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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK CAPSTONE VERTEBRAL BODY SPACER; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

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MEDTRONIC SOFAMOR DANEK CAPSTONE VERTEBRAL BODY SPACER; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE Back to Search Results
Catalog Number 2960822
Device Problem Migration or Expulsion of Device (1395)
Patient Problems Bronchitis (1752); Chest Pain (1776); Pain (1994); Numbness (2415)
Event Type  Injury  
Event Description
In 1990s, the patient was diagnosed with back pain.From 1995 till the present date, the patient has had the same complaint of back pain.In the surgery of 2008, the following products were also used other that rhbmp-2/acs: cages, fixation device/screws, autograft bone.On (b)(6) 2008, the patient underwent right frontal ommaya reservoir placement.In the surgery of 2010, the following products were also used other that rhbmp-2/acs: fixation device/screws,graft, autograft bone.The patient also got hardware removal in this surgery.Posterolateral fusion was performed in this surgery of 2010 as well.Since the fusion surgeries, the patient has been experiencing worsening back pain and hip pain resulting from subsidence and cage migration.The patient also had the problem of numbness in left leg.On (b)(6) 2010, the patient underwent mri due to degenerative disc disease.From (b)(6) 2008 till 2011 (approx), the patient was diagnosed with back and leg pain, sciatica,chest pain, bronchitis, acute medical conditions and degenerative disc disease.The patient underwent hip surgery for broken hip in (b)(6) 2014.In 2014, the patient also underwent amputation of toes on right foot.In (b)(6) 2014, the patient underwent hip replacement.Post the surgeries, the patient is on wheelchair because of severe pain and has also been experiencing hip pain in addition to back pain.Since (b)(6) 2012, the patient is being diagnosed with back pain, sciatica and leg pain.
 
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) 2009 the patient presented for an office visit due to abdomen pain.(b)(6) 2009 the patient presented for an office visit with pain under right arm and cough.(b)(6) 2009 the patient presented for an office visit due to low back pain with radiation to the left leg.(b)(6) 2009: the patient presented with chief complaint of lower back pain.(b)(6) 2009 the patient presented for an office visit with chief complaint of osteopenia and back pain.The patient presented with chief complaint of right rib pain.(b)(6) 2009: the patient presented with chief complaint of right rib pain.(b)(6) 2009 the patient presented for medicine refills.(b)(6) 2009: the patient underwent x-rays of chest.Impression: interval clearing of right medial lung base densities consistent with plate atelectasis with no new abnormality.Underlying chronic lung changes were stable.(b)(6) 2009 the patient presented for an office visit due to pleuritic chest pain.(b)(6) 2010 the patient presented for medicine refill.(b)(6) 2010 the patient presented for medicine refills.(b)(6) 2010 the patient presented for medicine refills.(b)(6) 2010 the patient presented for an office visit.(b)(6) 2010 the patient presented with diagnosis of osteoporosis and anxiety.(b)(6) 2010 the patient presented with anxiety and depression and back pain.(b)(6) 2010 the patient presented with back pain.The patient presented for medicine refills.(b)(6) 2010 the patient presented with postoperative lumbar spine pain.Fentanyl 50 mg was increased.(b)(6) 2010 the patient presented with left hip and back pain.
 
Event Description
On (b)(6) 2008: the patient underwent chest x-ray due to preop surgery.Impression: no acute cardiopulmonary disease.On (b)(6) 2008: the patient surgery using rhbmp2 on the lumbar spine at levels l2-s1 with tlif approach along with cages, fixation devi ce/screws, autograft bone.On (b)(6) 2010: the patient underwent mri of lumbar spine w/wo due to lumbar degenerative disk disease.Impression: l2-s1 plif.No significant central canal or foraminal stenosis.On (b)(6) 2010: the patient surgery using rhbmp2 on the thoracic spine at levels t11-s1 with plif approach fixation device/screws,graft, autograft bone.Currently patient complaints of back pain and hip pain resulting from subsidence and cage migration.Patient alleges having back pain and numbness in the left leg which was never resolved after the surgery and got worse.On (b)(6) 2010: the patient presented for a follow up (b)(6) 2008 -2011(date approx): the patient presented for office visit with diagnosis of back, leg pain and degenerative disk disease.On (b)(6) 2010: the patient presented for a follow up.The patient underwent mri of thoracic spine w/wo contrast due to thoracic fusion, degenerative disc disease pain.Impression: no evidence of significant lumbar spine degenerative disc disease or central canal stenosis.There is partially evaluated degenerative changes in the cervical spine most notably at c5-c6 and c6-c7.The patient underwent mri of lumbar spine w/wo contrast.Impression: extensive artifact from lumbar spine hardware limits examination.Central canal is grossly patent.In (b)(6) 2014(date unknown): the patient underwent hip surgery due to fractured hip.In (b)(6) 2014(date unknown): the patient underwent surgery to remove rod in hip.In 2014(unknown date and month): underwent amputation of two toes on right foot.On (b)(6) 2015: the patient underwent ct maxillofacial w/o due to lefort ii fracture.Impression: most consistent with lefort i fracture and one fracture plane extending into the left orbital floor.The patient underwent ct angiography of head and neck w/o due to mallixofacial fracture.Impression: examination limited by extreme patient motion; however, this limitation is only superior to the circle of willis.Facial fractures described on separate report.No acute intracranial findings.Atherosclerotic plaque and calcification are at both common carotid bifurcations with 50% stenosis of the right internal carotid artery.Atherosclerotic calcification with mild narrowing of the intracranial left internal carotid artery which is likely not hemodynamically significant.No definite abnormality of the remaining intracranial vasculature.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that on (b)(6) 2006: the patient underwent shoulder left 3 views.Impression: 1.5 x 2 cm ossification posterior to the humeral head which appears to reflect an avulsion fracture of the humeral head.On (b)(6) 2006: the patient underwent pa/lat chest x-ray.Impression: findings in keeping with subacute fracture involving the left 4th and 5th anterior ribs.Callus formation is seen about the fracture site.No acute pulmonary parenchymal disease or evidence of overt congestive failure detected.On (b)(6) 2008: the patient underwent mri lumbar without contrast.Impression: lumbar spondylosis and scoliosis.Extruded disc fr agments at l3-4, l4-5 and l5-s1.Narrowed neural foramina at multiple levels but most pronounced to the left at l4-5 and l5-s1 (l5-s1 is the most severe).Multiple tarlov cysts of the sacrum.On (b)(6) 2008: the patient underwent lumbar 5 views.Impressions: post-surgical changes of l2-s1 discectomy and laminectomy with pedicle screws and rods from l2-s1 with scoliosis.No acute fracture or subluxation.The patient presented with mid to lower back pain.On (b)(6) 2009: the patient underwent lumbar 5 views.Impressions: scoliosis and postsurgical fixation.No acute fracture identified.On (b)(6) 2009: the patient underwent pa/lat chest x-ray due to cough, right rib pain.Impression: linear scarring or atelectasis in the costophrenic angles with an otherwise unremarkable chest.On (b)(6) 2009: the patient presented with shortness of breath, cough and chest pain.Impression: acute copd exacerbation, early right lower lobe pneumonia.The patient underwent pa/lat chest x-ray.Impression: hyperinflation consistent with emphysema or asthma.No acute disease in the chest.On (b)(6) 2009: the patient underwent pa/lat chest x-ray.Impression: interval clearing of right medial lung base densities consistent with plate atelectasis with no new abnormality.Underlying chronic lung changes are stable.On (b)(6) 2009: the patient underwent chest iv x-ray.Impression: no acute disease in the chest.On (b)(6) 2009: the patient was discharged home with the following diagnosis.Chronic obstructive pulmonary disease exacerbation.Tobacco addiction.Depression.Osteoporosis.Chronic neck and back pain.On (b)(6) 2009: the patient presented with left leg and low back pain.On (b)(6) 2009: the patient presented with chest pain.The patient underwent chest iv x-ray.Impression: no acute disease in the chest on (b)(6) 2010: the patient presented with bilateral hip and leg pain.On (b)(6) 2010: the patient underwent lumbar 5 view x-ray.Impression: left convex scoliosis with spinal stabilization rods from t11 through s1 with interval extension of the rods.Disc implant grafts are noted in the lumbar spine and there is an old l1 anterior compression fracture.No acute bony abnormality is seen.On (b)(6) 2010: the patient presented with left hip pain radiating to ankle.The patient underwent chest iv x-ray.Impressions: no acute disease in the chest.On (b)(6) 2010: the patient presented with leg pain.On (b)(6) 2010: the patient underwent hip bilateral 2 views each due to pain in lumbar region.Impressions: demonstrates mild degenerative joint space narrowing at both hips, slightly more advanced on the left with no acute bony findings.On (b)(6) 2011: the patient presented with chronic leg pain.On (b)(6) 2011: the patient presented with leg pain.On (b)(6) 2011: the patient presented with left leg and left foot pain.On (b)(6) 2011: the patient presented with left foot pain.The patient underwent foot left 3 views.Impressions: severe hallux valgus deformity.On (b)(6) 2011: the patient underwent lumbar spine 5 views.Impressions: left convex curvature of the lower thoracic and lumbar spine with spinal stabilization rods from t11-l5, disc implant grafts in the lower lumbar spine and old anterior compression deformity of l1 stable.No new or acute findings.On (b)(6) 2011: the patient underwent pa and lat chestx-ray.Impressions: underlying emphysema with no active chest disease or interval change.On (b)(6) 2012: the patient underwent chest pa and lat x-ray due to shortness of breath and chest pain.Impressions: emphysema.On (b)(6) 2012: the patient presented with fall injury.The patient underwent 2 views of lateral ribs and chest pa/lat.Impressions: no acute fracture noted in this left rib series.A non-displaced acute fractures may be initially occult.No acute pulmonary parenchymal disease, parenchymal contusion or pneumothorax detected.On (b)(6) 2012: the patient presented with low back pain radiating towards down both legs.Per the medical records.The patient has decreased range of motion.On (b)(6) 2013 the patient was diagnosed for calf and foot pain.Musculoskeletal review ofthe patient is positive for pain, swelling, tenderness, of the right calf and right foot.All other systems negative.On (b)(6) 2013 the patient was diagnosed for chronic pain post narcotic withdrawal.The patient underwent x-rays of chest pa and lateral due to cough and chest pain.Impressions: no acute infiltrate is identified.Fairly recent healed fractures of the right anterolateral 4th through 7th ribs are noted.There is rod and screw stabilization again demonstrated within the lower thoracic and lumbar spine.On (b)(6) 2013 the patient came for an office visit with complains of pain to the top of head, forehead, left frontal area, left side of the back of head, left occipital area, left base of the skull, right frontal area, right side of the back of head, right occipital area and right base of the skull.Neurological review of the patient is positive for headache, elevated bp.All other systems negative.On (b)(6) 2013 the patient underwent ct head w/o contrast.Impressions: the brain has a normal unenhanced ct appearance.The sinuses are clear.Bony changes of advanced right temporomandibular joint arthritis.On (b)(6) 2013 the patient underwent abdomen acute series due to nausea and vomiting.Impressions: no acute chest or abdominal finding.On (b)(6) 2013 the patient presented with chest pain and shortness of breath at er.She had positive sputum for gram stain.She had positive urinary tract infection.She was a little hyponatremic.Her chest x-ray was negative and didn't show any rib fractures or any pneumonia.On (b)(6) 2013 the patient underwent x-ray of chest due to chest pain.Impressions: emphysema.No acute infiltrate.On (b)(6) 2014 the patient presents with a history swelling, tenderness, blackened tips of toes and foot pain.The patient was diagnosed for cellulitis of toe.Musculoskeletal review of the patient was positive for rash, necrotic appearing area tips of right 2, 3 toes.Impressions: cellulitis of toe.On (b)(6) 2014 the patient underwent x-ray of right foot due to sores and necrosis.Impressions: no acute bony finding.Faint soft tissue ulceration at the distal tip of the third toe is noted with no bony findings to suggest osteomyelitis in the second and third toes.Moderate hallux valgus and bunion deformity at the first metatarsal phalangeal joint.On (b)(6) 2014 the patient came for an office visit with pain in right toe.The patient was diagnosed for cellulitis of toe.Musculoskeletal review indicated patient positive for erythema, pain, of the right third toenail.All other systems negative.On (b)(6) 2014 the patient underwent ct angiogram of the aorta and bilateral lower extremity runoff.Impressions: there is mild at the rosclerotic mixed plaque in the distal abdominal aorta, common iliac arteries and common femoral arteries maximum luminal narrowing 20-25%.No high-grade stenosis or occlusions.The superficial femoral arteries, popliteal arteries and bilateral tibial and peroneal arteries are widely patent with no focal plaque or stenosis.There is patent three-vessel runoff confirmed to the ankles.Peripheral vascular flow to the feet is slower than normal despite absence of significant vacular stenosis.Consider low cardiac output and/or peripheral vasoconstriction or vasospasm.There is mild delayed vascular filling of the distal lower extremity arteries diffusely, left minimally more delayed than the right.No renal or mesenteric artery stenosis.On (b)(6) 2014 the patient came for an office visit with recurrent pain from distal ischemic right 2nd and 3rd toes.Assessment: right diphasle dp, blue toe distal 2nd and 3rd toes pad w/ulcer.On (b)(6) 2014 the patient presented with the following pre-op diagnosis: right 2nd and 3rd ischemic toes with dry gangrene.The patient underwent right 2nd and 3rd distal toe amputation.On (b)(6) 2014, the patient presented with complaint of left hip pain and was diagnosed for: left hip fracture chronic obstructive pulmonary disease gait abnormality peripheral vascular disease.Adult failure to thrive.Osteoporosis/osteoarthritis.Impressions: left hip fracture.On (b)(6) 2014 the patient underwent x-rays of pelvis due to acute pain and recent fall.Impressions: acute, mildly comminuted, superiorly displaced fracture of the left proximal femur involving the lower femoral neck and greater trochanter but not quite reaching the lesser trochanter.The left femoral head is anatomically located in the acetabulum but there is right angle varus angulation.Displaced acute right greater trochanter fracture with no malalignment at the right hip.Paired spinal rods in the lumbar spine with advanced degenerative disc disease at the lumbosacral junction.On (b)(6) 2014 the patient underwent x-rays of left knee three views.Impressions: very early osteoarthritis with mild medial femoral tibial joint space narrowing.No acute bony finding.On (b)(6) 2014 the patient underwent x-rays of chest pre-op.Impressions: no acute chest finding or interval change.On (b)(6) 2014 the patient presented with the following pre-op diagnosis: left intertrochanteric hip fracture.The patient underwent the following procedure: cephalomedullary rodding of left intertrochanteric hip fracture.No complications were noted.Intra-op fluoroscopy demonstrated a cephalo medullary nailing of a left intertrochanteric fracture.On (b)(6) 2014 the patient underwent x-rays of chest due to cough.Impressions: no acute disease in the chest.No focal infiltrate or e dema.On (b)(6) 2014 the patient underwent x-ray of left hip 2 views post-op follow-up due to pain.Findings: the patient is status post ceph alomedullary nailing of left intertrochanteric fracture.There is residual varus attitude of the femoral head relative to the shaft.The femoral heads appear normally situated within their respective acetabuli.On (b)(6) 2014 the patient underwent x-ray ap view of the pelvis and ap and frog-leg lateral views of the left hip.Impressions: previous internal fixation of the left intertrochanteric femur fracture with the cephalomedullary nail and femoral neck pin intact.Mild varus angulation is stable.No new bony fracture or hardware complication.On (b)(6) 2014 the patient presented with complaints of chronic pain at left lower extremity, swelling left foot and ankle affecting the left upper thigh, left quadriceps, left knee and left shin, anterior aspect of left ankle and dorsum of left foot.The musculoskeletal review indicated patient positive for pain, of the left hip, left leg, l foot, l ankle.The patient underwent x-rays of left lower extremity, left foot, left ankle and left hip.On (b)(6) 2014 the patient underwent x-ray of left ankle three views due to pain.Impressions: soft tissue swelling left ankle that is most prominent laterally.No acute bony abnormality is appreciated.On (b)(6) 2014 the patient underwent x-ray of left foot three views due to pain.Impressions: severe hallux valgus deformity of the first metatarsal phalangeal joint of the left foot.No acute bony abnormality is appreciated.On (b)(6) 2014 the patient underwent x-ray of left hip two views due to pain.Impressions: lntertrochanteric fracture of the left hip with cephalomedullary nailing again demonstrated.The tip of the nail projects superior to the subcapital femoral neck which raises the possibility of cortical breakthrough.No change in the degree of varus angulation at the fracture is identified compared to on (b)(6) 2014.On (b)(6) 2014 the patient was diagnosed for the following: failure of hardware left hip.Peripheral vascular disease.Chronic obstructive pulmonary disease.Hypertension.Asthma.The patient underwent the following procedure: cutout of the cephalomedullary rod (hip hardware).Left hip hemiarthroplasty.The patient tolerated the procedure well.Post-op diagnosis: over the past several days the patient has had bilateral foot swelling.She has known peripheral vascular disease.Swelling has gotten worse over the past several days and she does have some purplish discoloration to her right second and third toes where she has had an amputation.On (b)(6) 2014 the patient underwent bilateral lower extremity venous ultrasound.Impressions: no evidence of deep venous thrombosis of the lower extremities is demonstrated on this examination.On (b)(6) 2014 the patient was diagnosed for the following pre-op diagnosis: left femoral neck fracture.Left femoral neck fracture hardware failure.The patient underwent the following procedure: left hip hemiarthroplasty for fracture.Left hip hardware removal.On (b)(6) 2014 the patient underwent x-rays ap of pelvis.Findings: the study demonstrates interval removal of the left hip screw and replacement with a revision type hip prosthesis with a trial head.On (b)(6) 2014 the patient underwent x-rays of left hip 2 views.Findings: interval left bipolar hip replacement is noted.The prosthesis appears intact and well aligned.No other significant changes are detected.On (b)(6) 2014 the patient underwent x-rays ap pelvis and ap and lateral views of the left hip due to pain.Findings: show no evidence of acute fracture or subluxation.Left hip arthroplasty remains in anatomic alignment without complicating hardware features.Previously fracture from the right greater trochanter is unchanged.There is moderate right hip degenerative joint space narrowing.Postoperative changes of the lower lumbar spine are again noted.On (b)(6) 2015 the patient presented with injury, pain, swelling, tenderness around the left jaw and left cheek and nose resulting from a fall, while walking.The patient underwent ct head w/o contrast, ct sinuses maxilofacial, ct cervical w/o contrast.She was diagnosed forfacial bone(s) closed fracture, hyponatremia.On (b)(6) 2015 the patient underwent ct of brain due to fall.Impressions: facial bone fractures.Small vessel ischemic disease.No acute intracranial abnormality.On (b)(6) 2015 the patient underwent ct of the face (axial images of the face).Impressions: non-displaced facial fractures involving the left pterygoid plates, consistent with a non-displaced left lefort type ii fracture.There also appears to be a non-displaced fracture in anterior and posterior walls of the right maxillary sinus.On (b)(6) 2015 the patient underwent ct of the cervical spine.Impressions: djd.No acute osseous abnormality.Large amount of air within the soil tissues left neck and face.On (b)(6) 2015 the patient underwent ct of head w/o contrast due to fall.Impressions: no acute intracranial hemorrhage, focal edema, mass effect, midline shift or abnormal extra-axial fluid collections are detected.Focal hypodensity is noted adjacent to the frontal horn of the right lateral ventricle suspected to represent lacunar infarct of undetermined age.This is best assessed by mri with diffusion weighted imaging.Multiple facial fractures.On (b)(6) 2015 the patient underwent ct of the facial bones and sinuses w/o contrast due to fall.Impressions: left orbit floor fracture, non-displaced, extending to the left anterior maxillary sinus wall.There is extensive subcutaneous emphysema, deep neck soft tissue air and intra-orbital air on the left.Bilateral lateral and medial maxillary sinus wall fractures are present extending to the base of the left pterygoid plate.Nasal bone and nasal septal fracture are evident.On (b)(6) 2015 the patient underwent ct cervical spine w/o contrast.Impressions: no acute fracture is at detected in this ct cervical spine study.There is extensive subcutaneous emphysema along the left side of the neck.Approximately a two-to-three me there are degenerative anterior subluxation of c3 on c4 noted.Degenerative disc changes are present at the c5-6 and c6-7 levels peri.It was reported that on (b)(6) 2012: the patient presented for an office visit.His assessment diagnosed him with lumbosacral back pain, general oa, copd, thoracic back pain, osteoporosis and gait abnormality.On (b)(6)2013, (b)(6) 2014: the patient presented to the office for check up.The patient complains of fatigue and insomnia.Review of systems: cardiovascular: chest pain.Exertional dyspnea.Deep cough hurts bad.Musculoskeletal: muscle pain and numbness in extremities.Joints: pain and stiffness.Low back pain: chronic.Extremities pain.Location: left leg/foot.Numb toes, prn.On (b)(6) 2013: the patient presented for check up and medsefill.On (b)(6) 2013: the patient presented for follow up and high blood pressure.On (b)(6) 2013, (b)(6) 2014: the patient presented for follow up.Patient complains of chills, night sweats, fatigue, insomnia and weight gain and chest pain.On (b)(6) 2014: the patient presented with a swollen jaw.The patient complained its getting worse since onset.Review of systems: cons titutional: patient complains of.Insomnia.On (b)(6) 2015: the patient presented with nausea.She reported having diarrhea a few weeks back.On (b)(6) 2015: the patient presented for a check up.The patient had a fall on (b)(6) 2015 and broke her nose.She busted both sinus.She had a steel plate in left jaw, she was worried she had knocked it out of place.On (b)(6) 2015: the patient presented for a check up.Review of systems : constitutional: patient complains of.Fatigue.Insomnia and weight gain.6 lbs gained since last visit.
 
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Brand Name
CAPSTONE VERTEBRAL BODY SPACER
Type of Device
SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
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 Key4971228
MDR Text Key6315485
Report Number1030489-2015-01930
Device Sequence Number1
Product Code MQP
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,consumer
Reporter Occupation Attorney
Type of Report Initial,Followup
Report Date 05/30/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number2960822
Device Lot NumberH08D2818
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 07/13/2015
Initial Date FDA Received08/05/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received12/01/2015
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 Age00050 YR
Patient Weight61
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