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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET

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MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Syncope (1610); Edema (1820); Bone Fracture(s) (1870); Headache (1880); Hearing Loss (1882); Hepatitis (1897); High Blood Pressure/ Hypertension (1908); Pneumonia (2011); Staphylococcus Aureus (2058); Scarring (2061); Swelling (2091); Tinnitus (2103); Vertigo (2134); Weakness (2145); Dizziness (2194); Stenosis (2263); Numbness (2415); Neck Stiffness (2434); Post Operative Wound Infection (2446); Confusion/ Disorientation (2553)
Event Type  Injury  
Manufacturer Narrative
(b)(4).Neither the device nor applicable imaging films were returned to manuacturer for evaluation therefore cause of event cannot be d etermined.
 
Event Description
It was reported that on: (b)(6) 2008: the patient was admitted with the diagnosis of stenosis c3-c7 and myelopathy.The patient underwent the following procedures: 1.Cervical decompression via cervical laminoplasty, c4-c7, with cervical laminectomy at c3.2.Application of laminoplasty miniplates 3.Neuromonitoring with somatosensory evoked potentials (ssep) and transcranial motor-evoked potentials.Per the op notes, laminoplasty miniplates were placed in a standard fashion from c4-c7.The screws were placed in a standard fashion; two into the lateral mass and one into the lamina itself.After placing the plates, the surgeon tested that the construct was nice and firm.No patient complications were reported.On (b)(6) 2008: the patient was discharged.On (b)(6) 2009: the patient presented with spondylolisthesis.The patient complained of buttock pain, right greater than left; and leg pain.On (b)(6) 2009: the patient was admitted with the following diagnosis: l3-s1 lumbar spinal stenosis and l4-l5 degenerative spondylolisthesis.The patient underwent the following procedures: 1.Posterior decompression, l3-s1.2.Posterior spinal fusion, l4-s1.3.Interbody fusion l5-s1.4.Use of rhbmp-2/acs.5.Nuvasive neural monitoring.Per op notes, after performing decompression, the sizing of the graft was done.This was 8mm graft, which measured 8x26.The rhbmp-2/acs and a copious amount of bone graft were tamped up anteriorly.Then, two cages were placed in the posterolateral corner on both the right side and the left side.Then, the surgeon compressed gently and the connecting rods were placed.Cap nuts were also placed.The transverse processes at l3 and l4 were decorticated.Then, posterolateral fusion was performed on l5-s1.Final intraoperative films were obtained, which showed good placement of pedicle screws as well as interbody device.No patient complications were reported.The patient underwent c-arm fluoroscopy and radiography, intra-op.Impression: posterior rod and particular screw fixation with anterior subluxation l4 upon s1.On (b)(6) 2009: the patient underwent x-rays of the chest to evaluate for pneumonia.Impression: 1.Left subpulmonic pleural effusion.Mild left basilar atelectasis.2.No evidence of pneumonia or pulmonary edema.27 apr 2009: the patient underwent x-rays of lumbar spine due to lumbar spine fusion.Impression: spinal fusion l4-5 s1.She also underwent x-rays of the right ankle due to pain.Findings: there is a questionable avulsion fracture of the tip of the medial malleolus.The patient was discontinued with her foley catheter.On (b)(6) 2009: the patient was discharged.On (b)(6) 2009: the patient was admitted with back pain as chief complaint and pain in bilateral lower extremities.The pain was described as sharp, throbbing and continuous.On (b)(6) 2009: the patient was discharged.On (b)(6) 2009: the patient underwent x-rays of cervical and lumbar spine status-post orthopedic surgery.On (b)(6) 2009: the patient presented for an office visit and was diagnosed with spinal stenosis of lumbar region.The patient also had complaint of weakness in bilateral lower extremities.She had chronic low back pain.On (b)(6) 2009: the patient presented with wound infection after injury.She had a blister.She also complained of hypertension, lumbar radiculopathy and urinary frequency.Musculoskeletal examination revealed right leg decreased strength and right leg decreased sensation.On (b)(6) 2009: the patient presented with the diagnosis of spinal stenosis.On (b)(6) 2009: the patient presented for an office visit for physical therapy.The patient also complained of stiffness in spine and lower extremity, pain in bilateral lower extremity, weakness.The activities that aggravated the pain were standing, walking, sitting and bending.On (b)(6) 2009: the patient presented with syncope.She slumped over in chair and complained of slight lightheadedness after the fall.She underwent x-rays of the chest due to pain.Impression: no acute radiographic findings.On (b)(6) 2009: the patient presented with the following diagnoses: vasovagal syncope, hypertension and spondylosis of lumbar joint.On (b)(6) 2009: the patient underwent x-rays of l4-s1, which showed solid fusion.On (b)(6) 2009: the patient presented for gynecologist visit for routine examination.She also presented for screening for breast cancer and eczema.She underwent routine bilateral mammography.Impression: negative mammogram.On (b)(6) 2009: the patient presented for postoperative examination of lumbar fusion.On (b)(6) 2010: the patient presented with complaints of abscess to right buttock for one week, oozing bright red blood and increasing in size from quarter size to palm size.She described it be extremely painful.The patient underwent the following procedure: irrigation and debridement.She was discharged on the same day in good condition.On (b)(6) 2010: the patient presented for wound check post the treatment of buttock abscess.On (b)(6) 2010: the patient presented with rectal lump for the past one week.She had slight pain but was concerned about drainage/odor.The wound was irrigated copiously and cleansed.There were no patient complications.On (b)(6) 2010: the patient presented for suture removal from buttocks.She underwent tissue biopsy culture.Result: heavy growth staphylococcus aureus.On (b)(6) 2010: the patient presented for wound care of buttock abscess.Repacking of wound was done.On (b)(6) 2010: the patient presented with tinnitus.She also complained of hypertension, chronic (b)(6), reflux esophagitis, vertigo and hearing loss.On (b)(6) 2010: the patient was admitted with the chief complaint of gastrointestinal bleeding.She also complained of lower abdominal cramping and dizziness over the past couple of days.She was diagnosed with lower gastro-intestinal hemorrhage, hypertension and postlaminectomy syndrome of cervical region.The patient underwent chest x-rays.Impression: no acute cardiopulmonary disease.The patient also underwent electrocardiography examination, which was normal.On (b)(6) 2010: the patient underwent electrocardiography which was normal.The patient was discharged home in stable condition.On (b)(6) 2010: the patient presented with degenerative arthritis of lower back.The patient underwent x-rays of lumbar spine which showed solid fusion l4-s1.On (b)(6)2010: the patient presented with bilateral tinnitus.On (b)(6) 2010: the patient presented with the primary diagnosis of lower gastro-intestinal hemorrhage.Assessment: lower gastro-intestinal hemorrhage; hypertension; chronic (b)(6); diverticulosis of colon; reflux esophagitis; lumbar spondylosis.On (b)(6) 2010: the patient underwent ct scan of the brain for the complaints of dizziness and tinnitus.It showed an incidental small left frontoparietal meningioma.In addition, ventriculomegaly was noted.On (b)(6) 2010: the patient presented with the diagnosis of lichen simplex chronicus.On (b)(6) 2010: the patient presented with bilateral sensorineural hearing loss.On (b)(6) 2010: the patient presented with the diagnosis of diverticulosis of colon.The patient underwent colonoscopy.Impression: 1.Diverticulosis in sigmoid colon - this finding accounts for patient's recent rectal bleeding.2.Colon polyp.On (b)(6) 2010: the patient presented for physical therapy visit due to lumbar degenerative disc disease.On (b)(6) 2010: the patient presented with the diagnosis of tinea corposis.On (b)(6) 2010: the patient presented with peripheral edema.The patient had some swelling in the right foot and ankle.She also complained of lower back pain (which increased with bending), neck tightness and intermittent pain in right leg.On (b)(6) 2010: the patient underwent x-rays of lumbar spine which showed solid fusion at l4-s1.She also underwent x-rays of cervical spine status post spine surgery.Impression: spine surgery follow-up.On (b)(6) 2010: the patient presented with spondylosis of lumbar joint.On (b)(6) 2010: the patient underwent ct scan of the brain for the complaints of dizziness and tinnitus.Impression: 1.No acute intracranial findings.There is continued ventricular greater than sulcal prominence, stable compared to the prior ct.This may be related to central atrophy although changes from normal pressure hydrocephalus are also possible.2.Unchanged small calcified extra-axial left frontotemporal lesion, most likely an incidental meningioma.On (b)(6) 2010: the patient presented with lumbosacral radiculopathy and meningioma.She also had complaints of persisting right leg pain and right footdrop, and an abnormal ct scan.Impression: residual right l5 distribution weakness from lumbar radiculopathy.Her gait instability was the combination of the right anterior tibialis weakness and possibly a mild contribution of her cervical myelopathy.On (b)(6) 2011: the patient underwent x-rays of the lumbosacral spine due to follow-up.Impression: there has been l4-s1 laminectomy and posterior spinal fusion.There is a spacer device at l5-s1.Vertebral bodies are maintained in height.Grade 1 anterolisthesis at l4-5 is also noted.She also underwent x-rays of the cervical spine.Impression: there have been left sided laminoplasties at c4-c7.There is reversal of the cervical lordosis, with prominent c5-6 and c6-7 disc space narrowing/endplate spurring.On (b)(6) 2011: the patient presented with cervical pain.She also had complaints of lower back pain and right ankle weakness.She underwent x-rays of the cervical and lumbar spine, which looked good.On (b)(6) 2011: the patient underwent mri of cervical spine for status post c3-c6 decompression with gait instability and to evaluate for stenosis.Impression: 1.Interval status post c3-c6 laminectomy changes with significant improvement in the spinal canal c3-c6.2.Interval increase posterior ligament hypertrophy at c1-c2, effacing thecal sac with minimal spinal stenosis.3.Interval increase degenerative change at t1-t2, t2-t3, t4-t5, particularly with moderate spinal stenosis at t1-t2, and ligament hypertrophy posterior to the t4, and probably mild-to-moderate spinal stenosis at the t4 to t4-t5 with probably subtle abnormal signal in the cord at that t1-t2 and t4.4.No significant interval change in the t2 hyperintensity at c4-c5.On (b)(6) 2011: the patient presented for routine physical examination.Neurological examination revealed decreased right leg strength, decreased right great toe dorsiflexion.On (b)(6) 2011: the patient presented for physical therapy visit.She had complaints of thoracic and lumbar radiculopathy, weakness in right leg, numbness in all toes.Assessment: right lower extremity weakness post cervical myelopathy; chronic low back pain with weak abdominals and poor body mechanics.On (b)(6) 2011: the patient underwent x-rays of lumbar spine due to surgical follow-up.On (b)(6) 2011: the patient presented with degenerative arthritis of lower back.X-rays of the lumbar spine were reviewed which revealed good solid fusion.Mri of her cervical spine was also reviewed which showed decompression at c3-7 and some mild stenosis at t1-2.On (b)(6) 2011: the patient presented for presbyopia.On (b)(6) 2011: the patient presented for glaucoma suspect.She also complained of lumbar radiculopathy, degenerative arthritis of lower back and footdrop.On (b)(6) 2011: the patient was admitted with the chief complaint of back pain.The patient tripped and fell while walking with cane on concrete.The pain was aggravated with ambulation.She underwent x-rays of the lumbosacral spine due to trauma.Impression: no new fracture since (b)(6) 2011; stable l4-s1 posterior surgical fusion.The patient was discharged on the same day.On (b)(6) 2011: the patient was admitted with chief complaint of abscess.She presented with bump to left forearm.The swelling, pain did not improve with warm compress.On (b)(6) 2011: the patient presented with footdrop and lumbar radiculopathy.On (b)(6) 2011: the patient presented with the diagnosis of footdrop.She underwent nerve conduction examination.Impression: 1.Normal left superficial peroneal sensory study.2.Normal left peroneal distal motor latency and ncv with low amplitudes.3.Needle emg shows chronic reinnervation changes and only minimal motor units without active denervation.The results were consistent with a chronic lumbar radiculopathy.On (b)(6) 2012: the patient underwent x-rays of lumbosacral spine due to follow-up.On (b)(6) 2012: the patient with the follow-up of degenerative arthritis of lower back.On (b)(6) 2012: the patient presented with the diagnosis of pruritus of vagina.She had complaints of vaginal discharge and itching.On (b)(6) 2012: the patient presented for follow-up of abscess.The patient was also diagnosed for scar of skin.She had persistent swelling and pain at incision site.On (b)(6) 2012: the patient underwent bilateral mammography due to routine screening.Impression: negative mammogram.On (b)(6) 2012: the patient underwent routine bacterial culture test.Result: moderate growth corynebacterium species.On (b)(6) 2012: the patient underwent mri of lumbar spine due to wound drainage.Impression: 1.There is now mild spinal stenosis at the l2-l3 level related to hypertrophic change and retrolisthesis.2.The patient's sinus tract appears to extend to superficial scar tissue and enhancement.No connection to the thecal sac is appreciated on mri imaging.On (b)(6) 2012: the patient presented for follow-up of fusion of lumbosacral spine.On (b)(6) 2012: the patient was diagnosed with subconjunctival hemorrhage.She had bleeding in left eye since a day.On (b)(6) 2012: the patient with the follow-up of degenerative arthritis of lower back, hypertension and chronic (b)(6).She complained of pain in surgical site.On (b)(6) 2012: the patient was admitted with the chief complaint of leg pain.She also had complaint of hypertension.She fell and had swelling to her right ankle secondary to twisting it when she fell down.Extremities examination revealed moderate edema and tenderness over lateral ankle.Musculoskeletal examination also revealed low back pain and restricted motion of neck.She underwent x-rays of right ankle which revealed right bimalleolar fracture with widened medical clear space and partial anterior dislocation of the ankle.She also underwent x-rays of the knee which was normal.The patient was discharged on the same day.Electrocardiography examination was also done, which revealed normal results.On (b)(6) 2012: the patient was admitted with the following pre-op diagnosis: closed fx ankle, bimalleolar.She underwent right ankle "orif".No patient complications were reported.The patient also underwent right ankle x-ray which revealed surgical correction maintained; hardware in place.On (b)(6) 2012: the patient underwent x-rays of the right ankle due to post-op follow up.Impression: post orif changes of the right distal fibula; podiatry follow-up.The patient was discharged home in stable condition.On (b)(6) 2012: the patient presented for follow-up visit post right ankle surgery.On (b)(6) 2012: the patient presented for follow-up visit status post lumbar surgery.She underwent x-rays of lumbar spine which revealed solid fusion l4-s1.She also underwent x-rays of the ankle.Impression: podiatry follow-up.On (b)(6) 2012: the patient presented for follow-up visit post right ankle surgery.The patient underwent right ankle x-ray which revealed hardware in place.On (b)(6) 2013: the patient underwent x-rays of the ankle as a follow-up of bone fracture.On (b)(6) 2013: the patient presented with a history of decompressive lumbar laminectomy.Impression: probable infected lumbar spinal hardware.On (b)(6) 2013: the patient underwent ct scan of the brain due to headaches.Impression: 1.Stable appearance of small extra-axial low signal intensity mass in the left parietal region most consistent with extra-axial meningioma with no mass effect upon the adjacent brain.No change since (b)(6) 2010.2.Moderate enlargement of the third and lateral ventricles of the brain as seen on prior study.Fourth ventricle and the aqueduct of sylvius appear normal.3.Stable postoperative changes the upper cervical spine and evidence of upper cervical spinal stenosis without focal cord compression.The cord is draped over posterior soft tissue and angulated at this level.On (b)(6) 2013: the patient presented for rechecking of lumbar spondylosis.She had periodic drainage from lumbar wound.On (b)(6) 2013: the patient was admitted for drainage of lumbar wound.She underwent the following procedures: excision of wound tract, exploration of wound, removal of hardware (bone plate screw wire or pin), left s1 and culture of deep wound.Per op notes, left s1 screw was removed and cultured.The patient had a solid interbody fusion so there was no problem to remove the screw.All the other hardware appeared to be solid, so they were left in place.No patient complications were reported.On (b)(6) 2013: the patient complained of some nausea and dizziness.On (b)(6) 2013: the patient complained of pain and spasms.Right foot weakness was also noted.She also complained of episodes of confusion.On (b)(6) 2013: the patient complained of incisional pain and difficulty in mobility.She also noted some baseline right lower extremity weakness.On (b)(6) 2013: the patient was discharged in good condition.On (b)(6) 2013: the patient presented for follow-op status post lumbosacral spine surgery.The lower portion of the wound was still draining slightly.On (b)(6) 2013: the patient underwent x-rays of pelvis due to osteoarthritis.Impression: moderate osteoarthritis of the hips, right greater than left.She also underwent x-rays of the lumbosacral spine.Findings: hardware appears intact and unchanged from (b)(6) 2012; grade 1 anterolisthesis of l4 on l5 is unchanged; multilevel degenerative changes are present.On (b)(6) 2013: the patient presented for follow-up visit post right ankle surgery.The patient underwent x-rays of right ankle which revealed healed fibular fracture and hardware in place.On (b)(6) 2013: the patient presented for physical therapy.Gait examination revealed foot drop on the right.Assessment: multiple problems weakness and right ankle poor core range of motion with limited neck rotation balance.On (b)(6) 2013: the patient presented for follow-op status post lumbosacral spine surgery.She complained low back pain.On (b)(6) 2013: the patient presented for follow-up visit post right ankle surgery.The patient underwent x-rays of right ankle which revealed fracture healed and hardware in place.On (b)(6) 2013: the patient presented for physical therapy, post the ankle surgery.Gait examination revealed foot drop on the right.On (b)(6) 2013: the patient was admitted with chief complaint of left side shoulder pain.The pain had been continuous for the past 2 days.The pain worsened with lying down.She also complained of mild dizziness.Musculoskeletal examination revealed tense "l" trap.Electrocardiography was also done which revealed normal results.She was discharged on the same day in stable condition.On (b)(6) 2013: the patient presented with neck pain and stress.Neck was supple, mild tenderness at base of left neck along sternocleidomastoid.On (b)(6) 2013: the patient presented with the diagnosis of closed "fx" ankle, bimalleolar.Gait examination revealed ankle foot orthosis.On (b)(6) 2013: the patient presented with the diagnosis of hyperopia, presbyopia, astigmatism and glaucoma suspect.On (b)(6) 2013: the patient presented for aftercare surgery of musculoskeletal system.The patient complained of slight dizziness and felt off balance.Gait examination revealed ankle foot orthosis.On (b)(6) 2013: the patient underwent routine bilateral screening mammography.Impression: negative mammograms.On (b)(6) 2013: the patient was admitted for dizziness with nausea and upset stomach prior to syncopal episode.She underwent electrocardiography which displayed normal results.The patient was discharged on the same day.On (b)(6) 2013: the patient underwent electrocardiography which was normal.On (b)(6) 2013: the patient underwent x-rays of right ankle which revealed hardware in place.She also underwent x-rays of lumbosacral spine as a follow-up for bone fracture.On (b)(6) 2013: the patient presented for an office visit status post lumbosacral spine surgery.On (b)(6) 2013: the patient presented with gait abnormality.She also had complaints of dizziness and weakness in right leg.Impression: cervical myelopathy; foot drop.On (b)(6) 2014: the patient presented for follow-up visit post right ankle surgery.She had limited mobility.On (b)(6) 2014: the patient presented for an office visit one year status post right ankle "orif" and complained of intermittent pain in ankle with some edema.On (b)(6) 2014: the patient was admitted with headache, which had been worsening for the past week.She had increased pain in upper neck towards the base of her skull.Musculoskeletal examination revealed neck pain.She had chronic weakness of the toes bilaterally.The patient x-rays of the cervical spine due to pain.Impression: post-surgical and degenerative changes.She was discharged on the same day.On (b)(6) 2014: the patient presented for routine follow-up for myelopathy.
 
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Brand Name
INFUSE BONE GRAFT
Type of Device
FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
Manufacturer (Section D)
MEDTRONIC SOFAMOR DANEK USA, INC
4340 swinea rd
memphis TN 38118
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 Key5017315
MDR Text Key23525532
Report Number1030489-2015-02014
Device Sequence Number1
Product Code NEK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P000058
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Attorney
Report Date 07/27/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/20/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received07/27/2015
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) Other;
Patient Weight70
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