BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3170044 · Received June 14, 2013

    Report

    Report Number
    1030489-2013-02278
    Event Type
    Injury
    Date Received
    June 14, 2013
    Report Date
    May 17, 2013
    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

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(4) 2008, THE PATIENT UNDERWENT AN EXTREME LATERAL INTERBODY FUSION OF L4-5 VERTEBRAE USING RHBMP-2/ACS IN A PEEK CAGE WITH MASTERGRAFT PUTTY. IN 2011, THE PATIENT WAS DIAGNOSED WITH SIGNIFICANT STENOSIS IN THE AREA OF THE FUSION. AS A RESULT, THE PATIENT HAS REQUIRED EXTENSIVE MEDICAL TREATMENT, INCLUDING HAVING TO UNDERGO AN ADDITIONAL SURGERY ON (B)(6) 2011 TO REMOVE EXCESS BONE. THE PATIENT REPORTEDLY SUFFERED INJURIES AND DAMAGES, INCLUDING BUT NOT LIMITED TO, ECTOPIC BONE GROWTH, AN INFLAMMATORY REACTION TO INFUSE, CHRONIC PAIN, AND DAILY SEVERE DISABLING PAIN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2007: THE PATIENT UNDERWENT X-RAYS OF THE LUMBAR SPINE. IMPRESSION: MILD ROTARY SCOLIOSIS, CONVEX LEFT; MARKED DEGENERATIVE CHANGES OF THE L4-5 DISC AND MODERATE DEGENERATIVE CHANGES OF THE L5-S1 DISC; NO SPONDYLOLISTHESIS WAS EVIDENT; AT L4-5, THE PATIENT APPEARS TO BE STATUS POST LEFT LAMINECTOMY; THERE IS A GENERALIZED DISC BULGE PRESENT ALONG WITH FACET AND LIGAMENTUM FLAVUM HYPERTROPHY CAUSING MODERATELY SEVERE SPINAL STENOSIS AND EXIT FORAMINAL STENOSIS, RIGHT GREATER THAN LEFT; THERE IS NO EVIDENCE FOR RECURRENT DISC EXTRUSION. THE PATIENT UNDERWENT MRI OF THE LUMBAR SPINE. IMPRESSION: MODERATELY DEGENERATIVE DISC DISEASE AT L4-5 AND L5-S1; AT L5-S1, THERE IS A GENERALIZED DISC BULGE, CAUSING MINIMAL EXIT FORAMINAL STENOSIS. (B)(6)2007: THE PATIENT PRESENTED WITH WORSENING LEFT LEG PAIN, RADIATING DOWN TO THE FEET. (B)(6) 2008 : THE PATIENT PRESENTED WITH PREOPERATIVE DIAGNOSES OF L4-5 DISC DEGENERATION WITH GRADE I SPONDYLOLISTHESIS. THE PATIENT UNDERWENT A L4-5 INTERBODY FUSION VIA LEFT XLIF APPROACH AND PLACEMENT OF PEEK CAGE WITH RHBMP-2/ACS. PER THE OP NOTES, THE PEEK CAGE WAS PACKED WITH RHBMP-2/ACS AND MASTERGRAFT PUTTY. RHBMP-2/ACS WAS INITIALLY PLACED INTO THE DISC SPACE WITH MORSELIZED AUTOGRAFT BONE. THE PEEK CAGE WAS THEN IMPACTED INTO POSITION UNDER DIRECT FLUOROSCOPIC GUIDANCE. NO COMPLICATIONS WERE NOTED. (B)(6) 2009: THE PATIENT UNDERWENT MRI OF THE RIGHT FOREARM. IMPRESSION: NORMAL STUDY. (B)(6) 2009: THE PATIENT UNDERWENT DISTAL LEG MRI. IMPRESSION: MILD TENDINOSIS OF THE EXTENSOR HALLUCES LONGUS, OTHERWISE NORMAL EXAM. (B)(6) 2010: THE PATIENT UNDERWENT MRI OF THE LUMBOSACRAL SPINE. IMPRESSION: STATUS POST L4-S1 ANTERIOR AND POSTERIOR FUSIONS. THE LEFT L5-S1 ANTERIOR INTERBODY FUSION MATERIAL IS SEEN IN CLOSE PROXIMITY TO THE POSTERIOR DISC MARGIN WITHOUT DEFINITE CONTACT OF THE LEFT S1 NERVE ROOT. L2-3 AND CENTRAL AND FORAMINAL STENOSIS. LEFT INTRA AND EXTRA FORAMINAL L2-3 DISC PROTRUSION. (B)(6) 2010 : THE PATIENT PRESENTED FOR CT OF THE LUMBAR SPINE. IMPRESSION: THE L4-S1 FUSION APPEARS TO BE INTACT; DEGENERATIVE CHANGES OF THE DISCS AND FACET JOINTS, WITH SPINAL STENOSIS AT L2-3, L3-4, AND L4-5. THE PATIENT UNDERWENT X-RAYS OF THE LUMBAR SPINE. IMPRESSION: INTACT L4-S1 FUSION; SLIGHT SCOLIOSIS, CONVEX LEFT, DEGENERATIVE CHANGES OF THE DISCS AND FACET JOINTS, WITH A SLIGHT L2-3 RETROLISTHESIS, WHICH IS CORRECTED WITH FLEXION (B)(6) 2011: THE PATIENT UNDERWENT A POST MYELOGRAM CT OF THE LUMBAR SPINE. IMPRESSION: STATUS POST RIGHT SIDED PEDICLE SCREWS AT L5 AND S1 AND LEFT SIDED PEDICLE SCREWS AT L4, L5, AND S1 WITH POSTERIOR VERTICAL ROD FIXATION. NO EVIDENCE OF PEDICLE SCREW LOOSENING OR FRACTURE. INTERBODY FUSION CAGES WITH BONY BRIDGING ACROSS THE VERTEBRAL BODIES OF L4, L5, AND S1. LEFT FACET BONY FUSION AT L5-S1. HEMILAMINECTOMY DEFETS OF L4-5 AND L5-S1. MILD TO MODERATE CENTRAL CANAL STENOSIS AND MILD LEFT FORAMINAL STENOSIS AT L2-3. MILD TO MODERATE LEFT LATERAL RECESS AND FORAMINAL STENOSIS AT L5-S1. MILD FORAMINAL STENOSIS AT L4-5; MINIMAL RIGHT FORAMINAL STENOSIS L5-S1. (B)(6) 2011 : THE PATIENT PRESENTED WITH LEFT LEG PAIN. IMPRESSION: LEFT L5-S1 RADICULOPATHY SECONDARY TO FORAMINAL STENOSIS. (B)(6) 2011 : THE PATIENT PRESENTED WITH THE FOLLOWING PREOPERATIVE DIAGNOSES: CHRONIC LEFT L5-S1 RADICULOPATHY SECONDARY TO ACQUIRED LATERAL RECESS STENOSIS SECONDARY TO HYPERTROPHIC OVERGROWTH OF BONE PRODUCING LATERAL RECESS STENOSIS AND FORAMINAL STENOSIS AT L5-S1; STATUS POST XLIF L4-5. THE PATIENT UNDERWENT THE A LEFT L5 HEMILAMINECTOMY AND COMPLETE FACETECTOMY AND TAKEDOWN OF HYPERTROPHIC BONE. FINDINGS DURING PROCEDURE: THE SCREWS AND ROD WERE LATERAL ENOUGH THAT THEY DID NOT HAVE TO BE REMOVED, ABLE TO DECOMPRESS THE CANAL BY DOING THE COMPLETE HEMILAMINA AS WELL AS FACETECTOMY AND TAKING DOWN THE OVERGROWTH BONE THAT WAS AT THE LATERAL PORTION OF THE SPINAL CANAL AND EXTENDING INTO THE FORAMEN COMPRESSING THE NERVE ROOT. (B)(6) 2011: THE PATIENT UNDERWENT MRI OF THE LEFT WRIST. IMPRESSION: 10 X 9 X 4 MM VOLAR RADIOSCAPHOID GANGLION CYST; DEGENERATIVE THINNING OF THE TRIANGULAR FIBROCARTILAGE DISC WITHOUT EVIDENCE OF A FULL THICKNESS TEAR. (B)(6) 2011: THE PATIENT UNDERWENT MRI OF THE LEFT KNEE. IMPRESSION: FULL THICKNESS VERSUS NEAR FULL THICKNESS TEAR OF THE ANTERIOR CRUCIATE LIGAMENT; GRADE 1 MCL SPRAIN; SMALL LATERAL TIBIAL PLATEAU BONE CONTUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272075 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA M110703AAC

    Patients

    Seq Age Sex Outcome Treatment
    1 00046 YR Required Intervention