BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3190427 · Received June 26, 2013

    Report

    Report Number
    1030489-2013-02534
    Event Type
    Injury
    Date Received
    June 26, 2013
    Report Date
    September 26, 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.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN L5-S1 POSTERIOR/POSTEROLATERAL FUSION INVOLVING RHBMP-2/ACS. SURGEON MIXED RHBMP-2/ACS WITH AUTOGRAFT AND USED A PEEK CAGE. PATIENT WAS DIAGNOSED WITH ECTOPIC BONE GROWTH, AN INFLAMMATORY REACTION TO RHBMP-2/ACS, CHRO NIC PAIN, AND ADDITIONAL SURGERIES. AS A RESULT, PATIENT HAS REQUIRED EXTENSIVE MEDICAL TREATMENT. PATIENT HAS NEVER RECOVERED FROM HIS SURGERY INVOLVING RHBMP-2/ACS, AND HE CONTINUES TO HAVE DAILY SEVERE DISABLING PAIN THAT PREVENTS HIM FROM PERFORMING MANY BASIC ACTIVITIES OF DAILY LIVING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: ON (B)(6) 2009, THE PATIENT UNDERWENT L5-S1 POSTERIOR LUMBAR INTERBODY FUSION, LOCAL MORSELIZED AUTOGRAFT, AND BONE MORPHOGENIC PROTEIN ALLOGRAFT, L5-S1 POSTERIOR NON-SEGMENTAL INSTRUMENTATION, L5-S1 POSTEROLATERAL ARTHRODESIS, L5-S1 PLACEMENT OF INTERVERTEBRAL BI OMECHANICAL PROSTHETIC DEVICE. THE PRE-OP DIAGNOSIS WAS L5-S1 SPONDYLOLISTHESIS AND DEGENERATIVE DISK DISEASE. AS PER-OP NOTES, ¿¿.LATERAL GUTTERS WERE DECORTICATED WITH A DRILL AND PACKED WITH LOCAL MORSELIZED AUTOGRAFT AND A BONE MORPHOGENIC PROTEIN ALLOGRAFT. A CARBON FIBRE/PEEK CAGE WAS FILLED WITH BONE MORPHOGENIC PROTEIN ALLOGRAFT AND TAPPED INTO POSITION UNDER FLUOROSCOPE GUIDANCE¿¿¿ THE PATIENT ALSO UNDERWENT DECOMPRESSIVE LAMINECTOMY L5 WITH MICROFORAMINOTOMIES DECOMPRESSING THE L5 AND S1 NERVE ROOTS, BILATERAL. THE DISCHARGE DIAGNOSIS WAS LUMBAR SPONDYLOLISTHESIS L5 ¿ S1, ASTHMA, POSTOPERATIVE ANEMIA, AND MRSA IN WOUND ON THE LEFT FOREARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289843 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA M110804AAI

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Required Intervention