BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3963234 · Received July 29, 2014

    Report

    Report Number
    1030489-2014-03321
    Event Type
    Injury
    Date Received
    July 29, 2014
    Report Date
    November 30, 2015
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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 FUSION PROCEDURE AT L3-S1 USING RHBMP-2/ACS ON (B)(6) 2008 . PATIENT'S POST-OPERATIVE PERIOD MARKED BY SEVERE LOWER BACK PAIN AND LEFT LOWER EXTREMITY PAIN AND NUMBNESS. A LUMBAR MRI SCAN CONDUCTED ON (B)(6) 2009 REVEALED DISC PROTRUSIONS AND OSTEOPHYTIC RIDGING NARROWING THE NEURAL FORAMINA BILATERALLY AT THE SURGERY SITE. ON (B)(6) 2012, PATIENT UNDERWENT A REVISION SURGERY AT HIS SURGICAL LEVEL TO RELIEVE THE SEVERE STENOSIS CAUSED BY THE OSTEOPHYTIC RIDGING. CURRENTLY, PATIENT CONTINUES TO EXPERIENCE CONSISTENT AND SIGNIFICANT BACK PAIN, SEVERELY IMPAIRING HIS ABILITY TO WALK AND STAND FOR ANY LENGTH OF TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON, (B)(6) 2008 THE PATIENT UNDERWENT L3, L4, L5 AND S1 LAMINECTOMY, MEDIAL FACETECTOMIES AND FORAMINOTOMIES. 2) L3, L4, L5 AND S1 PEDICLE SCREW FIXATION AND FUSION WITH AUTOLOGOUS LAMINA GRAFT AND BONE MORPHOGENIC PROTEIN. PREOPERATIVE DIAGNOSIS: L3, L4, L5 AND S1 DEGENERATIVE DISC DISEASE, LUMBAR STENOSIS, SPONDYLOSIS AND LUMBAR RADICULOPATHY. PEROP NOTES: IT WAS OBSERVED THAT THE PATIENT HAS SIGNIFICANT FACET ARTHROPATHY WITH HYPERTROPHY AND INFOLDING OF THE LIGAMENTUM FLAVOR. THERE WAS FAIRLY SEVERE LATERAL RECESS STENOSIS AND BILATERAL FORAMINAL STENOSIS. BILATERAL MEDIAL FACETOMIES AND FORAMINOTOMIES WERE MADE WITH LEKELL, 3MM AND 4MM KERRISON RONGEURS AND THE NERVE ROOTS CAREFULLY PALPATED. ATTENTION WAS THEN PAID TO THE PEDICLES. THE PEDICLES WERE CAREFULLY CANNULATED UTILIZING THE TRANSVERSE PROCESS FACET AND MEDIAL PALPATION TO IDENTIFY THE LANDMARKS. MEDTRONIC LEGACY SCREWS MEASURING GREATER THAN 6MM WERE PLACED OF VARYING LENGTHS. THE LATERAL FACET JOINTS, TRANSVERSE PROCESSES. AND RESIDUAL BONE WAS CAREFULLY DECORTICATED WITH MIDAS REX DRILL AT L3, L4, L5, L5 AND S1 AND SACRAL ALA. THE BONE THAT HAD BEEN REMOVED FROM LAMINAE AND SPINOUS PROCESSES THAT HAD BEEN CLONED OF SOFT TISSUE AND GROUND IN THE BONE GRINDER WAS THEN ROLLED INTO COLLAGEN SPONGES CONTAINING BONE MORPHOGENIC PROTEIN, WHICH HAD BEEN PREPARED ACCORDING TO MANUFACTURER'S INSTRUCTIONS. ONE LARGE AND ONE MEDIUM WERE UTILIZED. THIS WAS PLACED IN THE INNER TRANSVERSE REGION AT L3, L4, L5, AND S1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440786 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA M110705AAG

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention