EVIDENCE OF HARDWARE FAILURE, POSTERIOR LATERAL FUSION, L5-S1 USING DEMINERALIZED BONE MATRIX, REMOVAL OF TWO CAP SCREWS, LEFT L5-S1. SURGERY WAS PERFORMED UNDER LOCAL ANESTHESIA. "I IDENTIFIED THE TORQUE SCREW TOPS, BUT THE CAP SCREWS WERE STILL INTACT AND THE HARDWARE WAS COMPLETELY SOLID." DISSECTED LATERALLY AND DECORTICATED THE LATERAL MASSES FROM THE TRANSVERSE PROCESSES AND LATERAL FACET JOINTS AT L5-S1 ON THE LEFT AND LAMINA ON THE RIGHT OF L5-S1. I THEN PULLED EVO3 DBM ONTO THE LAMINAR BONE ON THE RIGHT AND TRANSVERSE PROCESSES ON THE LEFT. THE WOUND WAS IRRIGATED AND THE INCISION WAS CLOSED. "ALL COUNTS WERE CORRECT AT THE END OF THE CASE." ON (B)(6) 2010 - SURGICAL CONSENT FOR "RE-DO FUSION, INSTRUMENTATION, L5-S1." THE REASON FOR THE SURGERY IS "NONUNION, HARDWARE FAILURE." CONSENT SIGNED BY THE PT AND DOCTOR. ON (B)(6) 2012 CT LUMBAR SPINE POST-MYELOGRAPHY WITH REFORMATION (HETEROTOPIC BONE GROWTH). ON (B)(6) 2010 - SURGICAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174401 INFUSE BONE GRAFT DEVICE (RHBMP-2) INFUSE NEK MEDTRONIC INC

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention| S