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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK CD HORIZON SPINAL SYSTEM

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MEDTRONIC SOFAMOR DANEK CD HORIZON SPINAL SYSTEM Back to Search Results
Catalog Number UNKNOWN
Device Problem Migration or Expulsion of Device (1395)
Patient Problems Muscle Spasm(s) (1966); Weakness (2145); Stenosis (2263); Neck Pain (2433)
Event Type  Injury  
Manufacturer Narrative
(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.
 
Event Description
It was reported that on: (b)(6) 2006: patient presented with chief complaint of left ankle injury and low back pain which was injured 3 days ago when patient fell into a jacuzzi.Patient complains of pain and swelling and also a severe pain in her low back radiating down her left extremity.Physical educations reveals following: there is diffuse subjective tenderness about the lumbar spine.She has moderate stiffness in all planes.Patient has positive straight leg raise test on the left which elicits pain the left thigh anteriorly to her knee.The left ankle has diffuse swelling and limited range of motion.X-ray of lumbar spine show mild degenerative change with no evidence of acute pathology.X-ray of left ankle show soft swelling but no evidence of fracture, dislocation or moetise widening.Impression: left lateral ankle ligament sprain, lumbar strain and radiculopathy, possible herniated disc.(b)(6) 2006: patient underwent mri of lumbar spine without and with contrast due to leg pain radiating to both legs.Impression: prior partial laminectomy at l5.Mild degenerative stenosis at l4-5.Diffuse mild degenerative spondylosis.(b)(6) 2006: patient presented with chief complaint of low back pain.Physical examination reveals following: spinal motion is limited.Rocking the patient into extension aggravated the pain.She has positive straight leg raising on the left with duplication of leg pain.Positive lasegue sign.The knee to chest maneuver with rocking and twisting of the lumbar spine aggravates the pain.She cannot hold her legs in the supine position due to pain and the pain is increased when she lowers them to the bed.Palpation results in tenderness.Review of mri: mri scan shows lumbar degenerative disc disease l4-5 and l5-s1.Diagnoses: previous laminectomy l4-5 with good results.Lumbar degenerative disc disease l4-5 and l5-s1 probably resulting in mechanical back pain.(b)(6) 2006: patient presented with following pre-operative diagnosis of status post previous left l5-s1 laminectomy and micro-discectomy with recurrent disc herniation and intractable s1 radiculopathy.Congenital spinal stenosis, l4-5 with large herniated nucleus pulposus on the left at l4-5 with intractable l5 radiculopathy and foot drop.And underwent following procedures: re-do left l5-s1 laminectomy, medial facetectomy and neural foraminotomy with decompression of the s1 nerve root.Re-do left microdiskectomy.Left l4-5 hemilaminectomy, medial facetectomy and neural foraminotomy with microdiskectomy and decompression of the l5 nerve root.No complications were noted.(b)(6) 2006: patient underwent lumbar myelogram due to radiculopathy, foot drop, status post laminectomy and microdiscectomy l5-s1.Impression: minimal ventral compression on the dural sac at l2-l3,l3-l4 and l4-l5.There is some mild displacement and effacement of the left l5 nerve root at the l4-5 disc space.(b)(6) 2006: patient presented with following preoperative diagnoses: status post l4-5 and l5-s1 laminectomy and microdiskectomies with decompression of l4, l5 and s1 nerve roots for progressive neurological deterioration of the left leg with foot drop.Status post myelogram l2-3 with possible chronic post myelogram cerebospinal fluid leakage.Lumbar wound dehiscence secondary to chronic bedrest.And underwent following procedure: irrigation and debridement and primary closure l4 to sacral lumbar wound dehiscence.No evidence of any infection or cerebrospinal fluid leakage in lumbar wound from l4 to the sacrum.Left l2-3 hemilaminectomy and wound exploration for dural tear with no dural tear or evidence of cerebrospinal fluid leakage encountered.No complications were noted.Postoperative diagnosis: no evidence of chronic post myelogram dural tear with cerebrospinal fluid leakage.(b)(6) 2006: patient presented for pain management consultation.Patient still complains of headache, low back pain and left leg pain and left foot drop.Patient appears to be in mild distress.The patient is tender over the surgical wound area as well as with some spasm of the lumbar paraspinal muscles.The patient with severely limited range of motion of the lumbar spine in all planes.Patient has difficulty changing positions.On examination the patient revealed decreased light touch sensation to left lateral and posterior thigh as well as left lateral dorsal foot.Assessment: post procedure arthrodesis status.Post lumbar spine surgery pain.Lumbar myofascial pain.Left foot drop.(b)(6) 2007: patient presented for first follow up after undergoing a procedure for irrigation and debridement and a closure of a wound dehiscence on (b)(6) 2006.Patient complains of bronchial type cough and pain in her leg and her buttocks all the way down on the left.(b)(6) 2007: patient presented for follow up for her emergent lumbar decompressions performed for progressive neurological deficit.Patient complains that she does soil the bed without warning.On examination patient is found to have normal bladder function.(b)(6) 2007: patient underwent mri of lumbar spine without and with contrast due to low back pain radiating into left leg.Left foot numbness.Impressions: status post left l5 hemilaminectomy.New fluid collection in the laminectomy defect and left epidural space.Left lateral disc herniation at l5- s1.The left l5-s1 nerves are likely compressed.Bulging disc at l5-s1 causing right lateral recess and neural foramen stenosis.Multilevel degenerative disease.Evidence of chronic but ongoing atrophy of the left paraspinous and gluteus muscles.(b)(6) 2007: patient presented for follow up for her rather emergent lumbar decompression l4-5 and l5-s1 for foot drop and intractable pain.Patient had a fall on (b)(6) after which she developed increase in leg pain and numbness in l5 distribution.She does subjectively have decreased sensation and she has positive straight leg raising.An mri scan was performed.It looks like she has extruded her l5-s1 disc with some cephalad migration which is compromising the l5 nerve root.She had epidural injection three weeks ago which increased her leg pain.(b)(6) 2008: patient presented for office visit due to lumbar back pain that radiates left side and headaches.Pain is severe and worsens with walking, prolonged standing, sitting and change of weather.Review of symptoms: positive for constipation, weight loss, sleep disturbances and loss of appetite.Lumbar spasms.Range of motion is limited.Spinal tenderness to digital palpation.Active problems: lumbar herniated nucleolus pulposis, l2-3, l3-4.Lumbar stenosis.Cervical herniated nucleus pulposus, uncomplicated (slipped disc).Radiculopathy to lower extremities.Radiculopathy to upper extremities.Migraines.Post lumbar laminectomy pain syndrome.Medical treatment plan and prognosis: procedure left lumbar trans-foraminal epidural steroidal injection under fluoroscopy with left sacroiliac joint on (b)(6) 2008.(b)(6) 2008: patient underwent mri of the lumbar spine with <(>&<)> without contrast due to history of lumbar laminectomy; history of spinal stenosis; radiculopathy.Impression: spondylosis with bulging discs from l2-3 to l5-s1 with narrowing at l4-5 and l5-s1.There is suspicion for a superimposed left foraminal protrusion at l2-3.Considerable foraminal stenosis at l4-5 and l5-s1 bilaterally.Note is made of modic type i changes at l4-5 and l5-s1 with bone marrow edema secondary to degenerative disc disease with secondary inflammatory changes.(b)(6) 2008: patient states that he has new onset irritable bowel syndrome and acid reflux disease, lower back pain that radiates bilaterally side.Review of systems and active problems unchanged from (b)(6) 2008.Pain is worse with laying down.Review of systems: nausea.(b)(6) 2008: patient presented with chief complaint: severe migraines also lower back pain shoots down to both legs.Reason for visit: post procedure.Continuous lumbar epidural catheter insertion under fluoroscopy.Review of systems: vomiting, nausea.Physical examination reveals tender bilateral sacroiliac joint with radicular pain limited range of motion tender to palpation.(b)(6) 2008: patient has profound numbness in the s1 distribution on the left and she thinks she is getting on the right.She has significant back pain.X-rays show significant disc collapse at l5-s1 and to a lesser degree at l4-l5.She has degenerative changes at l4-5, but to a significant lesser degree.Impression: she will need an anterior lumbar interbody fusion at l5-s1.(b)(6) 2008: patient underwent mri of lumbar spine without and with contrast due to history of low back pain and bilateral hip and leg pain and evaluation for hnp/nerve root impingement.Impressions: osseous degenerative changes without acute osseous abnormalities, left lateral protrusion at l2-3 results in no definite impingement.Disc bulge at l3-4 contributes to canal and foraminal narrowing without stenosis or impingement.Post surgical changes at l2-3,l4-5 and l5-s1.No definite residual or recurrent disc herniation is identified, but there is neural foraminal stenosis at each level.Fluid collection dorsal to the left sided facetectomy defects at l4-5 and l5-s1 likely represents seroma associated with prior surgery but could represent pseudomeningocele and is non specific.(b)(6) 2008: patient presented for follow up for intractable back pain.Patient has developed three level degenerative disease.(b)(6) 2008: patient presented for history and physical examination for upcoming anterior lumbar inter-body fusion at l5-s1.(b)(6) 2008: patient underwent x-ray of chest due to cough.Impression: normal chest.(b)(6) 2008: patient was admitted due to low back pain and left leg pain.Patient presented with pre-operative diagnosis of degenerative disk disease, multi-segment and underwent following procedures: anterior retroperitoneal l5-s1 exposure,alif,l5-s1.Patient presented with preoperative diagnosis of status post previous l4-5, l5-s1 laminectomy and decompression for intractable radiculopathy and early cauda equina syndrome.Lumbar degenerative disk disease l3-4,l4-5 and l5-s1 with intractable diskogenic back pain with unsalvageable l5-s1 disk and following procedure were performed: alif, l5-s1 via the anterior retroperitoneal exposure using 2 danek bone dowels packed with bmp.Anterior stabilization with instrumentation using pyramid plate.Procedure performed under biplanar fluoroscopy guidance.Per op notes: ".2 circular parallel holes were reamed through the double barrel working tube into the l5-s1 disk space.Disc material was removed.Both holes were tapped, packed with bmp into 2 bone dowels and threaded into l5-s1 disk space through the double barrel working tube into good position.Pyramid plate was sized to span the anterior aspect of the l5-s1 disk space and secured in position with one screw obliquely through the plate at l5, two screws through the plate in the anterior to posterior direction into the sacrum.A locking plate was applied.Intra-op x-rays were taken and instrumentation was found to be in good position." patient presented with preoperative diagnosis: status post anterior lumbar inter-body fusion and at l5-s1.Lumbar degenerative disk disease, l3-4 and l4-5 with intractable diskogenic back pain.Status post previous left l4-5 laminectomy and decompression and underwent following procedures: posterior instrumented fusion, l3-5 using dynesys pedicle instrumentation and bone morphogenic protein and locally harvested bone graft.Posterior intertransverse fusion, l5-s1 using bmp and locally harvested bone.Per op notes ".Spinous process was removed with rongeur.It was morselized and packed with bmp and packed into the facets and along the inter-transverse gutter from l3 to the sacrum.Space between pedicel screws, cut off the universal spacer for the proper size.The dynamic stabilizing cord through the eyelets of the pedicle screws and attached our universal spacers for each segment at l3-4 and l4-5.Proper tensioning and tightening of locking screws was also performed.The wound was copiously irrigated.Patient tolerated the procedure well." patient underwent x-ray of lumbosacral spine due to low back pain.Impression: intrapedicular screws l3,4,5.Anterior fusion with plate and screw devices and intervertebral disk spacer device l5-s1.(b)(6) 2008: patient underwent ct of lumbar spine without contrast due to low back pain.Impressions: apparent bulge versus post surgical material is noted in the anterior l5-s1 epidural space.There is instrumentation and attempted fusion of the lower three lumbar levels, anterior with inter-body device at l5-s1 and posterior at l4-5 and l3-4.Small gas bubbles are seen in the prevertebral l5-s1 region.These may be post surgical in origin but clinical correlation is recommended to exclude.Patient was discharged.(b)(6) 2008: patient presented for history and physical examination for upcoming anterior lumbar inter-body fusion at l5-s1.(b)(6) 2008: patient presented for follow-up for her anterior lumbar inter-body fusion at l5-s1 with posterior dynamic stabilization of l3-l4 and l4-5 for intractable pain due to multilevel degenerative disease.A cat scan was performed postoperatively which showed all the implants were in ideal position.Patient had a slip and fall injury and since then she had a exacerbation of some leg pain.X-rays performed today show no fracture or loosening of implants due to fall.As per doctor leg pain is not due to any malpositioning or loosening of implant.(b)(6) 2008: patient was admitted.(b)(6) 2008: patient underwent mri of lumbar spine with and without contrast due to low back pain radiating into right toes.Impression: mild epidural scarring at l4-5 on the left.Large amount of epidural scarring within the left side of the spinal canal encasing the exiting s1 nerve root at l5-s1 and causing mild spinal stenosis.(b)(6) 2008: patient presented with chief complaint of back and leg pain following a fall.Patient also complains of increased radiculopathy(left greater than right) with the primary pain distal to the knees and the distribution l5.She has axial lbp l4-5,s1.She has had loss of bowel control.On physical examination, lower extremities have tenderness to palpation over the l% dermatome distal to the knee with some s1 component.Impression: low back pain, radiculopathy, post op lumbar laminectomy with fusion and instrumentation, possible partial cauda equina syndrome by physical examination, soft tissue edema of the lumbar paravertebrals, prior laminectomy of neck and degenerative disk disease.(b)(6) 2009: patient was admitted.(b)(6) 2009: patient presented for orthopedic surgical consultation due to low back pain and bilateral leg pain, numbness and weakness after fall 4 days ago.She points to lumbosacral junction as the area of her back pain.A repeat mri done today showed implants to be in good position and the only area of possible compromise is the neuroforamen through the l5 nerve on the left, but she is definitely in s1 deratome to her pain with it being into her calf and heel and plantar aspect of her foot.She hurts most areas in her low back where i palpate worse at the top aspect of her incision and over the lumbosacral junction into the right of midline.(b)(6) 2009: patient underwent myelogram of the lumbar spine due to low back pain and left leg pain.Impressions: findings consistent with some mild nerve root impingement on the left at l4-5 and l5-s1.Patient underwent ct of lumbar spine with contrast due to lower back pain.L3-4 and l2-3 show only minor bulging.There has been minor progression in recession of the inferior l5 endplate into the inter-body device.Small left l4-5 protrusion versus scar tissue contacting the undersurface of the ganglion.Inter-body device placement at l5-s1 and dynamic stabilization across l3-4 and l4-5.There is residual scar versus residual material in the left l5-s1 posterolateral quadrant displacing posteriorly the left s1 nerve root at its axolla without impingement and extending laterally into both foramina with moderate to moderately severe bilateral foraminal narrowing.(b)(6) 2009: patient presented with chief complaint: leg pain, cold and numb.Reason for visit: follow up and medication.Active problems: lumbar herniated nucleolus pulposis, l2-3, l3-4.Lumbar stenosis.Cervical herniated nucleus pulposus, uncomplicated (slipped disc).Radiculopathy to lower extremities.Radiculopathy to upper extremities.Migraines.Post lumbar laminectomy pain syndrome.Lumbar surgery (b)(6) 2008 (15-s1 anterior fusion, 12-13, l3-14, and 14- l5 spacers).Patient is disable since 1996.Patient has been having neuropathic pain down the legs clearly leg pain bilaterally.Admitting diagnosis: post lumbar laminectomy pain syndrome complex regional pain syndrome medical treatment plan and prognosis: procedure book for bilaterally lumbar sympathetic block.(b)(6) 2009: patient presented with chief complaint of pain in whole body.Review of systems: nausea, constipation, sleep disturbances.Positive lumbar facet loading, positive patrick test on the left.Admitting diagnosis: lumbar facet joint disease.Fibromyalgia.Left sacroiliitis.(b)(6) 2009: patient presented with chief complaint: frequent headaches, low back pain that radiates to bilateral lower extremities.Reason for visit: post procedure.Diagnostic left lumbar facet joint injections and left sacroiliac joint injections under fluoroscopy.Review of systems: constipation, sleep disturbances.Admitting diagnosis: osteoarthritis.Degenerative disc disease.( cervical.Lumbar) depression.Anxiety cervical facet syndrome, failed back syndrome, post lumbar laminectomy pain syndrome.Urine drug screen for medication usage compliance.Positive for mtd.Medical treatment plan and prognosis: procedure book for bilaterally lumbar sympathetic block.(b)(6) 2009: patient presented with chief complaint of neck pain, low back pain that radiates to bilateral lower extremities (is worse on the left side).Reason for visit: bilateral lumbar sympathetic nerve block under fluoroscopy.Review of systems: nausea, constipation, sleep disturbances, loss of appetite.Admitting diagnosis: post lumbar laminectomy pain syndrome, failed back syndrome,osteoarthritis, degenerative disc disease.(b)(6) 2010 :patient presented with chief complaint of low back pain radiating down the legs, left more than right.Review of systems: nausea, vomiting, constipation, sleep disturbances, loss of appetite.Range of motion: limited.Reduced lumbar extension.Admitting diagnosis: post lumbar laminectomy pain syndrome.Lumbar surgery (b)(6) 2008 (l5-s1 anterior fusion, l2-l3, l3-l4, and l4- l5 spacers).Lumbar herniated nucleolus pulposis, l2-3, l3-4.Lumbar stenosis.Lumbar facet arthropathy.(b)(6) 2010: patient was admitted.(b)(6) 2010: patient underwent mri of lumbar spine without and with contrast due to low back pain and diminished sensation in the left lower extremity status post fall.Impressions: there is a small to moderately sized left foraminal l2-3 herniation contacting the ganglion.(b)(6) 2010: patient presented for orthopedic consultation for intractable back and left leg pain, numbness and weakness.Patient rec ently fell off ladder on her back and left leg and admitted with intractable back and left leg pain.The patient states that her whole leg is numb in a non-dermatomal pattern.The leg gives away when she attempts to weight bear on the left leg and she has pain again in a nondermal pattern.She has symptoms in the dorsum and plantar aspects of her left foot and pain beginning in the left buttock area.Patient underwent ct of lumbar spine without contrast due to chronic low back pain.Impression: no evidence for prosthetic loosening.Continued soft tissue mass on the left at the l4-5 level in the lateral recess which appears to result in a lateral recess stenosis.Note is made of a soft tissue density mass on the left at the l2-3 level measuring 11 x7 mm in size which is related to a recently described disk herniation.(b)(6) 2010: patient underwent left l2 selective nerve root block.No complications were noted.Impressions: successful uncomplicated left l2 selective nerve root block.(b)(6) 2010: patient underwent mri of cervical spine without contrast due to severe neck pain.Impression: moderate central stenosis at c3-4, fusion across c5-6.(b)(6) 2010: patient underwent x-ray of chest for picc line placement for long term iv medication.Impression: the right picc line tip is mid superior vena cana 5 cm above the ca voa trial junction.Patient underwent x-ray of lumbar spine due to low back pain and lower extremity pain.Impression: interval placement of l4-5 inter-body disk spacer device.Patient presented with following preoperative diagnosis: status post previous anterior lumbar inter-body fusion l5-s1 with previous l4-5 laminectomy and posterior stabilization using dynesys pedicle screw l3-4 and l4-5.Recent slip and fall off of a ladder resulting in left extruded l2-3 disc herniation with cephalad migration.Disruption of l4-5 degenerative disk disease with increase in disc bulge contributing to radiculopathy.Chronic narcotic use including methadone and oxycontin with failed conservative care and underwent following procedures: extreme lateral inter-body fusion via the left flank retroperitoneal approach at l4-5 using a coherent spacer packed with osteocell with nerve monitoring guidance.Posterior instrumented fusion l4-5 using a spire plate at l4-5 and fusion was performed using locally harvested autograft bone mixed with osteocell.Revision l4-5 laminectomy and decompression with excision of extruded disk herniation.Completed a anterior and posterior 360 degree fusion at l4-5.Patient tolerated the procedure well.Following implants were used: l4-5 coronet spacer/osteocell; 45 mm spire plate l4-5, set screw.(b)(6) 2010: patient was admitted to morton plant rehab center with diagnosis of lumbosacral neuritis, esophageal reflux, diaphragmatic hernia, hypothyroidism, opioid dependence, depressive disorder (b)(6) 2010: patient underwent mri of lumbar spine without and with contrast due to drainage following surgery.Impression: there is no evidence of epidural abscess.There is contrast enhancement surrounding the left l5 nerve root at the mid body of l5.The findings are most likely that of postoperative fibrosis.There is a left foraminal herniated nucleus pulposis at l2-3.There has been a development of a small collection in the subcutaneous soft tissues containing both fluid and gas.This measures 1.4 cm in greatest transverse dimension and extends from l3 to l5.This is slightly to the right of the scar of the incision.This does not appear to communicate with the deeper structures nor is the fluid collection in contact with the internal fixation devices.(b)(6) 2010: patient complained of severe headache and persistent clear drainage from her incision.It appears patient has a dural tear.(b)(6) 2010: patient was admitted.Patient presented with preoperative diagnosis of status post previous direct lateral interbody fusion l4-5 with posterior stabilization with instrumentation using spire plate.Revision left l4-5 laminectomy and decompression and discectomy.Left l2-3 laminectomy with excision of massive extruded disk herniation.Status post posterior inter-transverse fusion.Possible delayed csf leak secondary to dural tear.Following procedures were performed: exploration of lumbar wound focusing at l2-3 and l4-5 with repeat microscopic examination and manipulation of the dural nerve roots without any evidence of dural tear.Curving laminectomies using subcutaneously harvested fat graft and duraseal.Removal and later replacement of spire plate l4-5.Irrigation and debridement l2-3 and l4-5 including inter-transverse space.Exploration of l2-3 and l4-5 areas with widening of laminectomies of both levels.Repair of possible dural leak using subcutaneous harvested fat graft and dura coseal.Patient tolerated the procedure well.Post-operative diagnosis: no dural tear found after repeat examination of l2-3 and l4-5 under microscope.Spire plate was explanted and replaced.(b)(6) 2010: patient presented for infectious disease consultation.Patient complains of left lower extremity weakness, mild cough.Lumbar spine surgical area is draining.(b)(6) 2011: patient was discharged (b)(6) 2011: patient presented for office visit.Patient still requires a walker to ambulate and has some mild dysesthesias to the left anterior thigh.Patient has positive cultures for streptococcus from the incision site and a picc line is in place for receiving antibiotics.X-rays of lumbar spine (ap and lateral) reveal all instrumentation to be in good position with no evidence of loosening.(b)(6) 2011: patient presented for follow up for her degenerative lumbar spine at l4-5.Patient continues to have some left foot weakness mostly involving the peroneal tendons.She has some extensor hallucis longus weakness as well.(b)(6) 2011: as per doctor patient regularly misses appointment which is severely compromising the quality of medical care given to her.(b)(6) 2011: patient presented with chief complaint of low back and lower extremity pain.Patient underwent ultrasound guided caudal epidural steroidal injection.(b)(6) 2011: patient presented with chief complaint: low back pain.Reason for visit: follow-up.Therapeutic caudal epidural steroid injection under fluoroscopy overall improvement significant (greater than 50%) reported.Medical treatment plan and prognosis: diagnostics: procedure.Diagnostic bilateral lumbar facet joint injections, anesthetic only, l3/4, 4/5 and l5/s1.Therapeutics: toradol injection.No side effects reported.(b)(6) 2011: patient presented with chief complaint: lower back pain with bilateral lower extremities radiculopathy and neck pain with muscle spasms.Reason for visit: follow-up.Diagnostic bilateral lumbar facet joint injections under fluoroscopic.Spine: spinal tenderness to digital palpation in lumbar and cervical area.Trigger point injection procedure: the affected area: bilateral c3-c6 area.There was no complications.(b)(6) 2011: patient underwent mri of cervical spine.Impression: cervical dextroscolosis is noted.C2-3 level: disc herniation indents the anterior thecal sac and deforming the anterior coed margin.Herniation measures 4 mm transverse diameter.C3-4 level: 2mm of posterolisthesis of c3 on c4 suggests ligamentous laxity or strain.Loss of disc height and hydration.Diffuse circumferential disc bulge indents the anterior thecal sac.Hypertrophic facets and ligamentum flavum indent the posterolateral thecal sac.C4-5 level: loss of disc hydration.C5-6: the neural foramina is stenotic bilaterally.Patient underwent mri of lumbar spine.Impression: there is lower lumbar levoscoliosis.Loss of disc height and hydration with diffuse circumferential disc bulge in combination with hypertrophy of the facets and ligamentum flavum indenting the thecal sac.The neural foramina is stenotic bilaterally.L3-4 and l4-5 levels: loss of disc height and hydration with disc bulge, spondylosis and hypertrophy of the facets and ligamentum flavum indenting the thecal sac producing central stenosis.The neural foramina are narrowed bilaterally.Bilaterally pedicle screws and stabilization rods are noted.L5-s1 level: prior discectomy and fusion.The neural foramina are narrowed bilaterally.Anterior plate and screws are noted at l5-s1.Posterior fusion is noted at this level.(b)(6) 2012: patient presented with chief complaint of lower back pain, neck pain, headaches.Physical examination musculoskeletal: spasms in cervical region and lumbar region.(b)(6) 2012: patient presented for follow up visit with chief complaint of low back pain and neck pain.(b)(6) 2012: patient presented with chief complaint: neck pain.Reason for visit: follow-up.Rfa of the left cervical facet joints c2/3, 3/4, 4/5 and c6/7.(b)(6) 2012: patient presented with chief complaint of lower back pain, neck pain, muscle spasm reason for visit: follow-up.Therapeutic radiofrequency lesioning of the right cervical medial branch nerves with cervical nerve block under fluoroscopy.(b)(6) 2012: patient underwent mri of left shoulder and thoracic spine due to pain in entire thoracic area and limited range of motion.Impression: tendinopathy of supraspinous and infra spinous tendons.There is upper thoracic levoscoliosis with mid thoracic dextroscoliosis centered lumbar levoscoliosis.Superior margin of the mambrium lies at the t2 level.No gross lateral tear.T1-t2: loss of disc hydration.T2-3: loss of disc height and hydration.Neural foramina is patent.T3-4: loss of disc height and hydration with diffuse circumferential disc bulge indenting anterior thecal sac.T4-5: loss of disc height and hydration.T7-8: loss of disc height and hydration with diffuse circumferential disc bulge in combination with hypertrophy of facets and ligaments flava indenting the thecal sac.T8-9,t9-10: loss of disc height and hydration.Hemangioma is noted within the t12 vertebral body.(b)(6) 2012: patient presented for follow up visit with chief complaint: low back pain radiating into the hips.Medical treatment plan and prognosis: therapeutics: procedure.Rfa of the left lumbar facet joints, l3/4, 4/5 and l5/s1.(b)(6) 2012: patient presented with chief complaint of neck pain, upper back pain, low back pain reason for visit: follow-up.Therapeutics radiofrequency lesioning of left lumbar medial branch nerves under fluoroscopy.Review of systems: nausea.Vomiting , constipation, sleep disturbances.(b)(6) 2012: patient presented with chief complaint: neck pain.Reason for visit: follow-up.Rfa of the right lumbar facet joints.(b)(6) 2012: patient was admitted.Admitting diagnosis: intractable vomiting.Febrile illness.Anemia of chronic disease.Chronic low back pain.Gerd.Migraines.Hashimoto thyroiditis.Rheumatoid arthritis.Post traumatic stress disorder.History of obstructive sleep apnea.(b)(6) 2012: patient presented for follow-up visit.Chief complaint: shoulder and hip pain; low back pain; insomnia.(b)(6) 2012: patient presented with preoperative diagnosis of lumbar wound infection.Patient presented to hospital with lumbar induration and erythema and severe back pain.Very dense scar tissue was present.There was a purulent discharge coming from round the spinous process with purulent fluid present around the spire plate on both sides of the l4-5 interspace.The plate appears to be loose.The plate was removed along with the adjacent spinous process as a single piece.There was also some purulent drainage from the lateral recess at l4-5.Post-operative diagnosis: lumbar wound infection with infected spire plate.Spinous process osteomyelitis.Infected dynesys system which was removed.(b)(6) 2012: patient presented with preoperative diagnosis of symptomatic biliary dyskinesia and underwent following procedure: laparoscopic cholecystectomy.No patient complications were reported.(b)(6) 2012: patient was discharged.Discharge diagnosis: spinal abscess, status post lumbar spine wound debridement with hardware removal.Chronic cholecystitis status post laparoscopic cholecystectomy.(b)(6) 2012: patient underwent x-rays of bilateral hips due to history of rheumatoid arthritis.Impression: chronic findings with no acute abnormality.Evidence of prior surgery.Evidence of lower extremity catheter extending above pelvis.2013: patient underwent ncv and emg due to low back pain radiating to the bilateral extremities with numbness and tingling.Impression: abnormal examination: there is electro-diagnostic evidence consistent with radiculopathy affecting the left l5-s1 nerve roots.
 
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Brand Name
CD HORIZON SPINAL SYSTEM
Manufacturer (Section D)
MEDTRONIC SOFAMOR DANEK
1800 pyramid place
memphis TN 38132
Manufacturer (Section G)
MEDTRONIC SOFAMOR DANEK
1800 pyramid place
memphis TN 38132
Manufacturer Contact
greg anglin
1800 pyramid place
memphis, TN 38132
9013963133
MDR Report Key5152267
MDR Text Key28385767
Report Number1030489-2015-02688
Device Sequence Number0
Product Code NQP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Attorney
Report Date 09/28/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/15/2015
Is this an Adverse Event Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received09/28/2015
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Weight68
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