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

Catalog Number 7510800

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Angina (1710); Fatigue (1849); Headache (1880); Hearing Loss (1882); High Blood Pressure/ Hypertension (1908); Incontinence (1928); Ischemia (1942); Muscle Weakness (1967); Nerve Damage (1979); Neuropathy (1983); Pain (1994); Swelling (2091); Weakness (2145); Burning Sensation (2146); Tingling (2171); Dizziness (2194); Stenosis (2263); Malaise (2359); Numbness (2415); Neck Stiffness (2434); Sleep Dysfunction (2517); Ambulation Difficulties (2544)

Event Type  Injury  

Event Description

It was reported that the patient underwent a posterior lumbar fusion at l5-s1 using rhbmp-2/acs.Reportedly, sometime post-op, the patient was seen for follow up and complained of increasing back pain and radiating pain to her legs and feet; at times she was unable to walk.The patient continued to experience daily, disabling pain.

Manufacturer Narrative

(b)(4).Neither the device nor applicable imaging study films or patient medical records 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/used 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.

Event Description

It was reported that on, (b)(6) 2005 the patient presented for an office visit.The patient underwent, tympanogram.Audiogram.Impression: asymmetric hearing loss, left ear greater than right ear but audiogram does not support this.Asymmetric tinnitus.Allergic rhinitis.(b)(6) 2005 the patient came for a follow-up.Impression: asymmetric tinnitus - uncertain etiology.Mri shows no evidence of acoustic neuroma, "glorrius" tumor or carotid stenosis.(b)(6) 2006: patient presented with hypertension.Patient underwent chest x-ray.Impression: normal chest.The patient presented for a consultation.Impression: left temporal headache.(b)(6) 2006: patient presented with hypertension.Patient underwent chest x-ray.Impression: normal chest.The patient presented for a consultation.Impression: left temporal headache.(b)(6) 2006 the patient came for a follow-up.Impression: status post temporal artery biopsy negative for giant cell arteritis.

Manufacturer Narrative

(b)(4).

Event Description

It was reported that on (b)(6) 2006: the patient presented with rash and arthritis.(b)(6) 2007: the patient presented with dm, hw and arthritis.(b)(6) 2010: the patient presented with pain in finger, head pain and neuropathy.(b)(6) 2010: the patient presented with pain and numbness.(b)(6) 2012: the patient underwent xr knee one or two views left.Impression: advanced degenerative change with portable loose bodies.(b)(6) 2012: the patient presented with radicular pain.(b)(6) 2013: the patient presented with bad nerve damage in feet and back pain.(b)(6) 2013: the patient presented with shoulder pain.(b)(6) 2014: the patient presented with complaint of pain.(b)(6) 2015: the patient underwent chest two view.Impression: no acute cardiopulmonary process.(b)(6) 2015: the patient presented with abdominal pain and chest pain.

Event Description

On (b)(6) 2013 the patient presented with complaint of lower back pain.Assessment: cervical spondylosis without myelopathy.Assessment: cervical spondylosis without myelopathy; degeneration of cervical intervertebral disc; cervical radiculalgia, rheumatoid arthritis; thoracic or lumbar radiculitis; lumbar postlaminectomy syndrome.

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patient presented with the pre op diagnosis of lumbar disc degenerative disease with instability and radiculopathy l5-s1.The patient underwent the following procedures: bilateral non segmental pedicle screw instrumentation l5-s1; posterior lateral arthrodesis using compression resistant matrix, locally harvested bone graft and bone morphogenic protein; lumbar decompression at l5-s1 to decompress the l5 nerve root; lumbar decompression at l5-s1 to decompress the s1 nerve root.Use of locally harvested bone graft morselized.Per the op notes, a posterior lateral arthrodesis was then completed using compression resistant matrix, bmp soaked sponge and locally harvested bone graft which had been morselized.This spanned the transverse process of l5 which had been previously decorticated and the sacral ala which had also been decorticated.X-rays of the lumbar spine showed intra pedicular screens placed at the level of l5 and s1.The alignment of the lumbar spine is stable compared to a previous exam.No patient complications were noted.On (b)(6) 2011 the patient was discharged from hospital.On (b)(6) 2011: patient presented for post-op visit with low back pain and weakness.On (b)(6) 2011 patient presented for follow up on multiple complaints.Assessment: dm; pvd; bet; htn.On (b)(6) 2011 the patient presented with a history of chronic neck and lower back pain.She complained of increased pain of her neck, left scapular and superscapular regions.She had multiple points of tenderness to the medial scapular and superscapular regions on the left.Assessment: cervical and lumbosacral spondylosis without myelopathy; right cervical radiculopathy; multiple trigger points about the scapular and superscapular regions on the left.On (b)(6) 2011 the patient presented with the diagnosis of low back pain and underwent ct of the lumbar spine.Impression: dextroscoliosis with degenerative disk disease.Posterior fusion at the l5-s1 level with intact hardware in anatomic alignment.On (b)(6) 2011: patient presented with back pain and increased neck pain with radiation into her shoulders and also to left arm to fingertip level.Assessment: cervical spondylosis; lumbar spondylosis; right cervical radiculopathy.Patient underwent cervical epidural steroid injection.No complications reported.On (b)(6) 2012 the patient presented for a follow-up visit and complained of diaphoresis; hair loss/thinning, and severe bruising.There was edema on bilateral legs.Assessment; fatigue; edema, htn; gerd; dm.On (b)(6) 2012 the patient presented with a history of chronic neck and lower back pain.She complained of increased pain of her neck and left arm.Assessment: cervical and lumbar spondylosis without myelopathy; right cervical radiculopathy.On (b)(6) 2012 the patient presented with pain in limbs and underwent x-ray of left foot.Impression: mild hallux valgus deformity with associated mild osteoarthritis.X-rays of the right foot showed mild osteoarthritis.X-rays of the left hand showed mild degenerative change.X-rays of the right hand showed degenerative change.X-rays of the left hip showed mild osteoarthritis.X-rays of the right hip showed minor osteoarthritis.X-rays of the left wrist showed advanced degenerative change with what appears to be avascular necrosis of the scaphoid.X-rays of the right wrist were negative.On (b)(6) 2012 the patient presented with the diagnoses of back ache and cervical spondylosis.On (b)(6) 2012 the patient presented for a follow up after surgery.The pain was mild, throbbing, aching with radiation down to her back and legs.On review of systems, there were fatigue, head ache, back pain, muscle weakness, nausea, urinary incontinence, difficulty walking and bone/joint pain.On (b)(6) 2012 the patient presented for post-op visit with complaints of neck pain and back pain.Impression: the patient was able to perform adls.The patient had no difficulty with ambulation.The patient has full control over her bladder and the patient¿s bowel function was adequate.Assessment: degeneration, disc, cervical.On (b)(6) 2012 the patient presented with the diagnosis of rheumatoid arthritis.On (b)(6) 2012 the patient presented with the diagnosis of diabetes.Also the patient presented for office visit for follow-up of rheumatoid arthritis and with complaints of pain to hands, feet and back.Assessment: rheumatoid arthritis.On (b)(6) 2012 the patient presented with back pain and neck pain.Per patient, pain radiated down to legs and patient described pain as aching, piercing, throbbing, shooting and sharp.Review of system revealed headache, chest pain, abdominal pain, diarrhea, nausea, vomiting, dizziness, insomnia, constipation and night sweats.Assessment: cervical spondylosis without myelopathy; cervicalgia; cer vical radiculopathy; lumbago; lumbosacral spondylosis without myelopathy (b)(6) 2012 the patient presented with the diagnosis of rheumatoid arthritis.On (b)(6) 2012: the patient presented for follow up for osteoarthritis.On (b)(6) 2012 the patient presented for a follow up and complained of moderate, aching back pain.On review of systems, there were fatigue, head ache, back pain and bone/joint pain.The pain was mild and intermittent, and was located in bilateral shoulder and arm.Musculoskeletal examination revealed neck stiffness.Palpation evaluation revealed: maximum tenderness at pericervical, spinous process, radicular pain.Assessment: degenerative disc disease, lumbar; degenerative, disc, cervical.On (b)(6) 2012 patient presented for physical therapy with dull, aching pain in left knee and thigh.Edema, weakness, stiffness on left lower extremity was noted.On (b)(6) 2012 patient presented for physical therapy with dull, aching pain in left knee.Edema and weakness on left lower extremity was noted.On (b)(6) 2012 patient presented for physical therapy with continuous, dull, aching pain in left knee.The pain was worse in the morning.There were stiffness, edema, sba and non pitting edema on left lower extremity.On (b)(6) 2012 the patient was discharged from physical therapy.On (b)(6) 2012: the patient presented with chief complaint of knee pain.The patient complained of pain in her lateral anterior, medial knee and lateral hip\thigh.Patient also had some nerve damage in her bilateral toes and had tingling there all the time.On (b)(6) 2012: the patient visited office with the complaint of back pain and neck pain.The pain was described as an ache, burning, deep, dull, numbness, piercing, sharp, shooting and throbbing.In the system review the patient was found positive for: dizziness, headache, insomnia.The physical exams revealed: moderate pain, with motion, in lumbar spine.Assessment: lumbosacral spondylosis without myelopathy.On (b)(6) 2012: the patient underwent for evaluation for ¿pvd¿.Impression: impression: normal bilateral lower extremity resting ¿abi¿ and ¿pvr¿ study; toe-branchial indices were performed on all five toes bilaterally and were within normal limits.On (b)(6) 2012: patient presented with rheumatoid arthritis.On (b)(6) 2012, (b)(6) 2013 the patient presented for an office visit with complaint of back pain.Patient also complained of cervical and left radicular pain to fingertip level.Location of pain was lower back, arms, legs and neck.Assessment: cervical spondylosis without myelopathy.On (b)(6) 2013: patient presented with backache.On (b)(6) 2013: the patient presented for follow-up visit with complaint pain to lower back and rheumatoid arthritis.Assessment: rheumatoid arthritis; neck pain; therapeutic drug monitoring.On (b)(6) 2013: the patient presented for follow-up office visit with complaint of neck pain.There was radiation of pain to the bilateral shoulders.Musculoskeletal examination revealed back pain, bone/joint symptoms, muscle weakness, neck stiffness.Assessment: cervicalgia; degeneration disc, cervical; disc displacement, cervical; pain- neck; spinal stenosis, cervical.On (b)(6) 2013: the patient presented with complaint of back pain.Location of pain was lower back, arms, legs and neck.Assessment: brachial neuritis or radiculitis; cervical spondylosis without myelopathy; degeneration of cervical intervertebral disc; displacement of cervical intervertebral disc; radiculitis, thoracic or lumbar, degeneration of lumbar or lumbosacral inter vertebrae; lumbosacral spondylosis without myelopathy; diabetic neuropathy.On (b)(6) 2013: patient presented for follow up and long term use medicines issue.On (b)(6) 2013: the patient presented for an office visit with rheumatoid arthritis.The patient¿s chronic problems remained same.Assessment: rheumatoid arthritis; cervicalgia; therapeutic drug monitoring.On (b)(6) 2013: patient presented for follow up with lots of pain in arms.Per patient, pain radiated down to arms and described pain as aching, piercing, throbbing, shooting and sharp.Review of system revealed back pain, bone/joint pain and muscle weakness.On (b)(6) 2013 the patient presented for evaluation of headache, located on the left side starting at the base of head radiating to the temporal area and it was dull and aching in nature with occasional sharp shooting pain with some confusion and concentration difficulty.There was also some general muscle weakness on the right side of the body and tingling and numbness in the limbs as well.There were decreased sensation on the lateral part of the arm and the forearm for light touch, temperature and pinprick sensation, and on the right posterior part of the thigh and the leg.There were mid and lower cervical spasm.Also there were mid and lower lumbar paraspinal muscle spasm and tenderness.Impression: transient period of amnesia, possible transient global amnesia versus complex partial seizure versus tla; generalized muscle weakness with gait impairment; intractable headache with neurological impairment; memory problem, rule out dementia.On (b)(6) 2013: the patient presented with complaint of back pain.Location of pain was lower back, arms, legs, neck, feet, hands and shoulders.Assessment: brachial neuritis or radiculitis; cervical spondylosis without myelopathy; degeneration of cervical intervertebral disc; degeneration of lumbar or lumbosacral intervertebr; lumbosacral spondylosis without myelopathy; spinal stenosis in cervical region; cervical radiculalgia, rheumatoid arthritis; lumbar radiculitis; unspecified arthropathy involving shoulder region.On (b)(6) 2013 the patient presented with admission diagnosis of malaise and fatigue nec.On (b)(6) 2013 the patient presented for a follow up and stated that her head aches were intermittent.The patient had difficulty in con centration.There were decreased sensation distally on both lower extremities and right lateral thigh, and tenderness in cervical and lumbar region.Eeg was normal.Nerve conduction studies and emg studies were consistent with diabetic poly neuropathy and right s1 radiculitis.Impression: transient global amnesia; generalized muscle weakness secondary to muscle deconditioning and diabetic neuropathy; lumbar post laminectomy syndrome; head aches, no evidence of temporal arteritis noted and has normal sed rate; chronic memory impairment (b)(6) 2013: patient presented with back, arms, legs and feet pain.Per patient pain radiated down to arms and legs and described pain as aching, burning, stabbing, piercing, throbbing and sharp.Review of system revealed headache.On (b)(6) 2013: the patient presented with complaint of back pain.Pain had radiated to the left arm, right arm and legs.Patient¿s neuro analysis revealed headache, insomnia and musculoskeletal examination revealed back pain, joint pain and neck pain.Assessment: brachial neuritis or radiculitis; cervical spondylosis without myelopathy; degeneration of cervical intervertebral disc; rheumatoid arthritis; lumbar or thoracic, radiculitis; postlaminectomy syndrome of lumbar region.On (b)(6) 2014: the patient presented with complaint of back pain which radiated to the right arm.Assessment: post laminectomy syndrome of lumbar region; degeneration of lumbar or lumbosacral intervertebr; lumbosacral spondylosis without myelopathy; spinal stenosis in cervical region; rheumatoid arthritis.On (b)(6) 2014: the patient presented for an office visit with complaint of back pain.Patient presented with pain all over body including back pain.Per patient pain radiated to legs and described pain as aching, burning, stabbing, piercing, throbbing and sharp.Musculoskeletal review revealed muscle weakness, back pain, joint pain.Assessment: postlaminectomy syndrome of lumbar region, spinal stenosis in cervical region, diabetic neuropathy, rheumatoid arthritis.On (b)(6) 2014 the patient presented with the chief complaint of bilateral shoulder pain and back pain.Location of pain was upper back, middle back, lower back, neck and shoulders.The patient has radiated to the left arm, right arm, left calf, right calf, left foot, right foot, and thighs.She described the pain as ache, burning, deep, dull, numbness, piercing, sharp, shooting, stabbing and throbbing.Assessment: post laminectomy syndrome of lumbar region; cervical spondylosis without myelopathy; degeneration of cervical intervertebral disc; degeneration of lumbar or lumbosacral inter vertebrae; diabetic neuropathy; spinal stenosis in cervical region; rheumatoid arthritis.On (b)(6) 2014 the patient presented with admission diagnosis of joint pain in shoulder and back pain.Assessment: postlaminectomy syndrome of lumbar region, rheumatoid arthritis, radiculitis, thorascic or lumbar.Cervical spondylosis without myelopathy, degeneration of lumbar or lumbosacral inter-vertebrae, on (b)(6) 2014 the patient presented for office visit with complaints of back pain.Assessment: degeneration of lumbar or lumbosacral intervertebral disc, cervical spondylosis without myelopathy, lumbago, osteoarthritis, lumbosacral spondylosis without myelopathy, spinal stenosis inn cervical region.On (b)(6) 2014 the patient presented with complaints of back pain.Assessment: postlaminectomy syndrome of lumbar spine, degeneration of cervical intervertebral disc, brachial neuritis or radiculitis nos, spinal stenosis in cervical region, lumbosacral spondylosis without myelopathy, diabetic neuropathy, rheumatoid arthritis.On (b)(6) 2014 the patient presented with complaints of rheumatoid arthritis.Assessment: osteoarthritis, unspecified whether generalized or therapeutic drug monitoring, rheumatoid arthritis.On (b)(6) 2014 the patient presented with admits diagnosis of joint pain in shoulders and low back pain.Assessment: post laminectomy syndrome of lumbar spine, degeneration of cervical intervertebral disc, cervical and lumbosacral spondylosis without myelopathy, osteoarthritis, spinal stenosis in cervical region.On (b)(6) 2014 the patient presented with the history of chronic low back and bilateral leg pain.Right leg worse.The patient underwent ct of the lumbar spine.Impression: post surgical changes in the lumbar spine without evidence for hardware complication.On (b)(6) 2014 the patient presented with admission diagnosis of lumbago and principal diagnosis of post lami nectomy syndrome-lumbar.On (b)(6) 2014 the patient presented with complaints of low back pain.Assessment: post laminectomy syndrome of lumbar region, lumbosacral spondylosis without myelopathy, radiculitis thoracic or lumbar, degeneration of lumbar or lumbosacral intervertebral disc, brachial neuritis or radiculitis nos, cervical spondylosis without myelopathy, degeneration of cervical intervertebral disc, spinal stenosis in cervical region, rheumatoid arthritis, osteoarthritis localized primary involving shoulder region.On (b)(6) 2014 the patient presented with principal diagnosis of rheumatoid arthritis.On (b)(6) 2014 the patient presented for office visit with low back pain.Assessment: post laminectomy syndrome of lumbar region, lumbosacral spondylosis without myelopathy, radiculitis thoracic or lumbar, degeneration of lumbar or lumbosacral intervertebral disc, brachial neuritis or radiculitis nos, cervical spondylosis without myelopathy, degeneration of cervical intervertebral disc, spinal stenosis in cervical region, rheumatoid arthritis, osteoarthritis localized primary involving shoulder region, diabetic neurpathy, diabetes mellitus type 2 uncomplicated, hypertension-benign.On (b)(6) 2014 the patient presented for a follow up on ¿dm¿.The patient had an episode where she can¿t communicate or speak or remember how to do simple tasks.Assessment: dm; ha; back pain; foot ulcer.On (b)(6) 2014 the patient presented for office visit with complaints of all over and low back pain.Assessment: post laminectomy syndrome of lumbar region, radiculitis thoracic or lumbar, cervical spondylosis without myelopathy, degeneration of cervical intervertebral disc, spinal stenosis in cervical region, rheumatoid arthritis, lumbago.On (b)(6) 2014 the patient presented with principal diagnosis of unspecified joint pain and low back pain.Assessment: post laminectomy syndrome of lumbar region, lumbosacral spondylosis without myelopathy, radiculitis thoracic or lumbar, degeneration of lumbar or lumbosacral intervertebral disc, brachial neuritis or radiculitis nos, lumbosacral and cervical spondylosis without myelopathy, degeneration of cervical intervertebral disc, spinal stenosis in cervical region, rheumatoid arthritis, diabetic neuropathy.On (b)(6) 2015 the patient presented with principal diagnosis of rheumatoid arthritis and joint pain in shoulder, low back pain.Asse ssment: post laminectomy syndrome of lumbar region, lumbosacral spondylosis without myelopathy, degeneration of lumbar or lumbosacral intervertebral disc, displacement of cervical intervertebral disc without myelopathy, rheumatoid arthritis, osteoarthritis, diabetic neuropathy, knee joint replacement, on (b)(6) 2015 the patient presented with complaints of back problems.Assessment: post laminectomy syndrome of lumbar region, lumbosacral spondylosis without myelopathy, spinal stenosis in cervical region, degeneration of cervical intervertebral disc, cervicalgia.

Manufacturer Narrative

Concomitant products: rod, screws, set screws, graft expander, cancellous matrix, local bone graft (implant (b)(6) 2011).

Manufacturer Narrative

Following are the image review findings: (b)(6) 2006 mammogram no spinal anatomy imaged (b)(6) 2006 left knee mri medial joint line arthritis is seen with irregularity and narrowing of the tibial cartilage.Cruciates appear intact, medial meniscus is not well visualized.Some fragmenting appears along the medial edge.Bone quality appears to be maintained but some bony edema is suggested in antero-medial tibia (b)(6) 2007 chest x-ray pa film with normal inspiration.Cardiac shadow is normal, bony anatomy appears normal including ribs, shoulders and spine.Pulmonary fields show no infiltrates or effusions, some prominence of hilar vasculature is noted on the right.(b)(6) 2007 renal us no spinal anatomy imaged (b)(6) 2007 abdominal ct contrasted ct of gi track.Spinal anatomy is visualized but is very small and over penetrated making assessment difficult.No clear fracture, tumor or stenosis is appreciated.(b)(6) 2008 cervical spine series open mouth view suggests degenerative changes on the left between the c1 and c2 lateral pillars.Otherwise spinal alignment is normal.Mild disc narrowing is seen at c5/6.(b)(6) 2008 vascular renal cta coronal and sagittal views suggest a mild apex left scoliosis with bridging spurs on the right at l2/3 and l1/2.(b)(6) 2009 cervical mri left sided c1/2 articulation is grossly deformed and enlarged with lateral indentation of the thecal sac, but without cord compression.Midline cord compression is seen at c4/5 and c5/6 anteriorly.No cord signal changes are noted.(b)(6) 2009 lumbar mri small right paracentral hnp is seen at l5 displacing the s1 root dorsally a few mm.Sagittal stir and t2 show advanced collapse of the l5 disc.Lordosis is maintained.No fractures or tumors are appreciated.Some irregularity and sclerosis are noted at the l5 disc.The remainder of the disc spaces are maintained on axial view.(b)(6) 2010 left hand x-rays no digital fractures or malalignment.Scapholunate advanced collapse is seen (slac wrist).Arthritis of radiocarpal joint and proximal carpal row.Oblique and lateral views show no additional pathology.(b)(6) 2010 abdominal ct contrasted abdominal study.This does not highlight spinal pathology well.Some degenerative changes are again seen at l5 with right paracentral bulge.(b)(6) 2010 cardiac cath no spinal anatomy visualized aortic arteriogram no spinal anatomy visualized (b)(6) 2010 lumbar mri disc degeneration has progressed, now involving l5, l3, l1 and t12.Hemangioma is seen in the body of l2.Again no central stenosis is appreciated.Only the right s1 root is displaced at all.(b)(6) 2011 chest x-rays pa and lateral views show normal pulmonary, cardiac and bony shadows.Thoracic spine also appears normal.Shoulders appear normal on these films but are not well demonstrated.(b)(6) 2011 head angio ct no spinal tissues imaged carotid ultrasound no spinal tissues imaged (b)(6) 2011 cardiac us no spinal anatomy visualized mammogram no spinal anatomy imaged (b)(6) 2011 xr panorex oral mandible is edentulous (b)(6) 2011 left knee x-rays shows advanced medial compartment arthritis with varus deformity and bone-on-bone changes.Spurs and cysts are present.Calcifications and spurring are seen in the patellofemoral arthritis as well.(b)(6) 2011 head/sinus ct spinal articulation at c1/2 can be seen with severe posttraumatic arthropathy and hypertrophy seen.No other spinal anatomy is imaged.(b)(6) 2011 lumbar mri sagittal t2 views show collapse and sclerosis at l5, and l1.Conus is behind l1.No stenosis is seen on axial views with the exception of a small punctate disc herniation at l5 on the right displacing the s1 root dorsally approximately 2 mm.(b)(6) 2011 chest x-ray pa and lateral views show normal pulmonary, cardiac and bony shadows.Thoracic spine also appears normal.Shoulders appear normal on these films but are not well demonstrated.(b)(6) 2011 lateral lumbar x-ray single lateral localization view with probe at the level of the l5 disc.Subsequent lateral view shows pedicle screws at l5 and s1 without peek spacer or rods in place.Screws appear well positioned.(b)(6) 2011 lumbar ct scout view shows final l5/s1 construct in good position with rods in place.Spacer cannot be verified on this film.Axial views show posterolateral fusion bone without interbody spacer.Right l5 screw is bicortical and extends beyond anterolateral body.Posterior decompression has been performed.(b)(6) 2012 cervical mri sagittal t2 and stir images show flattened cervical lordosis.Some bulging from c4 to c6 show near obliteration of the ventral subarachnoid space.Cord signal change is suggested at c4/5 to c7.Axial views show cord compression at c4/5 and c5/6.No fusion has been performed.(b)(6) 2012 lower extremity doppler us no spinal anatomy visualized (b)(6) 2012 left hand x-rays again seen is the slac wrist with widening of the navicular-lunate articulation, collapse of the proximal carpal row and advanced degeneration of the radiocarpal joint.Right hand x-rays there are some changes of radiocarpal arthritis here as well with some widening of the navicular-lunate articulation, but much less collapse than on the left.The remainder of the hand appears normal in all views.Left wrist x-rays advanced collapse is more apparent in these views.Involution is also seen of the proximal navicular consistent with avascular necrosis of the proximal pole.Right wrist x-rays impingement of the radial styloid is suggested here with some degree of arthritis aggravated by this syndrome.Some degree of cupping is seen in the distal radius.Left hip x-rays ap and frog leg views show some joint space narrowing.No deformity is apparent.Some calcification is also noted within the gluteus medius tendon.Neck shaft angle, coverage is all normal.Right hip x-rays ap and frog leg views show some joint space narrowing.No deformity is apparent.Lateral acetabular cysts are beginning suggestive of early degenerative arthritis.Pedicle screws at s1 with rods can be seen bilaterally.Neck shaft angle, coverage is all normal.Left foot x-rays prominent hallux valgus and metatarsus primus varus are suggested.Accessory navicular is seen of the medial pole.Some splaying of the forefoot is apparent.Lateral view shows spurring at the attachment of the plantar fascia to the os calcis.Degenerative changes are seen of the posterior subtalar facet.Right foot x-rays metatarsus primus varus again appears with less hallux valgus.Accessory navicular is again seen.No new fractures, tumors or arthritis is appreciated.(b)(6) 2012 cervical series inter-operative film shows needle within the c5/6 disc.Second view shows acdf with plate spanning c5/6.Graft is seen although it does not appear to be a peek device.(b)(6) 2012 cervical ct advanced arthritis is again seen on the left at c1/2.Plate and peek spacer is appreciated now at c5/6.Some residual bony spurring is noted in midline off of the superior endplate of c6 (b)(6) 2012 bone density test shows densities within a standard deviation of normal.(b)(6) 2012 ct head/brain no spinal pathology imaged.No spinal anatomy imaged left knee x-rays shows advanced medial compartment arthritis with varus deformity and bone-on-bone changes.Spurs and cysts are present.Calcifications and spurring are seen in the patellofemoral arthritis as well.Chest x-ray very poor study, under penetrated without sign of infiltrate, pneumothorax, cardiomegaly, or bony changes.Small c5/6 p late can be seen.(b)(6) 2012 left knee x-rays shows advanced medial compartment arthritis with varus deformity and bone-on-bone changes.Spurs and cysts are present.Calcifications and spurring are seen in the patellofemoral arthritis as well.Chest x-ray good quality study, no sign of infiltrate, pneumothorax, cardiomegaly, or bony changes.Small c5/6 plate can be seen.Study is essentially normal.Kyphosis is normal (b)(6) 2012 left knee x-rays interval total knee replacement has been completed.Alignment is good.Staples are in place in midline.Tibial, femoral and patellar components appear to be in good position and alignment.(b)(6) 2013 cervical mri t2 and stir sagittal images show artifact consistent with the anterior plate and screws at c5/6.Degenerative changes with bulging of the disc at c4 and posterior element hypertrophy at this level contributes to some degree of canal stenosis at this level.Axial views show enlargement of the c1/2 lateral pillars with encroachment in the left lateral subarachnoid space.Also seen is midline posterior spurring behind c4 and c5 causing some cord compression.(b)(6) 2013 cervical x-ray interval reoperation with decompression and acdf now from c4 to c6 held by plate, six screws and two interbody peek spacers.(b)(6) 2013 chest x-ray single supine portable film shows prominence of the right hilar vessels.The film is slightly under penetrated.No effusion or infiltrate is seen.Cardiac and bony anatomy is normal.New c4 to c6 plate can be seen.(b)(6) 2013 head ct coronal and sagittal views show no spinal anatomy.No gross abnormalities are noted.Axial views show irregularities of the anterior arch of c1.This could represent fracture of this structure although pieces are within normal position without subluxation.Angio mri no spinal anatomy imaged brain mri no spinal anatomy imaged (b)(6) 2013 carotid duplex us no spinal anatomy imaged (b)(6) 2013 echocardiogram no spinal anatomy visualized (b)(6) 2013 cervical ct acdf has been completed from c4-c5-c6.Spacers and screws are in good position.Plate is well seated on the anterior bodies and fusion is solid.Again seen is the irregularity of the anterior arch of c1 possibly representing previous healed fracture.Also seen is a distorted and enlarged left c1/2 articulation suggestive of fracture and post-traumatic arthritis.Cysts and sclerosis are seen through the lateral masses of c1 and c2.(b)(6) 2013 left shoulder x¿rays ap internal and external rotation views show some inferior spurring off the humerus.Mild ac arthritis is also noted.Axillary lateral shows bone on bone arthritis of the glenohumeral joint with spurring also off the interior glenoid.(b)(6) 2013 right shoulder x¿rays ap internal and external rotation views show inferior spurring off the humerus as well.Mild ac arthritis is also noted.Axillary lateral shows advanced arthritis of the glenohumeral joint but less than on the left.Bone on bone is noted inferiorly with abduction.(b)(6) 2013 left shoulder mri edema is noted within the subarticular humeral bone and within the glenoid neck.Advanced djd is again seen.Effusions are seen bilaterally in the subarticular capsule as well as dissecting anteriorly below the subscapularis.(b)(6) 2013 chest x-rays pa chest film showing normal lung fields, cardiac shadow and bony detail.Shoulders can be seen although state of the glenohumeral joints is suspect.A two level cervical plate is visible from c4 to c6.Diaphragm and gastric bubble are all normal.Lateral view shows some degree of disc narrowing but normal thoracic kyphosis without fracture.(b)(6) 2013 left shoulder x-ray ap view shows interval replacement of the humeral head with hemi-arthroplasty.Staples are in place.Good fit of the proximal humeral canal is achieved.No glenoid component looks to be in place.(b)(6) 2013 left shoulder x-ray replacement of the humeral head with hemi-arthroplasty is again seen.Staples are in place.Good fit of the proximal humeral canal is achieved.No glenoid component looks to be in place.External rotation view shows modular head attachment and rough glenoid surface.Internal rotation view shows head well reduced.(b)(6) 2014 left shoulder x-ray replacement of the humeral head with hemi-arthroplasty is again seen.Staples have been removed.Good fit of the proximal humeral canal is achieved.No glenoid component looks to be in place.External rotation view shows modular head attachment and rough glenoid surface.Internal rotation view shows head well reduced.No spinal anatomy is imaged.(b)(6) 2014 right shoulder mri study shows abundant effusion, end stage glenohumeral arthritis and apparent incompetent rotator cuff.No fracture or tumor is evident.No spinal anatomy is imaged.Right shoulder arthrogram contrast is seen within the right shoulder with injecting needle superiorly placed.Inferior sulcus shows contrast.Rotator cuff incompetency is suggested but cannot be verified as no contrast is seen in the subacromial space.(b)(6) 2014 right shoulder x-rays interval hemi-arthroplasty has been performed on the right, similar to that done on the left.Staples are in place.Good proximal fit and alignment have been achieved.(b)(6) 2014 right shoulder x-rays ap, internal and external rotation views are obtained.Again good reduction is maintained.Staples have been removed.(b)(6) 2014 left knee x-rays standing views of the left total knee replacement are shown.Lytic changes can be seen anterior to the tibial post and accompanying sclerosis in the supracondylar femur under the implant.Whether this represents lysis, healing fracture etc.Cannot be determined without history.(b)(6) 2014 chest x-rays cardiac, pulmonary tissues are normal.Diaphragms are intact.Rib contours appear normal.Hemi-arthroplasties in both shoulders and anterior cervical plate from c4 to c6 are visible.Lateral view shows mild degenerative disc narrowing with normal kyphosis.(b)(6) 2014 chest x-ray cardiac, pulmonary tissues are normal.Diaphragmatic borders are normal with gastric bubble well positioned.R ibs appear normal.Hemi-arthroplasties in both shoulders and anterior cervical plate from c4 to c6 are visible.Lateral view shows mild degenerative disc narrowing with normal kyphosis.Lumbar x-rays multiple ap views show l5/s1 pedicle screws with posterolateral fusion.Slight scoliosis is seen at the thoracolumbar junction with advanced bone spurring between t12 and l1 on the right.Posterolateral bone appears solid.Ap pelvis is also seen showing some increased sacroiliac arthritis on the left.Hips are well reduced but show moderate joint space narrowing in the regions of the weight bearing domes.(b)(6) 2014 mammogram no spinal anatomy imaged (b)(6) 2014 carotid duplex us no spinal anatomy imaged.

• 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 Key: 4290373
• MDR Text Key: 5057019
• Report Number: 1030489-2014-04606
• Device Sequence Number: 1
• Product Code: NEK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,consumer,health profess
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2013
• Device Catalogue Number: 7510800
• Device Lot Number: M111052AAJ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/29/2015
• 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 Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 107