BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 5232192 · Received November 18, 2015

    Report

    Report Number
    1030489-2015-02761
    Event Type
    Injury
    Date Received
    November 18, 2015
    Report Date
    September 28, 2015
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). NEITHER DEVICE NOR APPLICABLE IMAGING STUDIES RETURNED TO MANUFACTURER FOR EVALUATION. ORIGINAL MDR SUBMISSION ON 10/21/2015 FAILED DUE TO FDA SYSTEM ISSUES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2009, PATIENT UNDERWENT MRI OF T1 WEIGHTED SAGITTAL IMAGES. SAGITTAL FAST SPIN-ECHO AND GRADIENT AXIAL IMAGES. ON (B)(6) 2011, PATIENT PRESENTED DUE TO LOW BACK PAIN RADIATING TO THE LLE. THE PAIN WAS ACHING DEEP, DULL AND SHARP, IMPRESSION: THERE IS STRAIGHTENING OF THE NORMAL CERVICAL LORDOSIS. THERE IS DIFFUSE CERVICAL SPONDYLOSIS FROM C3-4 THROUGH C6-7 WITH MILD DEGENERATIVE CENTRAL SPINAL STENOSIS AT THESE LEVELS, AS WELL AS MILD BILATERAL FORAMINAL STENOSIS. ON (B)(6) 2011, PATIENT ADMITTED DUE TO 1. STENOSIS, L4-L5. FLEXIBLE SPONDYLOLISTHESIS, L4-L5. PATIENT UNDERWENT THE FOLLOWING PROCEDURE: POSTEROLATERAL FUSION, L4-L5. LAMINECTOMY AND FORAMINOTOMY, L4-L5. POSTERIOR NONSEGMENTAL INSTRUMENTATION, L4-L5. USE OF FLUOROSCOPY. USE OF LOCAL GRAFT. USE OF RH-BMP2/ACS MASS GRAFT. USE OF ELECTROMYOGRAPHIC MONITORING. OP NOTE: FOLLOWING THIS, LOCAL AUTOGRAFT ALONG WITH RH-BMP2/ACS MASS GRAFT WAS PLACED IN THE LATERAL GUTTERS. THIS COMPLETED THE POSTEROLATERAL FUSION, L4-L5, ALONG WITH LAMINECTOMY AND FORAMINOTOMY, L4-L5, WITH POSTERIOR NO SEGMENTAL INSTRUMENTATION, L4-L5 UNDER FLUOROSCOPY. DURING THE PROCEDURE, THE RETRACTORS WERE RELAXED EVERY FIFTEEN MINUTES AND THE WOUND WAS IRRIGATED WITH AN ANTIBIOTIC SOLUTION TO MINIMIZE THE CHANCE OF INFECTION. ON (B)(6) 2011, PATIENT DISCHARGED FROM HOSPITAL. ON (B)(6) 2011, PATIENT PRESENTED FOR X-RAY EXAM LOWER SPINE 2-3 VIEWS SPINE, LUMBAR PRESENTED WITH LUMBAR SPINE SURGERY. ON (B)(6) 2011, PATIENT UNDERWENT RAD - SHOULDER, LEFT. FINDINGS: AP INTERNAL ROTATION, AP EXTERNAL ROTATION AND TRANSCAPSULAR VIEWS OF THE LEFT SHOULDER DEMONSTRATE NO EVIDENCE FOR FRACTURE OR DISLOCATION. NO BLASTIC OR LYTIC LESIONS ARE NOTED. NO SUBSTANTIVE GLENOHUMERAL JOINT ARTHROSIS IS SEEN. THE AC JOINT IS INTACT. THE SOFT TISSUES AND FAT PLANES ARE NORMAL. THE ACROMION DEMONSTRATES A TYPE II CONFIGURATION. IMPRESSION: NO EVIDENCE FOR FRACTURE OR DISLOCATION. ON (B)(6) 2011, (B)(6) 2012, PATIENT PRESENTED WITH LUMBAR SPINE PAIN ON (B)(6) 2012 PATIENT PRESENTED DUE TO SPONDYLOLISTHESIS DEGENERATIVE. ON (B)(6) 2012, PATIENT PRESENTED WITH MRI LUMBAR SPINE. IMPRESSION: THERE HAS BEEN INTERVAL POSTERIOR FUSION AT L4/5 WHERE THERE IS 3 MM ANTEROLISTHESIS WHICH APPEARS SLIGHTLY LESS THAN ON THE PREVIOUS STUDY. THERE IS NO SIGNIFICANT STENOSIS. AT L5/S1 LEFT LATERAL DISC OSTEOPHYTE COMPLEX CONTACTS LEFT L5 NERVE ROOT DISTAL TO THE NEURAL FORAMEN WHICH IS UNCHANGED. ON (B)(6) 2012, PATIENT PRESENTED WITH CERVICAL SPINE PAIN AND LUMBAR SPINE PAIN. ON (B)(6) 2012, PATIENT PRESENTED FOR FOLLOW-UP DUE TO LUMBAR SPINE PAIN. MRI- AT L4/5 THERE IS APPROX. 3 MM ANTEROLISTHESIS WITH HYPERTROPHY OF THE FACET JOINTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764540 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA M11064AAG

    Patients

    Seq Age Sex Outcome Treatment
    1 Other