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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 7510800 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Ossification (1428); Dyspnea (1816); Edema (1820); Fatigue (1849); Fever (1858); Headache (1880); Hematoma (1884); High Blood Pressure/ Hypertension (1908); Muscle Spasm(s) (1966); Nausea (1970); Nerve Damage (1979); Neuropathy (1983); Pain (1994); Loss of Range of Motion (2032); Rash (2033); Swelling (2091); Thyroid Problems (2102); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Weakness (2145); Tingling (2171); Chronic Obstructive Pulmonary Disease (COPD) (2237); Stenosis (2263); Depression (2361); Inadequate Pain Relief (2388); Numbness (2415); Neck Pain (2433); Neck Stiffness (2434); Sleep Dysfunction (2517)
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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.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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Event Description
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On (b)(6) 2008, patient presented with preoperative diagnosis of: mechanical low back pain.Kyphotic deformity of the lumbar spine.Pseudarthritis.Patient underwent following operations: partial removal of hardware, l2-l4.Exploration of fusion.Posterior arthrodesis, l4-l5 and l5-s1.Legacy 5.5 instrumentation systems was used.Per op notes, the bone graft consisted of infuse, allograft bone, and demineralized bone matrix into the lateral gutters and subsequently once the bone graft was in place, hemostasis was achieved.No patient complications were noted.On (b)(6) 2008, patient presented for first postoperative visit.Doctor renewed vicodin and increased lyrica to 75mg.On (b)(6) 2009, patient presented for follow up of lumbar spine.Doctor advised lyrica.On (b)(6) 2010, patient presented for follow up of multilevel lumbar decompression and posterior instrumented fusion.Doctor advised lyrica.On (b)(6) 2010, patient underwent x-ray for lumbar spine.Impression: status post lumbosacral spine fusion.No evidence of lumbosacral spine fracture or hardware failure.There is 4 mm of retrolisthesis at l3-l4 which is probably chronic.On (b)(6) 2010, patient presented for follow up.Doctor¿s impression was primary upper lumbar/lower thoracic pain.On (b)(6) 2011, patient presented with persistent pain in her leg, left greater than right.Patient underwent x-ray of ls spine which shows posterior pedicle screw instrumentation l2 to s1 with transforaminal lumbar interbody grafts at l4-l5 and l5-s1.There is no evidence of hardware failure.There does not appear to be a significant amount of bone in the lateral recesses, left greater than right.Impression: low back pain.Lumbar radiculopathy on (b)(6) 2011, patient underwent ct lumbar spine without contrast due to lumbar radiculopathy.On 13 jun 2011 patient presented with lumbar ct scan which shows evidence of posterior pedicle screw instrumentation l2 to s1.There is no evidence of hardware failure.However, the right pedicle screws at l5 and s1 possibly compromise the right lateral recess exiting nerve root.On(b)(6) 2011, patient presented for follow up.Doctor reviewed ct scan which shows solid appearing fusion.From prior ct it was noted to have possible compromise involving the l5-s1 right pedicle screws.On (b)(6) 2011, patient presented with low back, bilateral lower extremity pain.Doctor¿s assessment was: low back, bilateral lower extremity radiculopathy.Presumably failed back surgery syndrome.On (b)(6) 2011, patient presented with preoperative diagnosis of: hammertoe deformity, second, third and fourth, right foot.Contraction deformity, second, third and fourth, right foot.Patient underwent following procedures: hammertoe correction with pro toe implant, second, third and fourth digits.Tenotomy, second, third and fourth extensor tendons.Excision of exostosis, distal phalanx, second toe.On (b)(6) 2012, patient presented with significant left sided pain and tenderness through the left side.Doctor¿s assessment was neck pain and left cervical radiculopathy.Left lower extremity pain could also be secondary to her neck.On (b)(6) 2012, patient underwent mri of cervical spine.Impression: multilevel spondylosis.Degenerative findings look most pronounced at c4-5, c5-6, and c6-7.At these levels there is foraminal stenosis without suggestion of significant central stenosis.On (b)(6) 2012, patient presented for follow up.Doctor reviewed mri c spine which shows multilevel disc osteophyte complexes with evidence of cervical kyphosis.On (b)(6) 2012, patient presented with left sided neck pain and intermittent radiculopathy down her left arm.Patient underwent spinal tests cervical-vertebral artery test which indicates a vertebrobasilar insufficiency.Doctor¿s assessment: neck pain is creating significant pain/disability during routine adls such as sleep disturbances.Patient presented with restricted range of motion, muscle imbalances and muscle weakness around her cervical spine.On (b)(6)2012, patient underwent ct lumbar spine without contrast.Impression: no definite changes from (b)(6) 2012.Fusion and laminectomy without definite space occupying hematoma.Hardware and fusion as described.Stable medial placement of right l5 and s1 pedicle screws.Please see of above and prior report for a detailed description.Stable possible l3-l4 right paracentral disc herniation versus scarring.Imaging of the central canal by noncontrast ct is limited and significant abnormalities may be missed.On (b)(6) 2012, patient presented with increasing lower back pain.Doctor recommended muscle relaxant and anti inflammatory medicines.On (b)(6) 2012, patient underwent ct for chest.Impression: small right upper lobe pulmonary nodules.Mild diffuse emphysematous changes.Status post cholecystectomy with probable increased capacity dilation of the common bile duct.Otherwise remarkable.On (b)(6) 2012, patient presented with ct of chest which showed small right upper lobe pulmonary nodules.There were diffuse emphysematous changes.On (b)(6) 2012, patient presented with increasing pain in her neck, across her shoulders and down into her arms.Doctor¿s impression was cervical spinal stenosis.On (b)(6) 2013, patient presented with pain in neck that diffusely radiated across shoulder subsequently down into her arms.Doctor¿s impression was cervical spinal stenosis.On (b)(6) 2013, patient presented with preoperative diagnosis of: disc osteophyte complex c4-5, c5-6, c6-7.Cervical radiculopathy.Axial neck pain.Patient underwent anterior cervical discectomy and fusion c4-5, c5-6, c6-7 with allograft bone instrumentation.No patient complications are noted.Patient underwent x-ray for spine to check fracture or level of surgery which show tip of metallic instrument at the level of the c5-c6 disc space.Patient underwent x-ray for spine to check fracture or level of surgery which show metallic probe superimposed on the anterior aspect of the c4-c5 disc space.Patient again underwent x-ray of spine which shows satisfactory postop appearance of anterior screw-plate fusion.On (b)(6) 2013, patient presented for first postoperative visit.On (b)(6) 2013, patient presented for follow up.Patient underwent x-ray which shows the hardware to be in place and intact and the fusion to be consolidating well.On (b)(6) 2013, patient presented for follow up of anterior cervical discectomy and fusion.Doctor¿s assessment was that overall patient is doing well with some persistent left shoulder pain.On (b)(6) 2013, patient underwent mri of left shoulder due to pain in shoulder joint.Impression: relatively mild cuff disease, no high grade partial or full thickness cuff tear.Ac arthropathy.On (b)(6) 2013, patient presented for follow up.Patient had an mri od shoulder which show degenerative changes.On (b)(6)2013, patient underwent mri cervical spine due to neck pain.Impression: post surgical changes of c4-c7 acdf with no significant exit foraminal stenosis at any level.A left paracentral osteophyte at c5-c6.A low signal left paracentral structure at level c5 likely represents a screw protruding into the central canal.An osteophyte is considered less likely given the degree of susceptibility artifact.If evaluation of hardware positioning is clinically indicated, ct is the examination of choice.On (b)(6) 2013, patient presented with neck pain.Patient underwent mri of cervical spine which shows evidence at c4-c5 of some mild central stenosis.At c5-c6 there is a disc osteophyte complex resulting in some mild stenosis as well.Doctor¿s recommendation was selective nerve root block at c5-c6.On (b)(6) 2013, patient presented with continued neck and back pain.
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Event Description
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It was reported that on, (b)(4) 2014: patient presented for follow-up with back pain.(b)(6) 2014, (b)(6) 2015, (b)(6) 2014, : patient presented for follow up of chronic conditions.(b)(4) 2014: patient underwent x-ray of the chest.Impression: left upper lobe nodular density.No evidence of acute cardiopulmonary disease.(b)(6) 2015: the patient underwent x-ray of chest.Impression: less apparent nodular opacity in left upper lobe.(b)(6) 2015: the patient underwent upper gi endoscopy.Impression: normal esophagus.Erythematous mucosa in the antrum.Biopsied.A single gastric polyp.Biopsied.
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Manufacturer Narrative
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(b)(4).(pseudoarthrosis).
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Event Description
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It was reported that on (b)(6) 2008 the patient was presented for office visit with complication of urinary frequency.Impressions: patient with epigastric discomfort and previous history of antral gastritis.She as wearing a constrictive back brace girdle type apparatus that may be causing some intraabdominal pressure and exacerbating her reflux although her reflux symptoms are predominately the first thing in the morning and seem to be nocturnal.This apparatus may also have some effect on her urinary frequency which seems to be only during the day.Ua was negative for any sign of infection.On (b)(6) 2008 the patient was presented for office visit for a periodic assessment of her chronic medical conditions.Impressions: 1) left l5 sciatica, 2) hyperlipidemia, 3) insomnia, 4) hypothyroidism, 5) allergic rhinitis, 6) restless leg syndrome, 7) copd, 8) gerd, 9) osteoarthritis on (b)(6) 2008 the patient was presented for office visit with hypertension, hyperlipidemia, hypothyroidism, weakness, chronic obstructive pulmonary disease and osteoarthritis.Impressions: 1) degeneration, lumbosacral disc; 2) hyperlipidemia; 3) restless leg syndrome.On (b)(6) 2009 the patient was presented for office visit with numbness, fatigue and cough.Impressions: 1) degeneration, lumbosacral disc; 2) hyperlipidemia; 3) restless leg syndrome; 4) polyneuropathy in diabetes; 5) bronchitis on (b)(6) 2010 the patient was presented for office visit with hypertension, hyperlipidemia, hypothyroidism, weakness, chronic obstructive pulmonary disease and osteoarthritis.Impressions: 1) degeneration, lumbosacral disc; 2) hyperlipidemia; 3) restless leg syndrome 4) esophageal reflux.On (b)(6) 2010 the patient was presented for office visit with complication of skin rash.Impressions: dermatophytosis.On (b)(6) 2010 the patient was presented for office visit.Impressions: 1) copd, 2) malaise and fatigue, 3) edema.On (b)(6) 2010 the patient was presented for office visit for periodic assessments.Impressions: 1) copd 2) hyperthyroidism 3) hyperlipidemia 4) esophageal reflux 5) depression 6) lumbosacral degeneration.On (b)(6) 2010 the patient was presented for office visit with shortness of breath.Impressions: 1) copd 2) hyperthyroidism 3) hyperlipidemia 4) esophageal reflux 5) depression 6) lumbosacral degeneration.On (b)(6) 2011 the patient was presented for office visit for periodic assessments.Impressions: 1) copd 2) hyperthyroidism 3) hyperlipidemia 4) esophageal reflux 5) depression 6) lumbosacral degeneration.On (b)(6) 2011 the patient was presented for office visit with abdominal pain.Impressions: 1) acute gastritis, 2) hypertension, 3) hypothyroidism, 4) dehydration on (b)(6) 2011 the patient was presented for office visit for periodic assessments.Impressions: 1) copd 2) hyperthyroidism 3) hyperlipidemia 4) esophageal reflux 5) depression 6) lumbosacral degeneration.On (b)(6) 2011, the patient underwent surgery due to hammertoe.On (b)(6) 2011 the patient was presented for office visit with nostril swelling.Impressions: sinusitis on (b)(6) 2011, (b)(6) 2012 the patient was presented for office visit for periodic assessments.Impressions: 1) copd 2) hyperthyroidism 3) hyperlipidemia 4) esophageal reflux 5) depression 6) lumbosacral degeneration.On (b)(6) 2012 the patient was presented for office visit with edema.Impressions: manifestation/gout.On (b)(6) 2012 the patient was presented for office visit for periodic assessments.Impressions: 1) copd 2) hyperthyroidism 3) hyperlipidemia 4) esophageal reflux 5) depression 6) lumbosacral degeneration.On (b)(6) 2012 the patient presented for follow-up and reported fever with cough and was admitted to the er.On (b)(6) 2012 the patient presented for follow-up with minor complaints and poor sleep.On (b)(6) 2012 the patient presented for follow-up and reported neck pain, nausea and poor sleep.On (b)(6) 2012 the patient presented for follow-up and reported increased chronic pain, fatigue and poor sleep.On (b)(6) 2013, the patient underwent cervical diskectomy and fusion.On (b)(6) 2013 the patient presented for follow-up and reported chronic cough, runny nose, fatigue and poor sleep.On (b)(6) 2013 the patient presented for follow-up.On (b)(6) 2013 the patient presented for follow-up and reported back pain, shoulder pain and blood discharge from ear.On (b)(6) 2013 the patient presented with dehydration/flu.Since the rhbmp-2/acs surgery, the patient has been suffering from: radiating pain to the legs and arms difficulty breathing; difficulty swallowing; nerve injuries; constant severe pain; gastrointestinal problems; localized edema; tingling in neck and shoulders radiating to legs, left side is the worst; stenosis; mental anguish; depression.The patient also had limited range of motion of neck.
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Manufacturer Narrative
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Add'l info.
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Event Description
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It was reported that on (b)(6) 2006: patient underwent pa and lateral chest x-ray.Impression: no evidence of acute cardiopulmonary disease.(b)(6) 2006: patient underwent two chest views pa/lat.Impression: negative chest.(b)(6) 2006: patient presented with following discharge diagnosis: 1) acute sinusitis.2) exacerbation of chronic obstructive pulmonary disease.3) restless leg syndrome.4) hypothyroidism.5) gastroesophageal reflux disease.6) depression.7) history of insomnia.8) peripheral neuropathy.9) osteoarthritis.Patient underwent chest pa/lat x-ray.Impression: there is no evidence of acute disease.(b)(6) 2007: patient underwent abdomen and pelvis ct scan without contrast.Impression:1) no active abdomen or pelvic disease by a ct with oral contrast only.If colonic pathology remains suspected consider colonoscopy follow up.2) cholelithiasis is evident without findings of cholecystitis by ct scan.(b)(6) 2007: patient presented with hypothyroidism, depression, copd, and osteoarthritis.(b)(6) 2007: patient underwent the following procedure: esophagogastroduodenoscopy.Impression: 1) antral gastritis.2) nodular mucosa in the duodenal bulb.(b)(6) 2007: patient underwent colonoscopy.Impression: a few diverticulosis.Internal hemorrhoids.3) fair prep.(b)(6) 2007: patient underwent "ercp" impression: partial opacification of the pancreatic duct.Otherwise unremarkable.(b)(6) 2007: patient presented with cholecystitis.Underwent the procedure laparoscopic cholecystectomy(b)(6) 2007: patient underwent chest pa/lat x-ray.Impression: normal chest.(b)(6) 2008: patient presented with lumbar spine x-ray.Impression: no acute fracture or dislocation.Minimal levoconvex scoliosis.3) satisfactory position of metallic hardware status post fusion of l2-4 vertebral bodies.(b)(6) 2011: patient underwent ct scan of a/p with contrast.Impression: no definite evidence acute intra-abdominal process.Dilated common bile duct status post cholecystectomy possible compensatory.Recommend correlation with laboratory values.Mrcp can be obtained if there is biochemical evidence for biliary obstruction.Hysterectomy.Coronary arterial atherosclerosis.(b)(6) 2010: patient underwent x-ray of chest pa/lat.Impression: no evidence of acute cardiopulmonary disease.(b)(6) 2011: patient presented with abdominal pain and unclear etiology.(b)(6) 2011: patient underwent ct scan of lumbar spine.Impression: no evidence of spinal stenosis.Right pedicle screws at l5 and s1 possibly compromising the right lateral recess in the exiting nerve roots.(b)(6) 2012: patient presented with dog bite.(b)(6) 2012: patient presented with backpain and head and neck pain.(b)(6) 2013: patient underwent two chest view.Impression: no evidence of an acute cardiopulmonary process.(b)(6) 2015: patient underwent ct scan of a/p with contrast.Impression: no evidence of acute process in the abdomen or pelvis.
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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) 2010, the patient underwent x-ray of the right foot.Impression: no acute fracture of dislocation in the right foot.(b)(6) 2012, patient presented with complaint of posterior cervical pain that radiated down to thoracic low back and left lower extremity pain.Patient underwent procedure for cervical epidural injection, c7-t1, under fluoroscopy due to complaints of chronic neck pain and mri revealed multilevel cervical spondylosis.No complications were reported.(b)(6) 2012, the patient underwent x-ray of the right elbow.Impression: no significant radiographic abnormality.(b)(6) 2013, patient presented for office visit for cold symptoms.(b)(6) 2014, patient presented for office visit for follow-up on hyperlipidemia, hypothyroidism and hypertension.(b)(6) 2014, patient presented for office visit for follow-up on hyperlipidemia and hypothyroidism.(b)(6) 2014, patient presented for office visit due to vaginal discharge.(b)(6) 2014, patient presented for office visit for follow-up on hyperlipidemia, hypothyroidism, esophageal reflux and complain of de pression.(b)(6) 2014, patient presented for office visit due to cold symptoms.(b)(6) 2014, patient presented for office visit for follow-up on hyperlipidemia, hypothyroidism and cough.(b)(6) 2015, patient presented for follow-up visit for abdominal pain.Assessment: esophageal reflux, copd.(b)(6) 2015, patient presented for office visit for follow-up on hyperlipidemia, hypothyroidism, esophageal reflux and abdominal pain.(b)(6) 2015, patient presented for office visit due to uti and gerd.
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Manufacturer Narrative
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(b)(4).(pseudoarthrosis).
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Event Description
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It was reported that on (b)(6) 2008 the patient was presented for office visit with hypertension, hyperlipidemia, hypothyroidism, weakness, chronic obstructive pulmonary disease and osteoarthritis.Impressions: degeneration, lumbosacral disc; hyperlipidemia; restless leg syndrome.On (b)(6) 2009 the patient was presented for office visit with numbness, fatigue and cough.Impressions: degeneration, lumbosacral disc; hyperlipidemia; restless leg syndrome; polyneuropathy in diabetes; bronchitis on (b)(6) 2010 the patient was presented for office visit with hypertension, hyperlipidemia, hypothyroidism, weakness, chronic obstru ctive pulmonary disease and osteoarthritis.Impressions: degeneration, lumbosacral disc; hyperlipidemia; restless leg syndrome esophageal reflux.On (b)(6) 2010 the patient was presented for office visit with complication of skin rash.Impressions: dermatophytosis.On (b)(6) 2010 the patient was presented for office visit.Impressions: copd, malaise and fatigue, edema.On (b)(6) 2010, the patient was presented for office visit for periodic assessments.Impressions: copd, hyperthyroidism, hyperlipidemia, esophageal reflux , depression , lumbosacral degeneration.On (b)(6) 2010 the patient was presented for office visit with shortness of breath.Impressions: copd, hyperthyroidism, hyperlipidemia, esophageal reflux, depression, lumbosacral degeneration.On (b)(6) 2011 the patient was presented for office visit for periodic assessments.Impressions: copd, hyperthyroidism, hyperlipidemia, esophageal reflux, depression, lumbosacral degeneration.On (b)(6) 2011, the patient was presented for office visit with abdominal pain.Impressions: acute gastritis, hypertension, hypothyroidism, dehydration on (b)(6) 2011 the patient was presented for office visit for periodic assessments.Impressions: copd hyperthyroidism, hyperlipidemia, esophageal reflux , depression, lumbosacral degeneration.On (b)(6) 2011, the patient underwent surgery due to hammertoe.On (b)(6) 2011 the patient was presented for office visit with nostril swelling.Impressions: sinusitis on (b)(6) 2011, (b)(6) 2012 the patient was presented for office visit for periodic assessments.Impressions: copd, hyperthyroidism , hyperlipidemia, esophageal reflux , depression, lumbosacral degeneration.On (b)(6) 2012 the patient was presented for office visit with edema.Impressions: manifestation/gout.On (b)(6) 2012 the patient was presented for office visit for periodic assessments.Impressions: copd, hyperthyroidism, hyperlipidemia, esophageal reflux, depression , lumbosacral degeneration.On (b)(6) 2012 the patient presented for follow-up and reported fever with cough and was admitted to the er.On (b)(6) 2012 the patient presented for follow-up with minor complaints and poor sleep.On (b)(6) 2012 the patient presented for follow-up and reported neck pain, nausea and poor sleep.On (b)(6) 2012 the patient presented for follow-up and reported increased chronic pain, fatigue and poor sleep.On (b)(6) 2013, the patient underwent cervical diskectomy and fusion.On (b)(6) 2013 the patient presented for follow-up and reported chronic cough, runny nose, fatigue and poor sleep.On (b)(6) 2013 the patient presented for follow-up.On (b)(6) 2013 the patient presented for follow-up and reported back pain, shoulder pain and blood discharge from ear.On (b)(6) 2013 the patient presented with dehydration/flu.Since the rh-bmp2/acs surgery, the patient has been suffering from: radiating pain to the legs and arms difficulty breathing; difficulty swallowing; nerve injuries; constant severe pain; gastrointestinal problems; localized edema; tingling in neck and shoulders radiating to legs, left side is the worst; stenosis; mental anguish; depression.The patient also had limited range of motion of neck.On (b)(6) 2008 the patient was discharged with the following diagnoses: pseudoarthrosis.Low back pain.Lumbar radiculopathy.Degenerative disc disease.Lumbar spinal stenosis.Tobacco abuse.Restless leg syndrome.Hypothyroidism.Acute blood loss and anemia.Gastroesophageal reflux disease.Hyperlipidemia.On (b)(6) 2008 the patient called to report drainage from incision.On (b)(6) 2008 the patient presented for an office visit.She underwent partial removal of hardware of l2 to l4 with exploration of the fusion with posterior arthrodesis of l4-l5 and l5 -s1.On (b)(6) 2011: patient presented for office visit due to low back pain and spinal cord stimulator trial (b)(6) 2012: patient called and complained of left leg pain and swelling in foot.On (b)(6) 2012: patient presented with significant left sided pain and tenderness through the left side.She has pain and swelling which she described from the left side of her body from her neck all the way down to the tip of her toes.Patient states that her neck is the biggest complaint that she has.She has left arm pain and weakness which is fairly significant.She does have numbness and tingling at times in the left arm and does feel that she has weakness.Examination reveals that patient has mild tenderness to percussion along the lumbar spine.She is tender to palpation along the cervical spine.She has limited range of motion when turning to the left compared to the right and with extension and flexion.Patient does appear to have spasms noted.Patient underwent ap and lateral cervical spine x-rays with flexion and extension views which show significant amount of degenerative disk disease present throughout the cervical spine particularly c4 through c7.There does not appear to be any anterolisthesis with flexion and extension views.There is loss of disk space.There is particularly noted c4 though c7.There are possibly osteophyte complexes in the same area.Assessment: neck pain and left cervical radiculopathy.On (b)(6) 2012: patient underwent mri of cervical spine due to degeneration of cervical disc.Impression: multilevel spondylosis.Degenerative findings look most pronounces at c4-5, c5-6, c6-7.At these levels, there is foraminal stenosis without suggestion of significant central stenosis.On (b)(6) 2012 the patient was presented for office visit with edema.Impressions: manifestation/gout.On (b)(6) 2012: patient presented for office visit due to neck pain.Her mri of cervical spine is reviewed which shows multilevel disk osteophyte complexes with evidence of cervical kyphosis.On (b)(6) 2012: patient presented for physical therapy due to cervicalgia.Problems: left neck pain which is described as burning and radiating and left arm pain.Spinal tests: cervical-vertebral artery test indicates a vertibro-basilar insuff iciency.Assessment: patient presented with left sided neck pain and intermittent radiculopathy down her left arm.Neck pain is creating significant pain/disability during routine adls such as sleep disturbances.The patient presents with restricted range of motion, muscle imbalances around cervical spine and muscle weakness around her cervical spine.Multiple complaints of muscle tenderness, sub occipital region, upper trapezlus and interscapular.Patient describes intermittent numbness/tingling down her entire arm.Cervical paraspinals (c5-6-7) tender to palpation.Sub occipital region and ut: tight and restricted per palp (b)(6) 2012: patient presented for office visit with chief complaint of posterior cervical pain that radiates into the mid thoracic region.Patient complains of neck stiffness and diminished range of motion.Patient underwent epidural injection.Post procedure diagnosis: multilevel cervical spondylosis at c4-c5 , c5-c6 and c6-c7.On (b)(6) 2012: patient presented for office visit with chief complaint of chronic neck pain radiating into both shoulders.Patient underwent cervical epidural steroid injection c7-t1 under fluoroscopy.Impression: chronic neck pain with radiation into both shoulders, cervical mri reveals multilevel cervical spondylosis.On (b)(6) 2012: patient presented for office visit and reported that physical therapy worsened her neck pain and actually caused headaches which she was not having prior to the physical therapy.On (b)(6) 2012: patient underwent x-ray of neck spine due to neck pain.Impression: moderate multilevel cervical spondylosis is noted most pronounced at c4-c5 followed by c5-c6 and c6- c7.Patient underwent ct of cervical spine: impression: there is no evidence of instability.There is evidence of moderate severity osteophytes extending from c4 through c7 associated with multilevel foraminal narrowing most pronounced on the right at c4-c5 and on the left at c5-c6.On (b)(6) 2012: patient underwent ct of lumbar spine without contrast.Impression: fusion and laminectomy without definite space occupying hematoma.Hardware and fusion.Stable medial placement of right l5 and s1 pedicle screws.Stable possible l3-4 right paracentral disc herniation versus scarring.Imaging of the central canal by non contrast ct is limited and significant abnormalities may be missed.On (b)(6) 2012: patient presented for office visit with diagnosis of cervical radiculopathy and cervical pain and on examination her muscles are exceedingly tight.She also had a ct scan which shows evidence of stable fusion l3 to s1.On (b)(6) 2012 the patient presented for an office visit and was diagnosed with cervical radiculopathy.She underwent anterior cervical discectomy fusion c4-7.On (b)(6) 2012 the patient got the chest x-rays done.Impression: two views of the chest were provided.Cardiac and mediastinal silhouettes were normal.There was no evidence of pulmonary edema, pneumonia, pneumothorax or pleural effusion.There was new soft tissue nodular soft tissue density in the left lower lobe on the pa view measuring 9mm in diameter.Although this may represent a nipple shadow a new pulmonary nodule was not excluded and chest ct was recommended.Surgical clips were noted in the upper abdomen.The osseous structures are normal.The lung volumes were normal.On (b)(6) 2012 the patient underwent a chest ct with and without contrast.Impression: small right upper lobe pulmonary nodules.Followup chest ct in 3 months recommended if the patient had risk factors for lung carcinoma.Mild diffuse emphysematous changes.Status post cholecystectomy with probable increased capacity dilation of the common bile duct.Otherwise remarkable.On (b)(6) 2012 the patient had a chest ct which showed small right upper pulmonary nodules.There were diffuse emphysematous changes.On (b)(6) 2013, the patient underwent acdf surgery from c4-7.On (b)(6) 2012 the patient presented for an office visit.Impression: cervical spinal stenosis.On (b)(6) 2012 the patient was unable to have surgery due to hyperthyroidism.On (b)(6) 2013 patient presented for first postoperative visit.Ap and lateral cervical spine x-rays obtained show anterior plate and screw fixation c4 to c7 with interbody grafting at c4-c5, c5-c6 and c6-c7.No evidence of hardware failure or implant migration.On (b)(6) 2013, the patient presented with diagnosis : disc osteophyte complex c4-5, c5-6, c6-7 , axial neck pain , cervical radiculopathy.On (b)(6) 2013, the patient visited for follow up.On (b)(6) 2013, the patient presented for follow up and x-ray review.On (b)(6) 2013, the patient presented for follow up of her shoulder pain.On (b)(6) 2013, the patient was performed with mri cervical spine.On (b)(6) 2013, the patient was here for follow up.On (b)(6) 2013, the patient presented for follow up and mri was reviewed.She was cleared for pain relieving injection.(b)(6) 2013, the patient visited the facility.On (b)(6) 2013, the patient presented for follow up.On (b)(6) 2014, the patient presented for follow up and medicine refill.On (b)(6) 2014, the patient presented for follow up of her cervical spine.On (b)(6) 2008: patient presented with pain in her back.Impression: lumbar pseudoarthrosis.Patient presented with the following diagnosis: mechanical low back pain kyphotic deformity of the lumbar spine.Pseudoarthrosis.Procedure: partial removal of hardware, l2-l4.Exploration of fusion.Posterior arthrodesis, l4-l5 and l5-s1.On (b)(6) 2008: patient presented for an office visit.Ap and lateral show posterior pedicle screw instrumentation of l2 to s1 with transforaminal lumbar interbody fusion of l4-5 and l5-s1.No evidence of hardware failure.On (b)(6) 2008: patient presented for follow up.On (b)(6) 2010: patient presented with pain in lower back and leg.On (b)(6) 2011: patient was diagnosed with abnormality gait.On (b)(6) 2011: patient presented for office visit.Impression: low back pain, lumbar radiculopathy.On (b)(6) 2011: patient underwent ct lumbar spine without contrast.Impression: no evidence of spinal stenosis.Right pedicle screws at l5 and s1 possibly compromising the right lateral recess in the exiting nerve roots.On (b)(6) 2011: patient underwent ct scan of the lumbar which shows evidence of posterior pedicle screw instrumentation l2 to s1.No ev idence of hardware failure.However the right pedicles screws at l5 and s1 possibly compromise the right lateral recess exiting nerve root.On (b)(6) 2011: patient presented with ct scan which shows solid appearing fusion.On (b)(6) 2012: patient presented with significant left sided pain and tenderness.Patient has pain and swelling in the left side of her body from her neck to toes.Patient underwent ap and lateral cervical spine x-rays with flexion and extension views which show a significant amount of degenerative disk disease presented throughout the cervical spine.On (b)(6) 2012: patient presented for follow up.Patient underwent mri which shows multilevel disk osteophyte complexes with evidence of cervical kyphosis.On (b)(6) 2012: patient presented with cervical intervertebral disc degeneration.On (b)(6) 2012: patient presented with posterior cervical pain that radiates into the mid thoracic region.On (b)(6) 2012: patient presented with chronic neck pain radiating into both shoulders.Impression: chronic neck pain with radiation into both shoulders.2) cervical mri reveals multilevel cervical spondylosis.Patient underwent cervical epidural steroid injection c7-t1 under fluoroscopy.On (b)(6) 2012: patient underwent cervical epidural steroid injection c7-t1 under fluoroscopy.Patient presented with neck pain, headaches.On (b)(6) 2012: patient presented with neck pain.Patient underwent x-ray of the neck spine.Impression: moderate multilevel cervical spondylosis is noted, most pronounced at c4-c5, followed by c5-c6 and c6-c7.Patient underwent ct scan of cervical.Impression: there is evidence of moderate severity osteophytes extending from c4 through c7, associated with multilevel foraminal narrowing, most pronounced on the right at c4-c5 and on the left at c5-c6.On (b)(6) 2012: patient underwent ct of lumbar spine without contrast.Impression: no definite change from (b)(6) 2012.Fusion and la minectomy without definite space-occupying hematoma.Hardware and fusion as described.Stable medial placement of right l5 and s1 pedicle screws.Stable possible l3-l4 right paracentral disc herniation versus scarring.On (b)(6) 2012: patient underwent x-ray of the chest.Impression: no evidence of pulmonary edema, pneumonia, pneumothorax or pleural ef fusion.On (b)(6) 2013: patient presented with cervical spinal stenosis.On (b)(6) 2013: patient presented with the following pre-op diagnosis: disc osteophyte complex c4-5, c5-6, c6-7, cervical radiculopathy, axial neck pain.Operation: patient underwent anterior cervical discectomy and fusion c4-5, c5-6 c6-7 with allograft bone i instrumentation.Per op notes: the square graft was soaked in a platelet concentrate derived from the patient own blood and then tamped into position.On (b)(6) 2013: patient presented for an office visit post anterior cervical discectomy followed by interbody fusion and plating.Ap and lateral cervical spine x-rays shows anterior plate and screw fixation c4 to c7 with interbody grafting at c4-c5, c5-c6, c6-c7.No evidence of hardware failure or implant migration.On (b)(6) 2013: patient presented with disc osteophyte complex c4-5, c5-6, c6-7, axial neck pain, cervical radiculopathy.On (b)(6) 2013, (b)(6) 2008, (b)(6) 2013: patient presented for follow up.On (b)(6) 2013: patient underwent mri of left shoulder.Impression: relatively mild cuff, no high grade partial or full thickness cuff tear.Ac arthropathy.On (b)(6) 2013: patient presented for an office visit due to neck pain and cervical laminectomy.On (b)(6) 2013: patient underwent mri of the spine.Impression: postsurgical changes of c4-c7 acdf with no significant exit foraminal stenosis at any level.A left paracentral osteophyte at c5-6.A low signal left paracentral structure at level c5 likely represents a screw protruding into the central canal.An osteophyte is considered less likely given the degree of susceptibility artifact.On (b)(6) 2013: patient presented with neck pain.On (b)(6) 2013: patient presented with low back pain, degenerative disc disease, neck pain.On (b)(6) 2014: patient presented for follow up of her cervical spine.On (b)(6) 2009, per billing records , the patient visited the facility.On (b)(6) 2010 , the patient presented for x-rays of foot.On (b)(6) 2011, per billing records, patient visited the facility for some surgical procedure.On (b)(6) 2012, the patient presented for pathological examinations.On (b)(6) 2011: the patient presented with the chief complaint of low back pain, bilateral lower extremity pain.The patient underwent physical examination: assessment: low back bilateral lower extremity radiculopathy.Presumably failed back surgery syndrome.On (b)(6) 2012: the patient presented with chief complaint of chronic neck pain, cervical mri reveals multilevel cervical spondylosis and underwent cervical epidural steroid injection, c7-t1 under fluoroscopy.The patient presented with chief complaint of posterior cervical pain that radiates down the thoracic low back and left lower extremity pain.On (b)(6) 2012: the patient underwent cervical epidural steroid injection c7-t1 under fluoroscopy.
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Event Description
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It was reported that on (b)(6) 2010 the patient underwent x-ray of the right foot.Impression: no acute fracture of dislocation in the right foot.(b)(6) 2012 the patient underwent x-ray of the right elbow.Impression: no significant radiographic abnormality.
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Search Alerts/Recalls
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