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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 Fatigue (1849); Headache (1880); High Blood Pressure/ Hypertension (1908); Inflammation (1932); Itching Sensation (1943); Neuropathy (1983); Pain (1994); Loss of Range of Motion (2032); Swelling (2091); Stenosis (2263); Injury (2348); Arthralgia (2355); Depression (2361); Numbness (2415); Neck Pain (2433)
Event Type  Injury  
Event Description
Procedure: anterior lumbar interbody spinal fusion it was reported that the patient underwent spine fusion surgery on the lumbar region at levels l4-s1.During the surgery, the patient was implanted with rhbmp-2 and collagen sponge.The rhbmp-2 collagen sponge used to fuse more than one level of the spine and was placed outside a cage (i.E.In the disc space).Post-op, the patient complained of progressively worsening pain in his lower back and radiculopathy into his lower extremities.Patient still continues to experience chronic pain in his mid and low back, radiculopathy into his buttocks and bilateral lower extremities, and numbness in his right leg and foot.Patient injuries prevented her from practicing daily life activities and reportedly the patient has suffered serious and permanent injuries.The patient had to undergo a revision surgery.
 
Manufacturer Narrative
(b)(6).(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.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that on (b)(6) 2001: the patient had pre-op diagnosis of acl tear, right knee with tear of medial meniscus, right knee.For which patient underwent arthroscopic partial medial meniscectomy.Arthroscopic assisted acl reconstruction, bone-tendon bone.Patient tolerated the procedure well with no complications being reported.On (b)(6) 2002: patient presented with pre-op diagnosis of l5-s1 lytic isthmic spondylolisthesis with instability, bilateral foraminal stenosis and l5 nerve root compression, l4-5 spondylosis.For which patient underwent anterior lumbar interbody fusion after complete discectomy, use of cages, 16mm dia, 26 mm length at l5-s1, 23 mm length at l4-l5.Posterior spinal reconstruction with pedicle screw, 3d instrumentation.Posterolateral fusion with autograft left posterior iliac crest bone harvest.Bilateral l5-s1 foraminal decompression.Per op notes, a 16x26 mm implant size was selected for the l5-s1 site.The cage was packed with the rhbmp-2 product.The implants were placed in the usual fashion and had excellent mechanical fit.Then surgeon moved to l4-l5 site and selected 23x16 mm implant.These were also placed with excellent mechanical fit.The additional rhbmp-2 was then placed between two implants.Final x-rays showed good placement of both the implants.No irrigation was carried out after the implants and rhbmp-2 was placed.Later surgeon proceeded with a foraminotomy bilaterally at l5-s1.Surgeon was unable to use rhbmp-2 posteriorly since it could not be encapsulated within a solid structure.Autograft was used in this site, especially in lieu of instability pattern of l5-s1 spondylolisthesis.Final x-rays showed good lordosis, good placement of all instrumentation and acceptable screw placement.The patient tolerated the procedure well with no complications being reported.On (b)(6) 2002: patient got discharged.On (b)(6) 2002: patient underwent x-ray of abdomen.Impression: no complications are identified on myelogram and no evidence of focal disc protrusion seen.Patient also underwent ct scan of lumbar spine following myelography.Impression: minimal anterior soft tissue impression on thecal sac at l5-s1 level without evidence for significant central or foraminal stenosis.On (b)(6) 2002: patient came for follow-up six weeks' status posts his l4-s1 fusion.X-ray showed fairly accelerated bone growth.It appeared that the cages are completely incorporated.It also appears that the posterolateral fusion masses were well incorporating.On (b)(6) 2002: patient returns for follow-up of his l4 to s1 anterior and posterior reconstruction.On exam, he had no evidence of active radiculopathy.He unfortunately still had some sciatic type symptoms into the right lateral border of the right foot, but no active radiculopathy was noted.On (b)(6) 2003: patient returns for one year follow-up of his l4 to s1 ap fusion.Patient x-rays showed excellent incorporation and fusion from l4 to s1.The pedicle screw instrumentation was well-placed.On (b)(6) 2005: patient underwent ct scan of lumbar spine without contrast.Impression: moderate annular bulging l3-l4 eccentric to the right.No post-op changes noted from previous report.On (b)(6) 2005: patient presented for consultation regarding his back pain.Impression: l3-4 sprain/strain, small annular tear on the l3-4 disk to the right.On (b)(6) 2006, (b)(6) 2008: patient presented with complaint of cough.Assessment: acute bronchitis.On (b)(6) 2006: patient presented with complains of continued edema, swollen hand and feet.Assessment: edema, overweight, hypogonadism, testicular, polycythemia.On (b)(6) 2007: patient presented for reevaluation.Impression: transitional level degenerative change at l3-4.On (b)(6) 2007: patient presented for checkup of neck and complained of itchy eyes bilateral, sneezing seasonal, nasal congestion.Assessment: adjustment anxiety.Allergic rhinitis due to allergen.On (b)(6) 2007: the patient had pain in arm right elbow and left shoulder, flu shot.Assessment: medial epicondylitis of elbow; need for prophylactic vaccination and inoculation.On (b)(6) 2007: patient complained of high bp.Assessment: hypertension, polycythemia, screen lipid disorders.On (b)(6) 2007: patient underwent hematology consultation.On (b)(6) 2008: patient presented for evaluation of daytime fatigue in the setting of polycythemia.Impression: daytime fatigue.On (b)(6) 2008, (b)(6) 2011: patient had polysomnography interpretation.Impression: obstructive sleep apnea, mild; cpap was not used during this study.On (b)(6) 2008: patient presented for reevaluation.Impression: mild low back pain due to l3-4 spondylosis.On (b)(6) 2008, (b)(6) 2009, (b)(6) 2012, (b)(6) 2013, (b)(6) 2014, (b)(6) 2015: patient complained of more joint pains.Impression: hereditary hemochromatosis; secondary polycythemia due to testosterone, secondary to sleep apnea; hypothyroidism; lorazepam dependency.On (b)(6) 2008: patient returns with continued disability with his low back.Patient's plane x-rays showed a complete collapse in spondylosis at the l3-4 level.The more proximal levels appear to be well maintained.He has had a kyphotic settling of the l3-4 level consistent with loss of disc space integrity and laxity of the posterior ligamentous structures.On (b)(6) 2008: patient underwent mri of lumbar spine.Impression: l4-l5 and l5-s1 anterior and posterior fusion changes noted without residual or recurrent central or lateral recess stenosis.L3-l4 moderate spondylosis and facet arthrosis with mild bilateral foraminal stenosis.Shallow left posterolateral disc protrusion.L2-l3 mild spondylosis.L1-l2 and l2-l3 mild bilateral facet arthrosis.On (b)(6) 2008: patient presented for preoperative consultation for risk assessment.On (b)(6) 2008: patient presented for risk assessment prior to surgery.Assessment: oth spcf pre-op exam; need for prophylactic vaccination and inoculation, influenza; lumbar disc displacement; derangement of anterior horn of medial meniscus; hypertension; anxiety.On (b)(6) 2008: patient underwent pre-op x-ray.Assessment: oth spcf pre-op exam.On (b)(6) 2008: patient presented with pre-op diagnosis of l3-4 spondylosis with instability and junctional kyphosis above a previous l4 to s1 reconstruction with segmental collapse, bilateral foraminal stenosis and dynamic instability.And had post-op diagnosis: dynamic instability l3-4 with advanced disc and facet degenerative change and dynamic foraminal stenosis.For which patient underwent exploration of previous fusion l4 to s1, removal of previous hardware, harvest right posterior iliac crest for bone graft, instrumentation l3 and re-instrumentation l4 partial facetectomies for correction and stabilization of degenerative transitional facetectomy, instrumented posterolateral fusion.Patient tolerated the procedure well and no complications were reported due to event.Patient underwent x-ray of lumbar spine due to posterior l3-4 fusion above previous l4-s1 fusion existing conditions.Impression: posterior spinal fusion at l3-4, this had been revised.Previously there was posterior fusion from l4 through s1, which has been removed and new fusion has been performed at the l3-4 level.On (b)(6) 2008: patient presented for his first postoperative visit after undergoing exploration of a previous fusion, l4 to s1, removal of that previous fusion hardware and reconstruction l3-4 for spondylosis with instability and junctional kyphosis above previous fusion.Impression: status post exploration of previous fusion l4 to s1 with removal of that previous fusion hardware, reconstruction l3-4 for spondylosis with instability and junctional kyphosis above previous fusion.Segmental instrumentation and bone graft used.On (b)(6) 2008: patient returns for re-evaluation.X-ray showed an excellent posterolateral fusion mass with good maintenance of the l3-4 lordosis.On (b)(6) 2008: patient presented with complaint of knee injury, swelling and soreness.Assessment: contusion of knee; sprain and strain of unspecified site of knee and leg.On (b)(6) 2008: patient presented with complaint of cut finger.Assessment: open wound of finger without complication.On (b)(6) 2008: patient underwent mri of left knee.Conclusions: focal linear, somewhat complex tearing of the posterior horn medial meniscus along the superior articular surface.Lateral meniscus and knee joint ligaments are intact.Grade ii chondromalcia involving the medial femoral condyle and medial facet of the patella.Mildly thickened suprapatellar plica.On (b)(6) 2008: patient presented with hyperextension injury to his left knee.Impression: tear medial meniscus.On (b)(6) 2008: the patient had pre-op diagnosis of degenerative tear of medial meniscus, left knee.And post-op diagnosis as degenerative tear of medial meniscus, left knee plus chondromalcia, patellofemoral joint and medial femoral condyle.For which patient underwent arthroscopic partial medial meniscectomy.Arthroscopic debridement, medial femoral condyle and patellofemoral joint.Patient tolerated the procedure well with no complications being reported.On (b)(6) 2008, (b)(6) 2009: patient presented with complains of anxiety and gerd.Assessment: adjustment dis w anxiety, gerd.On (b)(6) 2010: patient presented with complaint of burning pressure in chest, inflammation on side of face, headache and tightness in chest.On (b)(6) 2010: patient underwent x-ray of chest due to upper respiratory infection.Impression: negative chest.On (b)(6) 2010: patient underwent colonoscopy.Impression: normal colonoscopy.On (b)(6) 2011: patient came for an evaluation of a chronic left shoulder problem.Diagnosis: his symptoms are most compatible with a rotator cuff problem but he does have some osteoarthritis as well.On (b)(6) 2011: patient underwent mri of the left shoulder without contrast.Conclusion: moderate approaching marked osteoarthritis of the left glenohumeral joint.Mild to moderate tendinopathy and ill-defined interstitial collagen fiber micro tearing of the distal supraspinatus tendon without larger or better defined partial or full-thickness tear.Mild inferior hypertrophy of acromioclavicular joint and mild subacromial spur/enthesophyte contribute to encroachment upon the subacromial space.Tendinopathy with some attenuation of the distal superior leading edge of the subscapularis tendon.Large glenohumeral joint effusion.On (b)(6) 2011: patient had physical therapy.Diagnosis: osteoarthritis left shoulder.Patient had a satisfactory response to corticosteroid injection.On (b)(6) 2011: patient presented with complaint of headaches and ear ringing on (b)(6) 2011: patient had mri of head without contrast.Conclusion: no evidence of intracranial mass hemorrhage or obstructive hydrocephalus.Abnormal signal within the globus pallidi bilaterally.Posterior fossa structures normal.Moderate cervical spondylosis as described above.Mild straightening of the normal cervical lordosis.Cervical and upper thoracic cord normal.Moderate facet arthroapthy c7-t1 with mild anterolisthesis with mild narrowing of the neural foramina without canal stenosis.On (b)(6) 2011: patient had an office visit for evaluation of bilateral tinnitus.On (b)(6) 2011: patient presented with new complaints of neck pain and headaches.Impression: c4-5 and c5-6 degenerative changes with spondylosis and modic changes particularly at c4-5 and foraminal stenosis.Left greater than right at c4-5 and bilaterally at c5-6.On (b)(6) 2011: patient got diagnosed with acute pharyngitis.On (b)(6) 2011: patient came for re-evaluation of neck.Patient had limited range of motion.Diagnosis: multilevel cervical spondylosis, degenerative disc disease status post previous lumbar fusion initially for spondylolisthesis and then transitional segment done six years later at l3-4.On (b)(6) 2011: patient underwent x-ray of hip due to pain.Conclusion: unremarkable single view both hips.On (b)(6) 2011: patient presented for an office visit with following assessment: cough; neck pain; headaches; shoulder pain; hip pain.On (b)(6) 2011: patient had x-ray of chest.Impression: no evidence of acute pulmonary disease.On (b)(6) 2011: patient presented with multiple aches and pain.On (b)(6) 2011: patient presented for a second opinion regarding cognitive and functional difficulties.Impression: cognitive difficulties related largely to attentional ability.On (b)(6) 2011: patient presented with chief complaint of numbness to the right leg greater than the left with intermittent right lower leg pain; low back pain, right greater than left.On (b)(6) 2011: patient got diagnosed with diffuse back pain, myalgias and diffuse arthralgias.On (b)(6) 2011: patient underwent emg examination of lower extremities bilaterally.Impression: normal emg.On (b)(6) 2011: patient presented for a follow up.Impression: cognitive disorder.Depression, not otherwise specified.On (b)(6) 2011: patient got diagnosed with severe neck pain and shoulder pain on left.Patient also had low back pain and was status post fusion at 2 levels.On (b)(6) 2012: patient got diagnosed with chest pain on left.On (b)(6) 2013, (b)(6) 2014: patient got diagnosed with urinary tract infection (uti); acute bronchitis; hypertension.On (b)(6) 2013: patient got diagnosed with anxiety, hypothyroidism and insomnia.On (b)(6) 2013: patient presented for an evaluation of midthoracic back pain.Assessment: degenerative disc disease thoracic spine.On (b)(6) 2013: patient got diagnosed with myalgias, hypothyroidism.On (b)(6) 2013: patient presented with right shoulder problem.Assessment: shoulder pain.On (b)(6) 2013: patient got diagnosed with hypertension, diffuse pain, low vitamin d and onychomycosis of the toes.On (b)(6) 2013: patient got diagnosed with foot pain in the right 3rd plantar metatarsal area, left eye pain, diffuse pain.On (b)(6) 2013: patient presented fro painful soft tissue lesion on the right foot.On (b)(6) 2013, (b)(6) 2014: patient got diagnosed with fibromyalgia with multiple comorbidities.On (b)(6) 2013: patient presented with fibromyalgia and chronic fatigue clinic.Impression: occupational therapy evaluation, functional limitations, client limited by hopelessness about his condition, but receptive to ot session and recommendations.On (b)(6) 2014: patient got diagnosed with fibromyalgia.On (b)(6) 2014: patient presented for prescreening evaluation for 2 day pain rehabilitation executive program related to chronic fibromyalgia pain.On (b)(6) 2014: the patient presented for an evaluation, biofeedback assisted relaxation.On (b)(6) 2014: patient presented for an evaluation of abnormal overnight oximetry.Impression: history of obstructive sleep apnea, abnormal overnight oximetry, fibromyalgia with chronic fatigue, depression, anxiety.On (b)(6) 2014, (b)(6) 2015: patient got diagnosed with hypothyroidism, low testosterone, erectile dysfunction, hemochromatosis.On (b)(6) 2014: patient presented with worsening cough.Assessment: pneumonia; sinusitis.On (b)(6) 2014: patient presented with chief complaint of left elbow pain and left shoulder pain.On (b)(6) 2014: patient presented with an acute left elbow injury sustained one week ago in a fall.Assessment: left elbow pain.On (b)(6) 2014: patient got diagnosed with hypertension, acute sinusitis, acute bronchitis.On (b)(6) 2015: patient presented for an evaluation of his neck pain.Assessment: mechanical neck pain.On (b)(6) 2015: patient presented with complaint of neck pain and neck rechecks.Assessment: mechanical neck pain.The patient mri revealed advanced multilevel degenerative changes in the cervical spine.On (b)(6) 2015: patient underwent imaging of cervical spine without intravenous contrast.Conclusion: progression of degenerative changes, with progressive disc space narrowing from c3 through c7.Mild central canal stenosis at c3-c4, c5-c6 and c6-c7.Multilevel foraminal stenosis, mildly progressive from the previous study.Severe on the right and moderate on the left at c3-c4.Severe on the left at c4-c5.Moderate on right and severe on the left at c5-c6.On (b)(6) 2015: patient presented for evaluation following right c2-c3 facet injection.Assessment: right c2-c3 facet arthroapthy.Mechanical neck pain.
 
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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 Key4893959
MDR Text Key6019878
Report Number1030489-2015-01374
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,Followup
Report Date 02/24/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/07/2015
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 Received02/24/2016
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 Weight109
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