BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3190826 · Received June 26, 2013

    Report

    Report Number
    1030489-2013-02536
    Event Type
    Injury
    Date Received
    June 26, 2013
    Report Date
    February 9, 2017
    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 L4-S1 FUSION USING RHBMP-2/ACS MIXED WITH AUTOGRAFT. IN 2010, THE PATIENT WAS DIAGNOSED WITH INJURIES INCLUDING BUT NOT LIMITED TO, ECTOPIC BONE GROWTH, AN INFLAMMATORY REACTION TO RHBM P-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 PREOPERATIVE DIAGNOSIS OF LUMBAR STENOSIS WITH FAILED HARDWARE, PRIOR FUSION AND UNDERWENT REMOVAL OF INSTRUMENTATION L4, L5, S1 PEDICLE SCREWS AND LAMINECTOMY OF L4 WITH REPLACEMENT OF PEDICLE SCREWS WITH ARTHRODESIS OF L4-5 AND L5-S1. CLINICAL HISTORY: PATIENT IS STATUS POST SPINAL INSTRUMENTATION PROCEDURE 3 YEARS AGO. PATIENT HAS ACUTE ONSET OF BACK PAIN APPROXIMATELY OVER THE LAST 6-8 MONTHS. PAIN HAS CORRELATED WITH X-RAY FINDING CONFIRMING THE RIGHT SIDE OF ROD HAD BROKEN. PROCEDURE DESCRIPTION: INCISION WAS MADE OVER THE PREVIOUS INCISION FROM THE L4 DOWN TO S1 SPACE. L4, L5 AND S1 SCREW WERE REMOVED BILATERALLY. THEN ROD ON LEFT WAS REMOVED, IT WAS INTACT. ON THE RIGHT SIDE THERE WAS FRACTURE WHICH WAS REMOVED. AFTER THIS NEW SCREWS (7.5 X 50 MM IN L4,L5 BILATERALLY, 8.5 X 40 MM INTO S1 BILATERALLY) WERE PLACED. AFTER THIS 2 NEW RODS WERE PLACED AND AUTOGRAFT BONE HARVESTED FROM L4 LAMINA AND MEDIAL FACET WAS PACKED INTO THE GUTTERS. 2 STRIPS OF BONE MORPHOGENIC PROTEIN (BMP). BONE WAS PACKED INTO GUTTERS AND BMP PACKED DOWN ON TOP OF BONE AND THEN THOROUGHLY IRRIGATED PRIOR TO THIS. PATIENT TOLERATED THE PROCEDURE WELL AND THERE WERE NO COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289972 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA M110808AAF

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention