BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3192790 · Received June 27, 2013

    Report

    Report Number
    1030489-2013-02572
    Event Type
    Injury
    Date Received
    June 27, 2013
    Report Date
    October 10, 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 THE PATIENT UNDERWENT A FUSION AT L4-5 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 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) 2007, THE PATIENT PRESENTED WITH FOLLOWING PRE-OP DIAGNOSES: DISC DISRUPTION AT L4-L5. DEGENERATIVE DISC AT L3- L4. LUMBAR DISC DISEASE AT L4- L5. THE PATIENT UNDERWENT FOLLOWING PROCEDURES: ANTERIOR DISKECTOMY AND ANTERIOR LUMBAR INTERBODY FUSION WITH CARBON FIBER CAGE, BONE MORPHOGENIC PROTEIN, AND DEPUY STABILIZING STANDALONE PLATE; POSTERIOR MOTION RESTRICTING THE AGILE SYSTEM AT L3-L4 ABOVE THE L4- L5 FUSION; RETROPERITONEAL SPINAL EXPOSURE OF L4-L5 WITH MOBILIZATION OF AORTA, INFERIOR VENA CAVA, ILIAC ARTERY AND VEIN AND URETER; ANTERIOR LUMBAR INTERBODY FUSION WITH PARTIAL VERTEBRECTOMY, DISCECTOMY AND CAGE INSERTION; REPAIR OF LEFT COMMON ILIAC VEIN WITH VASCULAR CLIPS. PER OP-NOTES,".. THE CAGE WAS INSERTED. THE FIRST CAGE TWISTED AND WAS EXTRACTED AND THE BMP WAS PLACED IN THE SECOND CAGE AND REINSERTED MORE SATISFACTORILY..."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291922 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 00055 YR Required Intervention