BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3193533 · Received June 27, 2013

    Report

    Report Number
    1030489-2013-02603
    Event Type
    Injury
    Date Received
    June 27, 2013
    Report Date
    December 12, 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 POSTERIOR APPROACH FUSION AT L5-S1 USING A ZIMMER PEEK CAGE AND RHBMP-2/ACS. SUBSEQUENTLY, 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) 2009: PATIENT PRESENTED WITH FOLLOWING PRE-OP DIAGNOSES: LUMBAR DEGENERATIVE DISK DISEASE. FOR WHICH, PATIENT UNDERWENT FOLLOWING PROCEDURES: POSTERIOR SPINAL FUSION, L5-S1. POSTERIOR LUMBAR INTERBODY FUSION, L5-S1. LAMINECTOMY, L5-S1. APPLICATION OF INTERVERTEBRAL MECHANICAL DEVICE AT L5-S1. POSTERIOR SPINAL INSTRUMENTATION, L5-S1. USE OF MICROSCOPE FOR MICRODISSECTION. USE OF LOCALLY HARVESTED AUTOGRAFT BONE AND DEMINERALIZED BONE MATRIX. FLUOROSCOPY. IMPLANTS: SPINE PEDICLE SCREWS AND RODS. SPINE INTERBODY PEEK. RHBMP-2. PER OP NOTES, A 10 MM DEVICE WAS CHOSEN BILATERALLY. A MEDIUM RHBMP-2 SPONGE, WHICH HAD BEEN SOAKING FOR ABOUT AN HOUR WAS THEN CUT. ONE QUARTER OF THE MEDIUM SPONGE WAS PLACED WITHIN EACH INTERBODY GRAFT AND THEN AN ADDITIONAL HALF OF THE SPONGE WAS PLACED WITHIN THE INTERBODY SPACE BETWEEN THE GRAFTS. PRIOR TO PLACEMENT OF THE GRAFTS AND THE RHBMP-2, THE DISC SPACE WAS COPIOUSLY IRRIGATED. THE RHBMP-2 WAS THEN PLACED. THE GRAFTS WERE THEN IMPACTED INTO THE DISC SPACE. THE POSITION OF THE GRAFTS WAS CONFIRMED UNDER FLUOROSCOPIC GUIDANCE. PATIENT TOLERATED THE PROCEDURE WELL WITHOUT ANY INTRAOPERATIVE COMPLICATIONS. ON (B)(6) 2009: PATIENT GOT ADMITTED FOR AN ACUTE CARE REHABILITATION PROGRAM FOLLOWING LUMBAR SPINE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292291 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 44 YR Required Intervention