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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
Ossification (1428); Arthritis (1723); Asthma (1726); Bronchitis (1752); Chest Pain (1776); Dysphagia/ Odynophagia (1815); Edema (1820); Fatigue (1849); Headache (1880); High Blood Pressure/ Hypertension (1908); Itching Sensation (1943); Muscle Spasm(s) (1966); Nausea (1970); Nerve Damage (1979); Undesired Nerve Stimulation (1980); Neuropathy (1983); Pain (1994); Rash (2033); Vomiting (2144); Burning Sensation (2146); Tingling (2171); Stenosis (2263); Depression (2361); Sore Throat (2396); Numbness (2415); Neck Pain (2433); Sleep Dysfunction (2517)
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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 c5 to c7, during which rhbmp-2/acs was used.The patient reportedly continues to experience pain and numbness.
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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.
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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 the patient was admitted to hospital where his surgeon performed a spinal fusion surgery at the cervical region of his spine from vertebrae c5-c6.During the surgery, rhbmp-2/acs was used.Patient's post-operative period was marked by significant osteophyte formation in his cervical spine.Later, the patient developed an osseous fusion at this region.Patient continues to experience severe and unrelenting back pain, difficulty breathing, chronic pain in his arms and legs, difficulty swallowing, and difficulty speaking.This prevents him from practicing and fully enjoying the activities of daily life to the extent he did preoperatively.No additional information has been provided.
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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 from (b)(6) 2013, the patient was diagnosed with nerve irritation, foot pain and shoulder pain.On an unknown date in 2010, the patient underwent chest tube placement after his lung collapsed.On an unknown date in 2010, the patient underwent surgery on fractured cheek bone.On an unknown date in (b)(6) 2011, the patient underwent fusion of toe.On an unknown date in (b)(6) 2012, the patient underwent amputation of right toe.Post the infuse surgery, the patient has been suffering from the following problems: difficulty swallowing, extreme pain, pain more often than before rhbmp-2/acs surgery, nerve injury, radiating arm pain, mental anguish and depression.He was also suffering from stinging numbness in neck radiating down right arm, numbness in both hands and sleep deprivation due to pain.The patient suffers from pain in neck when looking upwards.
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Event Description
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It was reported that on, (b)(6) 2013, per billing records, patient underwent x-ray of ribs.On (b)(6) 2014, patient presented for follow-up and reported neck pain.On (b)(6) 2014, patient presented for second cervical epidural injections due to neck pain.On (b)(6) 2014, patient underwent procedure for c4-5 epidural steroid injection under fluoroscopic guidance.
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Event Description
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It was reported in the patient's medical records that: on (b)(6) 2006, the patient presented with feeling of cramping in the left lower back while working.Assessment: soft tissue injury, muscle strain/sprain of the lumbar spine.On (b)(6) 2006, the patient underwent back exercises.Assessment: patient showed excellent progress with no problems noted.On (b)(6) 2006, the patient presented with right scapular back pain.Impression: muscular strain of the medial scapular musculature.On (b)(6) 2006, the patient presented for a follow-up of his posterior right scapula discomfort.Assessment cervical strain.On (b)(6) 2006, the patient underwent x-ray of complete cervical spine with obliques and complete right shoulder due to work comp injury to mid scapular area on (b)(6) 2006.Impression: the spine was normally aligned.No fracture or subluxation.There was degenerative disk narrowing at c5-c6.There is also osteoarthritis involving the facet joints and uncovertebral joints of the cervical spine.On (b)(6) 2006, the patient presented with discomfort due to back pain.Assessment: persistent back pain.On (b)(6) 2006, presented for a neurosurgical consultation with complaint of constant right scapular pain and shooting pain down the right upper extremity, with a needle like sensation into all his digits.On (b)(6) 2006, the patient presented for instructions on using home traction device.Assessment: the patient continues to have signs and symptoms of impinged nerve in the cervical spine region.On (b)(6) 2006, patient presented with persistent right-sided radiculopathy, with a markedly positive foraminal compression to the r ight and even on neck extension, causing right upper extremity pain and paresthesias.On (b)(6) 2006, patient underwent for radiology of main cervical spine due to right arm pain.Impression: 1.Decreased motion with flexion and extension.Alignment was preserved.2.Degenerative changes identified in the lower lumbar spine.Patient also underwent for radiology of main cervical myelogram r1 myelo due to right arm pain.Impression: 1.Mild spinal canal stenosis identified at c6-c7 with flattening of the anterior thecal sac and flattening of the ventral spinal cord secondary to a posterior disc osteophyte complex, somewhat asymmetric to the left.No other level demonstrated significant spinal canal stenosis.2.There was multilevel degenerative change as described with mild bilateral neural foraminal narrowing at multiple levels as described.On (b)(6) 2006, patient presented for review of electromyogram and demonstrated a right-sided c7 radiculopathy, and the ct myelogram demonstrated severe spondylosis at c5-c6, with severe bilateral foraminal stenosis at c6-c7.On (b)(6) 2007, patient presented with persistent right cervical radiculopathy and he had -1 to -2 paresis of his right triceps and wrist and digit extensors.On (b)(6) 2007, patient presented with preop diagnosis of intractable right cervical radiculopathy secondary to c5-6 spondylosis and foraminal disk fragment and c6 spondylosis and foraminal stenosis.Patient underwent following operations: 1.Microsurgical c5, 6 and 7 anterior osteophytectomy and harvest bone graft.2.Microsurgical c5-6 anterior cervical decompression, excision right foraminal disk fragments, midline and foraminal spondylectomy, excision of calcific posterior longitudinal ligament and 6x11 millimeters peek/autograft/0.4 milligrams bmp implant.3.Microsurgical c6-7 anterior cervical decompression, midline and foraminal spondylectomy, excision calcific posterior longitudinal ligament and 7x11 millimeters peek/autograft/0.4 milligrams bmp implant.4.C5 to c7 anterior cervical instrumentation with arcadis orbic iso-c-arm radioturf fluoroscopy.5.Placement of a round j-vac drain.6.Continuous neurophysiologic monitoring with the monitor demonstrating no excitation throughout the procedure.As per op notes, the anterior os teophytes of c5-6 and 7 were resected and the anterior vertebral surfaces flattened so as to eventually accept anterior cervical plate.The interspace at c5-6 was significantly narrowed and following incision of the annulus and removal of fragmented degenerated disk material the interspace was widened utilizing the midas rex high speed air drill with a small bone cutting bit and bone was harvested as well.Then distracting pins were placed at c5 and c6 and gentle distraction applied and the interspace drilled down to its posterior limits utilizing the 6 millimeters corner stone drill bit.Upon reaching the posterior limits, severe midline and foraminal spondylosis was identified.Several segments of sequestered disk material were extricated from the right c6 neural canal.The posterior longitudinal ligament was partially calcific.This was incised and sub totally resected and the spinal cord well decompressed.The neural canals were palpated with a blunt probe and they were free.Following satisfactory hemostasis with a tiny amount of floseal a 6x11 millimeter peek implant packed with autograft and 0.4 milligrams of bmp was placed at this level and gently countersunk.Then attention was focused at the even narrower c6-7 interspace.A partially calcific posterior longitudinal ligament was incised and subtotally resected and the spinal cord and the neural canals were freed and a blunt probe passed into each neural canal demonstrated the freedom.Then satisfactory hemostasis was obtained utilizing a tiny amount of flosseal and a 7x14 millimeters peek implant packed with autograft and 0.4 milligrams of bmp was placed at this level and gently countersunk.Then a 400 mm anterior cervical plate was positioned from c5 to c7 and 14 mm screws applied into c6, 15 mm screws applied into c5 and c7 and visualized radiographically.Satisfactory screw positioning and direction and implant position were noted.Then the locking mechanisms were activated.Then following satisfactory hemostasis utilizing bipolar coagulation the round j-vac drain was placed in the bed of the incision and normal anatomical closure was performed.Patient also underwent for radiology of main cervical spine post anterior cervical fusion.Findings: the patient has undergone anterior and instrumented fusion with interbody spacer at c5-c6 and c6-c7.There appeared good alignment and position of the components.On (b)(6) 2007, patient underwent for radiology of main cervical spine post cervical fusion.Impression: postop anterior cervical disc fusion of c5-c7.On (b)(6) 2007, patient underwent for radiology of main cervical spine with history of acdf.Impression: 1.Increasing prominence to the prevertebral soft tissues, particularly prominent adjacent to the c3 level.There was mild prominence seen here but it has increased.2.Continued postoperative changes with anterior plate and screws at c5-c7 as described.On (b)(6) 2007, patient underwent radiology of main cervical spine status post anterior cervical fusion.Impression: no evidence of complication.On (b)(6) 2007, patient presented with some interscapular pain and had residual paresthesias in his right hand.Patient also underwent yic of cervical spine status post anterior cervical interbody fusion.Findings: there was no significant interval change in the anterior instrument and interbody spacers at c5-c6 and c6-c7.The alignment of the cervical spine was well maintained.Minor anterior component soft tissue swelling had diminished slightly.On (b)(6) 2007, patient presented with mild restriction in neck extension, causing posterior nuchal discomfort.Patient also underwent radiology of main cervical spine.Impression: stable radiograph of the cervical spine.Patient also underwent for ct scan of cervical spine without contrast main c5 body post disc disease.Conclusion: 1.Anatomic alignment post interbody fusion at c5-c6 and c6-c7.2.No evidence of infection or graft displacement.On (b)(6) 2007, the patient presented with strained neck.Impression: the impression was neck pain.On (b)(6) 2007, the patient presented with diagnosis: cervicalgia.The patient was given electrical stimulation to the bilateral posterior cervical musculature.Assessment: the patient presented to physical therapy services with signs and symptoms consistent with muscle spasm due to pain and irritation from cervical fusion.On (b)(6) 2007, the patient presented with continued pain in the neck.He underwent electrical stimulation.Assessment: patient tolerated treatment well and reported decreased pain post treatment.On (b)(6) 2007, the patient presented with diagnosis: cervicalgia.He underwent manual therapy.Assessment: patient tolerated treatment well with no complaints of pain or problems during treatment.On (b)(6) 2007, the patient was given ultrasound to the posterior neck lateral to central.Assessment: patient tolerated treatment well with no complaints of pain or problems during treatment.On (b)(6) 2007, patient presented with posterior nuchal discomfort after working at heavy labor as a mechanic and maintaining his head extended or flexed.Impression: compared to his preoperative symptoms, he had significantly improved and his lateral cervical spine x-ray demonstrated satisfactory position of the interbody implants and the instrumentation.Patient also underwent yic of cervical spine status post cervical disc disease.Conclusion: compared to (b)(6) 2007, the anterior fusion plate and graft material at c5-c6 and c6-c7 is unchanged in appearance.There were no signs of plate or screw fracture.Disc space height was preserved through the areas.On (b)(6) 2008, the patient was given ultrasound to the posterior neck lateral to central.Assessment: patient tolerated treatment well with no complaints of pain or problems during treatment.Post treatment, patient states that the neck pain decreased.On (b)(6) 2008, patient presented with occasional paresthesias in the right hand and sometimes in both hands.Patient also underwent yic of cervical spine.Conclusion: compared to (b)(6) 2007 there were no changes in the alignment or in the appearance of the previously placed graft, screws and plate.On (b)(6) 2008, patient presented with occasional posterior nuchal discomfort status post microsurgical c5-6 and c6-7 acd peek/autog raft/bmp and acp on (b)(6) 2007.Patient also underwent radiology of single lateral view of cervical spine status post fusion.Impression: stable appearance of the anterior hardware from c5 through c7.Patient also underwent ct of cervical spine without contrast main c5 body.Impression: apparent development of osseous fusion at the intervertebral body spacers at c5-c6 and c6-c7.Foraminal narrowing was unchanged when compared to the previous examination.On (b)(6) 2008, the patient presented with pain to the cervical spine region, sharp pain to the left side of neck, also intermittent paresthesias to the left upper trapezius and down to the left ulnar nerve distribution.Assessment: the patient reported reduction of his cervicalgia complaints post treatment.On (b)(6) 2008, the patient underwent ultrasound to bilateral cervical paraspinal at c3-c6.Assessment: no c/o with today's treatment.On (b)(6) 2008, the patient came in for physical therapy.On (b)(6) 2009, the patient presented with splitting headaches, continued pain to the c5 to t1, left greater than right, paravertebral musculature.Assessment: patient reported no complaints with today's treatments.He was complaining of an exacerbation of left greater than right musculature in the cervical and high thoracic spine after lifting.He reported that with this current incident he was again receiving some paresthesias into the left upper extremity into the hands.On (b)(6) 2009, the patient diagnosed with cervicalgia and shoulder pain.Assessment: the patient responded well to treatment today and does report feeling better upon leaving.The patient was continuing to have intermittent complaints of exacerbation of his neck and paresthesias affecting the bilateral upper extremities.The patient did not reported any specific mechanism of injury for this exacerbation of pain.On (b)(6) 2009, the patient came in for physical therapy.On (b)(6) 2009, patient presented with left-sided neck pain and numbness radiating down the left upper extremity on head turning to the left.On (b)(6) 2009, patient underwent for rad main cervical spine min4 vis r1 cervical.Conclusion: solid appearing fusion.Patient also underwent for ct of cervical spine with contrast main c5 body and radiography of main cervical myelogram r1myelo.Impression: 1.Acdf c5-c7.2.Severe facet arthrosis and spondylitic change in the cervical spine resulting in left foraminal compromise at c2-c3.There is diffuse foraminal compromise as described above.On (b)(6) 2009, patient underwent for x-ray of cervical spine status post cervical fusion.X-ray demonstrated solid fusion at c5-c6 and c6-c7.On the ct myelogram, there is evidence of severe facet arthropathy unilaterally on the left at c4-c5, which may be responsible for his symptoms.Patient also had foraminal stenosis at c4-c5 bilaterally.The neurophysiologic study of emg/ncv demonstrates evidence of old c6 and c7 radiculopathies.On (b)(6) 2009, patient underwent for yic of cervical spine due to pain.Conclusion: unremarkable postoperative changes.Patient also underwent for yic thoracic spine w/swim with history of back pain.Conclusion: no acute findings.On (b)(6) 2009, patient presented for a cervical facet injection at c4-5.Patient was taken to fluoroscopy suite and under a fluoroscopic guidance; a 26 gauge spinal needle was advanced into the c4-5 facet on the left.This was then injected with 1 cc of 0.25% marcaine and 12mg of celestone.The patient tolerated the procedure well.On (b)(6) 2009, patient presented for pain service follow up for numbness in the left side of the head that radiates into the neck along with a shooting sensation that radiates into the left anterior and posterior arm with a pins and needles in left fingertips.On (b)(6) 2010, patient presented with continuous pain on his left side and patient underwent procedure for an rf lesioning at the c4-5 and c5-6 facets on the left.As per op notes, patient was taken to the fluoroscopy suite and under fluoroscopic guidance; a 20-gauge rf lesioning needle was placed at the c4-5 and c5-6 junctions of the median nerve.These were then stimulated.Lesions were made and we injected both sides with 6mg of celestone and 2 cc of 0.25% marcaine, and the patient was discharged status post rf lesioning at c4-5 and c5-6 on the left.On (b)(6) 2010, patient presented for pain service follow up for pain described as burning and shooting with pins and needles sensation located in patient's left arm.On (b)(6) 2010, patient was approached for follow up on (b)(6) 2010.A message was left on patient's answering machine at about 09:11 in the morning.But no return call was received in the pain service at that time.On (b)(6) 2010, patient presented with severe neck pain.Location of pain was left posterior neck, left shoulder, and left arm, left upper back and left mid back.Patient also underwent mri of the cervical spine status post cervical fusion due to neck pain with some upper extremity pain, left greater than right.Impression: 1.Status post anterior cervical fusion at c5 through c7.2.The most significant degenerative changes were disk narrowing and lateral recess narrowing left greater than right, at c3-4.There probably was mild central canal narrowing.3.The examination was compromised by mild motion artifact.Assessment: spondylosis, cervical on (b)(6) 2010, patient presented with worsening of neck pain particularly in flexion and extension.Assessment: anterior cervicalt c4-5 for facet arthropahty; spondylosis, cervical on (b)(6) 2012, the patient underwent x-ray of complete right foot.Findings: the resection of the distal phalanx of the great toe and the head of the proximal phalanx was noted.Postsurgical soft tissue changes had resolved.No acute osseous finding.On (b)(6) 2013, the patient was diagnosed with 1.Bilateral cavovarus heel alignment.2.Peripheral nerve paresthesias, improving.On (b)(6) 2013, patient presented with neck pain.Diagnosis: unfinished without diagnosis.Impression: chronic neck pain with multilevel degenerative changes and multiple facet arthropathy based on mr which demonstrated it somewhat poorly.On (b)(6) 2013, patient presented with significant neck pain, in particular on the left side just below the base of his skull and also for follow up after undergoing ct scan of his spine.Impression: diagnosis: unfinished w/o diagnosis.Cpt: no data for cpt.On (b)(6) 2013, patient presented with preop diagnoses of cervical facet syndrome and cervical degenerative disc disease and underwent procedure of left c2-c3, c3-c4 and c4-c5 intra-articular facet joint injections under fluoroscopic guidance.Complications: none on (b)(6) 2013, patient presented for visit after undergoing left-sided c2-c3, c3-c4 and c4-c5 facet blocks.Impression: severe facet arthropathy posteriorly as well as some neuroforaminal narrowing.Diagnosis: unfinished w/o diagnosis.Cpt: no data for cpt.On (b)(6) 2013, patient presented with preop diagnosis of cervical ddd and underwent procedure of c5-6 epidural steroid injection under fluoroscopic guidance.On (b)(6) 2014, patient presented with preop diagnosis of cervical degenerative disc disease and underwent repeat procedure of cervical epidural steroid injection under fluoroscopic guidance.On (b)(6) 2014, the patient underwent x-ray of l/s spine complete, due to low back pain.Findings: no vertebral compressions or subluxations were noted.Mild posterior spondylotic ridging noted at the lumbosacral level.Mild spondylotic osteophyte changes were noted at l3-l4 and l4-l5.The patient also underwent xr t spine ap and lateral, due to low back pain.Findings: there was undulating ossification of the anterior longitudinal spinal ligament consistent with dish.Minor endplate osteophytes.No compressions or hologic lesions were seen.Incidental note of cervical spine fixation plate.
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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) 1988: the patient presented with sore throat.On (b)(6)1993: the patient underwent x-ray of cervical spine.Impression: minimal osteoarthritic degenerative changes at the 5th ce rvical disc space.On (b)(6) 1994: the patient underwent x-ray of skull.Impression: fractures involving the left zygomatic arch, the lateral wall of the left maxillary antrum and a questionable fracture involving the inferior margin of the left orbital rim.On (b)(6) 1994: the patient underwent ct of head w/o contrast.Impression: multiple left-sided facial bone fractures involving the left zygoma, zygomatic arch, left inferior orbital rim and floor, and the walls of the left maxillary sinus.On (b)(6) 1994: the patient underwent x-ray of right ring finger.Impression: normal appearing bony structures.Soft tissue swelling surrounding the pip joint.On (b)(6) 1996: the patient underwent x-ray of cervical spine.Impression: slight straightening of the normal lordotic curvature.Otherwise unremarkable study.Mild degenerative endplate changes, primarily from t8 through t10.The patient underwent x-ray of lumbosacral spine.Impression: very minimal degenerative endplate changes.Otherwise unremarkable study.On (b)(6) 1997: the patient underwent x-ray of right knee.Impression: unremarkable views of the right knee with no acute bony injury or definable joint effusion identified.On (b)(6) 1997: the patient presented for excision of lesion on shoulder.On (b)(6) 1998: the patient presented with having occ.Chest pain for couple of weeks.On (b)(6) 1998: the patient underwent x-ray of cervical spine.Impression: minimal anterior spondylosis at the 5th cervical disc space.The cervical spine is otherwise normal and unchanged since (b)(6) 1996.On (b)(6) 1998: the patient presented with left arm pain and tingling, down in forearm and ulnar side hand.On (b)(6) 1998 and (b)(6) 1997: the patient presented for a follow up on hypertension.On (b)(6) 1998: the patient presented for a follow up on hypertension and sleep apnea.On (b)(6) 1999: the patient presented with a lump in his stomach muscle.On (b)(6) 2000: the patient presented for a follow up of dizziness, neck pain.On (b)(6) 2000, patient presented with degenerative joint disease, degenerative disc disease, cervical, thoracic, and lumbosacral spine.On (b)(6) 2001: the patient underwent x-ray of lumbar spine.Impression: mild degenerative end plate changes are present throughout the lumbar spine.On (b)(6) 2004 the patient was diagnosed with deviated nasal septum post trauma.He underwent septoplasty.On (b)(6) 2004 the patient visited the office for a follow up.On (b)(6) 2005 the patient underwent chest x-ray posterior/anterior and lateral views.A comparison was done with the x-rays on (b)(6) 2004.Impression: no cardiopulmonary abnormality noted.On (b)(6) 2005 the patient presented with sleep apnea.The patient underwent uvulopalatopharyngoplasty.On (b)(6) 2005: the patient underwent ct of abdomen and pelvis.Impression: findings do suggest diverticulitis with abnormal air collection and inflammatory reaction adjacent to the midportion of the sigmoid colon.Some arthritic changes noted within the lumbar spine with other findings as stated.On (b)(6) 2006 patient presented with pain over his left back on bending or twisting.On (b)(6) 2006 patient presented with pain over his left back just above the sacroiliac joint at about the level of the iliac crest.Rapid movements and lateral bending tended to bother him and he had trouble breathing.On (b)(6) 2006, patient underwent physical therapy.On (b)(6) 2006, patient presented with a history of tingling of his left upper arm, right arm numbness.On (b)(6) 2006, the patient presented for follow-up on right shoulder injury.He complains of tingling down his arm.On (b)(6) 2006 patient presented with "lightning pain," in his right shoulder and arm and neck.On (b)(6) 2006 patient underwent mri cervical spine.Impression: congenitally small cervical canal with multilevel disc herniation.I am most concerned for compromise of the right c6 root at c5-c6.Please see above discussion.On (b)(6) 2006: the patient underwent mri of c-spine w/o.Impression: congenitally small cervical canal with multilevel disc herniations.I am most concerned for compromise of the right c6 root at c5-c6.On (b)(6) 2006: the patient presented with discomfort and right arm pain and tingling and numbness.On (b)(6) 2007: the patient presented with back pain.On (b)(6) 2007: the patient presented to the clinic today with concerns about back pain.Ten days ago, the patient was leaning to the side while sitting on the toilet, he felt something pop in the thoracic area of his right back.Since then, he has had pain with any movement in the right thoracic area.Last night, he while doing the same activity, the pain increased and he rated it an 18 to 20, had difficulty straightening his back.On (b)(6) 2007, patient presented with neck pain.On (b)(6) 2007 patient was admitted for cervical pain that he rated about 4/10, that was aggravated with repetitive neck extension and left and right side bending.He still had some numbness and tingling in the bilateral arms and hands.He also had difficulty in lifting over 30 pounds because of neck pain and pull starting mowers.On (b)(6) 2007: the patient underwent total colon colonoscopy.On (b)(6) 2007: the patient presented with problem in right fingers.Impression: degenerative changes.Minimal degenerative changes in lumbosacral spine.We see lateral osteophytes in the mid and lower thoracic area.There is anterior wedging or compression of approximately t7, t8, t11.These are very minimal, and if they are compressions they're certainly quite old.Anterior osteophytes at all of these levels.On (b)(6) 2008 the patient complained of chest pain.On (b)(6) 2008, the patient presented for impairment rating.Patient was admitted for chronic neck and arm pain, status post cervical fusion at c5-6 and c6-7.On (b)(6) 2008 the patient presented with history of sleep apnea.On (b)(6) 2008 the patient presented with chief complaint of dry cough.On (b)(6) 2008: the patient presented with history of sleep apnea.On (b)(6) 2008 the patient presented with history of sleep apnea.Impression: split - night study showed mild osa with an ahi of 10.7 and rdi of 13.On (b)(6) 2008 the patient underwent cardiology diagnostic study.Impression: normal ett (b)(6) 2008 the patient underwent oximetry study.On (b)(6) 2008 the patient presented with complaints of nausea, vomiting, diarrhea and not feeling well.Impression: gastroenteritis.On (b)(6) 2009, patient presented with degenerative disc disease of lumbosacral spine, increased pain, fatigue.On (b)(6) 2010: the patient presented with rib pain.Impression: fractures of the left 7th and 8th ribs laterally with minimal displacement.On (b)(6) 2010 the patient presented for left ankle examination.There was a small circular calcification beneath the medial malleolus.The patient underwent x-rays of right knee.Impression: normal right knee.On (b)(6) 2010: the patient underwent ct face w/o contrast.Impression: comminuted, depressed left zygomatic arch fracture.Chronic maxillary, ethmoid, frontal and sphenoid sinus disease, mild.On (b)(6) 2010: the patient underwent ct maxillofacial w/o contrast.Impression: left sided facial fractures.On (b)(6) 2010 the patient underwent the x-rays of chest.On (b)(6) 2010: the patient underwent closed reduction of left zygomatic arch fracture.On (b)(6) 2010: the patient underwent x-ray of left clavicle.There is a fracture of the mid clavicle.There is inferior displacement and approximately 1 cm of override.There is no injury seen in the ac joint.The proximal humerus and the scapula show no obvious fractures, but there are fractures involving the 2nd, 3rd and probably ribs.On (b)(6) 2010: the patient presented with injury to left clavicle.The patient underwent insertion of a left closed tube thoracostomy.The patient underwent ct of chest.Impression: left-sided rib fractures and clavicle fracture.Left-sided pneumohydrothorax with subcutaneous emphysema.The patient underwent x-ray of chest.Impression: left-sided chest tube.No pneumothorax or hydrothorax.On (b)(6) 2010: the patient presented with pain, some hemoptysis.The patient underwent x-ray of chest.Impression: left-sided chest tube.No pneumothorax or hydrothorax.On (b)(6) 2010 the patient presented with seven broken ribs, a punctured lung and broken clavicle.On (b)(6) 2010: the patient underwent x-ray of each foot.Impression: moderate osteoarthritis.Heel spurs.No acute fracture.On (b)(6) 2010 the patient underwent the x-rays of chest.Impression: negative chest.On (b)(6) 2011 the patient presented with chief compliant of left shoulder pain.On (b)(6) 2011 the patient presented with chief compliant of left shoulder pain.On (b)(6) 2011, patient presented with pain in neck and arm.On (b)(6) 2011: the patient presented with chief complaint of right knee pain and recent instability.Impression: small right knee effusion.On (b)(6) 2011 the patient presented for left shoulder study.Impression: normal left shoulder.Old healed clavicular fracture.On (b)(6) 2011, patient presented with pain in toe, right great and arthritis.On (b)(6) 2011, patient presented with left ankle pain.On (b)(6) 2011: the patient presented with right hip arthritis.Impression: degenerative osteoarthritis as well as calcaneal spur.Evaluation of the right foot demonstrates degenerative osteoarthritis of the first mp joint.The remainder of the bony structures is intact.Calcaneal spur is present at the insertion of the achilles tendon.No additional abnormalities are identified nor significant change since (b)(6) 2010 on (b)(6) 2011: the patient presented with post-op right foot hip arthrodesis.Impression: arthrodesis first digit.Evaluation of the right foot demonstrates arthrodesis of the interphalangeal joint of the first digit.This arthrodesis is incomplete at this time.Degenerative changes are present in the first mp joint.No additional abnormalities are evident.The patient underwent right hip arthrodesis with hammerlock implant.On (b)(6) 2011: the patient presented with pain.Impression: surgical fusion of the dip joint of the first toe.Osteoarthritis heel spur no change.On (b)(6) 2011, patient presented with the incision on great toe draining, toe is swollen, and red in color.On (b)(6) 2011, patient presented for post-op visit s/p right hipj arthrodesis with hammerlock implant performed (b)(6) 2011.Pt states he had his toe stepped on by a large gentleman approx 2- 3 weeks ago and has immediate redness and swelling.On (b)(6) 2011: the patient presented with right great toe pain.Impression: post-operative changes in great toe.On (b)(6) 2012: the patient underwent x-ray of right foot.Impression: right foot toe amputation.The patient underwent amputation of right 1st distal phalanx and removal of implant.On (b)(6) 2012: the patient presented with tiredness, difficulty concentrating.On (b)(6) 2013: the patient underwent ct cervical spine w/o contrast.Impression: multilevel degenerative disc disease and facet arthrosis of the cervical spine with foraminal stenosis as described.Status post anterior cervical spine fixation from c5-c7 as described.On (b)(6) 2014, (b)(6) 2013: the patient presented with neck pain.On (b)(6) 2014 patient underwent lumbar facet injection, single level.On (b)(6) 2014, patient underwent lumbar facet injection, single level.On (b)(6) 2014, patient presented with lumbar degenerative disc disease with associated lumbar facet syndrome and low back pain.Patient underwent bilateral l3-4 facet medial branch blocks under fluoroscopic guidance.On (b)(6) 2015, patient presented with back pain.On (b)(6) 2015, as per telephonic conversation, patient presented with pain buttocks, top of foot toward big toe, front of thigh only to knee, and front shin.On (b)(6) 2015, patient underwent mri of the lumbar spine.Impression: mild lumbar degenerative disk disease and spondylosis with multilevel canal and foraminal narrowings as above.Mild foraminal stenoses are present at l3-l4.L5-s1 shows a right anterolateral recess narrowing without overt nerve root impingement.No large disk herniation or severe canal stenosis seen in the lumbar spine on this exam.Patient underwent mri of the thoracic spine w/o contrast.Impression: thoracic degenerative disk disease and spondylosis.Disk protrusion/osteophyte complexes are present at t4-t5 and t5-t6 as above.These cause right and left anterolateral recess stenoses, respectively, and contribute to narrowing of spinal canal dimensions and foraminal narrowings.No severe canal stenosis seen in the thoracic spine on this exam.
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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) 1994: patient underwent x-ray of cervical spine.Impression: unremarkable views of the cervical spine with no significant bony abnormality observed.On (b)(6) 1994: the patient underwent x-ray of skull.Impression: fractures involving the left zygomatic arch, the lateral wall of the left maxillary antrum and a questionable fracture involving the inferior margin of the left orbital rim.Patient underwent x-ray of mandible.Impression: normal mandible.On (b)(6) 1996: patient underwent x-ray of thoracic spine.Impression: mild degenerative endplate changes, primarily from t8 through t10.On (b)(6) 1999 patient presented as primary care outpatient.On (b)(6) 2000 patient presented as primary care outpatient for asthmatic bronchitis.On (b)(6) 2001 patient presented as primary care outpatient for numbness of fingers, especially left thumb on (b)(6) 2001 patient presented as primary care outpatient for mildly tender lump in rectum.On (b)(6) 2001 patient presented as primary care outpatient for rash on umbilicus.On (b)(6) 2002 patient presented as primary care outpatient for sore throat and pain while swallowing.On (b)(6) 2002, (b)(6) 2001, patient presented as primary care outpatient.On (b)(6) 2003 patient presented as primary care outpatient for pneumovax injection.On (b)(6) 2003 patient presented as primary care outpatient for depression and problems with sleep.On (b)(6) 2004 patient presented as primary care outpatient for tingling in thumbs.On (b)(6) 2015 patient presented as primary care outpatient for yellowish green sinus drainage with maxillary area pain with coughing and wheezing.On (b)(6) 2005 patient presented as primary care outpatient.On (b)(6) 2005 patient presented as primary care outpatient for mild dysphonia and post-op pain.On (b)(6) 2005 patient presented as primary care outpatient for thumb jam injury with pain and swelling.On (b)(6) 2006: the patient underwent mri of the cervical spine.Impressions: an accompanying cervical spine mri scan demonstrates what appears to be a large disc protrusion at c5-6 and also perhaps at c6-7 eccentric to the left.On (b)(6) 2006: the patient reported without traction severe right upper extremity radicular symptoms comes back and he is unable to extend his head.He is also severely sleep deprived because of these symptoms.On (b)(6) 2006: the patient was also presented for emg and nerve conduction studies.Interpretation: this test demonstrated neurophysiological evidence of a right c7 radiculopathy.There is evidence of ongoing denervation.On (b)(6) 2007 patient presented as primary care outpatient for follow-up on colonoscopy.On (b)(6) 2007 the patient presented with strained neck and probable muscle tear in right knee.Impression: the impression was neck pain.On (b)(6) 2007 patient presented as primary care outpatient.(b)(6) 2007:patient underwent radiologic study of lumbosacral spine.Impression: minimal degenerative changes.Patient underwent radiologic study of thoracic spine.Which showed lateral osteophytes in the mid and lower thoracic area.There is anterior wedging or compression of approximately t7, t8, t11.These are very minimal, and if they are compressions they're certainly quite old.Anterior osteophytes at all of these levels.On (b)(6) 2007: the patient was presented for office visit for emg and nerve conduction studies.Impressions: this test of the left upper extremity is normal.There is no neurophysiological evidence of a proximal nor distal entrapment neuropathies.On (b)(6) 2008 patient presented as primary care outpatient for back pain and hypertension.On (b)(6) 2008 patient presented as primary care outpatient for gastroenteritis, sleep apnea and depression.On (b)(6) 2009 patient presented as primary care outpatient for injury to left eye from bungee cord spring back.On (b)(6) 2009 the patient was presented for office visit for emg and nerve conduction studies due to pain down the left arm.Impressions: this test of the left arm demonstrated neurophysiological evidence of chronic or old c6 and c7 radiculopathies.On (b)(6) 2010 patient presented as primary care outpatient for cervical radiculopathy radiating down to arm on (b)(6) 2010 patient presented as primary care outpatient for right knee pain.On (b)(6) 2010 the patient underwent the x-rays of chest.Patient also presented for asthma management and non productive cough.On (b)(6) 2010: patient presented for plastic surgery consult for depressed left zygomatic arch fracture.On (b)(6) 2010, patient presented as primary care outpatient for clavicle fracture follow-up and evaluation.On (b)(6) 2010: the patient underwent x-ray of each foot.Impression: moderate osteoarthritis.Heel spurs.No acute fracture.Patient reported pain, edema and erythema.On (b)(6) 2010 patient presented as primary care outpatient for high fasting glucose with chronic depression.On (b)(6) 2011: the patient presented with recent instability.Impression: small right knee effusion.The patient presented with chief complaint of right knee pain.Patient presented for podiatry consult for worsening right hallux pain.On (b)(6) 2011: the patient presented for orthopedic consult for shoulder and knee evaluation.On (b)(6) 2011: the patient presented for sensory disturbance over lateral aspect of foot onto the foot and difficulty swallowing.On (b)(6) 2011: the patient presented for acute low back pain and symptoms of restless legs.On (b)(6) 2011: the patient presented for sensory disturbance over lateral aspect of foot onto the foot.On (b)(6) 2011, patient presented with pain in toe, right great and arthritis.Patient presented for consultation for "hipj arthrodesis" on (b)(6) 2011, patient presented for suture removal.On (b)(6) 2011, patient presented for injury to right great toe at surgical site.On (b)(6) 2011 patient presented as primary care outpatient for right hand's index finger swelling due to indolent infection from pasteurella canis.On (b)(6) 2012 patient presented as primary care outpatient for constipation, vomiting itching and nausea.Patient also reported neck pain.On (b)(6) 2012 patient presented as primary care outpatient for eye irritation.On (b)(6) 2012: the patient underwent x-ray of right foot.Impression: right foot toe amputation.The patient underwent amputation of right 1st distal phalanx and removal of implant.Patient reported failed and painful arthrodesis.On (b)(6) 2012, (b)(6) 2011, patient presented as primary care outpatient for wound evaluation and dressing.On (b)(6) 2012 patient presented as primary care outpatient for shoulder pain.On (b)(6) 2012, (b)(6) 2011, (b)(6) 2010, (b)(6) 2008, patient presented as primary care outpatient.On (b)(6) 2012 patient presented as primary care outpatient and reported severe neck pain.On (b)(6) 2013, patient presented as primary care outpatient and reported chronic pain and asthma (b)(6) 2013, patient presented as primary care outpatient and reported problems associated with alcohol consumption like hypertension, "chf" and depression etc.On (b)(6) 2014 patient presented as primary care outpatient and reported chronic pain and insomnia.Pain was reported as worsening and radiating to buttocks.
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