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MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
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| Catalog Number 7510200 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Aortic Insufficiency (1715); Congestive Heart Failure (1783); Dyspnea (1816); Endocarditis (1834); Fatigue (1849); High Blood Pressure/ Hypertension (1908); Mitral Regurgitation (1964); Muscle Spasm(s) (1966); Nausea (1970); Neuropathy (1983); Pain (1994); Loss of Range of Motion (2032); Swelling (2091); Thyroid Problems (2102); Loss of Vision (2139); Tingling (2171); Dizziness (2194); Hernia (2240); Regurgitation (2259); Discomfort (2330); Injury (2348); Numbness (2415); Sweating (2444); Sleep Dysfunction (2517); Ambulation Difficulties (2544)
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Event Type
Injury
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Event Description
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It was reported that the patient underwent spine fusion surgery on the lumbar region of his spine from vertebrae l5 to s1.The patient was implanted with rhbmp-2/acs.Post-operative period has been marked by chronic pain in the patient's low back and groin, with radiculopathy, burning pain and spasms into his legs.The patient underwent two revision surgeries due to these symptoms.The patient continued to experience severe and unrelenting pain in his lower back with radiculopathy into his legs and numbness and tingling down to his toes.The patient also reported having difficulty in standing, walking and performing daily life activities.The patient sustained serious and permanent injuries.
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Manufacturer Narrative
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(b)(6), (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.
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Manufacturer Narrative
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(b)(4).
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that on (b)(6) 2003: patient presented with back pain.On (b)(6) 2003: the patient underwent four level lumbar facet nerve blockade.Procedure: injection into the facet joint and/or facet joint nerve.Use of fluoroscopy for spinal injection.Non-contrast materials (gown, gloves, needles, tubing, syringes and spinal tray).Deppo-medrol or celestone soluspan or kenalog or betamethasone.Lidocaine or marcaine.On (b)(6) 2003: the patient underwent four level lumbar facet nerve rf neurotomy procedures.Procedure: radiofrequency lesion for nerve destruction.Use of fluoroscopy for needle placement.Noncontrast materials.Lidocaine or marcaine.Depo-medrol or celestone soluspan.On (b)(6) 2003: the patient underwent lumbar facet joint arthrography and blockade, 3 levels left side (l3-4-l5-s1).Procedure: radiofrequency lesion for nerve destruction.Use of fluoroscopy for needle placement.Noncontrast materials.Lidocaine or marcaine.Depo-medrol or celestone soluspan patient also underwent mri examination of the lumbar spine.Conclusion: mild l5-s1 disc degeneration with a small dorsal disc protrusion and cystic degeneration of the right facet joint including a small 3 mm synovial cyst projecting into the lateral subarticular recess without central neural compression.Findings are best seen on axial image.Ganglia exit without compromise.Mild l4-5 disc dehydration with a small left central high intensity annular fissure and disc bulge that indents the thecal sac slightly without neural compression or stenosis.On (b)(6) 2003: the patient underwent lumbar facet joint arthrography and therapeutic facet joint blockade.Procedure performed: injection into the facet joint and/or facet joint nerve.Use of fluoroscopy for spinal injection.Non-contrast materials (gown, gloves, needles, tubing, syringes and spinal tray).Deppo-medrol or celestone soluspan or kenalog or betamethasone.Lidocaine or marcaine.On (b)(6) 2004: the patient was diagnosed with low back pain.The patient had problems in performing the physical activities: bending, twisting, stooping, kneeling etc.The patient presented with muscle spasm, sensory loss, reflex changes, tenderness, limited rom, gait disturbance.On (b)(6) 2004: patient present for follow up visit.On (b)(6) 2004: the patient presented for regular checkup.Patient was diagnosed with back pain.On (b)(6) 2004: the patient underwent radiology exam.Conclusion: abnormal discogram at two levels, to include l4-5 and l5-s1.Appropriate control at l3-4.Positive 10 out of 10 concordance at l5-s1, with annular fissure, associated annular tear and protrusion of disc with associated deformity of the left s1 nerve root.Abnormal discogram at l4-5.No concordance, with a mild pain level reported.On (b)(6) 2004: patient present for follow up visit.On (b)(6) 2004: patient underwent radiology exam of lumbar spine 2-3 view due back pain.On (b)(6) 2004: patient presented with low back pain, facet syndrome.On (b)(6) 2004: the patient was diagnosed with degenerative disc disease, back pain, radiculopathy.The patient underwent l5-s1, anterior inter body fusion with fra spacer; l4-s1, post fusion and pedicle screws and anterior iliac crest harvest.Preoperative evaluation: mechanical low back pain secondary to l5-s1 degenerative disk disease and l4-l5 degenerative disk disease.Lumbar spondylosis.A trial fra spacer was put in, and it was felt that 19 mm fra spacer was most appropriate.The 19 mm fra spacer was packed in its center with rhbmp-2 and cancellous bone.The cancellous bone harvested from the anterior iliac crest was then packed with some grafton putty and the leftover of the rhbmp-2 between l5 and s1 bilaterally and l4 and l5 as well, with most of the graft going to l5-s1.Patient underwent a diskogram which demonstrated a 10/10 concordant pain with injection of the l5-s1 disc.Postoperatively, the patient was proceeded with the posterior exposure.No patient complications were reported.The patient underwent c-arm x-ray up to one hour.Impression: two fluoro spot images demonstrate a disc cage at l5-s1.The patient also underwent retroperitoneal exposure of the anterior lumbar spine for interbody fusion of the l5-s1.Preoperative diagnosis: degenerative disk disease, l5-s1.On an unknown date, postoperatively patient had complications.Patient had right leg spasms, right leg pain.Patient was reexamined and found to have a malposition or fracture of the right pedicle screw likely during that spasm event.On (b)(6) 2004: patient had severe spasm.Patient was unable to move.On (b)(6) 2004: patient presented for follow up visit.Patient had leg pain, spasms.Patient underwent lumbar ct which was normal.On (b)(6) 2004: patient had leg calf pain.On (b)(6) 2004: patient presented for follow up visit.On (b)(6) 2004: patient presented with leg pain.On (b)(6) 2004: patient had pain, severe spasm.On (b)(6) 2004: the patient underwent revision of right s1 pedicle screw.Preoperative diagnosis: malposition right s1 pedicle screw.The patient had mechanical back pain and severe degenerative disc disease.No patient complications were reported.On (b)(6) 2004: patient presented for pain.On (b)(6) 2004: patient presented for office visit.On (b)(6) 2004: patient underwent radiology exam of lumbar spine.On (b)(6) 2004: patient underwent radiology exam of lumbar spine.On (b)(6) 2004: patient had bad migraines.On (b)(6) 2004: patient presented for diagnosis of lumbar soft tissue mass.Patient underwent resection of the subcutaneous nodular soft tissue mass of the left lumbar paraspinous region.On (b)(6) 2004: the patient presented with unchanged constant aching, numbness in right leg.The patient had chronic lumbar pain.On (b)(6) 2004: patient presented for follow up visit.On (b)(6) 2004: patient presented with chief complaint of low back pain.Patient had decreased sensation in the right thigh.Patient had tenderness to palpation throughout the bilateral low back.Patient also had chronic muscle spasms and restricted range of motion.On (b)(6) 2004: patient presented for a follow up visit.On (b)(6) 2005: the patient presented with chief complaint of low back pain.Patient also had chronic lumbar pain status post, chronic muscle spasms and restricted range of motion.Also in night, both of the legs would tingle as when patient was lying down.On (b)(6) 2005: the patient presented with pain in low back, right foot, left foot, right leg, left leg.Patient had limited rom.On (b)(6) 2005: the patient presented with chief complaint of low back pain, degenerative spine.The patient had lumbar pain, status post fusion.Patient had chronic muscle spasms and severely restricted range of motion.Patient also underwent physical evaluation tests.On (b)(6) 2005: the patient presented with chief complaint of lower back pain on the left side.The patient also had leg pain on the right side.The pain radiated to the right leg and right foot.The patient underwent plain x-ray.Results: fusion with instrumentation l4-s1.The patient had painful and restricted spine range of motion.On (b)(6) 2005: patient had chief complaint of lower back pain, numbness and tingling in the leg.Patient pain got worse.The patient also had the deficit in the legs, depression, and muscle spasms in area of pain.On (b)(6) 2005: the patient presented with chief complaint of low back pain.Patient lumbar range of motion is severely limited.There were palpable spasms and tenderness over the left lower back.Sensation got decreased in the right anterior thigh.On (b)(6) 2007: patient presented with chronic back pain, hypothyroidism, anemia, endocarditis.Patient underwent mri.Impression: no evidence for thoracic diskitis or epidural abscess.On (b)(6) 2007: patient presented with chronic back pain, endocarditis, hyperthyroidism, anemia.On (b)(6) 2007: the patient presented for follow up visit and medications.On (b)(6) 2007: patient had aortic valve insufficiency problem, severe mitral regurgitation.On (b)(6) 2007: patient had quite shortness of breath low back pain, severe mitral resurge.Patient underwent ugi endoscopy with biopsy due to anemia.Impression: erosive esophagitis, small hiatal hernia, biopsied for sprue.On (b)(6) 2007: patient underwent colonoscopy, cvl coronaryangigram and ugi endoscopy.Patient had erosive esophagitis, small hiatal hernia biopsied for sprue.Preoperative diagnosis: recent endocarditis and aortic and mitral insufficiency.Aortic and mitral valve replacement.On (b)(6) 2007: the patient had chronic back pain, mild thrombocytopenia, mild leukopenia.Patient underwent echocardiogram transesophageal, color and spectral doppler, bubble contrast study.Impression: mitral valve p2 vegetation with flail.Nodular thickening of a2 as well with broad turbulent color flow jet of severe mitral regurgitation.Long aortic valve vegetation with associated moderately severe, if not severe aortic insufficiency.Bilateral enlargement borderline left ventricular size with normal wall motion and ef.Normal right ventricular size and systolic function.Severe pulmonary hypertension of 64 mmhg plus right atrial pressure.Patent foramen ovale with left-right color flow jet.Moderate sessile atheroma of the descending thoracic aorta.Clinical correlation recommended.The mitral valve does not appear to be ideal for repair.On (b)(6) 2007: patient underwent procedure of aortic valve replacement.Patient had quite shortness of breath.Preoperative diagnoses: bacterial endocarditis with severe mitral valve insufficiency.Severe aortic insufficiency.Moderate to severe tricuspid insufficiency.Patent foramen ovale.Congestive heart failure.On (b)(6) 2007: patient underwent various lab tests and presented for medications.On (b)(6) 2007: patient presented with sore, pain, anxiety, discomfort.On (b)(6) 2007: patient had complaint of pain.On (b)(6) 2009, (b)(6) 2010, (b)(6) 2011, (b)(6) 2012, (b)(6) 2013: the patient presented with chief complaint of low back pain.Patient had moderate lumbar spasm and tenderness.Patient also presented with insomnia, depression.On (b)(6) 2011, (b)(6) 2012: patient presented for medications.On (b)(6) 2011: patient underwent procedure of transforaminal lumbar epidural steroid injection.On (b)(6) 2012: the patient presented with chief complaint of low back pain.Patient had difficulty in performing activities of daily living.Patient had moderate lumbar spasm and tenderness.On (b)(6) 2012, (b)(6) 2013, (b)(6) 2014: the patient presented with chief complaint of low back pain.Patient had moderate lumbar spasm and tenderness.On (b)(6) 2014: the patient presented with chief complaint of low back pain.Patient had moderate lumbar spasm and tenderness.Patient also presented with insomnia, depression, anxiety.On (b)(6) 2014: the patient presented with chief complaint of low back pain.Patient had moderate lumbar spasm and tenderness.Patient also presented with insomnia, vision loss.On (b)(6) 2014: the patient presented with chief complaint of low back pain.Patient had moderate lumbar spasm and tenderness.Patient also presented with insomnia.On (b)(6) 2014: patient presented with chief complaint of low back pain.The pain was burning, dull, sharp and throbbing.Patient had moderate lumbar spasm and tenderness.On (b)(6) 2014: the patient presented with chief complaint of back pain.Symptoms were aggravated by bending, standing, twisting and walking.Review of systems revealed: vision loss, insomnia.On (b)(6) 2014: the patient presented with chief complaint of back pain.Symptoms were aggravated by bending, standing, twisting and walking.Review of systems revealed: vision loss, insomnia, constipation, decreased appetite, limited rom.On (b)(6) 2015: the patient underwent mri of lumbar.The patient had back pain.On (b)(6) 2015: patient presented for medications.On (b)(6) 2015: the patient underwent ct lumbar spine with reformations.Conclusions: solid appearing l5-s1 interbody fusion, solid bilateral dorsolateral bony and instrumented fusion from l4 through s1 (without instrumentation fracture or marginal lucency), unchanged minimal annular bulging at l1-2 and the following notable findings: no disc herniation, acute fracture, spondylosis or significant central stenosis.Hypertrophic degenerative facet arthrosis is moderate bilaterally at l3-4 and mild to moderate bilateral l2-3.No significant foraminal narrowing.The patient had lower back pain and pain in left leg.
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that on (b)(6) 2005: patient presented for a flu shot.On (b)(6) 2004: patient underwent x-ray of lumbar spine post lumbar fusion.Conclusion: interval evidence of healing of the l5 through s1 fusion.Alignment of the spine is anatomic.On (b)(6) 2007: patient presented for a follow-up visit for neurology exams.Impressions: patient has a right posterior cerebral artery stroke syndrome.On (b)(6) 2007: patient underwent an mri of lumbar spine.Impressions: no evidence of lumbar diskitis or epidural abscess.Post-op changes includes an anterior interbody fusion at l5-s1.Bilateral pedicle screws and vertical connecting rods at the l4-5 and s1 level and associated dorsal lateral fusion.Adequate spinal canal and foraminal decompression.Some motion artifact is present.On (b)(6) 2007: patient underwent a transesophageal echocardiogram.Impressions: normal left ventricular size and function.Presumed endocarditis of the mitral valve with moderate to moderately severe mitral regurgitation.Moderate aortic regurgitation.Ill-defined subpulmonic density.On (b)(6) 2007: patient presented with an x-ray of chest.Impressions: picc line was seen with tip in the superior vena cava.On (b)(6) 2007: patient had aortic valve insufficiency problem, severe mitral regurgitation.Patient also suffered from increased shortness of breath.Patient also presented for an office visit due to hyperthyroidism.Assessment: mild hyperthyroidism.Severe mitral and aortic regurgitation secondary to bacterial endocarditis with congestive heart failure and pulmonary hypertension.Combined anemia.Chronic back disease.On (b)(6) 2007: patient underwent procedure of aortic valve replacement.Patient had quite shortness of breath.Preoperative diagnoses: bacterial endocarditis with severe mitral valve insufficiency.Severe aortic insufficiency.Moderate to severe tricuspid insufficiency.Patent foramen ovale.Congestive heart failure.Patient also underwent a bone scan.Impressions: normal findings with no increased fracture risk identified.On (b)(6) 2007: patient underwent an unknown exam.Findings: severe destruction of anterior and posterior mitral leaflets, large vegetation on left coronary cusp of aortic valve.On (b)(6) 2007: per billing records, patient underwent electrocardiogram.On (b)(6) 2007: per billing records, patient underwent electrocardiogram.On (b)(6) 2007: patient got admitted for cardiac rehabilitation and underwent various lab tests.Assessment: severe mitral regurgitation; large vegetation on left coronary cusp of aortic valve; severely dilated tricuspid valve annulus at 47 mm; hyperthyroidism; anemia; low back pain.On (b)(6) 2007: patient got discharged to home.On (b)(6) 2007: patient presented with complaint of chronic low back pain.On (b)(6) 2007: patient presented for follow-up visit.On (b)(6) 2011: patient presented for a complete physical and refill of his medications and was referred for chronic nasal congestion.On (b)(6) 2011: patient presented for recheck of his "inr" following restarting after his epidural steroids.On (b)(6) 2011: patient presented with chronic coumadin for two valve replacements and to discuss anticoagulation management.On (b)(6) 2012: patient presented with mild dizziness state with lovenox after having his tooth pulled.On (b)(6) 2012, (b)(6) 2014: patient presented for physical exam and refill of his medications.Impression: arteriosclerotic cardiovascular disease.Lipid screening.Cigarette smoking.Valve replacement.Cancer screening.History of hyperthyroidism.History of cerebrovascular accident.Chronic back pain.Renal insufficiency.Abnormal liver enzymes.Immunizations.On (b)(6) 2015: patient presented for question on circulation, back pain, and thyroid adjustment.Impression: hypothyroidism; chronic back and leg pain.On (b)(6) 2004: the patient presented with unchanged constant aching, numbness in right leg.The patient had chronic lumbar pain.Impression: chronic lumbar pain status post fusion.On (b)(6) 2005: patient presented for office visit.Diagnosis: back pain.Impression: chronic lumbar pain, facet syndrome.On (b)(6) 2005: patient presented for follow up with chief complaint of chronic back pain.Impression: chronic lumbar pain status post fusion.Patient has chronic muscle spasms and restricted range of motion.On (b)(6) 2005: patient presented for follow up with chief complaint of back pain.Impression: chronic back pain.On (b)(6) 2005: patient presented for follow up with chief complaint of back pain.Impression: chronic lumbar pain post fusion.On (b)(6) 2006: patient presented for follow up with chief complaint of back pain.Impression: chronic lumbar pain.On (b)(6) 2006: patient presented with chief complaint of back pain.Impression: chronic low back pain with previous spine surgery.On (b)(6) 2007: patient presented with chief complaint of chronic back pain.Impression: chronic low back pain with previous spine surgery.On (b)(6) 2007: patient presented with chief complaint of chronic back pain.Impression: chronic low back pain with history of lumbar spine surgery and hospitalization for right occipital ischemic stroke.On (b)(6) 2007, (b)(6) 2008: patient presented with chief complaint of chronic low back pain.Impression: chronic left low back pain.On (b)(6) 2008: patient presented with chief complaint of left lower back and lower extremity pain.Impression: chronic left low back and lower extremity pain with history of anterior fusion at l5-s1 and posterior fusion from l4 through s1.On (b)(6) 2008: patient presented with chief complaint of low back pain.Impression: chronic left low back pain with history of anterior fusion at l5-s1 and posterior fusion from l4 through s1.On (b)(6) 2008: patient presented with chief complaint of left low back pain.Impression: chronic low back pain with history of anterior fusion at l5-s1 and posterior fusion from l4 through s1.On (b)(6) 2008: patient presented with chief complaint of chronic low back pain.Impression: chronic left low back pain with history of anterior fusion at l5-s1 and posterior fusion from l4 through s1.On (b)(6) 2008: patient presented with chief complaint of low back pain.Impression: low back pain with radicular symptoms.On (b)(6) 2009: patient presented with chief complaint of left low back pain.Impression: chronic low back pain with history of anterior fusion at l5-s1 and posterior fusion from l4 through s1.On (b)(6) 2009: patient presented with chief complaint of low back pain.Impression: chronic low back pain with history of anterior fusion at l5-s1 and posterior fusion from l4 through s1.On (b)(6) 2009: patient presented with chief complaint of low back pain.Impression: chronic low back pain with bilateral lower extremity paresthesias.On (b)(6) 2009: patient presented with chief complaint of low back and lower extremity pain.Impression: chronic low back pain with bilateral lower extremity paresthesias.On (b)(6) 2009: patient presented with chief complaint of low back and thigh pain.Review of systems revealed visual impairment.Impression: chronic low back pain with bilateral lower extremity paresthesias.On (b)(6) 2011: patient underwent procedure of transforaminal lumbar epidural steroid injection.Impression: technically successful transforaminal lumbar epidural steroid injection.Long term results are pending.On (b)(6) 2012, 0(b)(6) 2013, (b)(6) 2014: the patient presented with chief complaint of low back pain.Patient had moderate lumbar spasm and tenderness.Patient was positive for vision loss and nausea.On (b)(6) 2012: patient presented with chief complaint of low back pain.It occurred intermittently.On (b)(6) 2014: the patient presented with chief complaint of low back pain.Patient had moderate lumbar spasm and tenderness.Patient also presented with insomnia, depression, anxiety.On (b)(6) 2014: the patient presented with chief complaint of low back pain.Patient had moderate lumbar spasm and tenderness.Patient also presented with insomnia, vision loss.On (b)(6) 2014: the patient presented with chief complaint of low back pain.Patient had moderate lumbar spasm and tenderness.Patient also presented with insomnia and vision loss.On (b)(6) 2014: patient presented with chief complaint of low back pain.Patient was positive for fatigue, depression and insomnia.On (b)(6) 2014: the patient presented with chief complaint of back pain.Symptoms were aggravated by bending, standing, twisting and walking.Review of systems revealed: vision loss, insomnia.Assessment: post laminectomy syndrome of lumbar region.Impression: chronic low back pain, "lle" paresthesias.On (b)(6) 2014: the patient presented with chief complaint of back pain.Symptoms were aggravated by bending, standing, twisting and walking.Review of systems revealed: vision loss, insomnia, constipation, decreased appetite, limited rom.Assessment: postlaminectomy syndrome of lumbar region.On (b)(6) 2015: patient presented for office visit.On (b)(6) 2015: patient presented with chief complaint of lower back pain.Left leg pain worsening gradually.Review of systems revealed patient was positive for depression and insomnia.Assessment: postlaminectomy syndrome of lumbar region.On (b)(6) 2015: the patient underwent mri of lumbar.The patient had back pain.Patient could not complete the study because of pain in recumbent position.No central stenosis noted in lumbar spine with posterior instrumented two levels ap fusion from l4 to sacrum.On (b)(6) 2015: patient presented with chief complaint of lower back pain and pain in lateral left lower extremity.Review of systems revealed patient was positive for insomnia.Assessment: postlaminectomy syndrome of lumbar region.On (b)(6) 2015: patient presented with chief complaint of lower back pain and pain in lateral left lower extremity.Review of systems revealed patient was positive for leg swelling and vision loss.Assessment: degeneration of lumbar intervertebral disc.On (b)(6) 2015: patient presented with chief complaint of lower back pain and pain in lateral left lower extremity.Review of systems revealed patient was positive for vision loss, insomnia, anxiety and depression.Assessment: postlaminectomy syndrome of lumbar region.On (b)(6) 2015: patient presented with chief complaint of lower back pain.Review of systems revealed patient was positive for vision loss, weight gain, insomnia and diaphoresis.Assessment: postlaminectomy syndrome of lumbar region.On (b)(6) 2015: patient presented with chief complaint of lower back pain and left lower extremity pain.Assessment: postlaminectomy syndrome of lumbar region.Review of systems revealed patient was positive for fatigue, night sweats, decreased appetite, depression and insomnia.On (b)(6) 2015: patient presented with chief complaint of lower back pain.Review of systems revealed patient was positive for vision loss, decreased appetite, depression and insomnia.Assessment: postlaminectomy syndrome of lumbar region.Impression: left lower extremity pain has been better.On (b)(6) 2015: patient presented with chief complaint of lower back pain.Review of systems revealed patient was positive for vision loss, night sweats and insomnia.Assessment: postlaminectomy syndrome of lumbar region.
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Event Description
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It was reported that on: (b)(6) 2004: patient presented for follow up visit.Patient had leg pain, spasms.Patient underwent lumbar ct which was normal.Conclusion: right s1 transpedicular screw has an in-out configuration in the right s1 lateral recess and abuts the right s1 root.Correlation for right s1 root symptoms is suggested.Mild right l5-s1 subarticular recess stenosis due to calcification at the ligamentum flavum or possibly at the synovium of the adjacent subarticular recess.Paired l4, l5 and left s1 transpedicular screws with interconnecting rods are in good position.Immature lateral dorsolateral fusion bone from l4 to s1.Satisfactory appearance or interbody ring allograft and bone slurry at l5 -s1.The patient also underwent x-ray due to lumbar fusion.Conclusion: intact lumbar fusion.No obvious complication.On (b)(6) 2004: patient presented for pain.The patient underwent x-ray of lumbar spine due to pain, post-op fusion.Conclusion: status post anterior and posterior spinal fusion, l4 to s1.On (b)(6) 2004: patient underwent radiology exam of lumbar spine.Findings: a single lateral view demonstrated posterior spinal fusion from l4 to s1 with bilateral pedicle screws and posterior connecting rods at l4, l5 and s1.Inter-body bone graft material is seen at l5-s1.No other abnormality is noted.On (b)(6) 2005: the patient presented for follow up visit.
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