BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT XX SMALL KIT

    MDR report key: 1842431 · Received September 17, 2010

    Report

    Report Number
    1030489-2010-01236
    Event Type
    Injury
    Date Received
    September 17, 2010
    Date of Event
    July 7, 2010
    Report Date
    August 27, 2010
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC.
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LITERATURE CITATION: MANNION, ET AL. PROMOTING FUSION IN MINIMALLY INVASIVE LUMBAR INTERBODY STABILIZATION WITH LOW-DOSE BONE MORPHOGENIC PROTEIN-2 BUT WHAT IS THE COST?. THE SPINE JOURNAL 10. A REVIEW OF THE DEVICE HISTORY RECORDS CANNOT BE PERFORMED WITHOUT ADDITIONAL DEVICE INFO. WITHOUT RETURN OF THE DEVICE FOR EVAL OR REVIEW OF THE ASSOCIATED MRI, IT IS NOT POSSIBLE TO ASCERTAIN A CAUSE FOR THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT COMPLICATIONS WERE OBSERVED WITH THE USE OF LOW-DOSE BMP WITH AUTOGRAFT IN THE DISC SPACE. IN THIS PROSPECTIVE REVIEW, PTS UNDERWENT MINIMALLY INVASIVE FUSION SURGERY INVOLVING THE INSERTION OF PERCUTANEOUS PEDICLE SCREWS IN THE LUMBOSACRAL SPINE, TOGETHER WITH INTERBODY FUSION. IN THIS PT, WHO PRESENTED PREOPERATIVELY WITH SEVERE L4 RADICULOPATHY SECONDARY TO A GRADE I DEGENERATIVE SPONDYLOLISTHESIS, A TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) PROCEDURE WAS USED. SCREWS AND RODS WERE PLACED AFTER DECOMPRESSION AND DECORTICATION. THE SMALLEST COMMERCIALLY AVAILABLE DOSE OF RHBMP-2 (4.2 MG) WAS SOAKED INTO A COLLAGEN SPONGE. ONE-THIRD OF THE TOTAL WAS USED PER LEVEL FUSED (APPROX 1.4 MG RHBMP-2). THIS WAS DIVIDED INTO TWO, WITH HALF (0.7 MG) INSERTED INTO THE ANTERIOR DISC SPACE WITH BONE GRAFT AND THE OTHER HALF (0.7 MG) INSERTED INTO THE CAGE ALONG WITH MORE LOCAL BONE GRAFT. NO IMMEDIATE COMPLICATIONS WERE REPORTED. TWO MONTHS AFTER SURGERY, MAGNETIC RESONANCE IMAGING REVEALED A LARGE INFLAMMATORY CYST IN THE NEURAL FORAMEN ON THE OPERATED SIDE CAUSING SIGNIFICANT DISPLACEMENT OF THE NERVE ROOT. DESPITE THIS, THE PT'S SYMPTOMS OF LEG PAIN RESOLVED AND SHE HAS REMAINED ASYMPTOMATIC. NO OTHER DETAILS OR OUTCOMES WERE MENTIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSE BONE GRAFT XX SMALL KIT INFUSE BONE GRAFT NEK MEDTRONIC SOFAMOR DANEK USA, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other