BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3191836 · Received June 26, 2013

    Report

    Report Number
    1030489-2013-02558
    Event Type
    Injury
    Date Received
    June 26, 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.

    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 A FUSION AT L3-L4. 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 HER SURGERY INVOLVING RHBMP-2/ACS, AND SHE CONTINUES TO HAVE DAILY SEVERE DISABLING PAIN THAT PREVENTS HER FROM PERFORMING MANY BASIC ACTIVITIES OF DAILY LIVING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON: (B)(6) 2012: PATIENT PRESENTED WITH PREOPERATIVE DIAGNOSIS OF L4-5 AND L5-S1 PSEUDO ARTHROSIS AND L3-4 ADJACENT LEVEL DEGENERATIVE DISC DISEASE AND FACET ARTHROPATHY AND UNDERWENT L3-4 LATERAL TRANS-PSOAS ANTERIOR INTER-BODY FUSION, PLACEMENT OF L3-4 INTERVERTEBRAL CAGE, L3-4 LATERAL INSTRUMENTATION , EXPLORATION OF POSTERIOR LUMBAR WOUND FOR FUSION AT L4-5 AND L5-S1, REMOVAL OF L5-S1 INTER-SPINOUS PROCESS DEVICE, L3-4 AND RE DO OF L4-5 AND L5-S1 POSTERIOR ARTHRODESIS, ILIAC CREST BONE MARROW HARVEST, PLACEMENT OF MORCELLIZED ALLOGRAFT INCLUDING TRI CALCIUM PHOSPHATE, EVO-3, DEMINERALIZED BONE MATRIX AS WELL AS BONE MORPHOGENIC PROTEIN. INTRAOPERATIVE FLUOROSCOPY AND EMG MONITORING IS USED. PROCEDURE DESCRIPTION: A 14 MM PARALLEL CAGE WAS PACKED WITH A COMBINATION OF BONE MORPHOGENIC PROTEIN AND MOSAIC TRI CALCIUM PHOSPHATE. CAGE ALSO HAD PLATE INCORPORATED IN IT. CAGE WAS PLACED IN THE DISC SPACE AND WAS COUNTER SUNKED. SCREW HOLES WERE CREATED IN THE VERTEBRAL BODIES OF L3 AND L4.SCREWS WERE PLACED AND LOCKING MECHANISM WAS ENGAGED. A FINAL AP AND LATERAL X-RAY SHOWED EXCELLENT POSITIONING OF CAGE AND SCREWS. SUB-PERIOSTEAL DISSECTION WAS CARRIED OUT UNTIL SPINOUS PROCESS AND LAMINA FROM L3 TO S1 LEVEL WERE REACHED. L4-L5 INTER-SPINOUS PROCESS WAS FIRM IN ITS POSITION, HOWEVER L5-S1 INTER-SPINOUS DEVICE WAS COMPLETELY LOOSE. SO L5-S1 INTER-SPINOUS DEVICE WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291011 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 00036 YR Required Intervention