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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 7510800
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Chest Pain (1776); Neuropathy (1983); Pain (1994); Chronic Obstructive Pulmonary Disease (COPD) (2237); Numbness (2415); Sleep Dysfunction (2517); Ambulation Difficulties (2544)
Event Type  Injury  
Event Description
It was reported that the patient presented underwent a transforaminal lumbar interbody fusion (tlif) l4-l5 using a peek vertebral body spacer along with rhbmp-2/acs.Bmp2 was placed anteriorly in the disc space prior to insertion of the cage, as well as in the posterolateral gutters spanning the transverse processes.Following her surgery, the patient initially improved, but subsequently developed additional, new and/or worse pain, suffering, symptoms and disability.Specifically, the patient has experienced progressive, disabling pain in her lower back, radiating to her legs.The patient has experienced numbness in her feet and persistent hip pain.
 
Manufacturer Narrative
(b)(4).Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.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)(4).
 
Event Description
It was reported that on: (b)(6) 2006: the patient also underwent a physical therapy evaluation.On (b)(6) 2007, the patient presented for follow up.On (b)(6) 2007 <(>&<)> (b)(6) 2007, the patient underwent a mri scan without contrast of cervical, bracplex and up chest region.
 
Manufacturer Narrative
(b)(4).
 
Event Description
(b)(6) 2008: the patient underwent mri of the lumbar spine without contrast.Impression: 1.Small left sided protrusion at l4-5.2.Diffuse disc bulging at l3-4.(b)(6) 2008: the patient presented with low back pain, small left sided protrusion.(b)(6) 2008: the patient underwent x-rays of the chest due to fatigue, cough, smoker, chronic obstructive pulmonary disease.Impression: normal chest.(b)(6) 2008: the patient presented with the following chief complaints: pain in lower back, left hip, left leg extending to toes, left arm, neck and cramps.(b)(6) 2008: the patient presented with following complaints: pain in back, left leg, neck and throbbing in left arm.The patient also presented for an office visit with the following admitting diagnosis: cervical degenerative disc disease for which the patient underwent mri of cervical spine without contrast.Impression: degenerative disk disease with stenosis as described: c4-c5- there is diffuse annular bulge resulting in mild central stenosis; c5-c6 - there is mild diffuse annular bulge; c6-c7 -there is diffuse annular bulge resulting in mild central stenosis.The patient was also diagnosed for fatigue, cough, smoker, chronic obstructive pulmonary disease, cerviac and underwent ekg and chest x-ray, posterior anterior/lateral labs acdf of c4-5.(b)(6) 2008: the patient presented for neurosurgery consultation with significant cervical pain and radicular pain in the left upper extremity.Review of mri revealed disk-osteophyte complex at t4-5.(b)(6) 2008: the patient presented for an office visit with the following admitting diagnosis: fatigue, cough smoker, chronic obstructive pulmonary disease, cervicalgia, herniated cervical disk, c4- 5.The patient complained of pain in neck and left arm.The patient underwent the following procedures: 1.Anterior cervical discectomy c4-5.2.Anterior cervical fusion with structural arthrodesi s, c4-5.3.Anterior cervical instrumentation.4.Modification of structural bone graft.No patient complications were reported.(b)(6) 2008: the patient underwent x-ray of cervical spine cross table for site verification.It was found that a surgical instrument was seen with the tip at the level of the c5-c6 disc space.The patient also underwent x-ray of cervical spine for hardware placement.It was found that a surgical plate and screw with a spacer was seen at the level of c4-c5.Bony position and alignment was anatomic.(b)(6) 2008: the patient was discharged home in good condition.(b)(6) 2008: the patient presented with admitting diagnosis: disc dis nec/nos-lumbar.The patient also presented with pain in knee, ankle, foot, heel, toes and severe low back pain radiating to left leg.The pain was getting progressed and intolerable.The back pain was described as sharp, shooting, stabbing with radiation down the left buttocks, posterior thigh and posterior calf.The pain exacerbates in lying, standing, walking, bending/twisting, lifting and weather changing.The patient also had complaints of muscle pain, cramps, stiffness, difficulty in walking, poor memory, poor concentration and excessive worry.The patient had tenderness to palpation over the lumbar spinous processes and quadratus lumborum, left side is greater than right.Assessment: the patient had lumbosacral spondylosis, lumbar degenerative disc disease and severe low back pain with left lower extremity radiculopathy.Patient had mri evidence of l3-4 annular tear and central disk bulge deforming the thecal sac, also mild bilateral foraminal narrowing secondary to disk material at l4-5.There was an annual tear with a paracentral disk protrusion distorting the thecal sac affecting the emerging l5 nerve root.Musculoskeletal examination revealed tenderness to palpation over the lumbar spinous processes and quadratus lumborum, left side greater than right.The patient was tested positive for opiates.(b)(6) 2008: the patient presented with the following chief complaint: low back pain and left leg radiation.The patient also underwent left-sided transforaminal epidural steroid injection at l3-4, l4-5 and l5-s1.Assessment: the patient had lumbosacral spondylosis, lumbar degenerative disk disease, left lower extremity radiculopathy, l3-4 annular tear and central disk bulge deforming the thecal sac and bilateral foraminal narrowing secondary to disc material at l4-5 and a paracentral disk protrusion distorting the thecal sac affecting the emerging l5 nerve root.(b)(6) 2008: the patient presented for neurosurgery consultation approximately one month status post anterior cervical discectomy and fusion.(b)(6) 2008, (b)(6) 2009, (b)(6) 2009, (b)(6) 2009: the patient presented with admitting diagnosis: disc dis nec/nos-lumbar (b)(6) 2008: the patient presented for a follow up office visit for medication.The patient had pain in hip, thigh, knee, lower leg, calf and i-spine.The pain was reported to be aching, throbbing and constant.(b)(6) 2008: the patient presented with a chronic back pain & left lower extremity radiculopathy and underwent left sided transforaminal epidural steroid injection at l4-5 and l5-s1.Assessment: the patient had lumbosacral spondylosis, lumbar degenerative disk disease, left lower extremity radiculopathy, l3-4 annular tear and central disk bulge and bilateral foraminal narrowing secondary to disc material at l4-5.(b)(6) 2008, (b)(6) 2009, (b)(6) 2009, (b)(6) 2009: the patient presented for an office visit, with chronic low back pain and neck pain.The patient also complained of continued to have pain in her neck with upper extremity radiculopathy.Musculoskeletal examination revealed tenderness to palpation over the lumbar spinous processes and quadratus lumborum.Assessment: lumbosacral spondylosis, lumbar degenerative disk disease, severe low back pain and left lower extremity radiculopathy; previous mri revealed l3-4 annular tear and a central disc bulge with deformity of the thecal sac as well as bilateral foraminal stenosis secondary to disc material at l4-5.(b)(6) 2009: the patient presented for a follow up office visit for medication.The patient had complaints of pain in arm, forearm, wrist, fingers, shoulder, l-spine, hip, thigh, knee, lower leg, calf, ankle, foot, heel and toes.The pain was reported to be burning, sharp and intermittent.(b)(6) 2009: the patient presented with the following chief complaints: pain in neck, both shoulders.(b)(6) 2009: the patient presented with a severe back pain and left lower extremity radiculopathy and underwent left sided transforaminal epidural steroid injection at l4-5 and l5-s1.The patient had lumbosacral spondylosis, lumbar degenerative disk disease, chronic low back pain, left lower extremity radiculopathy, l3-4 annular tear and central disk bulge deforming the thecal sac and also bilateral foraminal narrowing secondary to disc material at l4-5.(b)(6) 2009: the patient presented for neurosurgery consultation approximately three months out from anterior cervical discectomy and fusion.(b)(6) 2009: the patient presented with complaints of pain in c-spine, t-spine, shoulder, neck, l-spine, hip, thigh, knee, lower leg, calf, ankle, foot, heel and toes.The pain duration was reported to be aching.(b)(6) 2009: the patient presented for an office visit with the following admitting diagnosis: cervicalgia.The patient underwent ct scan of the cervical spine without contrast due to back pain, status post fusion.Impression: c4-c5 anterior spinal fusion in anatomic alignment.Mild degeneration of the c6-c7 disc.(b)(6) 2009: the patient presented for neurosurgery consultation approximately four months out from anterior cervical discectomy and fusion and complained of low back pain.The patient underwent ct scan of the cervical spine which did not show good fusion.(b)(6) 2009: the patient presented for left sided transforaminal epidural steroid injections at l3-4 and l4-5.Assessment: the patient had lumbosacral spondylosis, lumbar degenerative disk disease, chronic low back pain, left lower extremity radiculopathy, l3-4 annular tear and a central disc bulge deforming the thecal sac, also bilateral foraminal narrowing secondary to disk material at l4-5.(b)(6) 2009: the patient presented for an office visit with the following admitting diagnosis: lumbago.The patient underwent mri of lumbar spine without contrast due to degenerative disc disease, lumbar pain.Impression: mild left paracentral protrusion of disk material at l4-l5 and mild bulging disc at l3-l4.(b)(6) 2009: the patient presented for a follow up office visit for medication.The patient had complaints of pain in l-spine, hip, thigh, knee, lower leg, calf, ankle, foot, heel and toes.The pain duration was constant.(b)(6) 2009: the patient presented for an office visit with the following admitting diagnosis: disc degeneration.The patient underwent ct scan of the cervical spine without contrast due to degenerative disc disease, lumbar pain.Impression: stable anterior fusion of the c4-c5 vertebra with surgical plate and screw.(b)(6) 2009: the patient presented with the following chief complaints: pain in neck, both shoulders, hands, leftfoot.The pain was described as ache, throbbing like toothache and constant.The patient was also diagnosed as a chronic smoker.(b)(6) 2009: the patient presented for a trial lumbar epidural steroid injection at l4-5.Assessment: the patient had a chronic low back pain, left lower extremity radiculopathy, lumbar degenerative disc disease, l3-4 annular tear and a central disc bulge causing deformity of the thecal sac with bilateral foraminal stenosis secondary to disc material at l4-5.(b)(6) 2009: the patient presented for neurosurgery consultation approximately five months from a cervical fusion.(b)(6) 2009: the patient presented with the following chief complaints: pain in neck, low back and left leg.(b)(6) 2009: the patient presented for an office visit due to history of degenerative disc disease of the lumbar and cervical spine.Risks and benefits of the surgical procedure were discussed.(b)(6) 2009: the patient presented for chest x-ray due to cough, chronic smoking.Impression: emphysematous changes.No acute air space disease.(b)(6) 2009: the patient presented with the preoperative diagnosis of l4-5 degenerative disc disease with instability and radiculopathy.The patient underwent the following procedures: 1.Left facet approach for discectomy.2.L4 inferior laminotomy, l5 superior laminotomy, l4-5 medical facetectomy for decompression of left l4 and l5 nerve roots.3.Transpedicular screw instrumentation, bilateral l4-l5.4.Left foraminal interbody arthrodesis using peek cage and local bone graft arthrodesis and infuse bmp l4-5.5.Bilateral posterior lateral arthrodesis using local bone graft and bmp, with infuse l4-5.Per-op notes, endplates both inferior and superior were decorticated and next a full-size crescent trial graft was brought into the field and a 9 mm appeared to have the best fit, both in superior and inferior aspect.It was in good contact with the vertebral body on either side.This peek cage was then packed with infuse, which had been previously soaked in the sponge and local bone graft that had been previously morcellized.Infuse which was in a large package was cut into 3 equal pieces.Once it was placed in the peek cage, one was used to perform a burrito with local bone graft.The burrito was placed anteriorly into the disc space followed by the peek cage, which was rotated and impacted into position.A lateral radiograph was taken which showed the pedicle screws and the cage to be in good position.The patient was extubated without complication and taken to recovery room in good condition.(b)(6) 2009: the patient underwent x-ray of lumbosacral spine, intra-op, for hardware placement.Impression: l3-l4 disk localization.The patient also underwent x-rays of lumbar spine, intra-op, for site verification, which showed that pedicle screws were placed in the l4 and l5 vertebra, in typical alignment.He also underwent x-rays of lumbar spine for hardware placement , which showed that intervertebral disk spacer was placed at l4-l5 disk level and pedicle screws were remained in stable position.(b)(6) 2009: the patient was discharged home.(b)(6) 2009: the patient called the facility with the following chief complaints: pain in left leg and left buttock.(b)(6) 2009: the patient presented with low back pain and lower extremity radiculopathy.Musculoskeletal examination revealed tenderness to palpation over the lumbar spinous processes and quadratus lumborum.Assessment: chronic back pain; left lower extremity radiculopathy; lumbar degenerative disk disease.(b)(6) 2009: the patient presented with the chief complaint of pain in neck, post-op l3/4 l4/5 transforaminal lumbar interbody fusion on (b)(6) 2009.(b)(6) 2009: the patient presented for neurosurgery consultation.The patient was relatively well postop from a lumbar decompression.(b)(6) 2010: the patient presented with low back pain and lower extremity radiculopathy.The pain was reported to be radiating into the legs.Musculoskeletal examination revealed tenderness to palpation over the lumbar spinous processes and quadratus lumborum.Assessment: chronic back pain; left lower extremity radiculopathy.(b)(6) 2010: the patient presented with the following chief complaints: hurting in neck, lower back pain, having some numbness in right groin area.The pain was described as aching and constant.(b)(6) 2010: the patient presented for neurosurgery consultation 3 months status post lumbar fusion.The patient reported groin numbness.(b)(6) 2010: the patient presented for an office visit post lumbar fusion.(b)(6) 2010: the patient presented for an office visit post lumbar fusion.The patient complained of severe back pain and severe left lower extremity radiculopathy.The most severe pain was reported to be radiating into the left leg.The patient also had difficulty in ambulating.(b)(6) 2010: the patient presented for a left transforaminal epidural steroid injection at l4-5 and l5-s1.The patient presented with status post discectomy with fusion.Assessment: the patient had a low back pain, severe left lower extremity radiculopathy.The patient had lumbar degenerative disc disease.(b)(6) 2010: the patient presented for an office visit due to chronic back pain, left lower extremity radiculopathy.Musculoskeletal examination revealed tenderness to palpation over the lumbar spinous processes and quadratus lumborum.Sensory examination revealed decreased sensation to light touch over the left lateral calf.Assessment: chronic back pain; left lower extremity radiculopathy.(b)(6) 2010: the patient presented for psychological tests for installation of a spinal cord stimulator.The patient presented with chronic back pain, lower extremity radiculopathy.Diagnostic impression (from dsm-iv): axis i: 1.Major depressive disorder, single episode, moderate.2.Generalized anxiety disorder.3.Pain disorder.Axis ii: no diagnosis.Axis iii: 1.Deferred to physicians.Axis iv: 1.Psychosocial stressors = considering installation of a spinal cord stimulator.Axis v: 1.Current global assessment of functioning equals 53.There did not appear to be any factors that would interfere with her ability to comply with post-operative instructions.(b)(6) 2010: the patient presented for spinal cord stimulator trial lead placement.Assessment: the patient had a complaint of severe back pain, lower extremity radiation, failed back surgery syndrome, status post discectomy with fusion in september with continued severe left leg burning pain.The patient also presented for admitting diagnosis: lumbago.(b)(6) 2010: the patient presented for an office visit status post spinal cord stimulator trial lead removal.The patient also presented with complaints of pain in low back, left leg and neck.(b)(6) 2010: the patient presented for an office visit with the following diagnoses: lumbago, lumbosacral neuritis, lumbar radiculop athy, chronic obstructive pulmonary disease, degenerative disc disease, back pain.The patient underwent spinal cord stimulator lead and generator implantation with these pre-op diagnoses chronic back pain, failed back surgery syndrome, bilateral lower extremity radiculopathy.There were no complications and the patient was discharged the same day.(b)(6) 2010, (b)(6) 2011: the patient presented for an office visit status post spinal cord stimulator implant.Musculoskeletal examination revealed tenderness to palpation over the lumbar spinous processes and quadratus lumborum bilaterally.Assessment: status post spinal cord stimulator implantation; chronic back pain; left lower extremity radiculopathy; status post discectomy with fusion.(b)(6) 2010: the patient presented with a complaint of back pain, muscle spasm in right knee and low back muscle spasms.(b)(6) 2011: the patient presented with a complaint of low back pain and chronic back pain with radiation into the hips and legs.The patient had post spinal cord stimulator implant.The patient had tenderness over the lumbar paraspinal musculature and had decreased sensation to light touch over the left lateral calf.Assessment: the patient had a chronic back pain with left lower extremity radiculopathy, status post discectomy and fusion.(b)(6) 2011: the patient presented with a complaint of pain which gets worse with change in weather.The patient also presented for medication refill.(b)(6) 2011: the patient presented for an office visit with the following diagnoses: abnormal ekg and chest pain.The patient unde rwent stress test.Impression: the stress test is positive for moderate sized anteroapical ischemia.(b)(6) 2011: the patient presented with chief complaint of abnormal stress.The patient had been having chest pain for five months.It was pressure like sometimes and heart burn other times.Associated symptoms included shortness of breath and multiple risk problems.The patient also underwent stress test.Impression: the stress test is positive for moderate sized anteroapical ischemia.The review of cardiac systems revealed the following problems: edema, murmur, claudication, fatigue, pnd.Impression: angina class ii, dyslipidemia with xanthoma, smoker.The patient also underwent x-rays of the chest due to chest pain, cad, ashd.Impression: no acute cardiopulmonary process.The patient also had the following diagnosis: 1.Abnormal ekg 2.Chest pain.(b)(6) 2011: the patient underwent x-ray of the chest.(b)(6) 2011: the patient presented for an office visit with the following admitting diagnosis: cor ath unsp vsl ntv/gft and the following procedure was performed: lhc w or w/o lv and closure 93458 (662).The patient also underwent the following procedures due to the indications of angina with positive anterior ischemia on stress test; procedures: 1.Left heart catheterization.2.Selective left coronary angiogram.3.Selective right coronary angiogram.4.Left ventriculogram.Impression: normal heart catheterization with multiple risk factors.Patient had the following post-diagnosis positive cardiolyte/stress test.(b)(6) 2011, (b)(6) 2012, (b)(6) 2012: the patient presented for an office visit for low back pain and neck pain.(b)(6) 2012, (b)(6) 2012, (b)(6) 2013, (b)(6) 2013: the patient presented for an office visit with pain in lower back and left leg, and described it as an ache and throbbing.The symptoms aggravated by bending, daily activities, lifting, sitting, twisting and walking.The patient was diagnosed with lumbosacral spondylosis without myelopathy, osteoarthritis, radiculitis, thoracic or lumbar degeneration of lumbar or lumbosacral intervertebral disc; lumbago.In the review of systems, the patient was found positive for back pain and insomnia.The physical exam revealed that the patient had moderate pain with motion in the lumbar spine.(b)(6) 2013: the patient presented for an office visit and complained that she couldn't rest and had back pain.The patient was discharged from clinic for failed uds.It was reported that on : (b)(6) 2006: patient underwent ct cervical spine without contrast due to cervicalgia.Impression: 1.Disc protrusion at c4-5 with mild cord compression.(b)(6) 2006: patient presented with neck pain, left arm pain, mid back, low back and left leg pain.Diagnosis: cervicalgia; radiculopathy; neck sprain/strain; muscle spasms; lumbago; lumbosacral pain; pain with psychological and medical factors; anxiety; depression; insomnia; noncompliant tobacco use against medical advice.(b)(6) 2008: patient underwent lumbar spine x-ray due to pain.Impression: no malalignment of fracture.(b)(6) 2008: patient underwent dipyridamole stress/rest nuclear cardiac imaging study due to chest pain.Conclusion: 1.Technically difficult study; 2.Normal left ventricular function; 3.No evidence of ischemia.(b)(6) 2008: patient underwent us le arterial duplex bilateral.Impression: no focal stenosis or hemodynamic narrowing.Patient also underwent us venous duplex bilateral.Impression: no evidence of deep vein thrombosis.(b)(6) 2008: patient underwent echocardiogram.Interpretation: 1.Overall left ventricular wall motion appears mildly hypokinectic.2.Estimated ejection fraction approx.45%.3.Mild left ventricular enlargement.4.Mild mitral regurgitation.(b)(6) 2008: patient presented with fatigue, cough, smoking and copd issues and underwent chest x-ray.Impression: normal chest.(b)(6) 2009: patient presented with for follow up on back pain and left lower extremity radiculopathy.Musculoskeletal review revealed tenderness to palpation over the lumbar spinous processes and lumbar paraspinal musculature.Assessment: lumbosacral spondylosis, lumbar degenerative disc disease, severe low back pain, and left lower extremity radiculopathy.(b)(6) 2009: the patient presented post surgery with pain in neck and both shoulders.Ct scan of her cervical spine did not show evidence of good fusion.(b)(6) 2009, (b)(6) 2009: patient presented with disc disease nec/nos - lumbar.(b)(6) 2009: the patient presented for a follow up office visit for medication.The patient had complaints of pain in l-spine, hip, thigh, knee, lower leg, calf, ankle, foot, heel and toes.The pain duration was constant.Patient presented for repeat injection therapy.(b)(6) 2009: patient presented with chronic low back pain and neck pain with upper extremity radiculopathy.Musculoskeletal review revealed tenderness to palpation over the lumbar spinous processes and quadratus lumborum bilaterally.Assessment: chronic back pain; left lower extremity radiculopathy; lumbar degenerative disc disease; l3-4 annular tear and a central disc bulge with deformity of the thecal sac as well as bilateral foraminal stenosis secondary to disc material at l4-5.(b)(6) 2010: patient presented with backache.(b)(6) 2010: patient underwent chest x-ray due to chest pain and cough.Impression: normal chest.(b)(6) 2010: patient underwent ct thorax with contrast due to copd, soa.Impression: 1.Mild emphysema in the upper lobes.2.No acute air space process or effusion.3.Right breast nodule.(b)(6) 2010: patient underwent mammogram diagnostic bilateral due to mass.Impression: no discrete nodule to correlate with prior ct finding.Overall pattern unchanged since the prior examination.Acr bi-rads category 2, benign findings.Patient underwent us right breast due to lump.Impression: simple cyst in the right breast in the upper outer quadrant.Acr bi-rads category 2, benign findings.(b)(6) 2011: patient presented status post spinal cord stimulator implant.Patient had a history of back pain with radiation into her bilateral legs.Musculoskeletal review revealed tenderness to palpation over the lumbar spinous processes and quadratus lumborum bilaterally.Assessment: status post spinal cord stimulator implantation; chronic back pain; left lower extremity radiculopathy; status post discectomy with fusion.(b)(6) 2011: the patient presented with a complaint of pain which gets worse with change in weather.The patient also presented for medication refill.Patient presented with backache.(b)(6) 2011: patient presented with abnormal tongue and persistent burning of the tongue for past 8 months and tingling of tongue.Patient had frequent fatigue and ringing of ears bilateral.Assessment: candidiasis; burning tongue; septal deviation; hypertrophy of nasal turbinates; tobacco use disorder; tinnitus nos.(b)(6) 2014: patient presented with chronic lower back and left leg pain and underwent ct lumbar.Impression: 1.Anterior and posterior fusion of l4 and l5 with an l4 laminectomy.2.L3-4 disc bulge with constriction of the thecal sac.There is no significant spinal stenosis or clear nerve root compression.3.Mild bilateral neural foramen narrowing at l5-s1.
 
Manufacturer Narrative
(b)(6) 2008 cervical mri sagittal views show flattening of the lordosis with disc bulge or small herniation at c4/5 chest x-rays normal chest x-ray.Cardiac, bony, pulmonary anatomy all normal.(b)(6) 2008 cervical series shows anterior plate at c4/5 with spacer in place.Initial film shows localization film at the same level.(b)(6) 2009 cervical ct acdf has been done at c4/5.Spacer is in place.Minimal to no resection of the uncovertebral joints is seen and there is moderate arthritis present.No residual cord compression is appreciated.(b)(6) 2009 lumbar mri sagittal stir sequences show degeneration of the l3, l4 and l5 discs.Bulging with annular tears are seen at l3 and l4.Axial views show annular tear in midline at l3 and paracentral subannular disc protrusion on the left at l4.No stenosis is seen at l3 or l5.(b)(6) 2009 cervical ct construct is again seen at c4/5.No other significant findings.(b)(6) 2009 chest x-ray pa and lateral views show normal lung fields.Normal bony anatomy, normal cardiac shadow.(b)(6) 2009 lumbar x-rays multiple films taken during l4/5 fusion.Interbody spacer and pedicle screws are seen.(b)(6) 2011 chest x-ray normal pa and lateral views are noted.No change from previous studies.(b)(6) 2011 cardiac catheterization no spinal pathology imaged.
 
Manufacturer Narrative
Additional information: (b)(4).Image review: disc 1 imaging unable to open.Reports provided for mri l spine, ct chest, carotid ultrasound, breast ultrasound, le venous ultrasound.Mri was preop.Root cause: indeterminate.
 
Event Description
It was reported that on (b)(6) 1997 the patient presented for a follow up and complained of lower abdominal pain <(>&<)> pain in the site of norplant implants.On (b)(6) 1997, (b)(6) 1998, (b)(6) 2007, (b)(6) 2008, the patient presented for a follow up and complained of lower abdominal pain.On (b)(6) 1998 the patient presented for a follow up and complained of vaginal discharge.On (b)(6) 1998 the patient presented with the pre op diagnosis of norplant in situ for five years.The patient underwent the following procedure: removal of norplant capsules.No patient complications were noted.On (b)(6) 1998 the patient presented with the pre op diagnoses of voluntary sterilization; irregular period; adnexal cyst.The patient underwent the following procedures: d <(>&<)> c; laparoscopy; application of silastic ring to both tubes; cauterization and drainage of left adnexal cyst.No patient complications were noted.On (b)(6) 1998 the patient presented with irregular menstrual periods-abscess.Diagnosis: uterine scrapings, proliferative endometrium.On (b)(6) 2007, (b)(6) 2008 the patient underwent pap smear test.Diagnosis: negative for intraepithelial lesion and malignancy.On (b)(6) 2008 the patient underwent bilateral screening mammogram.Impression: asymmetrical opacity in the outer quadrant of the left breast seen only on one projection.Birads category: on (b)(6) 2008, the patient presented for a follow up and complained of pain in pelvic area.On (b)(6) 2008 the patient underwent mammogram to evaluate nodule seen on prior mammogram.Impression: the left nodule previously seen in the lateral aspect of the breast is again identified in the same projection.On (b)(6) 2008 the patient presented with the pre op diagnoses of abnormal vaginal bleeding and endocervical cysts.The patient underwent the following procedures: fractional dilation <(>&<)> curettage; hysteroscopy; removal of the huge endometrial polyp; cauterization of the endocervical cyst.No patient complications were noted.On (b)(6) 2008 the patient underwent ultrasound of left breast due to left breast nodule <(>&<)> abnormal mammogram.Impression: birads category iii (b)(6) 2008 the patient presented for a follow up and complained of pain in back and legs.She also had lower abdominal pain.On (b)(6) 2008 the patient underwent ultrasound of left breast due to solid nodule.Impression: birads category 2 -benign, no evidence of malignancy.On (b)(6) 2008 the patient presented with a history of osteoporosis and underwent bone mineral densitometry, dexa scan.Impression: normal bmd of the lumbar spine.Low risk of fracture.Normal bmd of the left femoral neck.Low risk of fracture (b)(6) 2009 the patient underwent bilateral screening mammogram.Impression: no specific radiographic evidence of malignancy.On (b)(6) 2009 the patient presented for a follow up and complained of white vaginal discharge.She also complained of pain in lower abdomen.The patient underwent pap smear test.Diagnosis: epithelial cell abnormality; atypical squamous cells of undetermined significance.On (b)(6) 1998: patient underwent chest x-ray due to clinical history of chest pain and status post tubal ligation.Impression: no active disease.On (b)(6) 2001: patient underwent chest x-ray due to clinical history of chest pain and shoulder pain.Impression: no evidence of acute cardiopulmonary disease.Patient also underwent left shoulder x-ray.Impression: normal study.On (b)(6) 2007: patient underwent psychological evaluation and following tests were conducted: weschler adult intelligence scale - 3rd edition (wais-iii) and personality assessment inventory (pai).Patient had pain in lower back and symptoms of anxiety.Diagnostic impression: axis i - major depressive disorder, single episode, moderate generalized anxiety disorder, pain disorder associated with both psychological factors and a general medical condition.Axis ii: borderline intellectual functioning.Axis iii: general medical condition: protruding disc in neck, pinched nerve in neck, lower back pain, copd.Axis iv: psychosocial and environmental problems -l ack of financial income.Axis v: current gaf: 52.On (b)(6) 2010: patient presented for follow up.Diagnoses: copd, low back pain.On (b)(6) 2010: patient presented for b12 injection.On (b)(6) 2011: patient underwent mammogram screening.Impression: no significant interval change identified.Bi-rads category 2: benign finding.On (b)(6) 2006: the patient presented for follow-up visit.Diagnoses: osteoarthritis; low back pain; allergic rhinitis; chronic obstructive pulmonary disease; tobacco abuse; muscle spasms.On (b)(6) 2007: the patient presented for follow-up visit with left leg pain.Diagnoses: osteoarthritis; low back pain; rhinitis; chronic obstructive pulmonary disease; chest pain; muscle spasms.On (b)(6) 2007: the patient presented for follow-up visit with neck pain.Diagnoses: osteoarthritis; low back pain; allergic rhinitis; chronic obstructive pulmonary disease; tobacco abuse; muscle spasms.On (b)(6) 2008: the patient presented for follow-up with arthritis pain.Diagnoses: osteoarthritis; low back pain; chronic obstructive pulmonary disease.On (b)(6) 2008: the patient presented with worsening low back pain.Diagnoses: osteoarthritis; low back pain; rhinitis; chronic obstructive pulmonary disease; chest pain.(b)(6) 2008: the patient presented with left leg pain.She also had hip pain.Diagnoses: osteoarthritis; low back pain; rhinitis; chronic obstructive pulmonary disease.On (b)(6) 2008: the patient presented for a follow-up visit.She also had cold symptoms, sore throat, cough and stuffy head.Diagnoses: osteoarthritis; low back pain; rhinitis; chronic obstructive pulmonary disease; bronchitis.On (b)(6) 2009: the patient presented with pain in back and neck.She also had rash on abdomen.Diagnoses: osteoarthritis; low back pain; rhinitis; chronic obstructive pulmonary disease.On (b)(6) 2010: the patient presented for a follow-up to start b12 injections.She was diagnosed for anemia, chronic obstructive pulmonary disease, osteoarthritis, herniated nucleus pulposus and lumbago.(b)(6) 2010, (b)(6) 2011: the patient presented for b12 injection.On (b)(6) 2010, (b)(6) 2011, (b)(6) 2012, (b)(6) 2013: the patient presented for a follow-up visit.She was also diagnosed for insomnia, chest pain, hypertension, herniated nucleus pulposus, chronic obstructive pulmonary disease and osteoarthritis.On (b)(6) 2014, (b)(6) 2015: the patient presented for follow-up visit and complained of numbness and pain in left shoulder.She was also diagnosed for insomnia, chronic obstructive pulmonary disease and osteoarthritis.
 
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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 Key4290174
MDR Text Key22069326
Report Number1030489-2014-04604
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,Followup,Followup,Followup
Report Date 08/26/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Device Operator Health Professional
Device Expiration Date04/01/2011
Device Catalogue Number7510800
Device Lot NumberM110711AAH
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 11/03/2014
Initial Date FDA Received12/02/2014
Supplement Dates Manufacturer ReceivedNot provided
Not provided
Not provided
Not provided
Supplement Dates FDA Received04/15/2015
06/10/2015
07/06/2015
07/27/2015
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/13/2009
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; Required Intervention;
Patient Weight87
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