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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 7510400 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Ossification (1428); Arthritis (1723); Bronchitis (1752); Chest Pain (1776); Congestive Heart Failure (1783); Cyst(s) (1800); Dyspnea (1816); Edema (1820); Fatigue (1849); Fever (1858); Headache (1880); High Blood Pressure/ Hypertension (1908); Muscle Spasm(s) (1966); Nausea (1970); Nerve Damage (1979); Neuropathy (1983); Pain (1994); Pneumonia (2011); Seroma (2069); Swelling (2091); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Vomiting (2144); Weakness (2145); Tingling (2171); Chills (2191); Stenosis (2263); Injury (2348); Arthralgia (2355); Inadequate Pain Relief (2388); Arachnoiditis, Spinal (2390); Numbness (2415); Neck Pain (2433); Palpitations (2467); 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 a posterolateral fusion and an anterior lumbar interbody fusion surgery at l4-5 where rhbmp-2/acs was placed in the lateral gutters.The patient's post-operative period was marked by pain radiating down to her lower extremity.The patient also suffered from an inflammatory fluid collection and cystic changes following her surgery.She has since required the surgical implantation of a spinal cord stimulator, followed by its explantation when it failed to control the patient's pain.The patient continues to experience pain, numbness, and weakness that radiates into her lower extremities.This neurologic deficit has since developed into chronic foot drop.The patient's pain is exacerbated when she stands or walks.
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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)(6).(b)(4).
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Event Description
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It was reported that on, (b)(6) 2008, patient underwent mri of thoracic spine w/o contrast due to back pain.Impression: no significant thoracic spine pathology.Patient underwent mri of lumbar spine w/o contrast due to low back pain.Impression: right paracentral annular tear at the l4-5 level with a small disc herniation suggested on the saggital without frank central canal or nerve root impingement.Patient underwent mri of cervical spine w/o contrast due to neck pain.Impression: no disk herniation or spinal stenosis.Patient underwent mri of brain due to headache.Impression: no evidence of intracranial pathology.Mucosal reaction in the right spheroid sinus may be indicative of sinusitis.(b)(6) 2010 the patient was presented for office visit with cold symptoms.Assessments: 1) fatigue, 2) frequent, full bladder emptying, 3) localized knee joint pain, 4) foot pain, 5) vaginitis albicans candida.(b)(6) 2010 the patient was presented for office visit with headaches.Assessments: headaches, palpitations.(b)(6) 2010 the patient was presented for office visit with low back pain.Assessments: 1) allergic rhinitis, 2) vaginal discharge, 3) lower back pain, 4) acne vulgaris.(b)(6) 2011 the patient was presented for office visit with 3 months follow up, mobility exam, c/o sinus problems.Assessments: lower back pain, vaginal discharge, allergic rhinitis and appetite loss.(b)(6) 2011, (b)(6) 2011 the patient was presented for office visit.(b)(6) 2011, (b)(6) 2011, (b)(6) 2011, (b)(6) 2011 the patient was presented for office visit with back pain.Assessments: displacement of cervical intervertebral disc, osteoarthritis, sciatica due to displacement of lumbar disc.(b)(6) 2011: the patient underwent ct scan of abdomen and pelvis with contrast.Impression: atypical appearance of the appendix.This does not have the typical appearance of appendicitis but cannot entirely be excluded.Spinal stimulator device noted implanted in the buttock.Evidence of previous lumbar surgeries.Patient underwent imaging study of abdomen due to abdominal pain.Impression: no acute abnormality demonstated.(b)(6) 2011: the patient underwent ct scan of abdomen and pelvis.Impression: 1.Postop appendectomy changes, no abscess or free peritoneal air.2.Interval development of radiodense gallbladder contents likely represents contrast from recent ct study.Hemorrhagic cholecystitis is less likely consideration, please correlate clinically.Patient underwent imaging of abdomen and chest.Impression: no acute abnormality demonstated.(b)(6) 2011: the patient underwent ct scan of abdomen and pelvis with contrast.Impression: 1.The uterus removed as is the appendix with cysts in both adnexa suggesting ovarian cysts there is minimal free fluid in the pelvis possibly physiologic.2.There is a pelvic kidney with no obstruction about either kidney.3.Excess stool in the colon with no inflammatory changes seen about the colon.No bowel obstruction.4.Postop change about the spine.Patient underwent x-ray of abdomen.Impression: no free air with electro stimulation leads and borderline heart stable, with no florid failure or localized disease.(b)(6) 2012 the patient was presented for office visit with severe back pain.Assessments: displacement of cervical intervertebral disc, osteoarthritis, sciatica due to displacement of lumbar disc.(b)(6) 2012 the patient was presented for office visit with back pain.Assessments: displacement of cervical intervertebral disc, osteoarthritis, sciatica due to displacement of lumbar disc.(b)(6) 2012 the patient was presented for office visit with back pain and neck pain.Assessments: displacement of cervical intervertebral disc, osteoarthritis, sciatica due to displacement of lumbar disc.(b)(6) 2013, (b)(6) 2013 the patient underwent x-rays of chest due to cough.Impression: electro stimulation leads.Mild cardiomegaly without failure.Bronchitic changes.(b)(6) 2013, the patient was admitted with final diagnosis as : 1.Status asthmaticus.2.History of asthma.3.Urinary tract infection.4.Trichomonas vaginitis.5.Status post multiple laminectomies and rupture disc.6.Status post hysterectomy.7.Appendectomy.Patient underwent x-ray of chest.Comparison: (b)(6) 2013.Impression: no active cardiopulmonary disease.(b)(6) 2013, the patient was discharged from the facility.(b)(6) 2013, patient was admitted for exacerbation of asthma.(b)(6) 2013, patient presented in emergency room for two day history of chills, fever, cough productive of yellow sputum, and also wheezing.(b)(6) 2013, the patient presented because of cough.(b)(6) 2013: the patient underwent ct scan of the chest with contrast.Impression: noacute process demonstrated.Patient underwent various pathology examinations such as chemistry , hematology , urinalysis , coagulation etc.(b)(6) 2013: the patient was presented for office visit with back pain.Pain has radiated to the left calf, right calf, left thigh and right thigh.Assessments: sciatica due to displacement of lumbar disc, osteoarthritis.(b)(6) 2013, the patient visited the facility and underwent various radiography / ecg evaluations (b)(6) 2013 the patient was presented for office visit with back pain.Location of pain was lower back.Assessments: sciatica due to displacement of lumbar disc, osteoarthritis and chronic pain.(b)(6) 2014, the patient presented with following diagnosis : headache , pneumonia, cough.
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Manufacturer Narrative
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Additional information: (b)(6) 2008 lumbar discogram lateral view suggests normal l3 discogram.L4 and l5 show posterior extravasation into the dural canal.Distortion of the nuclear area is verified suggestive of degenerative changes.Overall alignment and disc height remains normal.Post-discogram ct shows contrast within the discs of l3, l4 and l5.Clear extravasation is seen on the right at l4.No clear extravasation or annular tear is seen now at l3 or l5.Bullet of contrast is disorganized at l3 on these studies.On (b)(6) 2008 lumbar ct shows new construct at l4/5 with clear alif with interbody spacer and pyramid plate and three screws.Posterior decompressive laminectomy with pedicle screw fixation noted as well.Large pseudo-meningocoele noted.Screw position is excellent.Portable lumbar c-arm films taken during procedure shows initial placement of the pyramid plate anteriorly with spacer, followed by posterior decompression and pedicle screw placement bilaterally at l4 and l5.On (b)(6) 2008 duplex ultasound no spinal pathology imaged lumbar series multiple films are taken postoperatively with staples in place.Pedicle screws and rods posteriorly and pyramid plate with screws anteriorly with interbody spacer.On (b)(6) 2008 ct directed sacroiliac injection showing needle approaching sacroiliac joint on the right (b)(6) 2008 lumbar mri sagittal films show very large fluid collection behind l4.This creates some narrowing of the dural sac at l4.Construct is as before at l4/5.On (b)(6) 2009 left knee mri grossly normal mri with no spinal pathology imaged.Right knee mri grossly normal mri with no spinal pathology imaged.On (b)(6) 2009 lumbar mri sagittal t2 images show previous l4/5 posterior decompression and fusion with pedicle screws.Midline pseudo-men ingiocoele is noted dorsal to the l4 disc.Axial views also show alif at same level.Full decompression is seen.Some clumping of the roots suggest some degree of arachnoiditis.On (b)(6) 2010 cervical mri t1, t2 sagittal and axial views are reviewed.Cervical lordosis is maintained.Minimal disc desiccation at all levels.No stenosis or hnp noted.Cord appears normal sitting centrally within a large canal.Brain mri no spinal pathology imaged (b)(6) 2010 lumbarmri conus is posterior to t12.Decompression is noted at l4/5.Fusion instrumentation is again seen at l4/5.Fusion is not verified.No stenosis is noted at any level.On (b)(6) 2010 lumbar series shows the previous l4/5 alif and posterior decompression and pedicle screw instrumentation.Flexion/extension views show no movement.Pyramid plate is off midline to the left.Oblique views show posterolateral fusion and interbody spacer in good position.On (b)(6) 2011 lumbar myelogram initial film is during the contrast injection at l2/3.Spinal stimulator unit is seen on the right centered at l3.Contrast shows no signs of central or foraminal stenosis.Chest x-ray shows normal cardiac, pulmonary and bony anatomy.Spinal stimulator leads sit in midline centered at t7/8.Post myeloct lumbar shows enlarged dural sac in the region of the previous decompression.No evidence of stenosis.Instrumentation is seen at l4/5.Only soft tissue windows are present making it difficult to see the canal across l4/5.Thoracic myelogram ct shows normal canal and bony relationships.Spinal stimulator is noted slightly to the left of midline.Again only the soft tissue windows are available.Cervical ct post myelogram shows no canal stenosis or cord deformity.No hnp is noted.Bony anatomy is normal.
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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) 2007, patient underwent x-ray of chest.Impression: no acute process or significant finding.On (b)(6) 2007, patient underwent ct of head w/o contrast.Impression: sub-acute ethmoid sinusitis.On (b)(6) 2008, patient underwent ultrasound of abdomen.On (b)(6) 2008, patient underwent x-ray of chest.Impression: negative chest.No change.On (b)(6) 2008, patient underwent x-ray of chest.Impression: no suspicious lung filtrates.On (b)(6) 2008, patient underwent ultrasound of pelvis.On (b)(6) 2008, patient underwent ct of sinuses q/o contrast.Impression: significant sphenoid sinusitis.On (b)(6) 2008, patient underwent ct of lumbar spine.Impression: satisfactory study in allowing for previous surgical intervention, l4-5.Patient underwent ct of cervical spine w/o contrast.Impression: negative study.Patient underwent ct of head without contrast.I mpression: negative study, no change.On (b)(6) 2009, the patient underwent x-rays of chest due to headache/congestion.Impression: no acute cardiopulmonary disease.On (b)(6) 2010, patient underwent radiologic study of left foot due to trauma.Impression: unremarkable study.On (b)(6) 2010, patient underwent ct of brain without contrast.Impression: no acute process demonstrated.On (b)(6) 2011, patient underwent x-ray of abdomen with chest.Impression: no free air with electro stimulation leads and borderline heart stable, with no florid failure or localized disease.On (b)(6) 2012, patient underwent ct of abdomen/pelvis w <(>&<)> w/o contrast due to abdominal pain.Impression: no acute abdominal pelvic pathology.Patient underwent x-ray of abdomen.Impression: no acute process seen when compared to prior study.On (b)(6) 2013 patient underwent x-ray of chest due to shortness of breath.Impression: mild bronchitis, no focal infiltrate.On (b)(6) 2012 patient underwent x-ray of chest due to chest pain.Impression: no acute process demonstrated compared to previous study.On (b)(6) 2013, patient underwent x-ray of chest due to shortness of breath and cough.Impression: no active cardiopulmonary disease.On (b)(6) 2013 patient underwent x-ray of chest due to shortness of breath.Impression: old granulomatous disease.On (b)(6) 2013, patient underwent x-ray of chest due to shortness of breath.Impression: mild congestive heart failure or fluid overload with left basilar infiltrate/pneumonia.On (b)(6) 2013, patient underwent x-ray of chest due to shortness of breath.Impression: diminished congestive heart failure and left basilar infiltrate, hyperaeration suggesting asthma or copd.On (b)(6) 2013, the patient underwent x-rays of chest due to pneumonia.Impression: no acute process demonstrated when compared to prior study.On (b)(6) 2013 patient underwent x-ray of chest due to chest pain.Impression: no acute cardiopulmonary disease.On (b)(6) 2013, patient underwent x-ray of chest due to shortness of breath and cough.Impression: no acute cardiopulmonary disease.On (b)(6) 2013, patient underwent x-ray of chest due to shortness of breath.Impression: cardiomegaly with granulomatous change and electro stimulation leads stable with no acute disease or failure.On (b)(6) 2013, patient underwent x-ray of chest due to congestion.Impression: top normal heart size, no active disease.On (b)(6) 2013, patient underwent x-ray of chest due to shortness of breath.Impression: old granulomatous disease without acute cardiopulmonary disease.On (b)(6) 2013, patient underwent x-ray of chest due to wheezing.Impression: slight congestion without focal infiltrate.On (b)(6) 2014, patient underwent x-ray of chest due to asthma.Impression: evidence of old granulomatous disease.On (b)(6) 2014, patient underwent x-ray of chest.On (b)(6) 2014, the patient underwent ct scan of the head or brain.Impression: no acute intracranial pathology.Patient underwent x-ray of chest due to cough.Impression: no acute process demonstrated when compared to prior study.On (b)(6) 2014, patient underwent ct scan of upper spine due to increasing weakness/numbness in right arm.Impression: no fractures or stenosis of the spinal structures is identified.No subluxation.I do not see a cause of the patient's numbness here.Mild positional changes.On (b)(6) 2014, the patient underwent x-rays of hand.Impression: no acute process demonstrated.On (b)(6) 2014, patient underwent x-ray of chest.Impression: no acute cardiopulmonary disease.On (b)(6) 2015, patient underwent ct scan of the lower spine.Impression: previous laminectomy and lumbar fusion at l4-5 level without evidence of recurrent stenosis.No evidence of acute pathology or significant pathology at other levels.Neurostimulator device noted in the right flank.On (b)(6) 2015, the patient underwent ct scan of the abdomen and pelvis with contrast.Impression: no acute intra-abdominal pathology.Slightly enlarged liver.Previous lumbar laminectomy and left pelvic surgery.On (b)(6) 2015: the patient underwent mri scan of cervical spine.Impression: no acute process demonstrated.On (b)(6) 2015: the patient underwent mri scan of lumbar spine due to abnormal gait.Impression: post l4-5 laminectomy with evidence of arachnoiditis.No evidence of significant disk herniation or canal stenosis at any level.On (b)(6) 2015, patient underwent x-ray of chest due to cough, impression: no acute cardiopulmonary disease.
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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) 2008: the patient underwent for ct scan of lumbar spine with contrast due to back pain.Impression: mild disc degenerative changes at l4-l5 and l5- s1.(b)(6) 2008: the patient underwent for ct scan of lumbar spine without contrast after recent spinal surgery.Impression: interval l4-l5 discectomy with anterior and posterior fusion.(b)(6) 2008: the patient underwent for x-ray of lumbar spine ap/lat due to indication of low back pain.Impression: l4/l5 fusion, similar from (b)(6) 2008.The patient also underwent bilateral duplex examination of the lower extremities due to leg swelling, post-operative.Impression: unremarkable bilateral duplex venogram.No evidence of deep venous thrombosis identified within either leg.Same day patient also underwent for special ct scan status postop lumbar spine surgery with bilateral si joint pain.Impression: successful bilateral si joint injections with immediate pain relief.(b)(6) 2009: the patient underwent mri of right knee due to knee pain.Conclusion: mild degenerative signal within the medial meniscus with no discrete tear.The patient also underwent mri of left knee due to left knee pain.Conclusion: degenerative signal within the medial meniscus with no discrete tear.The patient underwent for mri of lumbar spine with and without contrast due to lumbar pain, status post fusion.Conclusion: prior fusion at l4-l5 with no recurrent disc herniation or canal stenosis.Previously described large fluid collection within the posterior operative site has markedly decreased in size; cystic right-sided adnexal mass.For further evaluation, correlation with pelvic sonography would be helpful.(b)(6) 2010: the patient underwent for mri of cervical spine without contrast due to headache, neck pain and low back pain.Conclusion: negative mri of the cervical spine.The patient also underwent for mri of lumbar spine with and without contrast due to headache, neck pain and low back pain.Impression: unremarkable appearing postop spine.The patient also underwent for mri of brain without contrast due to headache, neck pain and low back pain.Conclusion: negative noncontrast mri of the brain.(b)(6) 2011: the patient underwent for ct scan of cervical spine due to bilateral lower extremity weakness and indication of recent insertion of spinal cord stimulator with increasing leg weakness.Impression: normal post-myelogram cervical ct.The patient also underwent for cervical, thoracic and lumbar myelogram.Impression: previous surgery as described otherwise normal lumbar, thoracic and cervical myelograms.The patient also underwent for ct of brain without contrast.Impression: normal ct of brain.The patient also underwent of ct of cervical spine.Impression: normal post myelogram cervical ct.The patient also underwent of ct of lumbar spine post myelogram.Impression: post-operative changes at l4-l5 with no hnp, stenosis, or post-operative complication identified.The patient underwent for ct of thoracic spine status post myelogram due to indication of bilateral lower extremity weakness.Impression: no focal hnp or post-operative abnormality is seen.(b)(6) 2014: the patient presented with complaint of low back pain which starts in the back and goes down both legs and headache.Patient complained of left knee pain and more weakness in her left hand.The pain interferes with sleep, mood, relationship, house chores, walking, exercise, employment.Lumbar spine review revealed well-healed incision right lower back from scs and vertebral spine tenderness, mild bilateral tenderness paraspinal.Assessment: lumbago, lumbar radiculopathy, long term use meds nec.(b)(6) 2014: the patient presented for pick up prescription.Assessment: lumbar radiculopathy.(b)(6) 2014: the patient presented for follow-up visit asking for leg braces due to chronic pain, has bad left knee, nipple tenderness and refill for lyrica.Patient complained of chest congestion.Musculoskeletal exam revealed gait as limping, left lower extremity normal, palpation medial tenderness, range of motion restricted to secondary to pain.Diagnosis: pain in joint, lower leg, acute bronchitis, lump or mass in breast, thoracic/ lumbosacral neuritis/radiculitis, chronic pain.Assessment: patient was instructed to continue prescribed medications and plan of care.(b)(6) 2014: the patient presented with chief complaints of low back, neck pain, left and right arm, left and right leg, headaches.Pain is best described as throbbing, stabbing, burning, tingling, numb.Assessment: 1.Lumbago; 2.Lumbar radiculopathy; 3.Cervicalgia; 4.Long term use meds nec.(b)(6) 2014: the patient presented for follow-up for low back pain and neck pain, lumbar pain.Patient is not sleeping well because of muscle stiffness and pain.Pain is best described as cramping, throbbing, sharp stabbing, burning, tingling and stinging numb.Lumbar spine review revealed normal curvature of spine, mild pelvic obliquity, somewhat flattened lordosis, limited range of motion in all directions; standing forward and + paraspinal spasm.Assessments: 1.Lumbago (primary); 2.Lumbar radiculopathy; 3.Cervicalgia; 4.Muscle spasm of back; 5.Long term (current) use of meds nec.(b)(6) 2014: the patient presented with complaint of neck and low back pain.For neck pain, patient reported the frequency of pain was constant.Location of pain was bilateral lateral neck, bilateral posterior neck and bilateral shoulder.There was radiation of pain down to the bilateral forearm and bilateral hand.The patient describes the pain as aching, burning and tingling.Numbness down to bilateral little fingers, bilateral middle fingers and bilateral thumbs.Aggravating factors included bending, coughing, driving and lifting above head.Relieving factors tried included narcotic analgesics.Associated symptoms include dropping objects, numbness, tingling and weakness.For low back pain, patient reported the problem was worsening and pain occurred persistently.Pain has radiated to ble.The patient described the pain as an ache and shooting.Symptoms were aggravated by bending, daily activities; sitting; standing and walking.Review of neuro system revealed symptoms positive for numbness and tingling, negative for dizziness.Musculoskeletal review revealed symptoms positive foe weakness.Lumbar exam revealed tenderness on the left side and right side.Assessment: carpal tunnel syndrome, ulnar nerve lesion.(b)(6) 2014: the patient presented with pre-op diagnosis of left ulnar neuropathy at the elbow and left carpal tunnel syndrome.Patient has indications of neck and back pain which radiated into both arms with numbness of all fingers.Patient underwent following surgeries: 1.Left ulnar nerve transposition.2.Left carpal tunnel release.The patient tolerated the procedure well with no complications noted.(b)(6) 2014: the patient presented with bilateral cervical fact 2-4 and neck pain.Assessments: 1.Spondylarthritis; 2.Neck pain; 3 facet syndrome; 4 neck pain.Patient underwent cervical medial branch block procedure under fluoroscopic guidance.Patient tolerated the procedure well and was discharged without complications.(b)(6) 2014: the patient presented for a post op visit with complains of hand pain and numbness in left index and ring finger.Impression: carpal tunnel syndrome - chronic; lesion of ulnar nerve - chronic.(b)(6) 2014: the patient presented for a post op visit status post carpal tunnel surgery and numbness in left index, middle and ring fingers not using hand much because of pain around left wrist.Patient reported status as worsening and was currently taking pain medication.The wound was healing.Impression: carpal tunnel syndrome.(b)(6) 2014: the patient presented for follow up regarding neck pain radiating to bue with tingling a pin to her bilateral fingertips and with complaint of low back pain.Pain is worsened by walking, lifting or carrying small loads, lifting or carrying heavy loads, lying on side, lying on back.Assessments: 1.Cervicalgia (primary); 2.Cervical radiculopathy; 3.Muscle spasm of back; 4.Lumbar radiculopathy; 5.Lumbago; 6.Long term (current) use of opiate analgesic.(b)(6) 2014: the patient presented for follow up regarding neck pain radiating to her bue and with complaint of low back pain.Cervical spine review revealed palpation is + for focal tenderness and muscle spasms in the paravertebral muscles, stability- there is loss of lordotic curve noted and tenderness in paraspinal muscles.Assessments: 1.Cervicalgia (primary); 2.Cervical radiculopathy; 3.Lumbar radiculopathy; 4.Lumbago; 5.Long term (current) use of opiate analgesic.(b)(6) 2014: the patient presented for cervical epidural steroid injection (cesi) and neck pain.Assessments: cervical disc degen; cervical disc displacement; radicular pain.Patient underwent cervical interlaminar epidural steroid injection with fluoroscopy.Patient tolerated the procedure well and was discharged without complications.(b)(6) 2014: the patient presented for follow-up visit with chief complaint of left shoulder pain, swelling in left hand/fingers.Patient has some pain and tenderness of left shoulder radiating into her arm.Pain is intolerable and having difficulty sleeping because of pain.Review of musculoskeletal system revealed joint pains, joint stiffness, and limitation of joint movements.Diagnosis: chronic pain; obstructive chronic bronchitis without exacerbate; asthma, unspecified, unspecified status; pain in joint, shoulder region.(b)(6) 2014: the patient presented for follow up regarding chronic neck pain and with complaint of chronic back pain with radicular pain to bilateral shoulders.Per patient, it is causing muscle tightness making her head hurt.Assessments: 1.Cervicalgia (primary); 2.Cervical radiculopathy; 3.Muscle spasm of back; 4.Chronic headaches; 5 lumbar radiculopathy; 6.Lumbago; 7.Long term (current) use of opiate analgesic.Patient underwent routine venipuncture without any complications.(b)(6) 2015: the patient presented with complaint of neck pain.Per report, pain description was burning, cramping, numb, stabbing, and tingling.Assessments: 1.Cervicalgia (primary); 2.Cervical radiculopathy; 3.Muscle spasm of back; 4.Chronic headaches; 5 lumbar radiculopathy; 6.Lumbago; 7.Long term (current) use of opiate analgesic.(b)(6) 2015: the patient presented for a follow-up visit, refill of her medications and complained of nausea and nipples tenderness with soreness.Review of musculoskeletal system revealed no symptom of joint pain and muscle weakness.Diagnosis: chronic pain; asthma, unspecified.Unspecified hypertension.
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Event Description
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It was reported that on (b)(6) 2011: patient presented with back pain, leg pain, wrist pain, feet pain and neck pain.Assessment: displacement of lumbar intervertebral disc, displacement of cervical intervertebral disc and osteoarthritis.(b)(6) 2011: patient presented with back pain, foot pain (foot drop and radicular pain from her lower back) and headaches.Assessment: sciatica due to displacement of lumbar disc.
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Manufacturer Narrative
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(b)(6).(b)(4).
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Event Description
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It was reported that on: (b)(6) 1998 the patient underwent x-rays of abdomen.On (b)(6) 1999 the patient presented for office visit.On (b)(6) 2001 the patient underwent x-rays of wrist.On (b)(6) 2001 the patient presented for office visit.On (b)(6) 2001 the patient underwent x-rays of neck spine, thoracic spine and lower spine.On (b)(6) 2001 the patient presented for office visit.On (b)(6) 2001 the patient underwent the x-rays of sinuses.On (b)(6) 2001 the patient presented for office visit.On (b)(6) 2008 the patient underwent ct of lumbar spine without dye and ct of neck spine.On (b)(6) 2009 the patient presented for office visit due to headache.On (b)(6) 2009 the patient presented for office visit due to chronic sinusitis.On (b)(6) 2009 the patient underwent x-rays of chest due (b)(6) 2009.The patient underwent x-rays of shoulder due to joint pain in shoulder and swelling of limb.On (b)(6) 2009 the patient presented for office visit.On (b)(6) 2010, (b)(6) 2011, (b)(6) 2012, (b)(6)2013, (b)(6) 2014, (b)(6) 2015: the patient presented for office visit.On (b)(6) 2010: the patient underwent for mri of cervical spine without contrast due to headache, neck pain and low back pain.On (b)(6) 2011: patient presented for office visit and underwent mri lumbar spine with <(>&<)> w/o contrast.On (b)(6) 2011: the patient presented for manual urinalysis test with examination using microscope.The patient also went to the hospital's emergency department.On (b)(6) 2011: the patient underwent x-ray examination of chest.On (b)(6) 2011: the patient underwent x-rays of the knee.On (b)(6) 2011: the patient underwent x-ray of chest.On (b)(6) 2011: the patient underwent ct scan of abdomen and pelvis with contrast.On (b)(6) 2011: the patient underwent removal of appendix.On (b)(6) 2011: the patient underwent ct scan of abdomen and pelvis and imaging of abdomen and chest.On (b)(6) 2011: the patient underwent ct scan of abdomen and pelvis with contrast.On (b)(6) 2012, (b)(6) 2013, , (b)(6) 2014, (b)(6) 2015: the patient underwent x-rays of chest.On (b)(6), (b)(6) 2013, (b)(6) 2014, (b)(6) 2015: the patient visited emergency department for a moderately severe problem.On (b)(6) 2012, (b)(6) 2013, (b)(6) 2014, (b)(6) 2015: the patient visited emergency department due to problem of high severity.On (b)(6) 2013, the patient underwent x-rays of chest due to cough.On (b)(6) 2013, the patient underwent x-rays of chest due to shortness of breath.On (b)(6) 2013 the patient underwent x-rays of chest due to pneumonia.On (b)(6) 2013 the patient underwent x-rays of chest.On (b)(6) 2014: the patient underwent ct scan of the head or brain.On (b)(6) 2013: the patient underwent ct scan of the chest with contrast.On (b)(6) 2013 the patient underwent ct of neck spine.On (b)(6) 2013 the patient presented for an office visit due to lumbago.On (b)(6) 2014: patient underwent ct scan of upper spine.On (b)(6) 2014: the patient underwent x-ray of both knees.On (b)(6) 2014: the patient underwent x-rays of hand.On (b)(6) 2014: the patient underwent x-rays of shoulder.On (b)(6) 2015: the patient underwent imaging of abdomen.On (b)(6) 2015: patient underwent ct scan of the lower spine.On (b)(6) 2015: the patient underwent x-rays of lower and sacral spine.The patient also underwent ct scan of the lower spine.On (b)(6) 2015: the patient underwent x-ray of sacroiliac joints.On (b)(6) 2015 the patient underwent x-rays of chest due to cough.On (b)(6) 2015: the patient underwent ct scan of the abdomen and pelvis with contrast.On (b)(6) 2015, the patient called to inform that she had severe muscle spasms.
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Manufacturer Narrative
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Add'l info: (b)(4).
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Event Description
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It was reported that on (b)(6) 2008: the patient assessment was done.Patient limitations: mobility.Limitations comment: pain, numbness right hand.The patient underwent rt carpal tunnel release.(b)(6) 2008: the patient was diagnosed with lumbar spondylosis.The patient underwent the following procedures: lumbar laminectomy, l4-5.Bilateral lateral arthrodesis, l4-5.Pedicle screw instrumentation, l4-5.Morselized autograft.5.Morselized allograft.Per op notes the endplates were drilled in preparation for arthrodesis.The appropriate size implant was selected by use of a trial.This was packed in morselized allograft, as well as rhbmp-2/acs, impacted into position, with excellent seating being noted.A 19 mm plate was applied, with a 30mm screw in l4 and 25 mm screws in l5.(b)(6) 2008: the patient underwent mri of the lumbar spine.Conclusion: prior fusion at l4-5 with no recurrent disc herniation or canal stenosis.There is a large fluid collection within the posterior operative site which causes indentation of the thecal sac.(b)(6) 2010 patient presented with symptoms of lgp, tingling in neck.(b)(6) 2010: patient underwent sagittal t1, axial flair, t2, t1, gradient and diffusion sequences are performed.Conclusion: negative non contrast mri of the brain.Sagittal t1, t2, stir and axial t2 and t2 star sequences are performed.Conclusion: negative mri of the cervical spine.(b)(6) 2010 patient presented for office visit.(b)(6) 2011: patient presented for office visit with chief complaint of low back and bilateral lower extremity pain with chronic lumbar radiculitis and underwent removal of trial spinal cord stimulator.(b)(6) 2011: patient presented with diagnosis of lumbar spondylosis and underwent following procedure: permanent spinal cord stimulator.Patient underwent x-ray of spine.(b)(6) 2011: patient presented for office visit due to chief complaint of lower extremity weakness.Review of system reveals that patient has occasional nausea and vomiting.Patient is noted for chronic back pain and lower extremity pain and paresthesias.Patient does have some memory loss and numbness and tingling in the left lower extremity.(b)(6) 2011, the patient presented for the similar test as performed on (b)(6) 2011: patient presented for office visit.(b)(6) 2011: patient presented with radiating knee pain and hand pain.Diagnosis: lumbar spondylosis, carpal tunnel syndrome.Instructions: bilateral hand pain.Patient was referred for multiple arthralgia.(b)(6) 2011: patient was referred for multiple arthralgia.(b)(6) 2011, (b)(6) 2012,(b)(6) 2011: the patient presented for an office visit.On an unknown date in 2014, the patient underwent nerve decompression.On an unknown date in 2014, the patient underwent carpal tunnel release - left hand.(b)(6) 2014: as per telephone encounter, patient was having severe muscle spasms.Since the rh-bmp2/acs surgery, the patient has been suffering from the following injuries: bone growth, bone resorption, extreme pain, pain more often than before rh-bmp2/acs surgery, localized edema, nerve injury, pain radiating into legs, foot drop, and sciatica.The symptoms also includes: pain in both legs that radiates from my back into my legs, sciatica, lower back pain, neuropathy, extreme pain, pain more often than before rh-bmp2/acs surgery, localized edema, nerve injury, muscle spasms and foot drop that continues to get worse.The patient is unable to perform daily activities.
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Event Description
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It was reported that on, (b)(6) 2008: patient presented with an office visit due to joint pain.On (b)(6) 2008: patient presented for an office visit.Impression: back and neck pain with associated numbness into the right leg.On (b)(6) 2008: patient underwent an unknown examination.Conclusion: there was moderate/ severe right carpel tunnel syndrome by conduction studies with on significant axonal loss.On (b)(6) 2008: patient presented for a follow-up visit due to severe numbness in her hands bilaterally.Impressions: lumbar spondylosis.Severe carpal tunnel syndrome on the right.On (b)(6) 2008: patient underwent a physical exam due to a history of hysterectomy, ulnar nerve decompression and tubal liquation.Impressions: multiple peripheral neuropathy.On same day, patient presented with diagnosis: right-sided median myeloneuropathy.Patient underwent following procedure: right sided carpel tunnel release.No patient complications were reported.On (b)(6) 2008: patient presented for a follow-up visit for a wound check.There was some soreness in and around the area of incision, not expected after the carpal tunnel surgery.She complained of low back pain and right leg.Patient was diagnosed with lumbar spondylosis and underwent an x-ray exam of l and c spine ap and lateral/ f<(>&<)>e views.Impression: normal exam.On (b)(6) 2008: patient presented with a follow-up visit post her carpal tunnel surgery.She complained of severe mechanical low back pain and bilateral radicular systems.On (b)(6) 2008: patient underwent a discogram/ ct exam.On (b)(6) 2008: patient also underwent a lumbar discogram exam.Impressions: partially concordant pain at l4-5.25 (b)(6)2008: patient presented for a follow-up visit due to increasing low back pain and bilateral lower extremity pain of a mechanical nature.Impressions: discogenic pain with annular tear with severe symptoms refractory to extensive conservative management.On (b)(6) 2008: patient presented with a follow-up exam.Impressions: diskogenic pain with annular tear with severe symptoms refractory to extensive conservative management.On (b)(6) 2008: the patient was admitted to the hospital with following diagnosis: lumbar spondylosis.Post-op sacroiliac joint pain.Co-morbidity chronic back pain and narcotic use with intractable low back pain.Sinus disease.Ulnar nerve and carpal tunnel syndromes.Impressions: sacroiliac tenderness with associated complaints in the lower extremities suggestive of nerve root swelling.There is no evidence of motor deficit.Her tenderness is exquisite over the sacroiliac joint.On (b)(6) 2008, the patient presented with ambulatory difficulty secondary to pain.Impression: bilateral sacroiliac joint tenderness with lumbar radiculopathy secondary to nerve root swelling.On (b)(6) 2008: patient got discharged with discharge diagnoses as: lumbar spondylosis.Postoperative sacroiliac joint pain.C o-morbidity chronic back pain and narcotic use with intractable low back pain.Sinus disease.Ulnar nerve and carpal tunnel syndrome.On (b)(6) 2008, the patient presented for staple removal post-op alif l4-5.On (b)(6) 2008, the patient called and complained of increasing radicular symptoms in her lower extremity.On (b)(6) 2008: patient also underwent a physical exam which revealed good strength in the lower extremities and ambulation without assistance.There was some subjective hyperalgesia in the left lower extremity and across the lumbosacral region.Impressions: increased radicular symptoms of a dysesthetic nature.On (b)(6) 2008, the patient presented for follow up and complaint of pain, burning sensation in both feet.Impression: stable course status post lumbar fusion.Peripheral neuropathy.The patient underwent lumbar spine x-ray.Impression: post fusion changes at l4-5 disc level ; no complicating process identified.On (b)(6) 2008 , the patient presented with pre-op diagnosis of right lower extremity pain ; post laminectomy syndrome.The patient underwent right l3 lumbar sympathetic nerve block procedure.On (b)(6) 2008, the patient underwent drug screening.The patient complaint of low back pain, neck pain and total body pain.On (b)(6) 2008, the patient presented for follow-up and complaint of low back pain , numbness and paresthesias in her hands persistent with her peripheral nerve entrapment syndrome.On (b)(6) 2008, the patient also underwent x-ray of lumbar spine due to back pain.Impression; evidence of interval anterior , interbody and posterior fusion at l4-5 with anatomic alignment.On (b)(6) 2009: patient underwent an mri of brain without contrast due to neck pain and headaches.Impressions: (b)(6) i malformation without any evidence of cervicomedullary kinking.Mild maxillary and sphenoid/ ethmoid sinus inflammatory disease.On (b)(6) 2009, the patient underwent cervical spine mri without contrast due to neck pain and upper extremity numbness.Impression: unremarkable non contrast cervical spine mri.On (b)(6) 2009, the patient presented for follow up status post lumbar decompression , fusion , and instrumentation.The patient complaint of tenderness over the si joints bilaterally.The mri of brain and cervical spine showed chiari malfunction without syringomyelia.Impression : asymptomatic adult chiari malformation.Lumbar spondylosis and knee pain.On (b)(6) 2009: patient underwent electromyography and nerve conduction study.Impressions: mild sensory polyneurotherapy.Reduced lower extremity sensory amplitudes.No electrophysiologic evidence of a focal tibial, peroneal, or sciatic neuropathy, polyneuropathy, or active lumbosacral radiculopathy by concentric needle emg of the bilateral lower extremities.The patient underwent x-ray of lumbar spine because of lumbar spondylosis.Evidence of anterior , interbody and posterior fusion at l4-5 with stable anatomic alignment.On (b)(6) 2010: patient presented with an office visit and underwent review of mri and physical examination.Impressions: mri study suggested for the lumbar spine and cervical spine.Patient also underwent x-ray of lumbar spine with flexion and extension views due to low back pain.Impression: stable appearing post fusion changes at the l4-l5 disc level.No evidence of instability identified.
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