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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
Catalog Number 7510400
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Ossification (1428); Calcium Deposits/Calcification (1758); Inflammation (1932); Neuropathy (1983); Pain (1994); Loss of Range of Motion (2032); Weakness (2145); Tingling (2171); Stenosis (2263); Numbness (2415); Neck Pain (2433)
Event Type  Injury  
Event Description
It was reported that on (b)(6) 2006: the patient presented for x-rays of the chest.Impression: no evidence of active pulmonary disease.On (b)(6) 2006: the patient underwent x-rays of the cervical spine.Impression: mild degenerative disc disease at the c6-7 level; otherwise normal cervical spine.On (b)(6) 2006: the patient underwent x-rays of the thoracic spine.Impression: normal thoracic spine.On (b)(6) 2006: the patient underwent x-rays of the lumbar spine.Impression: mild degenerative disc disease at the l5-s1 level.Otherwise normal lumbar spine.On (b)(6) 2007: the patient presented for adenosine stress test.Impression: no evidence of ischemia following the adenosine infusion.On (b)(6) 2008 : the patient presented with the following preoperative diagnoses: disc herniation, l4-5; disc herniation, l5-s1; lumbar spondylosis: lumbar retrolisthesis, l5-s1; lumbar degenerative disc disorder with spondylosis.The patient underwent the following procedures: decompressive laminectomy and foraminotomy, partial facetectomy, l4-5, l5-s1; posterior spinal fusion, l5-s1, with pedicle screws; posterior lumbar interbody fusion, l5-s1 with cage; use of rhbmp-2/acs.No patient complications were reported.On (b)(6) 2008: the patient presented with cervical adenitis of the left side of his neck.On (b)(6) 2008: the patient presented with pain in his lower back, buttocks, and psis tenderness.On (b)(6) 2008: the patient presented with numbness.Impression: status post lumbar fusion l4-s1.On (b)(6) 2008: the patient presented with lower back pain that radiates into his left leg, anterior thigh, and has difficulty walking.The patient also reports numbness and tingling with this in that left leg.Impression: status post lumbar fusion l4-s1; lumbago; radiculopathy.On (b)(6) 2008: the patient underwent ct of the lumbar spine.Impression: spinal canal stenosis at the l4-5 level due to broad based concentric disc bulge , facet hypertrophic change , and ligamentum flavum buckling.; postoperative changes at l5-s1; on (b)(6) 2008: the patient underwent a lumbar myelogram.Impression: spondylolisthesis and anterolisthesis of l4 and l5 with findings of spinal canal stenosis at this level.On (b)(6) 2009: the patient presented with pain across his back.X-rays showhe has good fusion across the l5-s1 level, some mild bony overgrowth , but no gross displacement of the root.On (b)(6) 2009: the patient presented with low back pain.On (b)(6) 2009: the patient presented with severe low back pain with some bilateral leg pains as well.On (b)(6) 2009: the patient presented with pain in his back radiating to his lower legs, and walks with a bit of a limp.On (b)(6) 2009: the patient underwent 1 trigger point injection on the right side due to lower back pain.On (b)(6) 2009: the patient presented back and leg pain, more on the right.The patient also has some dysesthesias and paresthesias.On (b)(6) 2009: the patient presented with a knot in his left breast, pain in his right abdomen down into his leg, and chronic back pain.On (b)(6) 2009: the patient presented for bilateral diagnostic mammogram.Impression: 3.0 cm mass in the retroareolar region of the left breast corresponding to palpable left breast lump.Left breast ultrasound was subsequently obtained for further characterization.Impression: 2.7 cm solid appearing mass in the 12:00 position of the left breast corresponding to mammographic density and palpable left breast lump and suspicious for malignancy.On (b)(6) 2009: the patient presented for x-rays of the chest.Impression: no evidence of active pulmonary disease.On (b)(6) 2009: the patient presented with shortness of breath, a mass in his left breast which seems to be some swelling below the left breast area with chest discomfort.On (b)(6) 2009: the patient presented with pain in the lower back and buttocks, more in his right leg versus left leg, dysesthesias and paresthesias.On (b)(6) 2009: the patient presented with low back pain and bilateral lower extremity pain.On (b)(6) 2009: the patient presented with pain in the back and legs, some dysesthesias and paresthesias.On (b)(6) 2009/ (b)(6) 2010/ (b)(6) 2010: the patient presented with low back pain and bilateral lower extremity pain secondary to lumbar radiculopathy.Assessment: bilateral l5-s1 radiculopathy; low back pain; lumbar spondylosis; back syndrome.On (b)(6) 2009: the patient underwent the following procedures: bilateral l5-s1 trans-foraminal epidural steroid injections under fluoroscopic guidance; trigger point injection, right lumbar paraspinal muscles, gluteus medius muscle, and piriformis muscle.No complications were noted.On (b)(6) 2010: the patient presented for bilateral l5-s1 trans-foraminal epidural steroid injections under fluoroscopic guidance.No complications were reported.On (b)(6) 2010: the patient presented with radiculopathy.The patient underwent bilateral l5-s1 transforaminal epidural steroid injection under fluoroscopic guidance.No complications were reported.On (b)(6) 2010: the patient presented with radiculopathy.The patient underwent a right l5-s1 transforaminal epidural steroid injection under fluoroscopic guidance.No complications were noted.On (b)(6) 2010: the patient presented for radiologic diagnostic imaging.There is anterolisthesis of l4 on l5 that results in canal stenosis at this level.There is mild extradural impingement at l2-3 as well.At l3-4, there is mild to moderate circumferential disc bulging but no stenosis or high grade impingement.L2-3 also demonstrates mild to moderate circumferential bulging without focal impingement or stenosis.On (b)(6) 2010: the patient presented with bilateral leg pain and tingling in his feet.On (b)(6) 2010: the patient presented with leg pain, cellulitis on the bite area on his left thigh with redness.On (b)(6) 2010: the patient underwent mri of the cervical spine.Impression: multi-level impingement greatest at c3-4, c4-5, and c6-7.On (b)(6) 2010: the patient presented with difficulty swallowing.On (b)(6) 2010 : the patient presented with the following preoperative diagnoses: unstable spondylolisthesis l4-5; pseudarthrosis l5-s1.The patient underwent the following procedures: posterior lateral fusion l4-5 and l5-s1; posterior lumbar interbody fusion l4-5 with rhbmp-2/acs; excision of synovial cyst l4-5; posterior lumbar decompression discectomy l4-5; exploration and fusion l5-s1; removal of hardware l5-s1; posterior lumbar instrumentation l4-5; placement of interbody device peek cage l4-5; autograft local bone l4-5, l5-s1; continuous neurophysiological monitoring.Per the op notes, there was an incongruity between the l5 and s1 levels roughly at the level inferior to the l5 pedicle, determined to be a pseudoarthrosis.Once there was bleeding bone from both endplates, peek cage was loaded with rhbmp-2/acs.Next, another piece of rhbmp-2/acs and a competitor¿s product was paced anteriorly within the disk space.Following decortication, rhbmp-2/acs, local autograft and a competitor¿s product was placed out laterally in the gutters bilaterally.No complications were noted.On (b)(6) 2010: the patient presented with a preoperative diagnosis of dysphasia and throat pain.The patient underwent an esophago stroduodenoscopy with antral biopsy x2 and distal esophageal biopsy.The patient had a post-operative diagnosis of gastritis and probable monilia esophagitis.No patient complications were reported.On (b)(6) 2010: the patient presented with lateral groin pain and incisional low back pain.On (b)(6) 2010: the patient presented with pain going from his right back to his right side.On (b)(6) 2010: the patient presented for a left heart catheterization, left ventricular angiogram, and a coronary angiography due to chest discomfort and multiple risk factors for coronary artery disease.Impression: non-obstructive coronary artery disease; normal left ventricular systolic function with suggestion of diastolic dysfunction with mildly elevated left ventricular end diastolic pressure.On (b)(6) 2010: the patient presented with a preoperative diagnosis of symptomatic right inguinal hernia.The patient underwent a laparoscopic preperitoneal right inguinal herniorrhaphy with mesh.No patient complications were reported.On (b)(6) 2010: the patient presented with low back pain and cramping sensation in his left calf.On (b)(6) 2010: the patient presented with pain in the left upper part of his left hip.On (b)(6) 2010: the patient presented for x-ray of the left hip.Impression: normal left hip.On (b)(6) 2010: the patient presented with inflammation of the lower back.X-ray of the hip was unremarkable.On (b)(6) 2011: the patient presented with muscle spasms in the posterior part of the right neck.On (b)(6) 2011: the patient presented with severe neck pain, suboccipital headaches, interscapular pain, and trapezial pain.On (b)(6) 2011: the patient underwent a post myelography ct of the lumbar spine.Findings: l4-5, there is broad based posterior disc bulging and mild narrowing of the neural foramen is seen; l3-4, there is effacement of the ventral thecal sac due to broad-based posterior disc bulging.There is ligamentum flavum hypertrophy and hypertrophic facet degenerative disease.There is spinal stenosis with spinal canal measuring 8 mm.Bilateral lateral recess stenosis is seen and bilateral narrowing of the neural foramen is identified; l2-3, there is ligamentum flavum hypertrophy with hypertrophic facet degenerative disease.There is spinal stenosis with spinal canal measuring 8.3 mm.Bilateral lateral recess stenosis is seen and mild narrowing of the neural foramen is seen.On (b)(6) 2011: the patient presented with lumbar pain and radicular symptoms into his lower extremities but not truly neurogenic claudication.On (b)(6) 2011: the patient presented with the following preoperative diagnoses: lumbar post laminectomy syndrome; lumbar spinal stenosis; lumbar spondylosis without myelopathy.The patient underwent a bilateral l3-4 transforaminal epidural steroid injection under fluoroscopy.No patient complications were reported.On (b)(6) 2011: the patient presented with right sided abdominal discomfort.On (b)(6) 2011: the patient presented with, possibly, some underlying arthritis of his back or hip.On (b)(6) 2011: the patient presented with low back pain and radicular leg pain.X-rays taken in office show interbody graft and posterior pedicle screws well positioned at l4-5.Solid fusion mass is not appreciated.Assessment: stenosis above fusion.On (b)(6) 2011: the patient presented with muscle spasms of the right back area that go to the front.On (b)(6) 2011: the patient presented with pain in his back and into his right hip.On (b)(6) 2012: the patient presented for mri of the cervical spine.Impression: multilevel disc bulges, protrusions, and neural foraminal compromise with borderline canal compromise at a few levels and significant neural foraminal stenosis at multiple levels.On (b)(6) 2012: the patient presented with neck, left hand, right shoulder and left wrist pain.Impression: right shoulder pain; impingement syndrome.The patient underwent injections of depo-medrol and xylocaine into the shoulder.No complications.On (b)(6) 2012: the patient presented with neck, left hand, right shoulder and left wrist pain.Impression: right shoulder pain; impingement syndrome.On (b)(6) 2012: the patient underwent mri of the right shoulder.Impression: advanced degenerative arthrosis in the acromioclavicular joint with inferior bony spurring and mild inferior mass effect; subacromial/subdeltoid bursitis; there is full thickness tearing involving the majority of the supraspinatus tendon through some anterior and posterior fibers remain intact.There is moderate retraction of the torn fibers.There is no muscle atrophy; edema along the posterior inferior margin of the infraspinatus muscle as well as along the margins of teres minor muscle would suggest some muscle injury in the region.This is fairly mild; slap tear.There is some mild subchondral edema in the posterior osseous glenoid concentrated superiorly.This could be indicative of extension of the slap tearing into this area though this is not clearly visualized on the images.On (b)(6) 2012: the patient presented with pain in his right leg and general discomfort of arthritis.The patient has difficulty urinating with some urinary retention type problem with benign prostatic hypertrophy.The patient has numbness in his left and right leg and limited range of motion in his lower extremities.On (b)(6) 2012: the patient presented with right shoulder discomfort and limited range of motion.The patient also has muscle spasms in this area.On (b)(6) 2012: the patient presented with some back discomfort.The patient has some general joint and aching at the bottom of both feet with burning sensation of these areas.He has general numbness.On (b)(6) 2013: the patient presented with physiologic swelling of the left knee, possibly an underlying baker¿s cyst.On (b)(6) 2013: the patient presented with left knee pain.The patient underwent injection of depo-medrol and xylocaine into the left knee.No complications were reported.On (b)(6) 2013: the patient presented with degenerative disc disease of the back.The patient is hurting some in the left wrist.The patient has a cystic area on his left wrist.On (b)(6) 2013: the patient presented with left knee pain.Impression: knee joint effusion: baker¿s type popliteal cyst; mild pes anserinus bursitis, there is also a moderate degree of semimembranosus tibial collateral ligament bursitis; there is at least degenerative fraying along the free edge of the medial meniscus, there is also some slightly prominent intrasubstance signal without obvious areas of articular surface extension; high grade, probably full thickness chondromalacia throughout the medial femoral condyle.On (b)(6) 2013: the patient presented with neck and back pain.The patient also reports numbness, stiffness, tingling, weakness, swelling, loss of feeling, sleep disturbances, rom limitation, difficulty walking and headaches.Cervical x-rays show diffuse cervical osteoarthritis at c6-7.Impression: lumbar spine strain/sprain; low back pain; neuritis/ radiculitis cervical/upper limbs.The patient underwent injection of depo-medrol and xylocaine into the right gluteus.No patient complications were reported.On (b)(6) 2013: the patient underwent mri of the left knee.On (b)(6) 2013: the patient presented with left knee pain.The patient underwent injection of supartz in to the bilateral knee.No complications were reported.On (b)(6) 2013: the patient presented for injection of supartz in to the bilateral knee.No complications were reported.On (b)(6) 2013: the patient presented for injection of supartz in to the bilateral knee.No complications were reported.On (b)(6) 2013: the patient presented for injection of supartz in to the bilateral knee.No complications were reported.On (b)(6) 2013: the patient presented for injection of supartz in to the bilateral knee.No complications were reported.On (b)(6) 2013: the patient presented with left knee pain.Impression: left knee pain; osteoarthritis; pain knee/ lower extremity; tear medial meniscus-knee traumatic.On (b)(6) 2013: the patient presented with hypertension and degenerative arthritis of his back and left knee osteoarthritis.On (b)(6) 2013: the patient presented with left knee swelling and foot pain discomfort as well as limited range of motion.Impression: left knee pain; osteoarthritis; pain knee/ lower extremity; tear medial meniscus-knee traumatic.The patient underwent a left knee injection of depo-medrol and xylocaine.No complications were reported.On (b)(6) 2013: the patient presented with back pain.Lumbosacral x-rays were taken and noted a questionable break of cortical screw.Assessment: lumbar spine pain; low back pain; bursitis hip.The patient underwent a sterile trigger point injection of depo-medrol and xylocaine.On (b)(6) 2013: the patient presented with left foot pain and pain in the posterior ankle.The patient also reports numbness, sleep disturbances and difficulty walking.Impression: right achilles tendonitis; left foot pain.On (b)(6) 2013: the patient underwent x-rays of the feet.Right foot findings: no acute findings, achilles insertion heel spur; left foot findings: no acute findings, mild oa changes.On (b)(6) 2013: the patient presented with back problems and tenderness in his right foot and posterior part of the achilles area.On (b)(6) 2013: the patient underwent x-rays of the chest.Impression: no evidence of active pulmonary disease.On (b)(6) 2013: the patient presented with pain in the bilateral foot.The patient has right and left side pain, stiffness, swelling and radiation of pain on the involved sides.Impression: right ankle, left foot, and left knee pain; achilles tendonitis; pain knee/ lower extremity; pain in foot/joint/ankle.On (b)(6) 2013: the patient presented with left knee and back pain.Impression: left knee and lumbar pain; low backpain; bursitis hip; baker/popliteal cyst knee.On (b)(6) 2013: the patient underwent injection of depo-medrol and xylocaine into the left knee.On (b)(6) 2013: the patient presented with left knee and back pain.The patient states the injection treatments have not helped.The patient reports sleep disturbances, difficulty walking and radiation of pain on the involved side.Impression: left knee and lumbar pain; low back pain; bursitis hip; baker/popliteal cyst knee.On (b)(6) 2013: the patient presented with arthralgia and back pain.On (b)(6) 2013: the patient presented with left knee and back pain.The patient also reports stiffness, weakness , swelling, rom limitation, difficulty walking, and radiation of pain on the involved side.Impression: low back pain, bursitis hip, baker/popliteal cyst knee.The patient underwent an injection of medrol and xylocaine into the right and left knee.No patient complications were reported.On (b)(6) 2013: the patient presented with dizziness, sweating, and some chest discomfort of left anterior chest.He has some abdomen discomfort with nausea.Patient was referred to er.On (b)(6) 2013: the patient presented with severe substernal type chest pain with nausea.The patient was transported by ambulance to the medical center.On (b)(6) 2014: the patient presented with left knee and back pain.The patient also reports stiffness, weakness, swelling, rom limitation, difficulty walking, and radiation of pain on the involved side.Impression: low back pain, bursitis hip, baker/popliteal cyst knee.The patient underwent an injection of medrol and xylocaine into the left knee.No patient complications were reported.On (b)(6) 2014: the patient presented with a preoperative diagnoses of myofascial pain, right erector spinae muscle.The patient underwent a trigger point injection, right erector spinae muscle.No patient complications were reported.On (b)(6) 2014: the patient presented with the following preoperative diagnoses: lumbar degenerative disk; lumbosacral radiculitis; lumbago and myofascial pain, right erector spinae muscle.The patient underwent a lumbar epidural steroid injection and a trigger point injection, right erector spinae muscle.No complications were reported.
 
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.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.
 
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that on : (b)(6) 2008: other implants that were used in this surgery were: cancellous chips from smith <(>&<)> nephew; ecf peek by kimba; dbx mixt 10cc by musculoskeletal transplant foundation.On (b)(6) 2010: the patient presented with troubles with the heel and difficulty in strength as well as pain.He also had additional problem of bilateral leg pain.X-rays showed significant spurring at the insertional area of the achilles tendon and even above that at the posterior aspect of the os calcis there is prominence with a spur-like effect abutting against the tendon with some calcification within the tendon.Impression: haglund's deformity right heel with significant degeneration of achilles insertional pathology.(b)(6) 2010: the patient presented with low back pain and bilateral leg pain.He continued to be quite symptomatic and unable to tolerate his current level of pain along with radiculopathy.(b)(6) 2010: the patient underwent lumbar myelogram due to low back pain and bilateral leg pain.Summary of findings: solid appearing l5-s1 fusion with no significant impingement.Moderate to severe stenosis at l4-l5 due to anterior subluxation of l4 on 5 as well as posterior facet and ligamentous hypertrophy.Mild to moderate circumferential bulging at l3-l4.On (b)(6) 2010: the patient presented with lower extremity symptoms, quite significant in nature.He also had paresthesias in his hands bilaterally along with upper extremity symptoms.His lower extremity symptoms were more severe than his upper extremity symptoms.On (b)(6) 2010: the patient underwent mri of the cervical spine due to neck pain.On (b)(6) 2010: the patient underwent x-rays of the chest, pre-op.Impression: negative chest x-ray.
 
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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
huzefa mamoola
1800 pyramid place
memphis, TN 38132
9013963133
MDR Report Key3902935
MDR Text Key4677576
Report Number1030489-2014-02960
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,consumer
Reporter Occupation Attorney
Type of Report Initial
Report Date 09/02/2015
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 Expiration Date01/01/2010
Device Catalogue Number7510400
Device Lot NumberM110701AAK
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 06/09/2014
Initial Date FDA Received06/30/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/18/2007
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 Weight107
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