BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3162268 · Received June 11, 2013

    Report

    Report Number
    1030489-2013-02154
    Event Type
    Injury
    Date Received
    June 11, 2013
    Report Date
    November 21, 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.

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A NON-MEDICAL PROFESSIONAL THAT THE PATIENT UNDERWENT AN L5-S1 FUSION WITH RHBMP-2 AND PEEK CAGES. SUBSEQUENTLY, THE PATIENT WAS ALLEGEDLY DIAGNOSED WITH ECTOPIC BONE GROWTH, AN INFLAMMATORY REACTION TO RHBMP-2/ACS, CHRONIC PAIN, AND ADDITIONAL SURGERIES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON: (B)(6) 2005: PATIENT PRESENTED WITH PREOPERATIVE DIAGNOSIS OF LOWER BACK PAIN AND LUMBAR INTERVERTEBRAL DISK AND DEGENERATION L5-S1 AND UNDERWENT 1LUMBAR ANTERIOR DISCECTOMY AND ANTERIOR FUSION L5-S1. USE OF INTERVERTEBRAL DEVICES L5-S1 USING BILATERAL PEEK CAGES 16 MM HEIGHT BY 26 MM DEPTH. ANTERIOR VERTEBRAL INSTRUMENTATION L5-S1 USING LUMBAR PLATE. PREPARATION OF MEDIUM BONE MORPHOGENIC PROTEIN FOR SPINAL FUSION. DESCRIPTION OF PROCEDURE: A MIDLINE LUMBAR INCISION WAS MADE, A LEFT PARA-MEDIAN INCISION WAS MADE AND THEN A RETROPERITONEAL APPROACH TO THE L5-S1 DISK WAS PERFORMED. AFTER ADEQUATELY RETRACTING THE SOFT TISSUES, SURGEON THEN PERFORMED A BLOCK DISCECTOMY OF L5-S1 AFTER PLACING SEVERAL PINS TO RETRACT THE SOFT TISSUES. SURGEON SCRAPED THE END PLATES AND THEN SCRAPED BACK TO THE POSTERIOR ANNULUS. SURGEON THEN DILATED THE DISK SPACE UP TO SIZE #12 AND SELECTED A 16 MM DOUBLE BARREL DILATOR, AND THEN PASSED A DOUBLE BARRELED DRILL TOO. AFTER REAMING BOTH SIDES TO A 32 MM DEPTH, AND THEN IRRIGATING THE DISK SPACE, SURGEON THEN PLACED PAIRED 16 MM HIGH BY 26 MM DEEP INTERBODY CAGES. SURGEON THEN ROUGHENED THE BONE OF THE L5 AND S1 END PLATES, AND THEN PLACED RHBMP-2 SPONGES INTO THE L5-S1 INTERBODY CAGES, WITH THE RHBMP-2/ACS PREPARED SEPARATELY ON THE BACK TABLE. FLUOROSCOPIC VIEWS SHOWED GOOD POSITION OF THE IMP LANTS. AT THIS POINT, A 23 MM ANTERIOR LUMBAR PLATE WAS SELECTED, AND AFTER PREDRILLING AND USING AN AWL AND PRE-TAPPING, THE PLATE WAS SOLIDLY SECURED TO THE L5 AND S1 VERTEBRA USING A 35 MM SCREW AT L5 AND 30 MM SCREWS AT S1. FINAL AP AND LATERAL FLUOROSCOPIC VIEWS SHOWED EXCELLENT POSITION OF THE IMPLANTS. THE PATIENT EMERGED FROM GENERAL ANESTHESIA AND WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262102 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR Required Intervention