BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3484744 · Received November 22, 2013

    Report

    Report Number
    1030489-2013-04802
    Event Type
    Injury
    Date Received
    November 22, 2013
    Report Date
    January 11, 2016
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTEROLATERAL SPINAL FUSION AT L3-L5 USING BMP2 ON (B)(6) 2007. ON UNKNOWN DATE, PATIENT'S POST-OPERATIVE PERIOD WAS MARKED BY SEVERE, PAINFUL, AND DEBILITATING COMPLICATIONS WHICH INCLUDED, BUT WERE NOT LIMITED TO, THE NEED FOR ADDITIONAL SURGERY, PAINFUL MEDICAL TREATMENT, EXTREME PAIN, NERVE DAMAGE, NERVE IMPINGEMENT, AND SEVERE EXUBERANT ECTOPIC BONE FORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2007 THE PATIENT UNDERWENT THE FOLLOWING PROCEDURES: 1. POSTEROLATERAL SPINAL FUSION, L3-5. 2. PEDICLE SCREW INSTRUMENTATION, L3-5. 3. RIGHT ILIAC CREST BONE GRAFT. PREOPERATIVE DIAGNOSES: SPINAL STENOSIS AND DEGENERATIVE DISK DISEASE, L3 TO L5. AS PER OP-NOTES: THE TRANSVERSE PROCESSES OF L3, L4 AND L5 WERE DECORTICATED THE BILATERALLY. TWO LARGE RHBMP-2/ACS KITS WERE PREPARED ACCORDING TO MANUFACTURE'S INSTRUCTION, RECONSTITUTED WITH BMP AND SET FOR GREATER THAN 15 MINUTES. THEY WERE FILLED WITH ILIAC CREST AUTOGRAFT AND SEWN ONTO THEMSELVES. ILIAC CREST RHBMP-2/ACS COMPOSITE WAS PACKED OVER THE DECORTICATED POSTEROLATERAL ELEMENTS IN ORDER TO COMPLETE POSTEROLATERAL ARTHRODESIS FROM L3 TO L5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608610 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other