BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3163441 · Received June 11, 2013

    Report

    Report Number
    1030489-2013-02217
    Event Type
    Injury
    Date Received
    June 11, 2013
    Report Date
    August 15, 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

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

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON: (B)(6) 2008: PATIENT PRESENTED WITH THE FOLLOWING PRE-OP DIAGNOSIS: SCOLIOSIS. KYPHOSIS. PATIENT UNDERWENT THE FOLLOWING PROCEDURE: POSTERIOR SPINAL FUSION WITH INSTRUMENTATION, T4- PELVIS, LEFT ILIAC BONE MARROW HARVEST. PER OP-NOTE: "A SEPARATE STAB INCISION WAS MADE OVER THE LEFT ILIAC CREST. THE ANTERIOR-SUPERIOR ILIAC SPINE WAS IDENTIFIED. A BONE MARROW ASPIRATION NEEDLE WAS INTRODUCED. ABOUT 5 ML OF THE MARROW WAS ASPIRATED. THE ASPIRATE WAS ADDED TO THE BONE GRAFT. THE NEEDLE WAS REMOVED AND NO COPIOUS BLEEDING WAS NOTED. BONE GRAFT OBTAINED FROM THE ALLOGRAFT, BMP-2 AND BONE MARROW WAS MIXED TOGETHER AND PLACED OVER THE LATERAL GUTTER. THE ROD LINKAGE DEVICES WERE TIGHTENED TO THE SCREWS AND THESE WERE TORQUE TIGHTENED. THE FINAL FLURO- IMAGE SHOWED A GOOD POSITION OF THE INSTRUMENTATION. A DRAIN WAS PLACED UNDER THE FASCIA AND ANOTHER UNDER THE SKIN. THE INCISION WAS CLOSED AND THE PROCEDURE WAS COMPLETED WITHOUT ANY COMPLICATIONS." ON (B)(6) 2010: PATIENT PRESENTED WITH A PRE-OP DIAGNOSIS: C4-7 DISC BULGE AND FORAMINAL STENOSIS. PATIENT UNDERWENT A C4-7 ANTERIOR CERVICAL DISCECTOMY, C4-7 FUSION ANTERIOR CERVICAL GRAFT AND ANTERIOR CERVICAL PLATING PROCEDURES. PATIENT TOLERATED THE PROCEDURE WELL AND WAS TRANSFERRED TO THE RECOVERY ROOM.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A NON-MEDICAL PROFESSIONAL THAT THE PATIENT UNDERWENT A PROCEDURE FOR SPINAL FUSION FROM T4-L5 WHERE RHBMP-2 WAS MIXED WITH ALLOGRAFT AND AUTOGRAFT AND PLACED AT MULTIPLE LEVELS VIA AN ANTERIOR APPROACH. SUBSEQUENTLY, THE PATIENT WAS ALLEGEDLY DIAGNOSED WITH ECTOPIC BONE GROWTH, AN INFLAMMATORY REACTION TO RHBMP-2/ACS, CHRONIC PAIN, AND ADDITIONAL SURGERIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264703 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 00051 YR Required Intervention