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MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
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| Catalog Number 7510200 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Dysphagia/ Odynophagia (1815); Headache (1880); Neuropathy (1983); Seroma (2069); Swelling (2091); Weakness (2145); Burning Sensation (2146); Cramp(s) (2193); Stenosis (2263); Numbness (2415); Neck Pain (2433); Sleep Dysfunction (2517)
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Event Type
Injury
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Manufacturer Narrative
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(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.
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Event Description
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It was reported that on (b)(6) 2003, the patient underwent spine fusion surgery on the cervical region of his spine from vertebrae c5 to c6.The technique used was anterior cervical discecetomy and fusion.Reportedly, during the surgery, rhbmp-2 collagen sponge was used.Allegedly, patient's post-operative period had been marked by a period of improvement, followed by progressively worsening neck pain; weakness, pain and radiculopathy in his upper extremities, pain in his left posterior scapular region, numbness in his left thumb and index finger, headaches, and a lump in his throat when swallowing.
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that on: (b)(6) 2003: patient presented with complaint of pain.Review of patient's x-rays showed solid fusion at c5-6."he has osteophytes at c5-6 bilaterally and worse at 5-6 as compared to 4-5 and c7-t1." reportedly, the doctor believed 5-6 to be the cause of patient's complaints.On (b)(6) 2003: the patient got admitted for undergoing her spinal surgery and underwent the following admit diagnosis test: displacement of cervical intervertebral disc without myelopathy.Pre-op diagnosis: cervical spondylosis with radiculopathy c5-6 status post a c6-7 acdf.Her previous surgery had went on to a solid fusion at c6-7 but then he developed adjacent level disease at c5-6 and was found to have large autogenous spurs and numbness of the thumb and index finger on the left side.Procedures: complex redo anterior cervical discectomy at c5-6; anterior cervical fusion c5-6; removal of anterior cervical plate c6-7; placement of a new anterior cervical plate at c5-6 (note, different level than removal level); structure allograft fibular grafting.Per-op notes: "we decompressed the spinal cord and the nerve roots and did a complete discectomy at c5-6 bilateral foraminotomies, on the left side and after doing a thorough decompression we decorticated the end plate.Wo took two structured allografts fibularly, stuffed then with a small bmp diluted with 0.5cc and tapped it in, took an anterior cervical plate by cross with two screws in the c5, two screws in the c6.We obtained x-ray and found that these were in position.We then locked the plate, achieved hemostasis, placed in a drain and closed the wound in drain." no intra-operative complications were reported.On (b)(6) 2003: the patient was discharged from the hospital.On (b)(6) 2004: patient presented for follow up on his spinal fusion surgery.He complained of some numbness in his left thumb and index finger; sleep disturbances and slight headaches which come frequently.On (b)(6) 2004: patient presented for follow up on his three months post anterior cervical discectomy and fusion.Review of patient's x-rays showed solid fusion on flexion/extension views.Patient also complained of neck pain, slight headaches which come frequently, sleep disturbances, numbness and weakness.On (b)(6) 2004: patient presented for follow up on his spinal fusion surgery.Patient's physical examination revealed that he has some pain in his left posterior scapula region, and some pain with palm-down abduction but he has medial scapular pain with neck extension.Review of patient's x-ray revealed "solid fusion at 5-6 and 6-7.He does have adjacent level disease at 4-5 and c7-t1." patient also complained of shoulder pain, neck pain and lower back pain.On (b)(6) 2009: patient presented for follow up on his spinal fusion surgery (acdf at c5-6 with instrumentation removal, at c6-7 from (b)(6) 2003).Patient's chief complaint was neck pain with weakness and he has had this problem for the last two months.Reportedly, the arm pain is present bilaterally in the upper back, shoulder, and upper arms; also there are occasional headaches that are moderate and infrequent and they occur on the front of the head.Reportedly, the treatments have included shoulder injections, anti-inflammatory medications, and narcotic medications.Patient's review of system (ros) revealed change of vision, difficulty swallowing, calf cramps with walking, toothache, and gum trouble.Non-contrast ct of the cervical spine was performed in the axial plane with sagittal and coronal reconstructions.Impression: c5/c6 and c6/c7 anterior cervical disc fusion with hardware intact at c5/c6 and complete bone fusion across the disc space.Minimal residual endplate spurs at these levels, but no central canal stenosis.X-ray - cervical spine, 3 views (including lateral projections in flexion and extension), was performed and compared to (b)(6) 2009.Impression: unchanged anterior discectomies and fusion from c5 to c7, with instrumentation at c5-c6.There is no motion of the fused segments with flexion and extension.Degenerative disc disease, c2-c5."the patient notes that he has had a recent mri of the low back which shows he has problems at l4, l5 levels." reportedly, the doctor discussed with the patient that his anterior neck pain is not related to his cervical spine and that he should see an ears, nose and throat physician regarding this problem.The patient notes that he has a lump in his throat when swallowing.On (b)(6) 2015: due to neck pain, the patient had to undergo mri of the cervical spine, without contrast.Conclusion: solid instrumented c5-6 and non-instrumented c6-7 anterior interbody fusion, with mild residual central spinal canal narrowing and cord abutment/mild flattening at c6-7.Two mm ap right dorsolateral herniation and bulge at c3-4, with mild central stenosis and cord abutment/near abutment, along with moderate bilateral foraminal stenosis and c4 root encroachment.Severe disc degeneration at the sub-adjacent transitional c7-t1, also t1-2, with bulge abutting/nearly abutting the cord.Also, moderate bilateral foraminal stenosis at c7-t1 and moderate left/mild right foraminal stenosis at t1-2, with bilateral c8 and left t1 root encroachment.Mild-moderate disc degeneration at the superjacent transitional c4-5 level, with mild central and moderate bilateral foramina stenosis with bilateral c5 root encroachment.No facet arthropathy, fracture, osseous neoplasm or infection.No intrinsic cord abnormality, including no syrinx, mass or myelomalacia.The patient also had to undergo mri of the lumbar spine, without contrast.Conclusion: moderate-sized central to paracentral herniation and bulge and osteophyte at l5-s1, with severe disc degeneration, mildly impinges upon both intrathecal s1 roots, also with chronic moderate bilateral foramina stenosis/l5 ganglionic impingement.Moderate-sized, caudally extruded central herniation beyond bulge at l4-5, with severe disc degeneration, abuts left l5 root, also with mild bilateral foramina stenosis.Disc degeneration with bulge is severe at t11-12, moderate at t12-l1 and mild at l3-4, with cord abutment at t11- 12.Small right facet joint effusions at l3-4 and l4-5, with mild bilateral facet arthropathy at l3-4.No fracture, osseous neoplasm or infection and no intradural abnormality, including no cord/conus mass.
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Event Description
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It was reported that on : (b)(6) 2013: patient underwent ct cervical spine without contrast.Impression: no acute bony abnormality of the cervical spine.Severe left-sided neural foramen stenosis at c4-05 and c6-c7.On (b)(6) 2013: patient underwent x-ray cervical spine, 4 views.Impression: stable postsurgical and degenerative changes of the cervical spine.On (b)(6) 2013: patient presented for clinic visit and reported pain, sharp to burning and aching in nature, severe, worse with any manual work, radiating from the right neck into the left distal c6 dermatome where this was numbness.Reported relief with rest but symptoms are continuous to some extent.On (b)(6) 2013: patient underwent epidural injections.
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Manufacturer Narrative
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A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that on: (b)(6) 2004: patient underwent radiological test of lumbosacral spine due to pain.Findings: the metal plate and screws from the previous fusion at c6-c7 have been removed, and there is a new fusion of c5-c6 with an anterior metal plate and screws to the vertebral bodies.The alignment appears anatomic.There is bony fusion of the c6 and c7 vertebral bodies.There is disk space narrowing at c4-c5 with osteophytes.The pre-vertebral soft tissues are normal.Odontoid process is intact.On (b)(6) 2004: patient underwent radiological test of cervical spine due to recurrence of neck pain, left hand pain and tingling.Findings: ap, ap open mouth, lateral and swimmers lateral views of the cervical spine.Comparison to (b)(6) 2004 shows no significant interval change.Postoperative intervertebral disc space with graft again is noted, as well as paravertebral screws at c5 and c6 by a vertical metal plate.There is minimal narrowing and anterior spurring about c4-05.The disc space at c6-c7 appears fused.The remaining vertebral bodies and disc spaces are normal.No misalignment is demonstrated.A suggestion of spurring encroaching on the central canal is seen opposite the superior border of c6 without change.Soft tissues are normal.Impression: no change, postoperative cervical spine as described above.On (b)(6) 2005: patient underwent radiological test of lumbosacral spine due to low back pain and point tenderness.Impression: intervertebral disc narrowing secondary to disc degeneration at l4-l5 and l5-s1 levels.On (b)(6) 2005: patient presented for neurological consultation due to back pain.On (b)(6) 2006: patient underwent ct of lumbar spine without contrast due to worsening lbp with stiffness and pain referred to hip regions with stinging and pain.Impression: mild central and bilateral disc herniation l4-l5 with compromise of the neural foramina, more marked on the left: central and left lateral disc bulge l5-s1 with compromise of the left neuro foramina.On (b)(6) 2006: patient was reported to be claustrophobic with medications.On (b)(6) 2006: patient presented with chief complaint of low back pain, overweight, and myofascial pain syndrome.Patient also complained of swollen foot.On (b)(6) 2006: patient underwent nerve conduction study due to left hand numbness since 2001.Interpretation: no evidence of ¿cts¿ in left hand.On (b)(6) 2007: patient underwent mri of lumbar spine without contrast due to low back pain and left leg pain.Impression: broad base protrusion l5-s1 disc, worse on the left side with some compression of the left s1 nerve root.Non compressive disc bulge l4-l5 level.Moderate osteoarthritis with grade 1 retrolisthesis l5-s1 level.On (b)(6) 2007: patient underwent lumbar(left l4 and l5) nerve block injection due to pain in left lower back going down the left leg to the calf of the leg.Open mri indicated patient has left s1 root compression.Impression: successful fluoroscopic guided left l4 and l5 nerve block.On (b)(6) 2007: patient underwent i-123 thyroid uptake and scan for hyperthyroidism.Impression: mildly increased radiotracer uptake in the thyroid with a slightly elevated 24 hours uptake in the setting of suppressed tsh is consistent with graves' disease.On (b)(6) 2008: patient was diagnosed with: chronic severe low back pain due to herniated disc with left lower extremity radiculopathy and; moderate osteoarthritis of lumbar spine.On (b)(6) 2008: as per the billing records, the patient underwent x-ray of left hand.On (b)(6) 2009: patient underwent radiological test of cervical spine.Findings: impression: postoperative changes, degenerative changes: degenerative changes are noted in the mid and lower cervical vertebral joint with splits seen involving c4.No acute fractures.On (b)(6) 2009: patient presented with chief complaint of low back pain and neck pain.On (b)(6) 2009: as per the billing records, the patient underwent x-ray of chest.On (b)(6) 2009: as per the billing records, the patient underwent posterior-anterior and lateral x-ray of chest.On (b)(6) 2010: as per the billing records, the patient underwent anterior-posterior and lateral x-ray of knee.On (b)(6) 2010: patient underwent radiological test of cervical spine due to neck pain status post fusion c5-c6.Impression: no significant change, postoperative healed anterior fusion of c5-c6.Hypertrophic spurring c4.Patient underwent radiological test of lumbosacral spine due to low back pain, left toe feels numb.Impression: hypertrophic spurs l5 and s1.Narrowing of the 4th and 5th lumbar interspaces.On (b)(6) 2013: patient underwent radiological test of cervical spine due to recent lifting with pinching sensation.Impression: surgical fusion at c5-c6.Degenrative disc changes from c2 through c5.No significant interval change.On (b)(6) 2012: patient visited office for regular follow up for hypertension and chronic low back pain.On (b)(6) 2012: patient visited office for regular follow up and reported back pain.On (b)(6) 2013: patient underwent ¿nm bone density(dxa), axial and appendicular skeleton¿ test due to decreased tsh.Impression: bone mineral density measurements are within the adult normal range and not associated with increased risk for fracture.On (b)(6) 2013: patient presented for evaluation of subclinical hyperthyroidism.Assessment: patient has mild subclinical hyperthyroidi sm with no apparent progression over 5 years.On (b)(6) 2014: patient underwent radiological test of cervical spine due to degenerative disk disease and degenerative joint disease.Impression: no change.Post operative anterior fusion c5-c6.Hypertrophic osteoarthritis.On (b)(6) 2014, (b)(6) 2015: patient visited office for regular follow up and reported pain.Assessment: ¿he had no signs or symptoms of hyperthyroidism.He is a normal bone density.¿ on (b)(6) 2015: patient visited office for regular follow up.On (b)(6) 2015: patient visited office for regular follow up and reported increased pain in neck and back.On (b)(6) 2006, (b)(6) 2014, (b)(6) 2015: patient called for medication refill.On (b)(6) 2015: patient presented with chief complaint of low back pain.Patient¿s recent x-ray review revealed: low back pain-ddd with radicular symptoms; meralgia paresthetica; obesity-near morbid, bmi 39+; sleep apnea.On (b)(6) 2015: patient underwent spine fluoroscopy for lumbar epidural steroid injection due to lumbar radiculopathy.Impression: technically successful lesi.On (b)(6) 2015: patient presented for follow up visit.Reports pain in lower back.Assessment: patient has mild subclinical hyperthyroidism with no apparent progression.On (b)(6) 2016: patient underwent colonoscopy.Patient tolerated the procedure well and there were no immediate complications.Impression: diverticulosis.No polyps found.
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Manufacturer Narrative
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A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that on, (b)(6) 2003, patient presented for follow-up visit for wound check.Patient reported swelling in neck and was having difficult in swallowing and breathing.Patient underwent ct of neck with contrast.Impression: thin fluid collection extending from the anterior cervical spine to the left anterior neck medial to the internal jugular vein and carotid artery.This likely represents a post-operative seroma.There is however a thin ring of enhancement around this collection.There is no obvious encapsulated abscess formation.Patient underwent x-ray of neck soft tissues due to swelling in neck.Opinion: degenerative disc disease in the cervical spine and anterior discectomy and fusion of c5-7 with instrumentation at c5-6.There is moderate to severe prevertebral soft tissue swelling.On (b)(6) 2008: impression: slightly comminuted minimally displaced fracture through the distal phalanx of the fifth digit seen.On (b)(6) 2009 the patient was presented for office visit with right sided neck pain.The discomfort is worst when sitting down or lying down, calming with pacing or walking.Diagnosis: neck pain, acute disc disorder, myofascial strain/spasm, referred pain from acute coronary syndrome.The patient underwent x ray of the chest due to chest pain.Findings: there is mild elevation of the right hemi-diaphragm, with mild associated small right lung volume loss.There is also associated mild right basilar atelectasis.The patient also underwent x ray of the cervical spine.Findings: there is straightening of the cervical spine.Anterior spinal fusion instrumentation is seen in the c5-6 level.A degenerative osteophyte is seen.The pre-vertebral soft tissues are normal.The airway is widely patent.On (b)(6) 2009: as per the billing records, the patient underwent x-ray of chest due to chest pain, fever, cough and congestion.Impression: possible subtle opacity within the right medial lung may be related to atelectasis or superimposed airspace disease such as pneumonia.On (b)(6) 2009: as per the billing records, the patient underwent posterior-anterior and lateral x-ray of chest due to history of cough, congestion and shortness of breath.Impression: right hilar and infrahilar opacity compatibility with pneumonia.The left lung base opacity may represent atelectasis rather than airspace disease.On (b)(6) 2010: impression: mild anterior compartment arthrosis.On (b)(6) 2013: patient presented for an office visit.On (b)(6) 2013 the patient was presented for office visit wit pain in right lateral neck.The pain is throbbing, aching, intermittent in nature.The patient underwent x ray of the cervical spine.Impression: no acute process in the cervical spine.Diagnosis: muscle spasm and neck pain.On (b)(6) 2014, patient presented in emergency department with complaint of neck pain.Patient underwent x-ray of cervical spine.Impression: multilevel degenerative disc disease of the cervical spine; unchanged spinal fusion of c5-6; no fracture.Addendum: on further review by attending radiologist there is lucency of the superior c6 vertebral body adjacent to the anterior spinal fusion instrumentation concerning for implant loosening.This is not seen well seen on the current radiograph due to an overlying button, but is present on the comparison radiograph.On (b)(6) 2014, the patient presented with back and neck pain.The patient underwent cmt to the cervical spine.On (b)(6) 2015,the patient presented with back pain , middle back stiffness and neck stiffness.On (b)(6) 2015, patient underwent x-ray of lumbar spine, 2 or 3 views.Impression: progression arthritic and degenerative disc disease without acute bony abnormality.
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