BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3191152 · Received June 26, 2013

    Report

    Report Number
    1030489-2013-02542
    Event Type
    Injury
    Date Received
    June 26, 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 POSTEROLATERAL APPROACH L5-S1 FUSION USING RHBMP-2/ACS MIXED WITH AUTOGRAFT. SOME OF THE BMP/AUTOGRAFT MIXTURE WAS REPORTEDLY PLACED OUTSIDE THE CAGES IN THE PATIENT¿S SPINE. 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 HIS FROM PERFORMING MANY BASIC ACTIVITIES OF DAILY LIVING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON: (B)(6) 2005: THE PATIENT PRESENTED WITH THE FOLLOWING PREOPERATIVE DIAGNOSIS: RECURRENT L5-S1 DISK HERNIATION WITH DEGENERATIVE DISK AND DISCOGENIC PAIN, L5-S1. HE UNDERWENT THE FOLLOWING PROCEDURES: REDO DISCECTOMY, L5-S1 RIGHT. TRANSFORAMINAL INTERBODY FUSION WITH PEEK CAGE BONE MORPHOGENIC PROTEIN AND LOCAL AUTOGRAFT. POSTEROLATERAL FUSION, L5-S1, WITH AUTO GRAFT. POSTERIOR SPINAL INSTRUMENTATION, NON-SEGMENTAL, WITH TITANIUM SYSTEM. PER OP NOTES, ¿ THE ANTERIOR PORTION OF THE END PLATE WAS DECORTICATED WITH THE OSTEOTOME AND AUTOGENOUS BONE GRAFT WAS PACKED ANTERIORLY. PLEDGETS OF BMP WERE THEN PLACED, AND THEN THE CAGE WITH BMP CENTRALLY. X-RAY CONFIRMED POSITION. THE DISTRACTION WAS RELEASED. PERMANENT RODS WERE PUT IN PLACE WITH COMPRESSION, FIRST ON THE RIGHT AND LEFT, LOCKING THE CAGE IN PLACE ANTERIORLY. FINAL CHECK OF FORAMEN WAS MADE WITH NO EVIDENCE OF IMPINGEMENT:. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291397 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 00035 YR Required Intervention