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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 7510050 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Ossification (1428); Asthma (1726); Dysphagia/ Odynophagia (1815); Dyspnea (1816); Edema (1820); Headache (1880); Pyrosis/Heartburn (1883); Hemoptysis (1887); High Blood Pressure/ Hypertension (1908); Neuropathy (1983); Pain (1994); Loss of Range of Motion (2032); Swelling (2091); Vomiting (2144); Weakness (2145); Burning Sensation (2146); Tingling (2171); Dizziness (2194); Stenosis (2263); Arthralgia (2355); Depression (2361); Numbness (2415); Neck Pain (2433); Neck Stiffness (2434); Sleep Dysfunction (2517); Weight Changes (2607)
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Event Type
Injury
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Event Description
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It was reported that the patient underwent a spine fusion surgery on the cervical region of his spine from c3-c6, during which rhbmp-2/acs was used.Reportedly, sometime postop the patient began to experience unanticipated bone growth, pain in his neck with difficulty swallowing, breathing, and speaking.And painful headaches, as well as migraine headaches.
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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.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.(b)(4).
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Manufacturer Narrative
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Additional information.
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Event Description
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It was reported that on on (b)(6) 2010, (b)(6) 2011, patient presented for follow-up.On (b)(6) 2011, patient presented for follow-up.On (b)(6) 2011, patient presented for follow-up and reported neck pain and swelling.He was having difficulty in neck movement.Assessment: hypertension, asthma, diabetes mellitus, cerviccal radiculopathy, latent tuberculosis.On (b)(6) 2012, patient presented for follow-up on headache.
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Manufacturer Narrative
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(b)(4).
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Event Description
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Per medical records, it was reported that on (b)(6) 2015, the patient presented for general examination.(b)(6) 2015, the patient [presented for follow-up and pathology examination.(b)(6) 2015, the patient presented for physical examination.(b)(6) 2015 , the patient presented for proteinuria.(b)(6) 2015, the patient presented for headache and back pain.(b)(6) 2015 , the patient presented for follow-up and medicine refill on (b)(6) 2013 the patient presented with swelling in legs and burning in both legs.On (b)(6) 2013 the patient underwent esophagogastro duodenoscopy.Impression: no structures, polyps, masses or extrinsic compression on the esophageal lumen.No evidence of ulcers.Mild gastritis in the stomach.On (b)(6) 2013 the patient presented for evaluation due to gastro-intestinal bleeding and one episode of vomiting blood.The patient also has had the following problems: unspecified glaucoma ,hemorrhage of gastrointestinal tract, unspecified diabetes mellitus with renal manifestations, type ii or unspecified type, uncontrolled mood disorders, chronic obstructive asthma, unspecified, unspecified essential hypertension on (b)(6) 2013 the patient underwent chest x-ray.Impression: normal chest.On (b)(6) 2013 the patient presented with throat symptoms.He complains of difficulty in swallowing.On (b)(6) 2014, patient underwent x-ray of chest.Impression: lungs are free of infiltrate or edema.Heart is not enlarged.No central congestion.No pneumothorax.Regional bones are greatly intact.The patient also underwent the sonographic duplex venous legs bilat test.Impression : no sonographic evidence of deep venous thrombosis.On (b)(6) 2014 the patient presented for a follow up.He complained of continued episodes of hemoptysis.
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Manufacturer Narrative
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Additional information.
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Event Description
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It was reported that on, (b)(6) 2013, the patient presented for follow up and medicine refill.(b)(6) 2013, the patient presented for mri of lumbar spine and complaint of back pain.Impression ; 1) l2-3 and l3-4 disk space levels show no evidence of herniated disk , spinal stenosis or neural foraminal impingement.2) the l4-5, l5-s1 disk space levels demonstrate dissection of the disk.
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Manufacturer Narrative
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(b)(6).(b)(4).
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Event Description
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It was reported that on (b)(6) 2011 the patient was presented with right arm numbness and performed a mr cervical w/o contrast.Findings the axial t2 weighted images were limited by motion.There was congenital canal stenosis, there was straightening, there were disc osteophyte complexes and all levels.There was intervertebral disc space narrowing between c4-c5, c5-c6, c6 and c7, the vertebral body heights are preserved , the marrow signal was normal.There was increased t2 signal within the spinal cord on the right side at the c5-c6 level.In addition there might be subtle increased t2 signal within the spinal cord from c3-c6 which may represent compressive myelopathy.On (b)(6) 2011 patient presented with cervical fixation with vomiting.Per nrs, please eval for fixation position.Findings: there was interval plate and screw fixation of the cervical spine.Ther was a collar surrounding the soft tissues of the neck.The cardiac silhouette was not enlarged.The costophrenic angles were sharp.There was no pneumothorax.The lungs were clear.There was no evidence of the acute failure.Impression: orthopedic hardware is intact and well seated.No evidence of any acute cardiopulmonary disease.On (b)(6) 2011 the patient presented with eval disk.Per the medical records, mr lumbar w/o contrast using the technique multiplanar multi sequential mr images obtained through the lumbar spine without the administration of intravenous contrast.Findings: the vertebral body heights maintained with normal bone marrow signal intensity.Intervertebral disc space heights were preserved.There was loss of the normal t2 weighted signal intensity at the l5-s1 disc space compatible with disc desiccation.No significant spondylisthesis was seen.There was mild congenital canal stenosis of the lumbar spine.The conus medularis appears normal in size and morphology with the tip at l1.At l1-l2 there was mild facet aarthropathy bilaterally.At l2-l3 there was mild facet arthropathy and ligamentum falvum thickening bilaterally.At l3-4 there were an annual disc buldge and mild facet arathropathy and ligamentum flavum thickening causing moderate canal stenosis with cauda equine crowding as well as mild to moderated neural forminal narrowing.On (b)(6) 2011 the patient underwent c3-c4, c4-c5, c5-c6 anterior cervical discectomy and fusion with plating and intervertebral cage fixation device using a 5mm high carbon fiber cage was tamped into place followed by a placement of a skyline plate with 40mm screws x8.The cam mechanism was engaged.Lordosis was enlarged on the spine and the retractors were removed.There was no damage to any soft tissues.The wound was irrigated copiously with antibiotic impregnated saline and cosmetically closed over suction and drainage.He was extubatetd at neurological baselilne and tolerated the procedure well.There was no damage to any neuro or vascular structures.No csf leakage seen throughout.No electrophysiologic worsening of note.Sponge and needle count were correct at the end of the case to treat the pre-op diagnosis cervical stenosis and spondylosis.On (b)(6) 2011 the patient was discharged from hospital.On (b)(6) 2011 patient was presented for the evaluation of spondylosis post op.Using the producer gr c spine comp incl flex/ext.Findings: there was acdf of c3-c4 with anterior plate and paired intervebral body screws at the corresponding levels as well as interbody spacers.The surgical heardware appears intact and with loosening.There was loss of the cervical lordosis at c2-c3 with minimal retrolisthesis of c2 upon c3.There was no instability on dynamic views.Impressions: 1.Acdf of c3-c6 as described with hardware intact without radiographic evidence of loosening.2.No instability on flexion and extension views.On (b)(6) 2011 patient presented for pain and limited movement.Findings no fractures, dislocations or subluxations.Joints were maintained.No suspicious lytic or blastic lesions.Bone density was normal for age.Soft tissues were grossly normal.Visualized portion of the adjacent lung were well areated.Impression: no acute fractures or dislocations.On (b)(6) 2011, (b)(6) 2011 the patient presented to evaluate for psudoarthrosis using the technique ap and lateral radiographs of the cervical spine were obtained and submitted for review.On (b)(6) 2012, (b)(6) 2012 patient presented for chest pain using the technique pa and lateral chest.Impression: no radiographic evidence of a acute cardiopulmonary disease.On (b)(6) 2013 patient presented with gr chest 2 views for cough rt lower and chest pain; eval for infiltrate.Observations: postsurgical changes were noted in the lower cervical spine.Cardiomediastinal silhouette.Cardiac silhouette was normal.Trachea and mediastinum are midline.Patient presented with right lateral chest pain, hemoptysis.On (b)(6) 2014 patient was admitted in hospital with a history of with history of hemoptysis times several months.Patient had a ct of the chest and chest x-ray, both unremarkable.Patient was admitted to the hospital and continued with aggressive pulmonary toilet with albuterol and atrovent treatments.Patient was seen by dr.(b)(6), pulmonology whose impression patient with hemoptysis.Patient was advised to undergo a fiberoptic bronchoscopy.Physical examination: neck: no adenopathy.Chest: scattered rhonchi bilaterally.Assessment: hemoptysis.Chronic obstructive pulmonary disease.Obstructive sleep apnea.Status post cervical spine surgery after cervical spine injury approximately 4 years ago.Obesity.Hypertension on (b)(6) 2014 patient underwent a bronchoscopy that was fiberoptic bronchoscopy with findings consistent with no endotracheal tumor, obstruction or lesion noted.Patient tolerated procedure well.Patient post procedure remained hemodynamically stable, afebrile without any acute events.Patient continued empiric iv antibiotics and was awaiting cultures, as well as pathology results; however, patient left against medical advice on (b)(6) 2014.Patient for this reason without any d1scharge instructions, followups, or medications.Discharge diagnoses: hemoptysis.Chronic airway obstruction.Sleep apnea.Hypertension.Diabetes mellitus type 2.Mononeuritis.Cervicalgia.Esophageal reflux.Tobacco use disorder.Obesity.Patient underwent fiberoptic bronchoscopy, asymptomatic.On (b)(6) 2014 patient underwent x-ray.Patient underwent ct chest.In 2011(approx.): the patient underwent imaging and back surgery.The patient complained of pain on left side.From 2011 to present: the patient underwent pain management.In 2011: the patient presented with diabetes.On (b)(6) 2011: the patient underwent anterior cervical spine fusion due to cervical stenosis and spondylosis, neck pain pain and weakness in right side of body.Depuy bangle cage; depuy screws; depuy plate were also implanted.From 2014 to present: the patient presented with pain, spitting up blood problem.Allegedly, after the rhbmp-2/acs surgery, injuries include, but are not limited to bone overgrowth, cauda equina syndrome; nerve damage; pain on left side of head; swelling in neck; severe pain in neck; radiating pain to legs and arms; the pain is more severe and more frequent than before the rhbmp-2/acs surgery; difficulty swallowing; difficulty speaking; difficulty breathing; spitting up blood; osteoarthritis; erectile dysfunction; drop foot (left foot); mental anguish; depression.Also patient could no longer bend over and lift objects.
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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) 2011 the patient was presented with right arm numbness and performed a mr cervical w/o contrast.Findings the axial t2 weighted images were limited by motion.There was congenital canal stenosis, there was straightening, there were disc osteophyte complexes and all levels.There was intervertebral disc space narrowing between c4-c5, c5-c6, c6 and c7, the vertebral body heights are preserved, the marrow signal was normal.There was increased t2 signal within the spinal cord on the right side at the c5-c6 level.In addition there might be subtle increased t2 signal within the spinal cord from c3-c6 which may represent compressive myelopathy.Impression: congenital canal stenosis and spondylosis of the cervical spine which is prominent at c5-c6 with moderate cord compression.Mild cord compression at c3-c4.Compressive myelopathy at c5-c6 especially on the right.On (b)(6) 2012: patient presented for office visit with chief complaint of migraine.Patient states that since his surgery he has some weakness on his left side.He does have decreased range of motion of his neck in all directions.On (b)(6) 2012: patient presented with chief complaint of pain in left side neck and diagnosed with cervical radiculitis, cervical post laminectomy syndrome, myofascial pain.Patient complaints of pain over the neck area with radiation to bilateral arms and hands.Patient complains of numbness, tingling, weakness in the bilateral arms and legs.Review of system is positive for weight gain, neck pain stiffness, shortness of breath, back pain, arthralgias, headaches and stress.Rom of cervical spine is very limited with pain in all planes of motion.Palpation is positive in cervical paraspinal muscles, upper traps, levator scap, rhomboids, shoulders.Assessment: neck and arm pain.Spine- possible radiculitis left c7 vs spondylosis adjacent to surgery-significant muscle tenderness in paraspinals and traps.On (b)(6) 2012: patient underwent electrodiagnostic consultation.Impression: this is an abnormal study.There is electrodiagnostic evidence of a bilateral median neuropathy at the wrist (left sensory-motor, right sensory), "carpal tunnel syndrome." there is electrodiagnostic evidence of a left ulnar neuropathy across the elbow, "cubital tunnel syndrome.") there is no electrodiagnostic evidence of an acute left cervical radiculopathy or plexopathy.On (b)(6) 2012: patient presented for office visit and diagnosed with octal neuralgia and persistent headaches.The headaches continue to originate in the base of the skull on the left side with radiation anterior, up to the left ear and sometimes anterior to the frontal temporal region on the left.On examination he continues to have a trigger point at the base of the occiput on the left in the area of the occipital nerve groove.On (b)(6) 2012: patient presented for office visit and complains of pain in head, back and left foot.Patient complains of pain and symptoms are located over the left side of the neck with radiation to the occiput.Pain is worse with neck flexion.He had a recent emg which revealed bilateral median neuropathy and left ulnar neuropathy but no evidence of radiculopathy.Review of systems reveals patient is positive for weight gain, neck pain and neck stiffness, shortness of breath, back pain and arthralgias, headaches and stress.Range of motion of cervical spine is limited with pain in all planes of motion.Positive tenderness at left paraspinal muscles at c2-c3 level.Lumbar spine with pain on flexion greater than extension.Assessment: left sided neck pain likely secondary to c2/4 facet arthropathy with cervical paraspinal muscle spasms and myofascial pain; previous c3-c6 fusion.Axial low back pain.Left ankle pain possibly secondary to chronic ankle sprain (atfl).On (b)(6) 2012: patient presented for follow up visit and complains of left sided knee and foot pain.Patient reports his left ankle has now been swelling for a total of 2 months.He had x-ray imaging of the left ankle completed on (b)(6) 2012 that showed enthesopathy at the achilles tendon insertion of the calcaneus as well as the small plantar spur.There was no obvious fracture or loose intra-articular fragments on x-ray.Subtalar joint was preserved.There was a small enthesopathy at the calcaneal fibular ligament that was noted on independent review.There is difficulty with functional motion in the neck as well as with walking.On physical examination rotation to the left is reduced compared to the right.Inspection of the left ankle reveals minimal swelling compared to the right.There is tenderness to palpation over the lateral ankle complex particularly the atfl.Impression: cervical post laminectomy syndrome with previous c3-c7 anterior cervical diskectomy and fusion with secondary myofascial pain on the left side and radicular symptoms on the left.Left ankle sprain with failure to resolve after physical therapy and persistent use of ice as well as ibuprofen.On (b)(6) 2013: patient presented with chief complaint of pain in neck, left arm and left leg.Review of system reveals patient is positive for heartburn, swelling, depression.On physical examination patient has pain with rotation towards the left side.Patient has tenderness in the upper trapezius and deltoid on the left side.He is diffusely tender around the left shoulder.He is also tender to palpation at the left ankle at the mortise joint, but more specifically at the achilles tendon insertion.He is exquisitely tender with resisted ankle plantar flexion.He does have tight hamstrings on both sides.He does have tenderness diffusely around the left periscapular muscles.Impression: cervical post laminectomy syndrome with possible additional chronic radiculitis, also previous evidence of carpal tunnel ulnar neuropathy.Myofascial pain in the upper back and periscapular region.Rotator cuff impingement on the left side.On (b)(6) 2013: the patient presented for mri of lumbar spine and complaint of back pain.Impression: l2-3 and l3-4 disk space levels show no evidence of herniated disk, spinal stenosis or neural foraminal impingement.The l4-5, l5-s1 disk space levels demonstrate dissection of the disk.There is moderate spinal stenosis due to facet arthropathy.There is fluid in the facet joints.A broad based central bulging disk indents the thecal sac in the midline.There are moderate to large bilateral herniated protrusions noted compressing the nerve root in the foramen bilaterally.On (b)(6) 2013: patient presented for office visit.Patient's problem list as of today is cervical post laminectomy syndrome, cervical radiculitis, myofascial pain, carpal tunnel syndrome on both sides, ulnar nerve entrapment at elbow, ankle sprain and strain, rotator cuff tendinitis, achilles tendinosis.Patient presented with chief complaint of pain in neck and left heel.Patient complains of blurry vision, ringing in the ears, heartburn, joint pain and swelling depression and stress.Patient has reduced cervical range of motion towards the left side compared to the right.There was tenderness at the left ankle at the achilles tendon insertion as well as at the lateral ankle complex.There was more swelling in the left than it is on the right.Impression: cervical postlaminectomy pain with radicular pain intermittently on the left.Left ankle sprain with achilles tendinopathy that has not been resolved with physical therapy and anti inflammatories.On (b)(6) 2013, patient presented for evaluation of sleeping disorder with high suspicion of obstructive sleep apnea.Assessment: suspect severe obstructive sleep apnea.Morbid obesity, status post c-spine surgery after cervical spine injury three years ago.Asthma which developed in the past three years.On (b)(6) 2013, (b)(6) 2014, patient underwent following procedure: polysomnographic parameters are monitored: eog, submental emg, eeg c3 -c4, eeg 01-02, airflow, effort with abdominal and thoracic belts, snoring sensor, ecg, tibialis emg, and oximetry.Impression: during the study there were apneas and hypoapneas along with desaturations and arousals.There is severe obstructive sleep apnea.On (b)(6)2014: the patient presented to the office for a visit.Patient is complaining of seeing blood in the sputum.He does have some mild swelling in the lower extremities.Ct scan of chest done on (b)(6) 2014 revealed no acute infiltrate, no consolidations, no masses, no lymphadenopathy, no pleural effusion.Mild emphysematous changes were seen.Assessment: hemoptysis, severe obstructive sleep apnea benefiting from nasal cpap.Morbid obesity, diabetes mellitus, status post-cervical surgery.Significant weight gain since injury.Mild copd.On (b)(6) 2014: patient presented to hospital and underwent x-ray of chest 2 view.Impression: negative chest.Patient underwent following examination: "us duplex venous legs bilat." impression: no sonographic evidence of deep vein thrombosis.Patient underwent following examination: "nm pulm vent and perf imag" due to pulmonary emboli.Impression: negative v/q scan.On (b)(6) 2014: patient reported increased hemoptysis.Assessment: persistent hemoptysis, (b)(6) quantiferon to gold blood test indicative of prior exposure to (b)(6).".
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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