BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3191866 · Received June 26, 2013

    Report

    Report Number
    1030489-2013-02563
    Event Type
    Injury
    Date Received
    June 26, 2013
    Report Date
    October 24, 2016
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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 ON: (B)(6) 2008, THE PATIENT PRESENTED WITH PRE-OP DIAGNOSIS OF L4-L5 DISK HERNIATION, CENTRAL, WITH BILATERAL FORAMINAL NARROWING AND NERVE ROOT COMPRESSION, RIGHT GREATER THAN LEFT; DEGENERATIVE DISK DISEASE AND NERVE ROOT COMPRESSION WITH INSTABILITY. PATIENT UNDERWENT FOLLOWING PROCEDURES: L4-L5 DISKECTOMY, DECOMPRESSION, AND BILATERAL FORAMINOTOMY. L4-L5 ARTHRODESIS WITH POSTERIOR LUMBAR INTERBODY FUSION. L4-L5 PLACEMENT OF POLYETHERETHERKETONE (PEEK) IMPLANTS WITH RHBMP-2 AND AUTOLOGOUS BONE MEASURING 14 X 26 MM X 2. L4-L5 POSTERIOR SEGMENTAL STABILIZATION WITH INTERSPINOUS 45-MM PLATE WITH A BREAKOFF SCREW. INTRATHECAL INJECTION OF MORPHINE FOR PAIN CONTROL. PER OP-NOTES, THE PROCEDURE WAS THEN REPEATED IN ITS ENTIRETY IN A SIMILAR FASHION ON THE OPPOSITE SIDE. I WAS THEN ABLE TO SUCCESSFULLY PLACE TWO PEEK IMPLANTS MEASURING 14 X 26 MM THAT WERE PACKED WITH RHBMP-2 AND AUTOLOGOUS BONE BILATERALLY. THESE WERE VISUALIZED UNDER FLUOROSCOPY TO BE IN EXCELLENT POSITION. I THEN PROCEEDED WITH HEMOSTASIS AND PLACEMENT OF GELFOAM, WITH EXCELLENT RESULTS. I THEN PROCEEDED WITH POSTERIOR INTERSEGMENTAL STABILIZATION, REMOVING THE INTERSPINOUS LIGAMENT AND COMPRESSING THE DISK SPACE USING TWO KOCHERS WITH LAMINAR COMPRESSION AND PLACEMENT OF A 45-MM PLATE, COMPRESSING THE PLATE AND LOCKING IT WITH AN BREAKOFF, WITH EXCELLENT RESULT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A L4-L5 POSTERIOR FUSION USING RHBMP-2/ACS. THE PATIENT WAS DIAGNOSED WITH INJURIES INCLUDING BUT NOT LIMITED TO, ECTOPIC BONE GROWTH, AN INFLAMMATORY REACTION TO RHBMP-2/ACS, CHRONIC PAIN, AND ADDITIONAL SURGERIES. THE PATIENT HAS REQUIRED EXTENSIVE MEDICAL TREATMENT. REPORTEDLY, THE PATIENT HAS NEVER RECOVERED FROM HER SURGERY INVOLVING RHBMP-2/ACS, AND SHE CONTINUES TO HAVE DAILY SEVERE DISABLING PAIN THAT PREVENTS HER FROM PERFORMING MANY BASIC ACTIVITIES OF DAILY LIVING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291580 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention