BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 5091799 · Received September 21, 2015

    Report

    Report Number
    1030489-2015-02446
    Event Type
    Injury
    Date Received
    September 21, 2015
    Report Date
    August 24, 2015
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT (B)(6) 2005: THE PATIENT PRESENTED FOR AN OFFICE VISIT. PATIENT PRESENTED WITH BACK PAIN AND LEG PAIN. PATIENT UNDERWENT L2-5 REVISION DECOMPRESSION, L3-4 FUSION. (B)(6) 2008: PATIENT UNDERWENT MRI OF THE LUMBAR SPINE WHICH SHOWED MULTILEVEL DISC DEGENERATION AND POSTERIOR ELEMENT HYPERTROPHY, ALSO A SMALL POSTERIOR DISC PROTRUSION AT L5-S1 AND SMALL POSTERIOR DISC PROTRUSION AT L4-L5. (B)(6) 2008: PATIENT UNDERWENT TLIF AT L5-S1 TO RESTORE DISC HEIGHT AND DECOMPRESSION AT L4-L5. (B)(6) 2008: PATIENT PRESENTED FOR FOLLOW UP. ASSESSMENT: DEGENERATIVE DISC DISEASE. LUMBAR DISC HERNIATION. (B)(6) 2008: PATIENT PRESENTED WITH DEGENERATIVE DISC DISEASE, LUMBAR DISC HERNIATION. (B)(6) 2008: PATIENT UNDERWENT LUMBAR LAMINECTOMY L4-S1 WITH TLIF. PATIENT UNDERWENT TRANSFORAMINAL LUMBAR INTERBODY FUSION WITH LAMINECTOMY AT L4, L5, AND S1; DISCECTOMY AT L5-S1; INSTRUMENTATION AT L5 TO S1; ARTHRODESIS, INTERBODY L5 TO S1; APPLICATION OF INTERBODY DEVICE L5-S1; AND ARTHRODESIS, POSTEROLATERAL L4-L5 AND L5-S1. PATIENT PRESENTED WITH PRE OP DIAGNOSIS: 1.DEGENERATIVE DISK DISEASE. 2. LUMBAR STENOSIS. PROCEDURE: 1. TRANSFORAMINAL LUMBAR INTERBODY FUSION. 2. LUMBAR LAMINECTOMY L4. 3. LUMBAR LAMINECTOMY L5. 4. LUMBAR LAMINECTOMY S1. 5. LUMBAR DISKECTOMY L5-S1. 6. POSTERIOR INSTRUMENTATION L4, L5, S1. 7. ARTHRODESIS INTERBODY L5 TO S1. 8. APPLICATION OF INTERBODY DEVICE L5-S1. 9. ARTHRODESIS POSTEROLATERAL L4-5. 10. ARTHRODESIS POSTEROLATERAL L5-S1. 11. AUTOGRAFT MORSELIZED. PER OP NOTES: TRANSFORAMINAL LUMBAR INTERBODY FUSION: THE INFERIOR ARTICULATING PROCESS AND PARS INTERARTICULARIS OF L5 ON THE RIGHT WAS REMOVED AND BONE SAVED FOR AUTOGRAFT. THE PEDICLES ON THE LEFT AT L4, L5, AND S1 WERE THEN IDENTIFIED BY PALPATION AND PILOT HOLES DRILLED. RADIOGRAPHIC CONFIRMATION OF PEDICLE ENTRY AND TRAJECTORY WAS PERFORMED. THE PEDICLES WERE CANNULATED, TAPPED, AND 5.5 X 50 LEGACY SCREWS WERE INSERTED IN THE L4 AND L5, AND A 6.5 X 35 MM AT S1. A 60 MM PREBENT ROD WAS THEN PLACED IN THE L5-S2 INTERSPACE PLACED UNDER DISTRACTION. THE PEDICLES ON THE RIGHT SIDE WERE THEN IDENTIFIED BY PALPATION AND PILOT HOLES DRILLED. RA DIOGRAPHIC CONFIRMATION OF PEDICLE ENTRY AND TRAJECTORY WAS THEN PERFORMED. THE PEDICLES WERE CANNULATED AND TAPPED. L5-S1 INTERBODY ARTHRODESIS: THE L5-S1 INTERSPACE WAS THEN PREPARED FOR FUSION. WITH THE DISK SPACE DISTRACTED, A 26 X 12 MM INTERBODY SIZER WAS INSERTED WHILE PROTECTING THE L5 AND S1 ROOTS. THE 26 X 12 MM PEEK SPACER WAS THEN PACKED WITH AUTOGRAFT AND BMP AND GUIDED INTO THE DISK SPACE AND POSITIONING CONFIRMED RADIOGRAPHICALLY. THE MIXTURE OF AUTOGRAFT AND ALLOGRAFT MOSAIC WITH BMP WAS LAID OUT POSTEROLATERALLY FOR ARTHRODESIS. THE ROD WAS THEN REMOVED, AND A MIXTURE OF MOSAIC DBM AND BMP ROLLS WITH AUTOGRAFT BONE CHIPS WERE THEN PLACED OVER THE DECORTICATED TRANSVERSE PROCESSES OF L4 AND L5 IN THE SACRAL ALA BILATERALLY. THE PEDICLE SCREWS WERE THEN INSERTED IN THE PREVIOUS HOLES ON THE RIGHT, THE POSITION CONFIRMED RADIOGRAPHICALLY. A 60 MM PREBENT RODS WERE PLACED BILATERALLY AND THE CAPS INSERTED AND FINALLY TIGHTENED UNDER COMPRESSION ON BOTH SIDES. THE POSITION OF THE INSTRUMENTATION AND THE INTERBODY DEVICE WAS THEN CONFIRMED IN THE AP AND LATERAL PLAIN RADIOGRAPHICALLY. (B)(6) 2008: PATIENT UNDERWENT X-RAY OF THE SPINE. IMPRESSION: PATIENT HAD HAD LAMINECTOMIES BETWEEN L4 AND S1 WITH INSTRUMENTATION. THE PEDICLE SCREWS WERE IN GOOD POSITION AND THE INTERCONNECTING RODS WERE INTACT. THERE WERE BILATERAL POSTEROLATERAL FUSIONS. AN INTERBODY SPACER WAS SEEN AT L5-S1 IN GOOD POSITION. (B)(6) 2008: PATIENT UNDERWENT X-RAY OF THE SPINE. NO INTERVAL CHANGE IN THE APPEARANCE OF THE SPINE. ILEUS HAD RESOLVED. (B)(6) 2008: PATIENT UNDERWENT X-RAY OF THE SPINE. IMPRESSION: APPROPRIATE ALIGNMENT OF THE LUMBAR SPINE. NO EFFUSION. NO EVIDENCE OF HARDWARE FAILURE. (B)(6) 2008: PATIENT PRESENTED FOR FOLLOW UP. ASSESMENT: INTERVERTEBRAL DISC DISPLACEMENT LUMBAR, INTERVERTEBRAL DISC DEGENERATION LUMBAR. 01/09/2009: PATIENT PRESENTED FOR FOLLOW UP. PATIENT UNDERWENT X-RAY OF THE SPINE. IMPRESSION: WELL POSITIONED FUSION FIXATION DEVICE. (B)(6) 2009: PATIENT PRESENTED FOR FOLLOW UP. (B)(6) 2009: PATIENT PRESENTED FOR FOLLOW UP. PATIENT UNDERWENT X-RAY OF THE SPINE. IMPRESSION: ANATOMIC ALIGNMENT OF POSTERIOR FUSION FROM L4-S1. (B)(6) 2009: PATIENT PRESENTED WITH LOW BACK PAIN. (B)(6) 2009: PATIENT UNDERWENT TRANSFORAMINAL LUMBAR EPIDURAL STEROID INJECTION. (B)(6) 2009: PATIENT PRESENTED FOR FOLLOW UP. ASSESMENT: LUMBAGO, INTERVERTEBRAL DISC DEGENERATION LUMBAR. (B)(6) 2009: PATIENT UNDERWENT MRI OF THE LUMBAR SPINE. IMPRESSION: 1. POSTOPERATIVE CHANGES OF PRIOR LARAINECTOMY AT L4 AND L5 WITH POSTERIOR FUSION, L4-S1 WITH BILATERAL PEDICLE SCREWS AND RODS AT THE L4, L5 AND S1. 2. STABLE DISC EXTRUSION AT L4-L5 WITH MODERATE LEFT NEURAL FORAMINAL NARROWING. 3. BROAD BASED DISK BULGE, L3-L4, WITH MODERATE BILATERAL NEURAL FORAMINAL NARROWING SECONDARY TO DISC OSTEOPHYTE COMPLEX AND FACET HYPERTROPHIC CHANGE. (B)(6) 2009: PATIENT PRESENTED FOR FOLLOW UP. ASSESMENT: LUMBAGO, POSTLAMINECTOMY SYNDROME LUMBAR REGION. (B)(6) 2009: PATIENT UNDERWENT MRI OF THE LUMBAR SPINE. IMPRESSION: 1) SHALLOW CANAL AT L3-L4, ABOVE THE FUSION. 2) ENROACHMENT WAS SEEN, LEFT GREATER THEN RIGHT, WITH NERVE ROOT CUT OFF AT L3-L4. 3) LUCENCY SURROUNDING BOTH PEDICLE SCREWS. 1. PROBABLE INCOMPLETE FUSION AT L4-L5 WITH LUCENCY SURROUNDING THE L4 PEDICLE SCREWS BILATERALLY AND ABSENCE OF BONY BRIDGING. ASSOCIATED AT L4-L5 WAS A DISC BULGE WITH A FORAMINAL PROTRUSION ON THE LEFT. 2. AT L3-L4, MILD STENOSIS WAS SEEN WITH A PROTRUSION ECCENTRIC TO THE LEFT. 3. A DISC BULGE WAS SEEN WITH BORDERLINE CENTRAL CANAL STENOSIS AT L2-L3. 4. PLEASE NOTE THIS PATIENT HAD LOW-LYING CONUS WITH THE TIP AT L2-L3. (B)(6) 2009: PATIENT PRESENTED FOR FOLLOW UP. ASSESMENT: POSTLAMINECTOMY SYNDROME LUMBAR REGION, NONUNION OF FRACTURE LUMBAR PSEUDOARTHROSIS. (B)(6) 2009: PATIENT PRESENTED FOR FOLLOW UP. ASSESMENT: POSTLAMINECTOMY SYNDROME LUMBAR REGION. (B)(6) 2009: PATIENT UNDERWENT TRANSFORAMINAL LUMBAR EPIDURAL STEROID INJECTION. (B)(6) 2010: PATIENT PRESENTED FOR FOLLOW UP FOR HIS ONGOING LOW BACK PAIN ISSUES RADIATING DOWN HIS POSTERIOR THIGHS TO THE KNEES. (B)(6) 2010: PATIENT UNDERWENT MRI OF THE LUMBAR SPINE. IMPRESSION: ANATOMIC ALIGNMENT STATUS POST FUSION L4, L5 AND S1 SEGMENTS. (B)(6) 2010: PATIENT UNDERWENT CT SCAN OF THE LUMBAR SPINE WITH CONTRAST POST MYELOGRAPHY. IMPRESSION: 1. INTERVAL BONE GROWTH ILL THE FAR RIGHT LATERAL POSITION AT THE L4-5 LEVEL LIKELY REPRESENTING SOLID BONY FUSION. THERE WAS PERSISTENT LUCENCY SURROUNDING THE SCREWS. 2. SOLID FUSION AT THE L5-S1 LEVEL. 3. ANNULAR BULGE WITH MILD STENOSIS AT THE L3-4LEVEL. THERE WAS NOTE OF SOME DYNAMIC COMPONENT WITH EXTENSION ON THE PLAIN FILM EXAM. IMPRESSION: 1. SUGGESTION OF DYNAMIC RETROLISTHESIS AT L3-L4 WITH EXTENSION. 2. LATERAL RECESS ENCROACHMENT, RIGHT GREATER THAN LEFT, AT THE LI-L2 AND BILATERALLY AT THE L2-L3 AND L3-L4 LEVELS. PLEASE SEE THE CT MYELOGRAM. (B)(6) 2010: PATIENT UNDERWENT CT SCAN OF THE LUMBAR SPINE WITH CONTRAST POST MYELOGRAPHY. CONCLUSION: ALIGNMENT WAS WELL- PRESERVED. THERE DOES NOT APPEAR TO BE HIGH-QRADE CENTRAL OR FORAMINAL STENOSIS. AT L3.4, THERE WAS A SLIGHT DEGREE OF DYNAMIC LISTHOSIS A FEW MILLIMETERS, ON THE FLEXION VIEWS. (B)(6) 2010: PATIENT PRESENTED FOR FOLLOW UP. ASSESMENT: POSTLAMINECTOMY SYNDROME LUMBAR REGION. (B)(6) 2010: PATIENT PRESENTED WITH BACK PAIN, LOWER LUMBAR SHOOTS TO LEFT AND RIGHT BUTTOCKS AND BACK OF THIGH, LEFT AND RIGHT LEGS TO KNEES. PATIENT UNDERWENT X-RAY. IMPRESSION: ADJACENT SEGMENT DEGENERATION WITH STENOSIS, QUESTIONABLE NONUNION. (B)(6) 2010: PATIENT PRESENTED FOR FOLLOW UP FOR BACK PAIN. IMPRESSION: 1. INTERVAL BONE GROWTH IN THE FAR RIGHT LATERAL POSITION AT THE L4-5 LEVEL LIKELY REPRESENTING SOLID BONY FUSION. THERE WAS PERSISTENT LUCENCY SURROUNDING THE SCREWS. 2. SOLID FUSION AT THE L5-S1 LEVEL. 3. ANNULAR BULGE WITH MILD STENOSIS AT THE L3-4 LEVEL. THERE WAS NOTE OF SOME DYNAMIC COMPONENT WITH EXTENSION ON THE PLAIN FILM EXAM. (B)(6) 2010, (B)(6) 2011, (B)(6) 2012, (B)(6) 2013: PATIENT PRESENTED FOR FOLLOW UP. PATIENT PRESENTED WITH PAIN RADIATING TO HIS BILATERAL POSTERIOR THIGHS. ASSESSMENT: 1.LUMBOSAC DISC DEGENERATION 2. SPONDYLOLISTHESIS 3. SPINAL STENOSIS-LUMBAR. (B)(6) 2010: PATIENT PRESENTED WITH PRE-OP DIAGNOSIS: 1) ADJACENT SEGMENT DEGENERATION WITH STENOSIS, L3-4, L2-3 WITH INSTABILITY. 2) L4-5 NONUNION 3) RECURRING STENOSIS, L3-4, L4-5 4) NONUNION L5-S1. POST OP DIAGNOSIS: MILD SPINAL STENOSIS, L2-3 2) MODERATE TO SEVERE SPINAL STENOSIS, L3-4 3) RECURRING SPINAL STENOSIS, L4-5 WITH INSTABILITY, L3-4. OPERATION: 1) REMOVAL OF SEGMENTAL INSTRUMENTATION, L4-5, S1. 2) EXPLORATION OF L4 TO S1 FUSION. 3) L2 PARTIAL LAMINECTOMY, BILATERAL L2-3 LATERAL RECESS DECOMPRESSION, L3 TOTAL LAMINECTOMY, BILATERAL LATERAL RECESS DECOMPRESSION, FORAMINOTOMIES. 4. L4 REVISION LAMINECTOMY AND L5 PARTIAL REVISION LAMINECTOMY WITH DECOMPRESSION OF THE LATERAL RECESS BILATERALLY. 5. HARVEST OF LOCAL GRAFT. 6. L3-4 POSTEROLATERAL FUSION. 7. APPLICATION OF NONSEGMENTAL HARDWARE USING EXPEDIUM SCREW ROD SET, L3-4. 8. EXPLORATION, OF FUSION, L5-S1. 9. EXPLORATION OF FUSION, L4-S, CONFIRMATION OF FUSION AT BOTH LEVELS. PROCEDURE: THERE WERE HYPERTROPHIC FACETS AT L3-4, BOGGY SYRIOVIUM. EVENTUALLY, ONCE DECOMPRESSED, THERE SEEMED TO BE A SMALL CYST OFF THE LEFT FACET JOINT AT L3-4. HE HAD A SOLID FUSION AT L4-5. PATIENT HAD A SOLID CONFLUENT FUSION, VERY THICK AND HYPERTROPHIC ON THE RIGHT SIDE. WE OBTAINED X-RAYS, DEMONSTRATING GOOD POSITION OF THE PEDICLE MARKERS AND WE PRELI MINARILY PLACED 6.0, 50 NUN SCREWS. ONCE BONE GRAFTED WHERE SURGEON HAD DECORTICATED THE L3 TRANSVERSE PROCESS AND THE OLD FUSION MASS AND TAPPED THE PEDICLE, WE HAD PLACED A 6.0, 50 MM SCREW ON THE RIGHT L3 PEDICLE AND ON THE LEFT, A 6.0, 50 MM SCREW WITH EXCELLENT FIXATION OF THE SCREWS, HAD UPSIZED THE L4 LEFT DUE TO LUCENCY THAT HAD BEEN PRESENT PREOP AND WE HAD EXCELLENT FIXATION ON THE SCREW. THEN APPLIED A ROD TO FIT, ANTITORQUED IT INTO PLACE, OBTAINED FINAL FILMS, DEMONSTRATING EXCELLENT POSITION OF THE SCREWS AND RODS. IT HAD EXCELLENT STABILITY, APUNDANT BONE GRAFT IN THE POSTEROLATERAL GUTTERS, A WIDE OPEN CANAL. DEPUY SCREWS WERE USED. (B)(6) 2011, (B)(6) 2012, (B)(6) 2013: PATIENT PRESENTED FOR FOLLOW UP. PATIENT PRESENTED WITH RADIATING TO HIS BILATERAL POSTERIOR THIGHS. ASSESSMENT: 1.LUMBOSAC DISC DEGENERATION 2. SPONDYLOLISTHESIS 3. SPINAL STENOSIS-LUMBAR. PATIENT UNDERWENT X-RAY WHICH SHOWS SCREWS AND ROD IN GOOD POSITION. BONE GRAFT WAS PRESENT IN THE LATERAL GUTTERS. (B)(6) 2011: PATIENT PRESENTED FOR FOLLOW UP. PATIENT PRESENTED WITH LOW BACK PAIN. (B)(6) 2011, (B)(6) 2012, (B)(6) 2013: PATIENT PRESENTED WITH LOW, MID BACK PAIN, RIGHT AND LEFT HIP. (B)(6) 2011, (B)(6) 2012: PATIENT PRESENTED WITH LOW BACK PAIN, RIGHT AND LEFT HIP. (B)(6) 2011: PATIENT UNDERWENT LUMBAR MYELOGRAM. IMPRESSION: 1. BAR-TYPE DEFECTS WITH LATERAL RECESS ENCROACHMENT AND NERVE ROOT BLUNTING AT THE L1-2 AND L2-3 LEVELS. 2. WIDENING OF THE EPIDURAL SPACE POSTERIOR TO THE L5 AND THE L4 VERTEBRAL BODIES. . PATIENT UNDERWENT CT SCAN OF THE LUMBAR SPINE. IMPRESSION: 1, SEVERE STENOSIS AT THE L2-3 LEVEL DUE TO ANNULAR BULGE COMBINED WITH FACET ARTHROPATHY AND LIGAMENTOUS HYPERTROPHY. 2. MILD-TO-MODERATE STENOSIS AT THE L1-2 LEVEL DUE 10 ANNULAR BULGE COMBINED WITH FACET ARTHROPATHY AND LIGAMENTOUS HYPERTROPHY. 3. SOLID FUSION FROM L4THROUGH THE S1 LEVEL. THERE WAS EARLY INCORPORATION WITH ONGOING FUSION AT THE L3-4 LEVEL. (B)(6) 2012: PATIENT PRESENTED FOR FOLLOW UP. PATIENT PRESENTED WITH RADIATING TO HIS BILATERAL POSTERIOR THIGHS. ASSESSMENT: SPINAL STENOSIS-LUMBAR. PATIENT UNDERWENT X-RAY WHICH IMPRESSIVE FOR DYNAMIC STENOSIS L2-3 ABOVE HIS FUSION HE SEEMS TO HAVE A SOLID L3-4 FUSION, SCREWS WERE IN GOOD POSITION, EVEN ON THE PLAIN MYELOGRAM THE L2-3 DEMONSTRATES A VOID IN THE DYE COLUMN, AS WELL AS AT L1-2 ON THE AP VIEWS DEMONSTRATES THINNING OF THE DYE COLUMN. (B)(6) 2012: PATIENT PRESENTED FOR FOLLOW UP. PATIENT PRESENTED WITH LOW BACK PAIN. ASSESMENT: POSTLAMINECTOMY SYNDROME LUMBAR REGION, INTERVERTEBRAL DISC DEGENERATION LUMBAR. (B)(6) 2012: PATIENT PRESENTED WITH PRE OP DIAGNOSIS: ADJACENT SEGMENT DEGENERATION WITH SPINAL STENOSIS, L2-3, L1-2. 2. L2-3 INSTABILITY. 3. L3-4 NONUNION. POST OP DIAGNOSIS: ADJACENT SEGMENT DEGENERATION WITH SPINAL STENOSIS, L2-3, L1-2. 2. L2-3 INSTABILITY. 3. L3-4 NONUNION. OPERATION: 1. REMOVAL OF L3-4 INSTRUMENTATION. 2. EXPLORATION OF L3-4, CONFIRMATION OF NONUNION. 3. L1, L2, L3 LAMINECTOMY. 4. L2-3 FUSION. 5. L3-4 FUSION WITH AUGMENTATION. 6. L2, 3, 4 SEGMENTAL INSTRUMENTATION USING EXPEDIUM SCREW ROD SET. 7. HARVEST OF LOCAL GRAFT, APPLICATION TO POSTEROLATERAL GUTTERS. 8. ASPIRATION OF BONE MAR-ROW FOR WETTING OF HEALOS 10 MM WHICH WAS TO BE APPLIED TO THE POSTEROLATERAL GUTTERS. 9. APPLICATION OF HEALOS TO THE POSTEROLATERAL GUTTERS, L2-3, L3-4. OP NOTES: DECOMPRESSION WAS DONE, THEN PEDICLE SCREW OF L2 WAS ASPIRATED, INSERTED A 5.0, 45 SCREW AT L2. AT L3 WE PLACED A 7.0, 45 MM. AT L4 7.5, 45 MM IN THE L4 PEDICLE ON THE LEFT. ON THE RIGHT SIDE, 7.0, 50MM ON THE RIGHT L4 PEDICLE AND <(>&<)> 7.0, 50 ON THE RIGHT L3 PEDICLE. AFTER BONE GRAFTING, A ROD FIT TO SIZE, ANTITORQUED IT INTO PLACE, OBTAINED FINAL FILMS, DEMONSTRATED GOOD POSITION OF THE SCREW RODS. DEPUY SPINE SCREWS WERE IMPLANTED. (B)(6) 2012, (B)(6) 2013: PATIENT PRESENTED WITH LOW, MID BACK PAIN. (B)(6) 2012: PATIENT PRESENTED WITH LOW BACK PAIN AND SPASM IN BILATERAL BUTTOCKS. DIAGNOSIS: LUMBAR SPINAL STENOSIS. (B)(6) 2013: PATIENT PRESENTED WITH LOW BACK PAIN, STIFFNESS AND LIMITED MOTION. DIAGNOSIS: 1. MULTIPLY OPERATED LUMBAR SPINE. 2. STATUS POST MULTILEVEL DECOMPRESSION AND FUSION. (B)(6) 2013: PATIENT PRESENTED WITH NECK, MID BACK PAIN, LEFT SHOULDER, AND LEFT ARM. (B)(6) 2013: PATIENT UNDERWENT LUMBAR MYELOGRAM. IMPRESSION: 1. POSTERIOR INSTRUMENTED FUSION FROM L2 TO L4 WITH PRIOR FUSION EXTENDING CAUDALLY TO THE SACRUM, 2. ADJACENT LEVEL FINDINGS AT L1-L2. A POSTRNYELOGRAPHIC CT SCAN WILL BE OBTAINED. THE PATIENT TOLERATED THE PROCEDURE WELL. PATIENT UNDERWENT CT SCAN OF THE LUMBAR SPINE. PATIENT UNDERWENT CT LUMBAR SPINE WITH CONTRAST POST MYELOGRAPHY. IMPRESSION: 1. EXCELLENT FUSION FROM L3 TO S'1 WITH SUSPECTED INCOMPLETE INCORPORATION AT THE LEVEL OF THE DISC AT L2-L3 WITH LUCENCY OF THE L2 PEDICLE SCREWS. 2. ADJACENT LEVEL FINDINGS AT L1-L2 WITH MODERATELY SEVERE CENTRAL AND SEVERE BIFORAMINAL ENCROACHMENT AT L1-L2. (B)(6) 2013: PATIENT PRESENTED WITH LOW, MID BACK PAIN, LEFT HIP AND LEG. (B)(6) 2013: PATIENT PRESENTED FOR FOLLOW UP. PATIENT PRESENTED WITH RADIATING TO HIS BILATERAL POSTERIOR THIGHS. ASSESSMENT: 1.LUMBOSAC DISC DEGENERATION 2. SPINAL STENOSIS-LUMBAR. (B)(6) 2013: PATIENT PRESENTED FOR FOLLOW UP. INTERPRETATION: ABNORMAL EXAMINATION. THERE WAS ELECTRODIAGNOSTIC EVIDENCE OF A MILD CHRONIC LEFT L5 S1 RADICULOPATHY. THERE WAS NO EVIDENCE OF A LEFT LOWER EXTREMITY MONONEUROPATHY OR LUMBOSACRAL PLEXOPATHY. HE HAD CHRONIC NEUROPATHIC CHANGES CONSISTENT WITH A PREVIOUS INJURY TO THE L5-S1 NERVE ROOTS. (B)(6) 2013: PATIENT UNDERWENT LEFT L1-2 LUMBAR TRANSFORAMINAL INJECTION.LAM

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621892 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA M110708AAH

    Patients

    Seq Age Sex Outcome Treatment
    1