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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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| Model Number \ |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Bronchitis (1752); Chest Pain (1776); Fatigue (1849); Headache (1880); High Blood Pressure/ Hypertension (1908); Muscle Spasm(s) (1966); Neuropathy (1983); Pain (1994); Pneumonia (2011); Loss of Range of Motion (2032); Swelling (2091); Weakness (2145); Tingling (2171); Cramp(s) (2193); Stenosis (2263); Depression (2361); Numbness (2415); Neck Pain (2433); 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 an anterior lumbar interbody fusion (alif) surgery from l5 to s1 using rhbmp-2/acs.Reportedly, the patient¿s post-operative period has been marked by increasingly severe pain and weakness in her legs.The patient developed pain that radiates into her lower extremities.She has numbness, tingling, and loss of sensation down through her legs.
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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.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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Event Description
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It was reported that on (b)(6)2012 per billing records the patient presented for an office visit for x-ray exam of knee.(b)(6) 2008 , the patient presented for xr of lumbar spine.(b)(6) 2008, mr lumbar spine un siemens.(b)(6) 2009, the patient presented with chest pain and underwent znmmyosr-nm myocardial stress and rest.(b)(6) 2009, the patient presented for follow up of test results , diagnosis.Impression: acute bronchitis, viral syndrome.(b)(6) 2010, the patient presented for xray of right ankle because of the injury to right foot.Impression: no fracture or bony lesion.(b)(6) 2011, the patient presented for mri lumbar spine after complaint of lumbar pain radiating down to hip and anterior thigh.(b)(6) 2012, patient presented for xray /chest because of pneumonia.(b)(6) 2015 , the patient presented for ct abdomen pelvis w contrast and x ray (chest ) due to pain in abdomen and chest (b)(6) 2010 <(>&<)> (b)(6) 2011 , per billing records, the patient presented in the facility.(b)(6) 2010 <(>&<)> (b)(6) 2011 , the patient presented for pelvic and breast exam.(b)(6) 2014 , per billing records, the patient presented in the facility for urine pregnancy test , pelvic and breast exam , fluzone vaccine.(b)(6) 2015 , per billing records, the patient presented in the facility.(b)(6) 2012: the patient presented with pain in her right knee and back pain.She had numbness going down her right leg.There was also swelling medially and laterally and around her patella.She had pain with walking, with sleeping and going up and down the stairs.Radiographs of both knees were reviewed which revealed slight medial tibial femoral joint space narrowing bilaterally, no fractures and no obvious loose bodies.Impression: the patient was being diagnosed for radiculopathy, sacroilitis on the left and postlaminectomy syndrome.(b)(6) 2010: patient presented with cholelithiasis due to abdominal pain.Impression: 1.Symptomatic cholelithiasis.2.Atypical chest pain, requiring nitroglycerin.3.Chronic leg and back pain.4.Depression/anxiety.(b)(6) 2010: the patient presented with a main concern of establishing care and discussing several issues (b)(6) 2010: the patient presented for follow up of her labs pap and breast exam (b)(6) 2010: patient presented with gallbladder cholecystectomy, histologic features consistent with cholesterolosis and cholelithiasis.Status post laparoscopic cholecystectomy.(b)(6) 2010: the patient presented with cough runny nose and wheezing and also to get the depo shot.(b)(6) 2015: the patient presented with the following impression: 1.Obesity.2.Hypertension.3.Periodic limb movement disorder.4.Mild opstructive sleep hypopnea syndrome, hi<(><<)> 1 with oxygen desaturation.
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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) 2001: patient sustained an industrial injury.(b)(6) 2012: patient presented with osteoarthritis.(b)(6) 2013: patient presented with back and lower extremity pain.(b)(6) 2013: patient presented with following impression: 1) multilevel degenerative disc and facet changes.2) mild dilatation of the central canal spinal cord distally versus a mild syrinx.3) moderately severe spinal canal stenosis at the l3-4 level with accompanying mild bilateral neural foraminal stenosis and mild to moderate stenosis of the adjacent lateral recesses of l4 bilaterally, which is secondary to a triad of degenerative disc and facet change as well as ligamentum flavum redundancy.4) broad based, right paracentral and lateral disc protrusion at l4-5 which results in moderately severe right sided neural foraminal stenosis.The underlying degenerative disc and facet changes at this level also causes mild left sided neural foraminal narrowing, mild central canal stenosis and mild lateral recess stenosis at the l5 level.5) changes of prior anterior fusion at l5-s1.(b)(6) 2013 patient underwent mri of lumbar spine.Impression: 1) persistent disc herniation and posterior element hypertrophy producing moderately severe canal stenosis above the fusion at l4-5.There was right neural foraminal narrowing without definite impingement on the exiting foraminal right l4 root.2) slight radiographic improvement in disc herniation and canal stenosis at the l3-4 level with left paramedian protrusion narrowing the left subarticular recess with possible traversing left l4 root impingement.3) stable appearance at the operated l5-s1 level.4) stable appearance of caudal thoracic cord syrinx.(b)(6) 2013, (b)(6) 2014, (b)(6) 2015: patient presented with chief complaint of back, right hip and right leg, foot , knee and head pain.Patient's pain control has worsened.Assessment: post laminectomy syndrome, spinal stenosis, bilateral primary osteoarthritis of knee, fibromyalgia, migraine.(b)(6) 2015: patient underwent right hip injection.(b)(6) 2015: patient underwent right trochanteric bursa injection.
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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 the patient was presented for office visit with constant pain in her lower back radiating into both legs.She also reported numbness and tingling in both lower extremities, lower back spasms, sleeping difficulty due to pain.She has difficulty in walking.She underwent mri of the lumbar spine that demonstrated l5-s1 degenerative disc disease with bilateral neuroforaminal stenosis.There is a central disc protrusion that measures approximately 6mm in ap diameter.There is loss of disc height with dehydration of the disc.On (b)(6) 2003 the patient was presented for office visit for follow up evaluation.She underwent mri of the lumbar spine which demonstrated severe l5-s1 degenerative disc disease as well as l4-5 and l5-s1 right neuroforaminal stenosis.There is loss of disc height with desiccation at the l5-s1 level.Diagnosis: l5-s1 lumbar degenerative disc disease; l4-5 lumbar stenosis; lumbar radiculopathy.On (b)(6) 2003 the patient underwent: minimally invasive l4-5 right sided hemilaminotomy and foraminotomy; use of intraoperative microscope for microsurgical dissection using a minimally invasive technique; use of intraoperative fluoroscopy; use of intraoperative free run electromyelogram recordings using nuvasive neural monitoring system.Perop notes: using a minimally invasive discectomy system, a k wire was placed percutaneuously in a trajectory towards the l4-5 disc space.On (b)(6) 2004 the patient was presented for office visit for follow up evaluation.She complained of severe right lower extremity pain and pain in her right foot and reported difficulty in walking.Diagnosis: status post l5-s1 interbody fusion; right l4-5 formenotomy; probable right l5 radiculopathy.On (b)(6) 2004 the patient was presented for office visit with severe right leg pain and numbness across the top of her foot.The patient underwent ct scan of lumbar spine.Impressions: persistent posterior disc extrusion at the l5-s1 level resulting in mild central canal stenosis as well as moderate bilateral recess encroachment.Also at l4-5 there is moderate bilateral neural foraminal encroachment, right greater than left, at the l4-5 level.At l4-5 there is a disc bulging measuring 4mm in the greatest ap diameter.At l5-s1 there is a focal central disc protrusion measuring 6mm in the greatest ap diameter resulting in effacement of the anterior thecal sac and causing moderate bilateral neural foraminal encroachment and moderate bilateral recess encroachment.Diagnosis: persistent right lumbar radiculopathy due to persistent l5-s1 and l4-5 neural foraminal stenosis and l5-s1 disc protrusion.On (b)(6) 2004 the patient was presented for office visit with severe right leg pain that radiates down her posterior right leg into the lateral right ankle and across the dorsum of her right foot.She complained of numbness in the 1st web space of her right foot with occasional burning in this region.On (b)(6) 2004 the patient underwent: minimally invasive l5-s1 foraminotomy right side; redo minimally invasive l4-5 forminotomy right side; use of intraoperative microscope for microsurgical dissection for minimally invasive system; use of intraoperative fluoroscopy for intraoperative localization.Preoperative diagnosis: lumbar radiculopathy.Perop notes: with the facetectomy, the lateral aspect of the disc space could be visualized and palpated using a forminal probe.There was large lateral osteophyte disc.This appeared to be compressing the l5 nerve root and decompress it posteriorly.The facetectomy was completed to expose the 1% nerve root and decompress it posteriorly.On (b)(6) 2004 the patient was presented for office visit with sudden episode of bilateral lower leg pain and cramping leg pain.Diagnosis: status post l5-s1 fusion; status post lumbar foraminotomy, l4-5.On (b)(6) 2004 the patient was presented for office visit.Diagnosis: status post lumbar fusion and lumbar foraminotomy.On (b)(6) 2015 the patient underwent robotic assisted total laparoscopic hysterectomy, bilateral salpingo oophorectomy, extensive lysis of adhesions, transobturator tape placement, cystoscopy, flexible sigmoidoscopy.
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Event Description
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It was reported that on; (b)(6) 2008: patient underwent x-ray of lumbar spine and complains of low back pain.Conclusion: lumbar spine demonstrating anterior fusion l5-s1 which appears to be intact.No evidence for acute fracture or subluxation.Degenerative changes are identified at all levels with mild disc space narrowing in the lumbar spine and small marginal osteophytes however significant disc space narrowing and moderate osteophytes are identified at the thoracal lumbar junction.(b)(6) 2008: patient underwent x-ray of lumbar spine due to fall, right lower back pain.Conclusion:no significant change.No evidence for acute fracture or sublaxation.Degenerative changes are identified at multiple levels with anterior lumbar fusion l5-s1 which appears to be stable.Patient underwent x-ray of pelvis due to fall,right lower back pain.Conclusion: single view pelvis demonstrates no evidence of fracture or dislocation (b)(6) 2010: patient underwent doppler ultrasonography of complete abdomen due to abdomen pain.Conclusion: cholelithiasis and possible choledochal lithiasis; possible diffuse fatty infiltration of the liver.It appears that the pancreatic duct is generous in caliber.This can be seen with stone or other obstruction in the distal common bile duct at the level of the sphincter of oddi.(b)(6) 2010: patient underwent 2d echo with doppler and color flow(adult echocardiography procedure).(b)(6) 2010: patient underwent bilateral digital scanning mammogram with cad.Impression: bi-rads category 2 benign findings.(b)(6) 2010 : patient underwent "or chole and/or pancreatogram due to lap chole.Conclusion: normal operative cholangiogram (b)(6) 2011, the patient underwent bilateral digital screening mammogram with cad.Impressions: bi-rads category 2 benign findings.(b)(6) 2014 the patient underwent bilateral digital screening mammogram with cad and tomosynthesis.Impressions: bi-rads category 2 benign findings.
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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 for an office visit due to low blood pressure and sleep disorder.(b)(6) 2004 patient presented for an office visit.On (b)(6) 2004 patient underwent ct of the lumbar spine without contrast including 3d multiplanar reformation.Impression: postoperative changes are identified related to a right anterolateral fusion with bilateral pedicle screws at the l5 and s1 levels with an anterior fusion plate.There is no evidence of hardware complication.There is a persistent posterior disc extrusion at the l5-s1 level resulting in mild central spinal canal stenosis as well as moderate bilateral recess encroachment and moderate bilateral neural foraminal encroachment.There are mild disc bulges at l3-4 and l4-5.They are essentially unchanged when compared to the prior examination.There is persistent mild bilateral neural foraminal encroachment at l3-4 as well as mild central spinal canal stenosis and moderate bilateral neural foraminal encroachment, right greater than left, at the l4-5 level.Disc material at this level approaches the transiting l5 nerve roots bilaterally.No new disc bulge of the lumbar spine is seen.The remainder of the other levels of the lumbar spine are unremarkable and unchanged when compared to the prior study of (b)(6) 2003.On (b)(6) 2004 patient presented for an office visit due to pain.Review of mri of lumbar spine.On (b)(6) 2004 the patient was presented for office visit due to pain is intolerable; it is worse since her surgery on (b)(6) 2003.Impression: s/p lumbar fusion on (b)(6) 2003 with persistent complaints of severe low back pain with right lower extremity radiation.Lumbar mri ((b)(6) 2004) evidence of minimal disk bulging at l1-2 and l2-3, 3 mm disk bulging at l3-4 resulting in mild bilateral neural foraminal encroachment, a 4 mm disk bulge at l4-5 resulting in central spinal canal stenosis and moderate bilateral neural foraminal encroachment, persistent disk extrusion at l5-s1 resulting in central canal stenosis and bilateral neural foraminal encroachment, and postoperative changes related to a right anterolateral fusion with bilateral pedicle screws at l5 and s1 with an anterior fusion plate, and no evidence of hardware complication.Chronic tension headaches and myofascial cervicalgia.Associated depression and sleep disorder.On (b)(6) 2004 patient presented for a medical-legal psychiatric evaluation.On (b)(6) 2004 patient for an office visit due to low back pain, strain, possible disc.Fatigue.Mood swings.Impression: mild anular disc bulge l3-4 and l4-5 with no evidence of neurologic impingement, nerve root.Question of left l5 nerve root impingement due to l5-s1 bony facet hypertrophy left side.On (b)(6) 2004 patient presented due to severe discomfort, numerous paroxysms of pain.Moderate bilateral occipital nerve tenderness.Impression: s/p lumbar fusion on (b)(6) 2003 with persistent complaints of severe low back pain with right lower extremity radiation.Lumbar mri evidence of central canal stenosis and moderate bilateral neural foraminal encroachment at l4-5, and a persistent disk extrusion at l5-s1 resulting in central canal stenosis and bilateral neural foraminal encroachment.Chronic tension headaches and myofascial cervicalgia.Associated depression and sleep disorder.On an unknown date in (b)(6) 2004: patient was admitted to the hospital and underwent a fusion at l5-s1.There was one episode in which she slipped from her walker, fell forward and injured her lower extremities.X-rays revealed no fracture.There was no symptomatic change after that incident.Six months after surgery there was increasing lumbar pain radiating into the right lower extremity and right foot with numbness and tingling constantly present.There may have been epidural injections in this time frame although the patient is uncertain.In any case, the conservative treatment was of no benefit.X-rays were repeated.On (b)(6) 2004 patient underwent ct scan of the lumbar spine due to right lower back pain, right greater than left leg pain and paresthesia.Diagnosis: right lumbar radiculopathy, l4-l5, l5-s1 lumbar stenosis.Status post l5-s1 anterior lumbar interbody fusion and right l4-l5 decompression.On (b)(6) 2004: patient presented with an office visit for follow-up.On (b)(6) 2004 patient presented due to ¿severe spasm¿ of her buttock and pain down the posterior aspect of each lower extremity to the ankle.S/p repeat lumbar spine surgery on (b)(6) 2004 with increasing complaints of pain and disability.Tension headaches associated with bilateral occipital neuralgias, and myofascial cervicalgia; 2 cervical trigger points as noted above.Associated depression and sleep disorder.On (b)(6) 2004 patient had right buttock pain in now ¿mild¿ and shed had experienced a dramatic decrease in her lower extremity cramping, spasm and sharp pain.Also she was complaining of a lot of upper back pain, neck pain, and headaches.Impression: s/p repeat lumbar spine surgery on (b)(6) 2004 with persistent complaint: of pain and disability; dramatically improved since a caudal epidural on (b)(6) 2004.Tension headaches associated with bilateral occipital neuralgias and myofascial cervicalgia.Resolving depression and sleep disorder.On (b)(6) 2005 patient presented due to ¿a lot of low back pain, and ¿sharp pain and muscle spasm¿ of both lower extremities.S/p repeat lumbar spine surgery on (b)(6) 2004 with persistent complaints of pain and disability.Tension headaches associated with bilateral occipital neuralgias and myofascial cervicalgia.Associated depression and sleep disorder.On (b)(6) 2005 patient presented due to bilateral lower extremity swelling due to the pre-op diagnosis: bilateral lumbosacral radiculopathy.Sip repeat lumbar spine surgery on (b)(6) 2004 with persistent complaints of pain and disability.Patient underwent the following procedures: caudal epidural steroid injection #1 under fluoroscopy, with conscious sedation.On (b)(6) 2005: patient presented with an office visit due to pain.Impressions: postlaminectomy syndrome, lumbar region.Occipital neuralgias, tension headaches, and myofascial cervicalgia.Associated depression and sleep disorder.On (b)(6) 2005: patient presented for a visit.Impressions: spinal repeat lumbar spine surgery on (b)(6) 2004 with persistent complaints of pain and disability.Tension headaches associated with bilateral occipital neuralgias and myofascial cervicalgia.Associated depression and sleep disorder.On (b)(6) 2005: patient underwent radiology exam due to back pain.Impressions: mild compressive deformities lower thoracic spine.Degenerative changes of the lumbar spine with l5-s1 fusion.On (b)(6) 2005: patient presented with a office visit due to low back ain radiating into the neck and into the right buttock and right leg.Patient complains of trouble in walking.On (b)(6) 2005: patient presented with an office visit due to pain.Impressions: post laminectomy syndrome, lumbar region.Occipital neuralgias, tension headaches, and myofascial cervicalgia; not active complaints at this time.Associated depression and sleep disorder.On (b)(6) 2005: patient presented with an office visit.Impression: postlaminectomy syndrome, lumbar region.Intermittent complaints of occipital neuralgias, tension headaches, and myofacial cervicalgia.Resolving depression and sleep disorder.On (b)(6) 2005: patient presented with an office visit.Impressions: s/p lumbar fusion and a subsequent foraminotomy with persistent complaints of pain.Intermittent complaints of occipital neuralgias, tension headaches, and myofascial cervicalgia.Associated depression and sleep disorder.Significant drowsiness secondary to low dose oxycontin.On (b)(6) 2005: patient presented with an office visit.Impressions: spinal lumbar fusion and a subsequent foraminotomy with persistent complaints of pain.Int complaints of occipital neuralgias, tension headaches, and myofascial cervicalgia.Associated depression and sleep disorder.On (b)(6) 2005: patient presented with left hip pain and left low back pain.She has pain on palpation at the level of l4, ls, 51 directly on palpation of her t-spine.Impression: new onset of sciatica on left side.Medication refill.On (b)(6) 2005: patient underwent an mri of the lumbar spine due to hip and leg pain.Impressions: degenerative and postsurgical changes are noted.The most significant findings are at l4-5 where there is a moderate size focal disc herniation from midline to right extending into the right foramen.The disc protrusion together with facet arthropathy and hypertrophy results in a moderate spinal canal stenosis particularly involving the right lateral recess.The disc protrusion extends into the right foramen which is at least moderately stenotic.On (b)(6) 2005: patient presented for an office visit due to her back pain and received prescriptions for gabitril, skelaxin, ambien and extra strength vicodine.She also told that it all started after a work injury 4 years ago.On (b)(6) 2005: patient presented for a follow-up of her back pain.Patient also says that she has been also feeling depressed.Assessment: depression.Chronic back pain.On (b)(6) 2006: patient presented for a follow-up on her back pain.Assessment: back pain and depression.On (b)(6) 2006: patient got admitted and underwent an x-ray of the lumbar spine due to back pain.Impressions: acute back pain.Sciatica.Patient was discharged on same day.On (b)(6) 2006: patient presented for a follow-up on due to her back pain and depression.Patient also had an incapacitating pain radiating down her right leg.Patient also underwent xray exam which showed no change in the hardware on her back.Assessment: back pain and depression.On (b)(6) 2006: patient presented for a follow-up due to numbness and tingling in her hands.Patient also feels anxious.Assessment: depression and back pain.On (b)(6) 2006: patient presented for a follow-up on her chronic back pain and depression.Patient says that her pain has been worse this week.However, she does admit that she has been doing a lot more activity.She is concerned that she might need another back operation.She has already had 2 surgeries on her back.Patient says the depression is a little better.She is taking 150 mg of the zoloft.Assessment: patient has a history of radiculopathy on her back.On (b)(6) 2006: patient presented for a follow-up due to difficulty in sleeping, anxiety, depression and suicidal tendencies.Plan: patient is to see her primary care provider.(b)(6) 2006: patient presented for a follow-up on her back pain and persistent insomnia.Assessment: back pain: patient has back pain with radiculopathy.She is referred to a physical therapy.Insomnia: i recommended discontinuing the ambien since this is not a good long-term medication.Depression.On (b)(6) 2006: patient presented with chronic back pain following two lumbar surgeries for an otj injury on (b)(6) 2001.Patient states she had several ruptured discs and she now has plates with screws inserted in lumbar spine.She walks stiffly and has difficulty getting in and out of the chair.Her range of motion is limited.Assessment: her (r) sacroiliac is quite tight and when the surgeon tried on an is support with a sacral pad, her pain is much.She states she can walk much easier.On (b)(6) 2006: patient presented for a follow-up and physical therapy due to depression and chronic back pain.
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Event Description
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It was reported that on (b)(6) 2003 the patient presented with preoperative diagnosis of right lumbar radiculopathy status post l5-s1 anterior lumbar decompression neuroforaminal stenosis of l4-5 and l5-s1, l5-s1 disc degeneration.L5-s1 discogenic low back pain.Retrolisthesis, l5 on s1 and underwent : minimally invasive l4-5 right sided hemilaminectomy and foraminotomy use of intraoperative microscope for microsurgical dissection using a minimally invasive technique use of intraoperative fluoroscopy use of intraoperative free run electromyelogram recordings using nuvasive neural monitoring system.Transperitoneal approach to l5-s1 disc space.L5-s1 anterior lumbar decompression.L5-s1 anterior lumbar interbody arthrodesis.Placement of an intervertebral carbon fiber cage l5-s1.Use of bone morphogenic allograft.Perop notes: using the minimally invasive discectomy system, a k wire was placed percutaneously in a trajectory towards the l4-5 disc space.As per op notes" a carbon fiber cage was selected and filled with bone morphogenic protein-soaked collagen sponges.This was then impacted directly into the disk space.C-arm fluoroscopy was utilized to guide the correct trajectory into the disk space and to confirm appropriate anterior posterior placement of the cage.Once this was confirmed, the anterior lumbar plate was then placed.Using a anterior plate, vertebral body screws were placed in the l5 and into the s1 body to secure an anterior lumbar plate.This was also performed using the c-arm fluoroscopy to guide an appropriate trajectory of the screws as well as the appropriate depth of the screws.Throughout the procedure, intraoperative emg recordings were performed." patient tolerated the procedure well.No complications were reported.On (b)(6) 2004: the patient presented with back pain and leg pain and was diagnosed with status post right l4-l5, l5-s1 foraminotomy and previous l5-s1 fusion.Low back pain.Right greater than left radiculopathy.Muscle spasm.Loss of strength.Gait difficulty."ad'" deterioration.On (b)(6) 2004: patient presented for office visit with chief complaint of right leg pain.Diagnosis: thoracic or lumbosacral neuritis or radiculitis.On (b)(6) 2005: patient presented with a office visit due to low back pain radiating into the neck and into the right buttock and right leg.Patient complains of trouble in walking.Patient states that pain radiates now to her left side and is severe.Patient ambulates with mildly antalgic gait.Ap and lateral x-rays were reviewed which show stable inter-body fixation at l5-s1 with an anterolateral plate.There is inter-body graft noted at the l5-s1 level.The disc space is not well visualized on lateral views due to iliac crest and on ap views due to fixation plate.Diagnosis: thoracic or lumbosacral neuritis or radiculitis.On (b)(6) 2006: patient presented for a follow-up due to difficulty in sleeping, anxiety, depression and suicidal tendencies.Plan: patient is to see her primary care provider.On (b)(6) 2006: the patient underwent x-ray of lumbosacral spine due to back pain.Conclusions: anterior fusion of l5-s1.Disc space narrowing and osteophyte formation seen at t12-l1.Otherwise unremarkable lumbar spine series.On (b)(6) 2007: the patient presented with herniated disc, pinched nerve and depression.On (b)(6) 2007: the patient presented with chronic pain fail back syndrome.On (b)(6) 2007: the patient underwent bilateral digital screening mammography due to asymptotic baseline exam.Conclusions: benign bilateral calcifications.No suspicious findings.On (b)(6) 2008, (b)(6) 2009: patient presented for regular follow up due to intensive pain.She could barely walk.Assessment: postlaminectomy syndrome of lumbar spine, morbid obesity, lumbosacral root lesions/radiculopathy, lumbar spinal stenosis.On (b)(6) 2009: the patient underwent x-ray of chest due to chest pain.Impression: unremarkable portable film of the chest.On (b)(6) 2009: the patient presented with 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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