BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3960330 · Received July 28, 2014

    Report

    Report Number
    1030489-2014-03317
    Event Type
    Injury
    Date Received
    July 28, 2014
    Report Date
    December 7, 2015
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6).

    Additional Manufacturer Narrative · 1

    (B)(4). NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. PRODUCTS FROM MULTIPLE MANUFACTURERS WERE IMPLANTED DURING THE PROCEDURE. ALTHOUGH IT IS UNKNOWN IF ANY OF THE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A FUSION SURGERY ON THE LUMBAR REGION OF HIS SPINE FROM L2 TO S1 SPINAL FUSION SURGERY ON (B)(6) 2009 USING RHBMP-2/ACS. SOMETIME POSTOP, THE PATIENT EXPERIENCED SEVERE LOWER BACK PAIN WITH RADIATING PAIN INTO HIS LOWER LEFT EXTREMITY. A CT SCAN PERFORMED ON (B)(6) 2010 REVEALS POSTERIOR OSSEOUS RIDGING AND POSTEROLATERAL OSTEOPHYTES. THE PATIENT HAS DIFFICULTY AMBULATING, AND IS BEDRIDDEN MOST OF THE DAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2009, PATIENT UNDERWENT FOLLOWING PROCEDURE: 1. L2 TO S1 POSTERIOR SPINE FUSION AND DECOMPRESSION WITH RE-EXPLORATION OF L5-S1 LEVEL. 2. L3-4, L4-5, L5-S1 INTERBODY FUSION, 3. LANX INSTRUMENTATION, 4. SPINAL CORD MONITORING; FOR PRE-OP DIAGNOSIS OF: LUMBAR SPONDYLOSIS. PER-OP NOTES: AFTER DECOMPRESSION BILATERAL PEDICLE SCREWS WERE PLACED AT L2-3, L4-5 AND S1, POSITION CONFIRMED BY RADIOGRAPHY. AT L5-S1 LEVEL TWO 12MM CAGES WERE IMPACTED IN VERTICAL FASHION FOLLOWED BY GRAFTON PUTTY. AT L4-5 LEVEL TWO 10MM CAGES WERE FILLED WITH AUTO AND ALLOGRAFT CHIPS. AT L3-4 10 MM CAGE WAS IMPACTED FOLLOWED BY AUTO AND ALLO-GRAFT CHIPS. THE TRANSVERSE PROCESSES OF L2, 3, 4, 5 AND S1 WERE DECORTICATED USING ALLOGRAFT CHIPS AND RHBMP-2 ACROSS 2-3 JUNCTION, AS WELL AS THE AUTOGRAFT HARVESTED FORM LAMINA. THIS WAS PLACED BILATERALLY COMPLETING THE POSTEROLATERAL FUSION. NO COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439424 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA M110803AAJ

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR Other