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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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Back to Search Results |
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| Catalog Number 7510600 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Bronchitis (1752); Chest Pain (1776); Inflammation (1932); Muscle Spasm(s) (1966); Neuropathy (1983); Pain (1994); Swelling (2091); Hernia (2240); Stenosis (2263); Numbness (2415); Respiratory Tract Infection (2420); Breast Mass (2439)
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Event Type
Injury
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Manufacturer Narrative
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(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.
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Event Description
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It was reported that on: (b)(6) 2004: patient presented with pre-op diagnosis of spondylolisthesis l5-s1 grade 3,low back pain, spondylosis, bilateral lower extremity radicular pain, stenosis, neural foraminal at l5-s1 bilaterally, bilateral pars defect, myelopathy and weakness and underwent lumbar fusion pedicle screw, l4 l5-s, iliac crest bone graft with following procedure: alignment of spondylolisthesis and arthrodesis; l4, l5 and s1 with cdb horizon top loading multiaxial pedicle screws.Decompressive laminectomy, l5 and s1.Medial facetectomy bilateral l5-s1.Bilateral foraminotomy, l5-s1.Iliac crest bone graft.Use of cancellous bone chips in autologous marrow.Use of osteofil 1-cm moldable strip (50mm), operating room microscope, intraoperative fluoroscopy and intraoperative cell saver.Cross link of right to left fusion rods.On (b)(6) 2006: patient presented with intractable, progressive regional low back pain secondary to discogenic sources and pseud arthrosis at levels l4 to the sacrum and patient underwent the following procedure: l4 to sacrum segmental pedicle screw instrumentation removal.Posterolateral fusion and exploration, l4 to sacrum.Posterolateral arthrodesis at l3-4 with revision pseud arthrosis repair at l4-5 and l5-s1.Re-instrumentation with pedicle screw instrumentation, l3-4, l4-5 and l5-s1.Per op; trial interbody devices are utilized, measuring a 12mm implant.An interbody peek implant is utilized.Bmp is placed within the center of this device and then it is pounded into place with good interference fit.Each pedicle screw was then replaced by size in diameter larger as a rescue screw and obtained good bone purchase in each pedicle of l4, l5 and sacrum at each level.Each pedicle was instrumented and probed in all four quadrants and then 6.5mm screw inserted without difficulty.Posterior rods are affixed to each of the four screws on each side.Screws were tightened to the rod with compression applied.The posterolateral area is decorticated, specifically the transverse process of l3 and the previous arthrodesis bed of l4 to sacrum.Bmp associated with the bone graft matrix is then applied in the posterolateral recess for bone grafting purposes.Wound was then closed in layered manner using vicryl suture at the paraspinal fascia, subcu and skin.On (b)(6) 2006: the patient presented for follow-up visit.X-ray shows stable interbody peek implants at l3-l4, l4-l5 with stable appearing segmental pedicle screws in bodies l3,l4, l5 and s1.On (b)(6) 2006: the patient presented for urticaria.On (b)(6) 2006: the patient presented for cough.On (b)(6) 2006: the patient presented for left lower extremity edema, recent onset, hypokalemia and fatigue.On (b)(6) 2006: the patient again presented for follow-up visit.On (b)(6) 2006: ap and lateral lumbar spine show stable-appearing ap fusion construct l3 to sacrum with pedicle screw stability and inter body radiolucent implants at l3-l4 and l4-l5.Posterolateral bone graft is visible but not yet completely healed.On (b)(4) 2007: the patient again presented for follow-up visit.On (b)(6) 2007: the patient presented for follow up visits.On (b)(6) 2007: the patient presented for bronchitis.On (b)(6) 2007: the patient presented for hypothyroidism, left shoulder pain and numbness in feet.On (b)(6) 2007: the patient presented with cellulitis abdomen.On (b)(6) 2007, (b)(6) 2008: the presented for radiculopathy.On (b)(6) 2007: the patient presented for radiculopathy.Uncomplicated ct guided aspiration of an anterior abdominal wall fluid collection.Impression: fluid collection within the subcutaneous tissues anterior to the hernia repair site, consistent with small abscess.Paramid line fat-containing ventral hernia near the umbilicus unchanged.Stable hypodense lesion in the posterior right liver, slightly small for characterization.On (b)(6) 2007: the patient presented with lumbar spine mri.Impressions: bony bridging is noted between these endplates and the anterior fusions are intact.The l4 through s1 bilateral pedicle screws appear to be the same as those from the prior exam.The horizontal bar at l4-l5 has been removed.The pedicle screw are stabilized by horizontal bars bilaterally.Within the l4 pedicles, there is more pronounced lucency along the inferior borders of the pedicle screws.No other lucencies surrounding the posterior instrumentation.Dorsolateral bone fusion from l4-l5 through l5-s1.It is solid bilaterally.No spinal canal stenosis.Persistent grade ii anterolisthesis of l5-s1 with stable sclerosis of the opposing endplates and stable moderate to severe bilateral neural foraminal stenosis.On (b)(6) 2008: the patient presented with entrapment syndrome left shoulder.On (b)(6) 2008: the patient presented for follow up visits.Ap and lateral of the lumbar spine show evidence of solid arthrodesis l3-sacrum with retained pedicle screw instruments and interbody grafts appear to be solid.On (b)(6) 2008: the patient presented with sinusitis and asthma.On (b)(6) 2008: the patient presented with left sided sciatica.On (b)(6) 2009: the patient presented for follow up visits.On (b)(6) 2009: the patient presented with hypothyroid with continued fatigue, elevated cholesterol, chf and back pain.On (b)(6) 2009: the patient presented for radiculopathy of thoracic spine without contrast and lumbar spine with and without contrast.Several small midthoracic disc herniations are noted.Moderately severe narrowing of both lumbosacral neural foraminal with some apparent deformity along both l5 nerve roots.On (b)(6) 2009: the patient presented with chronic low back pain with exacerbation.On (b)(6) 2009: the patient presented with viral upper respiratory tract infection.On (b)(6) 2009: the patient presented with influenza.On (b)(6) 2009: the patient presented with a solid arthrodesis l3 to sacrum and left shoulder pain.She went through mri scans and scans shows multiple-level degenerative disc disease but no evidence of serious central or lateral canal nerve impingement.Lumbar spine shows grade 3 l5-s1 spondylolisthesis, which remains unchanged.On (b)(6) 2009: patient returns to follow up on her left shoulder mri scan.Mri scan shows evidence of tendinopathy involving the supraspinatus muscle and enlarged ac joint.On (b)(6) 2009: the patient presented for office visit.On (b)(6) 2009: the patient presented for evaluation and second opinion of left shoulder pain.The patient presented with following impressions; left shoulder impingement with biceps tenosynovitis.On (b)(6) 2009: the patient presented for follow up on chronic back pain.On (b)(6) 2009: the patient presented for sebaceous cyst, upper back.On (b)(6) 2010,: the patient presented for follow up visits for low back pain and refilling request.On (b)(6) 2010: the patient presented for musculoskeletal problem.One week of progressively worsening right shoulder pain, no injury or overuse.Musculo-skeletal pain related to tendonitis, inflammation and muscle spasms.On (b)(6) 2010, (b)(6) 2011: the patient presented for follow-up visits.On (b)(6) 2011: the patient presented with persisting back pain.Ap and lateral lumbar spine taken today shows a solid arthrodesis with both an anterior interbody fusion and posterior fusion seen with retained instrumentation l3-sacrum.The patient was diagnosed with mechanical low back pain related to previous 3 level lumbar fusion and significant deconditioning with overnight status.Chronic pain management with long-term opioids.On (b)(6) 2011, (b)(6) 2012: the patient presented for medication follow-up and lower back pain.On (b)(6) 2012: the patient presented with cold and cough that is not improving.On (b)(6) 2012: the patient in for follow up on chronic pain.On (b)(6) 2012: the patient presented for med refilling.On (b)(6) 2012: the patient presented for pain medication management.The patient was diagnosed for pain in joint and shoulder region.Findings: two views right knee: there are mild degenerative changes in the patellofemoral compartment.No fracture or joint effusion.Two views left knee: there are mild degenerative changes within the patellofemoral compartment.The knee is otherwise negative without fracture or joint effusion.On (b)(6) 2013: the patient presented for follow up bilateral knee pain and left shoulder pain, sinusitis, potassium and calcium.On (b)(6) 2013: the patient presented for pain medication management.On (b)(6) 2013: the patient presented with chief concern of mole on back, cyst on upper back.Popping sensation in neck, hammertoes and follow up for back pain and med refills.On (b)(6) 2013: the patient presented with painful hammertoes, ingrown nails, fungal nails and dry skin.Patient stated she has lower back pain and neuropathy in both feet.On (b)(6) 2013: impression: patient is low risk for perioperative complications.On (b)(6) 2013: the patient presented with chief concern of medication refills, handicapped driving form, s/p hernia repair, excess skin and left foot pain.On (b)(6) 2013, (b)(6) 2014: the patient presented for follow up chronic low back pain, foot surgery and vitamin d deficiency.On (b)(6) 2014: the patient presented for mri.Mri demonstrated a/p fusion at l3-l4-5 and l5-s1 with trans-pedicular screws.Anterolisthesis of l5 on s1.Degenerative disc disease at l5-s1.The patient presented for chief concern of increase in chronic low back pain resulting in gait difficulty and difficulty getting out of bed over the past week.On (b)(6) 2014: the patient presented with back pain.Pertinent radiologic studies reviewed.On (b)(6) 2014: the patient presented for follow up visits for low back pain, myofascial pain and bilateral sacroiliac joint pain and underwent trigger point injection, bilateral sacroiliac joint injection, under fluoroscopic guidance.On (b)(6) 2014, the patient presented for follow up visits.On (b)(6) 2014: the patient presented with follow up from hospitalization for low back pain.Assessment: the doctor did not find any indications of si joint dysfunction and her lack of radicular symptoms suggests that this was a mechanical back pain exacerbation.On (b)(6) 2014: the patient presented for follow up visits for back pain.On (b)(6) 2014: the patient presented for follow up on pain management and lumps right lateral chest and base of neck.On (b)(6) 2014: the patient presented for follow up visits for mri.On (b)(6) 2014: the patient presented for follow up for back pain.On (b)(6) 2014: the patient underwent fluoroscopy.On (b)(6) 2014: the patient presented with concerns about continued low back pain and curiosity as to hardware removal surgery.Impression: low back pain and osteoarthritis of the lumbar spine.Currently the condition is moderately in severity, improving and responding to treatment.On (b)(6) 2014: the patient presented for follow up back pain and medication management.On (b)(6) 2014: the patient presented to the office with chief complaint of back pain, underwent s/p lumbar fusion.On (b)(6) 2014: the patient presented for office visit.On (b)(6) 2015: the patient presented to the office with chief complaint of back pain.On (b)(6) 2015: the patient presented for follow up and refill request.
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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) 2006: the patient underwent ultrasound of left lower extremity with duplex doppler due to left leg pain and swelling.Report: this left common femoral, superficial femoral popliteal and posterior tibial calf veins are patent and free of thrombus.On (b)(6) 2006: the patient underwent chest x-ray due to chest pain.Conclusion: 1.Negative for pulmonary emboli or dissections.2.Small hiatal hernia.On (b)(6) 2006: the patient underwent ct 0f head/brain due to left sided facial numbness.Impression: ct of head is negative.The patient also underwent carotid ultrasound.Conclusion: no hemodynamically significant stenosis in the internal carotid arteries bilaterally.On (b)(6) 2006: the patient underwent left lower extremity venous ultrasound due to swelling.Conclusion: no evidence for deep vein thrombosis in the left lower extremity.On (b)(6) 2007: patient underwent x-ray ap and lateral lumbar spine.It showed stable pedicle screw instrumentation from l3 to sacrum.No evidence of bony healing.On (b)(6) 2007: the patient was preoperatively diagnosed with rectal bleeding, recent hematochezia, rule out lower gastrointestinal source and underwent colonoscopy report.On (b)(6) 2007: patient underwent x-ray ap and lateral lumbar spine.It showed interbody radiolucent bio absorbable grafts in satisfactory position.Pedicle screws appear to be satisfactory.On (b)(6) 2007: patient underwent x-ray ap and lateral lumbar spine.It showed stable ap fusion construct l3 to sacrum.Screws and rods are intact.Right side posterolateral bone graft appears to be healing.On (b)(6) 2007: patient underwent x-ray ap and lateral lumbar spine.It showed segmental pedicle screw fixation from l3 to sacrum.The pedicle screws appear to be stable.Modest amount of posterolateral bone seen at l3-l4.On (b)(6) 2009: patient underwent abdominal ultrasound.Impression: cholelithiasis.Gallbladder wall thickening and some pericholecystic edema are suspicious for acute cholecystitis.No intra or extrahepatic bile duct dilatation.A 2.1 cm hypoechoic lesion in posterior segment of right hepatic lobe is indeterminate.On (b)(6) 2008: the patient presented with chronic low back pain.On (b)(6) 2009: patient presented for office visit.On (b)(6) 2009: patient underwent two views of the abdomen.Impression: no free air.Postoperative changes in lower lumbar spine.Normal bowel gas pattern.Patient underwent x-ray of chest.Impression: negative chest.Patient presented with chief complaint of finger laceration.Patient presented with following diagnosis: hypertension.Asthma.Low back pain.Hypothyroidism.Subcutaneous abscess.Incisional hernia.Review of systems revealed patient is positive for skin.Impression: abrasion, finger: no sutures indicated.On (b)(6) 2009: patient presented with chronic back pain.Patient presented with following diagnosis: hypertension.Asthma.Low back pain.Hypothyroidism.Subcutaneous abscess.Incisional hernia.Impression: acute on chronic low back pain.On (b)(6) 2009: patient presented with chief complaint of lower back pain.Patient presented with following diagnosis: hypertension.Asthma.Low back pain.Hypothyroidism.Subcutaneous abscess.Incisional hernia.Impression: acute exacerbation back pain.On (b)(6) 2009: patient underwent mri of left shoulder.Impression: mild to moderate supraspinatus and infraspinatus tendinopathy, without a more discrete tear.Mildly narrowed subacromial space.Mild to moderate subacromial bursitis.Long head of biceps tendon is intact and nondisplaced from bicipital groove.No glenohumeral degenerative changes are seen.No definite labral tearing.Patient also underwent ct lumbar spine.Impression: grade ii l5-s1 spondylolisthesis with disc collapse and with severe bilateral foraminal stenosis impinging the l5 nerve roots.Postoperative 360 degree fusion, l4- 5 and l3-4 with intact instrumentation.Fusion is clearly solid at l3-4 interbody and dorsolaterally at l4-5.Solid bridging bone at l4-5 interbody which has undergone remodeling.No acute fractures.Trace retrolisthesis and annular bulging at l2-3 with mild facet degeneration but no neural impingement.On (b)(6) 2010: patient presented with chief complaint of back pain.Patient presented with following diagnosis: hypertension.Asthma.Low back pain.Hypothyroidism.Subcutaneous abscess.Incisional hernia.Review of systems revealed patient is positive for back pain.Impression: acute on chronic back pain.On (b)(6) 2010: patient presented with chief complaint of spasms.Patient presented with following diagnosis: hypertension.Asthma.Low back pain.Hypothyroidism.Subcutaneous abscess.Incisional hernia.Review of systems revealed patient is positive for myalgias and joint pain.Impression: acute on chronic back pain.On (b)(6) 2010: patient presented with chief complaint of back pain.Patient presented with following diagnosis: hypertension.Asthma.Low back pain.Hypothyroidism.Subcutaneous abscess.Incisional hernia.Review of systems revealed patient is positive for back pain.On (b)(6) 2011: patient presented for office visit with chronic low back pain and rehab needs.Patient presented with following diagnosis: lumbago, status post lumbar fusion.Impression: chronic low back pain.On (b)(6) 2011: patient presented for office visit.Patient presented with following diagnosis: incisional hernia.Hypertension.Asthma.Low back pain.Hypothyroidism.Subcutaneous abscess.Osteoarthritis.Pedal edema.Status post lumbar fusion.Review of systems revealed decreased hearing.On (b)(6) 2011: patient presented for office visit with chief complaint of incisional hernia.Patient presented with following diagnosis: hypertension.Asthma.Low back pain.Hypothyroidism.Subcutaneous abscess.Incisional hernia.Patient underwent the following procedure: laparoscopic recurrent incisional hernia repair.On (b)(6) 2011: patient presented with chief complaint of chronic low back pain and rehab needs.Review of systems revealed she has numbness and tingling on right foot.Patient presented with following pre-op diagnosis: lumbago.Impression: chronic low back pain.Status post l3-s1 fusion.On (b)(6) 2011: patient presented with chief complaint of lumbago.Patient underwent ct lumbar spine without contrast.Diagnosis: lumbago.On (b)(6) 2011: patient underwent ct lumbar spine without contrast.Impression: posterior fusion hardware l3 to s1 and anterior interbody fusion l3-4 and l4-5 appears solid.No significant central canal or foraminal stenosis appreciated.1.5 cm anterolisthesis l5 on s1 with associated advanced disc degeneration and relatively severe bilateral l5-s1 foraminal narrowing.On (b)(6) 2011: patient presented for office visit with chief complaint of low back pain.Patient presented with following diagnosis: chronic low back pain.On (b)(6) 2011: patient presented for office visit with chronic low back pain.On (b)(6) 2013: the patient presented with chief concern of mole on back, cyst on upper back.Popping sensation in neck, hammertoes and follow up for back pain and med refills.Patient underwent x-ray bilateral mammogram.On (b)(6) 2013: patient underwent mammogram diagnostic and ultrasound.On (b)(6) 2013: patient presented for office visit.Patient presented for pre-op diagnosis: hammertoe, left and right foot.Capsulitis, left foot.Patient underwent the following procedure: arthroplasty, left and right foot.Steroid injection.On (b)(6) 2013: patient underwent x-ray bone density.Patient presented with following diagnosis: stress fracture of other bone.Conclusion: bone density within normal limits.On (b)(6) 2014: patient presented for office visit.On (b)(6) 2014: patient presented with following pre-op diagnosis: lumbago.On (b)(6) 2014: the patient presented for mri.Mri demonstrated a/p fusion at l3-l4-5 and l5-s1 with trans-pedicular screws.Anterolisthesis of l5 on s1.Degenerative disc disease at l5-s1.The patient presented for chief concern of increase in chronic low back pain resulting in gait difficulty and difficulty getting out of bed over the past week.Patient presented for office visit with severe back pain.Patient underwent following procedure: bilateral ¿si¿ joint and trigger point injections at pain clinic.Patient underwent mri lumbar spine.Impression: post-op changes bilateral transpedicular screw and fixation l3-s1.Intervertebral spacer devices in place l3-4 and l4-5.Marked narrowing of intervertebral space with associated degenerative changes of adjacent end plates at l5-s1, 1.5 cm anterolisthesis of l5 on s1.Moderate to marked bilateral foraminal narrowing at l5-s1.No significant canal narrowing at any level.Normal distal cord.On (b)(6) 2014: the patient presented with back pain.Pertinent radiologic studies reviewed.Patient presented with following diagnosis: myofascial pain and sacroiliac joint pain.Assessment: myofascial pain, sacroiliac joint pain and low back pain.Patient underwent following procedures: trigger point injection, bilateral sacroiliac joint injection, fluoroscopic guidance and sedation based on patient's level of anxiety.On (b)(6) 2014: patient presented with chief complaint of back pain and following pre-op diagnosis: lumbar degenerative disc disease, status post lumbar fusion, sacroiliac joint dysfunction.Review of systems revealed patient complains of headache and positive for asthma.Assessment: chronic low back pain.Recent exacerbation of back pain, patient underwent a sacroiliac trigger point injection and lumbar degenerative disk disease.On (b)(6) 2014: patient presented for office visit with hernia.Impression: patient has an enlarging lipoma on her right flank.On (b)(6) 2014: patient presented with chronic low back pain.On (b)(6) 2014: patient presented for office visit with upper back sebaceous cyst and right flank lipoma.Patient presented with following pre-op diagnosis: right flank lipoma, upper back sebaceous cyst.Patient underwent the following procedure: excision of right flank lipoma and of upper back cyst.On (b)(6) 2014: the patient presented for follow up visits for uri.Diagnosis: bronchitis and cough.On (b)(6) 2014: patient presented for office visit.Diagnosis: bronchitis and cough.Patient underwent ct chest.Conclusion: no pulmonary embolism.Cholecystectomy.Moderate sized hernia.Trace, diffuse bronchial wall thickening, which can be seen with chronic bronchitis or reactive airways disease.No bronchiectasis or focal pulmonary consolidations.On (b)(6) 2014: patient presented for office visit with chief complaint of back pain.Patient underwent mri lumbar spine.Impression: p ost-operative changes bilateral transpedicular screw and fixation l3-s1.Intervertebral spacer devices in place l3-l4 and l4-l5.Marked narrowing of intervertebral space with associated degenerative changes of adjacent end plates at l5-s1, 1.5 cm anterolisthesis of l5 on s1.Moderate to marked bilateral foraminal narrowing at l5-s1.No significant canal narrowing at any level.Normal distal cord.Assessment: sacroiliac joint disorder.Myofascial pain.Back pain.Patient underwent the following procedures: bilateral sacroiliac joint injection.Fluoroscopic guidance.Trigger point injection.Conscious sedation.On (b)(6) 2014: patient presented for office visit.Patient underwent x-ray mammogram.Impression: no radiographic evidence for malignancy.On (b)(6) 2014: the patient underwent mammogram screening.On (b)(6) 2014: the patient presented for follow up for back pain.Patient presented with following pre-op diagnosis: lumbar spondylosis, back pain.Patient underwent the following procedure: right sided l1, l2, l3 lumbar medial branch blocks under fluoroscopy.On (b)(6) 2014: patient presented for office visit.Patient underwent the following procedure: excision of right flank lipoma.Excision of back cyst.On (b)(6) 2014: the patient underwent fluoroscopy.Patient presented with following diagnosis: status post lumbar fusion, back pain, lumbar spondylosis.Patient underwent the following procedure: right lumbar ¿mbb¿ with sedation.On (b)(6) 2014: patient presented for office visit.On (b)(6) 2014: the patient presented to the office with chief complaint of back pain, underwent s/p lumbar fusion.Patient underwent the following procedure: sacro-iliac joint injection, bilateral.Fluoroscopic guidance.On (b)(6) 2014: the patient presented for office visit.Patient presented with following pre-op diagnosis: lumbar spondylosis, trochanteric bursitis, status post lumbar fusion.Patient underwent the following procedure: lumbar ¿rf¿ with sedation.On (b)(6) 2015: the patient presented to the office with chief complaint of back pain.Patient presented with following pre-op diagnosis: sacroiliac joint pain, status post lumbar fusion.Patient underwent the following procedure: bilateral ¿si¿ joint injection with sedation.On (b)(6) 2015: patient presented for follow up with lumbar pain.Patient presented with following pre-op diagnosis: back pain, status post lumbar fusion and decreased pulse.On (b)(6) 2015: patient presented for office visit.Patient presented with following pre-op diagnosis: back pain, status post lumbar fusion and decreased pulse.On (b)(6) 2015: the patient presented for follow up and refill request.Patient underwent mri lumbar spine.Conclusion: postoperative changes of fusion l3 to s1 posteriorly and interbody fusion l3-l4, l4-l5.No change in anterolisthesis of l5 with respect to s1.Resulting in narrowing and distortion of neural foramina partially evaluated due to hardware related artifact.Degenerative changes above fusion without significant stenosis as above.On (b)(6) 2015: patient presented for office visit.Patient presented with following diagnosis: status post lumbar fusion, failed back syndrome, back pain.Patient underwent the following procedure: casual ¿esi¿ with sedation.On (b)(6) 2015: patient presented for office visit.Patient presented with following pre-op diagnosis: status post lumbar fusion, degenerative lumbar disc, lumbar spondylosis, failed back syndrome.Patient underwent the following procedure: casual ¿esi¿ with sedation.On (b)(6) 2015: patient presented for office visit.Patient presented with following pre-op diagnosis: status post lumbar fusion, degenerative lumbar disc, failed back syndrome, lumbar radiculopathy.Patient underwent the following procedure: casual ¿esi¿ with sedation.On (b)(6) 2015: patient presented with complaint of pain in back.Assessment: l3-s1 lumbar fusion, bilateral si joint pain.Impression: sacroiliitis.On (b)(6) 2015: patient underwent mri of lumbar spine.Conclusion: posterior interbody fusion l3-l4 through l5-s1 with anterior interbody fusion at l3-l4 and l4-l5.No findings for hardware failure.Alignment is stable with stable grade 2 anterolisthesis of l5 with respect to s1.Prior l5 - s1 laminectomy with dorsal decompression of the canal.Severe up-down foraminal stenosis is again seen bilaterally at l5-s1 as on prior.Borderline left foraminal narrowing l4-l5.Slight degenerative retrolisthesis of l1 on l2 and l2 on l3.Shallow associated disc and facet degenerative changes at these levels without significant canal or foraminal stenosis at these levels.Cholelithiasis.A 1.7 cm circumscribed area of t2 prolongation medial aspect of the right lobe of the liver, nonspecific but likely reflecting a small cyst or hemangioma.Patient also underwent mri of pelvis due to low back pain and si joint pain.Impression: both hips are negative for occult fracture or avascular necrosis.Mild degenerative arthropathy both hips.Both h ips demonstrate some superior joint space narrowing with thinning of the articular cartilage and chronic appearing degenerative irregularity and fraying of the anterior labrum.There is some subchondral reactive edema within the anterolateral aspect of the left acetabulum.Intermediate signal abnormality within the inferolateral aspect of the gluteus maximus musculature, greater on the left.This is not at the tendinous attachment and more consistent with focal strain type injury.Postoperative changes fusion lower lumbar spine.Bony pelvis and si joints otherwise negative.Exam otherwise negative.On (b)(6) 2015: the patient presented for an office visit with chief complaint of pain.On (b)(6) 2015: patient presented for office visit.Patient presented with the following diagnosis: sacroiliac joint dysfunction.Patient underwent the following procedure: bilateral ¿si¿.Assessment: sacroiliac joint dysfunction.Status post lumbar fusion.On (b)(6) 2015: patient presented for office visit.Impression: recurrent lipoma on right knee and smaller lipoma on left knee.On (b)(6) 2015: patient presented for office visit.Patient presented with following pre-op diagnosis: recurrent right knee lipoma.Left knee lipoma.Patient underwent the following procedure: excision of recurrent right knee lipoma, excision of left knee lipoma.On (b)(6) 2015: patient presented for office visit.Patient underwent x-ray mammogram.Impression: no radiographic evidence for malignancy.On (b)(6) 2015: patient presented for office visit.Patient presented with following diagnosis: status post lumbar fusion, degenerative lumbar disc and lumbar radiculopathy.Patient underwent the following procedure: casual ¿esi¿ injection with sedation.On (b)(6) 2015: patient presented for office visit with chief complication of infection.Patient presented with following diagnosis: status post excision of lipoma.Cellulitis of left lower extremity.On (b)(6) 2015: patient presented for office visit.Patient presented with following diagnosis: failed back surgical syndrome and degeneration of intervertebral disc of lumbar region.Patient underwent the following procedure: casual ¿esi¿ injection with sedation.On (b)(6) 2015: patient presented for office visit with back pain.Patient presented with following diagnosis: status post lumbar fusion.On (b)(6) 2015: patient presented for office visit.On (b)(6) 2015: patient presented for office visit with chief complaint of abdominal pain.Patient presented with following diagnosis: right lower quadrant abdominal pain.Patient underwent ct abdomen/pelvis.Impression: no acute findings in abdomen or pelvis.Normal appendix.On (b)(6) 2015: patient presented for office visit with chief complaint of abdominal pain.Patient presented with following diagnosis: ¿rlq¿ abdominal pain, chronic back pain.
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Event Description
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It was reported that on: (b)(6) 2006: the patient underwent x-ray of lumbosacral spine due to low back pain.On (b)(6) 2006: the patient underwent x-ray of chest.Findings: normal chest.On (b)(6) 2011: the patient presented with an office visit to consult regarding incisional hernia.On (b)(6) 2012: the patient presented for an office visit with chief complaint of low back pain.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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