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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 7510800 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Ossification (1428); Abscess (1690); Anemia (1706); Asthma (1726); Bronchitis (1752); Chest Pain (1776); Cyst(s) (1800); Dysphagia/ Odynophagia (1815); Dyspnea (1816); Fever (1858); Headache (1880); Pyrosis/Heartburn (1883); High Blood Pressure/ Hypertension (1908); Muscle Spasm(s) (1966); Nausea (1970); Neuropathy (1983); Pain (1994); Loss of Range of Motion (2032); Swelling (2091); Thyroid Problems (2102); Urinary Tract Infection (2120); Vertigo (2134); Weakness (2145); Burning Sensation (2146); Tingling (2171); Chills (2191); Dysphasia (2195); Stenosis (2263); Urinary Frequency (2275); Sinus Perforation (2277); Discomfort (2330); Depression (2361); Numbness (2415); Neck Pain (2433); Neck Stiffness (2434); Sleep Dysfunction (2517); Ambulation Difficulties (2544)
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Event Type
Injury
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Event Description
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It was reported that the patient had undergone numerous previous operations for a failed anterior cervical fusion.The patient underwent anterior cervical exploration with removal of displaced anterior cervical graft with further corpectomy as well as replacement of the graft along with plating.Procedure: the patient underwent awake fiber optic intubation.The superior portion of the graft was displaced and could be well visualized, but the inferior portion was not visualized at all.It was the inferior portion that had dislodged.It was therefore decided to extend the incision in a t- shaped fashion to expose the inferior portion of the corpectomy.The graft was then removed using a kocher to expose the underlying corpectomy defect from c3 and to c7.A great deal of bone left over the c7 segment from the previous cage.The bone was resected using a standard handheld retractor as well as a bur.Of note, this was an extremely difficult operation given the amount of retracted tissues and the previous infection that was in this region.The bur was then used to dissect down through this deep hole to drill down to traverse from c7 up to c3.Bmp was placed in the fibular strut graft.It was shaped and malleted into the defect with great difficulty.Once it appeared flush with the endplates, fluoroscopy was used to confirm this.The inferior part could not be well visualized with fluoroscopy.Plating ensued.During the difficulty in plating the patient in the past, it was decided to use a modified type of plating technique with a screw placement to the previous graft using a single shaft axis posterior plating system.Using this technique, the graft was placed into position, and the plate was used to hopefully keep the graft in place.Copious irrigation was used over the operative site.The patient tolerated the procedure well.Patient also underwent surgeon guided fluoroscopy of spine in o.R.Impression: radiology imaging was provided for guidance during the procedure under the supervision of the surgeon.On (b)(6) 2005, patient presented with complaint of hearing a pop and experienced pain after this episode for status post acf.Assessment: displaced cervical fusion.Patient was scheduled for surgical repair.Patient also underwent for ct scan of reconstruction/reformat and ct scan of cervical spine without contrast.Impression: new bone strut graft from c5 through t1 with near anatomic alignment.Post-surgical change is noted.On (b)(6) 2005, patient presented for follow-up post cervical abscess due to (b)(6).Impression: the abscess was due to (b)(6).On (b)(6) 2005, patient presented for follow-up post cervical abscess due to (b)(6).Impression: no obvious physical exam evidence of phlebitis.On (b)(6) 2005, patient underwent us upper extremity veins unilateral left exam status post-surgical fusion with halo and acute left upper extremity swelling and pain.Impressions: limited evaluation of the jugular and subclavian veins.Patent axillary and brachial veins.On (b)(6) 2005, the patient presented for a neurosurgical follow up with right leg pain, occasional dysphagia and shortness of breath.On (b)(6) 2005, presented for follow up post cervical abscess due to (b)(6).Impression: patient had no systemic signs of infection and normal lab work including normal acute phase reactants.The patient was also presented for a wound check and complained of increased tenderness to her frontal halo pins insertion sites.On (b)(6) 2005, the patient presented for neurosurgical follow up with some pin site pain.On (b)(6) 2005, patient presented for halo adjustment and was advised for another follow up.On (b)(6) 2005, the patient presented for neurosurgical follow up with persistent pain around her pin sites which recently she had them tightened.On (b)(6) 2005, the patient presented for neurosurgical follow up with right thigh numbness and pain status post multiple anterior and posterior cervical fusions.On (b)(6) 2006, the patient underwent a ct scan of cervical spine without contrast.Conclusion: no significant interval change in hardware and bone strut position providing anterior fusion from c4 through t3 levels, with maturation of the c4-5 intravertebral bone graft.Stable appearance to posterior fusion hardware from c2 to t3.Degenerative spondylotic changes at several cervical levels.Patient underwent ct scan again for reconstruction with interpretation not requiring separate workstation.Conclusion: sagittal and coronal reformatted images were processed from the axial data set.On (b)(6) 2006, the patient presented for a neurosurgical follow-up with some pain in the base of her neck and into the shoulders bilaterally and occasionally into the left forearm.On (b)(6)2006, the patient presented for neurosurgical follow up with neck stiffness radiated to shoulders status post an anterior and posterior cervical fusion.On (b)(6) 2006, the patient presented with complaints of some achiness in the left side of her low back.Patient admitted to some transient numbness and tingling into her left thigh.On (b)(6) 2006, the patient underwent mammography screening.Impressions: no radiographic evidence of malignancy.No significant change from (b)(6) 2004.Yearly follow up was recommended.Bi- rads category ii (benign findings).On (b)(6) 2008, the patient underwent mri scan of cervical with and without contrast due to previous cervical spine surgery and cervical spondylosis and neck pain.Patient indicated that the symptoms radiated to the left arm.Impression: extensive postsurgical changes with anterior hardware were present.Additional bone graft fragments were present as well, primarily posteriorly.The hardware and the graft fragments relative to the native bone were much better seen on the previous ct scan.While there was mild central canal stenosis at about the c5 level related to the bony configuration in this area with a prominent posterior bony contour noted, no intrinsic spinal cord signal abnormality or syrinx is seen.The spinal cord does appear to be intended slightly by the bony contour.Attempting to allow for the hardware artifact and pattern of sectioning, there may be c7- t1 foraminal narrowing, left greater than right, and i cannot exclude impingement on the exiting left-sided nerve root.No abnormal enhancing lesions seen.No paraspinal collections seen.On (b)(6) 2008, the patient underwent ekg tracing.Findings: normal sinus rhythm.Left atrial abnormality.Diffuse nonspecific st-t abnormality.On (b)(6) 2008, the patient underwent abdomen radiology for flat and upright positions due to history of abdomen pain.Impression: no free air under the hemidiaphragm.Bowel gas pattern is otherwise nonspecific.No significant bowel distention.Soft tissue in the lower midline pelvis likely represented a mildly enlarged urinary bladder.On (b)(6) 2008, the patient presented with arm pains.Impression: the study was within normal limits.There were no findings to suggest bilateral cervical radiculopathies or peripheral neuropathy involving the arms at this time.On (b)(6) 2011, the patient underwent nm- thyroid image mult uptake test due to follow up nodule seen on ultrasound.Impression: uptake is in the hyperthyroid range.Possible old nodule in the lateral to upper aspect of the right thyroid lobe.Correlation with previous studies was recommended.On (b)(6) 2012, the patient presented with difficulty in swallowing, inability to lose weight and showed a mild elevated tsh level.On (b)(6) 2012, the patient presented with neck pain.On (b)(6) 2012, the patient presented for the follow up of cervicalgia.On (b)(6) 2012, the patient presented for a follow up of cervicalgia.On (b)(6) 2013, patient presented for the follow up of cervicalgia.On (b)(6) 2013, the patient underwent x ray of cervical spine due to neck pain.Impressions: extensive postoperative changes.No fracture was seen.On (b)(6) 2014, the patient presented with severe neck pain which radiated to both shoulders and right hip causing very limited distance walking without intolerable pain.On (b)(6) 2014, the patient presented with chronic worsening pain.Patient refused flu vaccine.On (b)(6) 2014, the patient presented for follow up.On (b)(6) 2014, the patient presented with worsening of neck pain.
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Manufacturer Narrative
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Concomitant product: plate, screws (implant (b)(6) 2005).(b)(4).Neither the device nor applicable imaging study films were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.Products from multiple manufacturers were implanted/used during the procedure.Although it is unknown if any of the devices contributed to the reported event, we are filing this mdr for notification purposes.
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Event Description
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It was reported that on (b)(6) 2008 the patient presented for an office visit due to diagnosis of type to diabetes mellitus.On (b)(6) 2009, (b)(6) 2006, (b)(6) 2003 the patient underwent dual energy x-ray tests.On (b)(6) 2010 the patient presented to the office for a follow up visit.On (b)(6) 2011 the patient presented with increased thyroid stimulating hormone with weight gain and question of nodules.On (b)(6) 2013 the patient underwent real time 2d gray scale and color doppler ultrasound of the thyroid gland.A comparison was made to a prior ultrasound performed on (b)(6) 2011.Impression: 1.New hypoechoic/ solid nodule within the lower pole of the left lobe of the thyroid measuring a maximum of 1 cm in diameter and new cystic nodule within the isthmus.2.Small scattered bilateral cystic nodules measuring 2-4 mm diameter.On (b)(6) 2015 the patient presented for a follow up visit.Impression: 1.Diabetes mellitus.2.Dyslipidemia.3.Multinodular goiter, clinically euthyroid without compressive symptoms.(b)(6) 2013, the patient presented for pre-op orientation , pre-op education and cataract extraction with iol implant surgery in right eye.(b)(6) 2013 , the patient made office visit and underwent cataract extraction with iol implant surgery related in left eye.
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Manufacturer Narrative
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(b)(6).
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Event Description
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It was reported that on on (b)(6) 2005, patient was admitted for complaint of intractable neck and arm pain.On (b)(6) 2005, patient was discharged from hospital with diagnosis of: cervical fusion dislodgement.On (b)(6) 2005, patient was discharged with following diagnosis: 1.Displaced construction with bone graft, 2.Hypokalemia, 3.Anemia, 4.Hypertension, 5.Gerd.(b)(6) 2013 the patient was presented for office visit with hip pain.Assessments: 1) lumbar spondylosis w/o myelopathy.
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Manufacturer Narrative
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(b)(4).
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Event Description
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Pre-op diagnosis for rh-bmp2/acs surgery: herniated c4-5, c5-c6 and c6-7 discs with myelopathy and intractable neck and arm pain; leg pain.On (b)(6) 2013, the patient underwent cataract surgery of right eye.On (b)(6) 2013, the patient underwent cataract surgery of left eye.Since the fusion surgery, the patient has been suffering from the following problems: constant pain in neck and upper back, numbness in neck and back, pain in both shoulders and arms, difficulty walking, difficulty breathing, difficulty speaking, difficulty swallowing, revision surgery, osteophytes, overgrown bone, foraminal narrowing and mental anguish.The patient also has the following problems: numbness in neck across back, tremors in left arm and hand, numbness in right thigh and both legs, pain in both hips, difficulty sleeping due to pain, discomfort in neck and back.
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Manufacturer Narrative
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Additional information : (b)(6) 2005 cervical ct sagittal reconstructions show a corpectomy of c5, c6 and c7 with metallic ventral corpectomy device spanning these levels and anterior plate spanning from c4 to t1.There has clearly been interval collapse of the anterior column since the index surgery as the superior screws now sit within the c3.4 disc space and the upper end of the plate is impinging upon c3.The lower aspect of the plate and lower screws are against the inferior endplate of t1.There is pronounced kyphosis of the cervical spine in this area and the corpectomy device sits out of alignment with the proximal end posterior and the distal end anterior to the remaining bodies above and below.Axial views show the plate eccentric to the right with the right c4 screw close to or in the vertebral foramen and the left screw in midline within the c3/4 disc.The c4 vertebral body appears to have fractured in a sagittal plane in midline.The t1 screws are in midline.The harms cage functioning as the corpectomy device appears mid body at c4 but ventral to the bodies at t1.On (b)(6) 2005 cervical ct interval revision has occurred.The anterior harms cage has been replaced by a fibular strut, and the anterior plate and screws have been removed and replaced by vertex posterior lateral mass screws and rods.The vertex construct appears to extend from c2 to t2 and the fibular strut appears in two fragments, a small one at c5/6 and a lower abutting strut from c6 to t2.This is seen in axial, coronal and sagittal reconstructions.The axial views show the lower aspect of the strut projecting anterior to the t2 body.The axial views also verify the c2, t1 and t2 screws are converging pedicle screws while the remainder from c3 to c7 are lateral mass screws, deviating outward.On (b)(6) 2005 cervical ct another interval revision has ben performed.Now the anterior construct has again been replaced.The fibular strut allograft is now only one piece and it is held into position by short plates.The upper plate has a single screw well positioned within c4, and the lower screw through the fibular strut.Below, a second plate with the upper screw through the fibular strut and the lower screw only barely engaged within the body of t2.This could very well have pulled out since only about 3 mm of the screw length is within the body of t3.Sagittal reconstruction appears to suggest the lower screw misses t2 all together, passes through the anterior t2/3 disc and into t3 only a few mm.Posterior instrumentation is again seen spanning c2 to t2.No evidence of nerve compression is seen.The fibular strut is still only partially within the area of vertebral bodies and projects ventrally in its lower aspect.
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Manufacturer Narrative
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(b)(4).
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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) 1988, (b)(6) 1989, (b)(6) 1993: patient presented due to hypertension.On (b)(6) 1988, (b)(6) 1989, (b)(6) 1990, (b)(6) 1991, (b)(6) 1992, (b)(6) 1993, (b)(6) 1995, (b)(6) 1996, (b)(6) 1998, (b)(6) 1999, (b)(6) 2002: patient underwent lab test.On (b)(6) 1988: patient underwent x-ray of chest.On (b)(6) 1989, (b)(6) 1990, (b)(6) 1991, (b)(6) 1992, (b)(6) 1993, (b)(6) 2000, (b)(6) 2001, (b)(6) 2002, (b)(6) 2003: patient presented for office visit.On (b)(6) 1989: patient presented with complaint of ganglion of the right wrist.Impression: recurrent ganglion right wrist.On (b)(6) 1989, (b)(6) 1991, (b)(6) 1992: patient experienced ache.On (b)(6) 1989: patient had neck pain which was getting worsened.On (b)(6) 1990: patient presented for pathology test.Clinical impression: r/o digitate wart vs.Skin tag., skin tags.Impression: dermatitis, papulose nigra, melisma and a digitate wart.On (b)(6) 1990; patient gained a weight a lot.Ankles got swollen.Sore when patient walked.On (b)(6) 1991: patient underwent mammography.Impression: prominent density within the left breast.On (b)(6) 1991: patient underwent breast sonogram.Impression: benign cyst.On (b)(6) 1991: patient presented with sinus congested, eye burning, ears itch, hoarse voice, post nasal drip, cough.On (b)(6) 1991: patient had sinus infection.Patient was experiencing nasal swelling and had headache.On (b)(6) 1992: patient presented for fever, chills.On (b)(6) 1992: patient was tired and wheezing.Patient had bronchitis, sore across entire chest and achy in shoulders and back.On (b)(6) 1992: patient had anemia.On (b)(6) 1993: the patient had sinus infection.On (b)(6) 1993: the patient had trouble in sleeping.On (b)(6) 1993: patient presented with diagnosis of hypertension and depression.On (b)(6) 1993: the patient had anxiety.On (b)(6) 1993, (b)(6) 1996, (b)(6) 1988, (b)(6) 1989, (b)(6) 1990, (b)(6) 1991, (b)(6) 1992, (b)(6) 1993: the patient had a follow up visit.On (b)(6) 1993: patient presented due to depression.On (b)(6) 1993, (b)(6) 1994: patient underwent polysomnography.Impression: obstructive sleep apnea.Intrinsic sleep disorder.On (b)(6) 1993, (b)(6) 1995: patient presented for an office visit.On (b)(6) 1993: patient called for appointment.On (b)(6) 1993: patient underwent mammography.Impression: new 12mm density at the outer mid left breast with the appearance of a cyst is noted in an otherwise unremarkable exam.On (b)(6) 1994: the patient presented with headache, sore throat, cough.On (b)(6) 1994: patient underwent x-ray of ls spine, pelvis.Impression: muscle spasm (b)(6) 1994: patient underwent x-ray of lumbar spine.Impression: mild degenerative changes with slight leveoscoliosis.No acute bony abnormalities.Patient underwent x-ray of pelvis.Impression: unremarkable study.On (b)(6) 1995, (b)(6) 1996, (b)(6) 1997, (b)(6) 1998, (b)(6) 1999, (b)(6) 2000, : patient presented for follow up visit.On (b)(6)1995, (b)(6) 1996: patient had red throat, neck supple, chest bilateral crackles with rare wheezing.On (b)(6) 1996: patient had sinusitis.On (b)(6) 1997: patient had maxillary sinus pain, bad cough, productive yellow sputum.On (b)(6) 1997: patient had left elbow pain, swelling, sinus problems.On (b)(6) 1997: patient presented for office visit for left elbow.On (b)(6) 1997: patient underwent bilateral mammography.Impression: no definitive pathology.On (b)(6) 1998: patient presented with ache.On (b)(6) 1998: patient presented with headache.Patient underwent x-ray of left shoulder and left upper arm.On (b)(6) 1998: patient underwent bilateral mammography.Impression: no mammographic evidence of carcinoma.Patient underwent x-ray of left shoulder.Impression: no significant abnormality.Patient underwent x-ray of left humerus.Impression: no significant abnormality.On (b)(6) 1998; patient presented with shoulder pain.On (b)(6) 1998: patient presented with chief complaint of left elbow pain.Impression; cervical degenerative disc disease.On (b)(6) 1999: patient fell on the slippery floor.On (b)(6) 1999: the patient underwent x-ray of lumbar spine and left 2nd toe due to low back pain.Impression: negative examination.On (b)(6) 1999: patient presented with chest pain.On (b)(6) 1999: patient presented due to leg cramps.On (b)(6) 1999: patient presented with joint pain.On (b)(6) 2000: patient presented with pain left ear.On (b)(6) 2000: patient had total hysterectomy for pap smear.On (b)(6) 2000: patient underwent mammography.Impression: bi-rads category ii-benign finding.On (b)(6) 2000: patient underwent emd and nerve conduction study.Impression: abnormal study.There is electrodiagnostic evidence of a mild left l5 radiculopathy.On (b)(6) 2000: patient was diagnosed with l5 radiculopathy.On (b)(6) 2000: patient presented due to intermittent pain to the calf.Inspection : increased lumbar lordosis.On (b)(6) 2000: patient underwent x-ray of left knee due to pain.Impression : mild degenerative change of the patella.On (b)(6) 2000: patient presented for evaluation of chronic paronychia with ingrown nail.On (b)(6) 2000: patient underwent therapy sessions due to l5 radiculopathy.On (b)(6) 2000: patient called and stated she had pain around heart in left breast area, also pain up into left shoulder.On (b)(6) 2001: the patient called.On (b)(6) 2001,(b)(6) 2002, (b)(6) 2003, (b)(6) 2004, (b)(6) 2006, (b)(6) 2007, (b)(6) 2008, (b)(6) 2009, (b)(6) 2010, (b)(6) 2012: patient presented for office visit due to ache., back pain, joint pain, hypertension, hyperlipidemia, right shoulder pain.On (b)(6) 2002, (b)(6) 2004: the patient called for medication.On (b)(6) 2002: the patient underwent left mammogram.Impression: the mass in the left breast is indeterminate.An ultrasound exam is recommended for the mass.Ultrasound of left breast impression: benign.On (b)(6) 2002: patient presented with complaint of right hand discomfort.Hand s get crampy and can¿t even work.On (b)(6) 2003: patient presented with complaint of ¿hhb¿, right hand pain, recent uri, sinus infection.Impression: rhinitis, uri (b)(6) 2003: the patient underwent colonoscopy.On (b)(6)2003: patient presented with complaint of back pain, losing weight, heart burn, left leg pain.On (b)(6) 2003: patient presented for office visit for bone mineral density.On (b)(6) 2003, (b)(6) 2004: the patient presented for an office visit.On (b)(6) 2004: patient presented with complaint of hypertension.On (b)(6) 2004: patient presented with complaint of hypertension, left shoulder lrom with pain.On (b)(6) 2004: the patient underwent the procedure colonoscopy to the cecum with polypectomy.Impression: colonoscopy to the cecum.P olypectomy of three small polyps in the ascending colon area, one was closest to the cecum, one was closest to the hepatic flexure and one was about in the middle and then at 20 cm there was a more significant peduculated polyp removed with snare and cautery.On (b)(6) 2004: the patient underwent examination of left shoulder due to pain and numbness.No evidence of fracture, dislocation, or soft tissue classification.Conclusion: negative exam.On (b)(6) 2004: patient was diagnosed with hypertension, hyperlipidemia, hypokalemia.On (b)(6) 2004: the patient presented with pain in shoulder and decreased range of motion.This got worsened and whole arm started aching.The patient experienced pain three weeks ago.The first digit was also numb.On (b)(6) 2004: the patient underwent pa and lateral radiographs test which revealed the lungs to be clear.Impression: no acute abnormality identified.On (b)(6) 2004: patient presented with complaint of wheezing, sweat, cough.Impression: cough, fever.On (b)(6) 2004: patient presented with complaint of wheezing.Impression; sinusitis with vertigo.On (b)(6) 2004: the patient was diagnosed with: dermatitis papulosa nigra, irritated nevus 3.Melasma.Patient was presented to the office for evaluation of moles.On (b)(6) 2005: patient presented with complaint of pain in neck radiating down left arm.She was diagnosed with radiculopathy, shoulder pain, hypertension.On (b)(6) 2005: the patient presented with neck pain.Patient also underwent mri and emg.On (b)(6) 2005,the patient also underwent mri of the cervical spine, which demonstrates a paracentral disc protrusion at c4-5 leading to bilateral foraminal narrowing.However, it does not appear to abut the cord.At c5-6 and c6-7, there are left paracentral disc protrusions that appear to displace the spinal cord.On (b)(6) 2005, presented for a neurosurgical follow-up with slight problems of shortness of breath and difficulty in swallowing.Im pressions: it appeared that patient had some dislodged hardware and bone plug and therefore explained to her the need for return to the operating room for replacement of both bone and her anterior cervical plate.On (b)(6) 2005: patient¿s friend called and they are going to do surgery on her neck.On (b)(6) 2005, (b)(6) 2006, (b)(6) 2007, (b)(6) 2008, (b)(6) 2009, (b)(6) 2010, (b)(6) 2011, (b)(6) 2014, (b)(6) 2015: the patient presented for an office visit and underwent various laboratory test and for medications.On (b)(6) 2005: the patient presented with complaint of stomach sickness, nausea.On (b)(6) 2005, patient was diagnosed with right lung ¿lld¿ congestion.Impression: acute bronchitis.On (b)(6) 2006: the patient presented with complaint of hypertension.On (b)(6) 2007: patient presented with complaint of increased swelling in feet, hypertension, neck pain.On (b)(6) 2007: patient presented with complaint of nosebleeds everyday.On (b)(6) 2007: patient presented with intermittent nasal bleeding on the right.On (b)(6) 2007: patient was diagnosed with hyperglycemia, hyperlipidemia, hypokalemia.On (b)(6) 2008: patient presented for office visit.On (b)(6) 2008: patient presented with complaint of cramps in hands, neck pain.On (b)(6) 2008, (b)(6) 2009, (b)(6) 2010, (b)(6) 2011: the patient underwent bilateral digital screening mammogram with cad.Impression: there is no mammographic evidence of malignancy.On (b)(6) 2008: the patient underwent unilateral right digital diagnostic mammogram.Impression: there is no sonographic evidence of malignancy.The 7mm oval mass in the right breast is consistent with a simple cyst and is benign.On (b)(6) 2008: the patient presented with chief complaint of neck pain.The patient underwent mri.On (b)(6) 2008: patient presented with complaint of urinary frequency.Had cramps in legs.On (b)(6) 2008: patient underwent various laboratory tests.Physical examination revealed: neck: halo appliance is intact on her neck.Extremities: warm without edema.The patient had anemia.On (b)(6) 2008: patient presented with complaint of worsening symptoms.On (b)(6) 2008, patient underwent blood sugars test.On (b)(6) 2008, (b)(6) 2009: the patient presented with complaint of hypertension, diabetes, hyperlipidemia.On (b)(6) 2009: the patient underwent retina tests.Impression: recent symptoms of photopsia with no ocular explanation.No evidence of diabetic or hypertensive retinopathy.On (b)(6) 2010: the patient presented with complaint of indigestion, heartburn, shortness of breath.On (b)(6) 2010: the patient presented with indigestion and heartburn.On (b)(6) 2010: the patient presented with complaint of cramps in fingers and legs.On (b)(6) 2010: the patient presented with complaint of left side hurts to move and touch.Hurts lying flat.On (b)(6) 2010: the patient underwent x-ray of chest-pa and lateral due to cough and left posterior chest pain.Impression: no acute ca rdiopulmonary process.On (b)(6) 2011: the patient underwent ¿us dvt¿ evaluation of right lower extremity because of right leg edema and swelling, calf pain.Impression: no evidence of deep venous thrombosis.No discrete hematoma was visualized within the distal right lower extremity.The patient also underwent x-ray tib/fib right views.Impression: no fractures or destructive changes within the distal right lower extremity.On (b)(6) 2011, (b)(6) 2012: patient was diagnosed with ¿ezo¿.Asthma.Diabetes.Hypertension.Neck pain.Diabetes.Paj neck.Hypokalemia.¿hyb¿.Urinary tract infection.On (b)(6) 2011: the patient presented with complaint of neck pain, felt like a burning sensation.On (b)(6) 2011: the patient presented with complaint of right lower leg pain.On (b)(6) 2011, (b)(6) 2012: patient called for refill.On (b)(6) 2011: the patient presented with complaint of arms and hands.On (b)(6) 2010: the patient presented with complaint of neck pain.On (b)(6) 2011: the patient was diagnosed with stomach pain.On (b)(6) 2011, the patient presented with increased thyroid stimulating hormone with weight gain and question of nodules.Impression: sub centimeter nodules as described, some of which appear to represent normal colloid cysts.On (b)(6) 2011: patient was diagnosed with hypothyroidism, hyperlipidemia, hypokalemia.On (b)(6) 2011: patient presented with thyroid nodule.On (b)(6) 2011: the patient underwent stress echo exam.On (b)(6) 2011: patient was diagnosed with abnormal thyroid, hypokalemia, diabetes.On (b)(6) 2012: the patient underwent dilated fundoscopic exam.The findings were: mild background retinopathy was found in right eye only.On (b)(6) 2012: the patient underwent abnormal thyroid scan.On (b)(6) 2012: the patient underwent 2d sress echo because of hypertension, hyperlipidemia.On (b)(6) 2012: the patient had chief complaint of worsening neck pain.On (b)(6) 2012: patient was diagnosed with abnormal gait with neck pain.On (b)(6) 2012: patient presented with neck pain.Patient also underwent colonoscopy screening.Last colonoscopy screening the patient underwent was one in 2004.On (b)(6) 2012, (b)(6) 2013: patient presented for office visit.On (b)(6) 2012, (b)(6) 2013: patient was diagnosed with hyperlipidemia, hyperglycemia, diabetes, neck pain.On (b)(6) 2012, the patient presented for bilateral digital screening mammogram.Impression: there is no mammographic evidence of malignancy.On (b)(6) 2013: patient presented with complaint of standing difficulty (hurts to stand).On (b)(6) 2013 the patient presented for pain, neuropathy.On (b)(6) 2013: patient presented with complaint of pain.On (b)(6) 2013: patient was diagnosed with abnormality of gait, mononeuritis.Patient condition had caused impaired ambulation (b)(6) 2013: patient presented with complaint of pain radiating to shoulders and arm.On (b)(6) 2013: patient presented with complaint of pain in head and across shoulder.On (b)(6) 2013: patient underwent x-ray of cervical spine.It showed two plates, 1 anterior to c4/5 and 1 posterior.On (b)(6) 2013: patient presented with complaint of neuropathy.On (b)(6) 2013: the patient underwent screening mammogram.On (b)(6) 2014: patient underwent bilateral digital diagnostic screening mammogram 3d/2d with cad.Impression: needs additional imaging evaluation.The 6 mm focal asymmetry in the right breast was indeterminate.On (b)(6) 2014: patient was diagnosed with red throat, supple neck.Impression: acute bronchitis.On (b)(6) 2014: patient presented for medication.On (b)(6) 2014: patient underwent unilateral right digital diagnostic mammogram.Impression: probably benign-follow up recommended.Patient also underwent ultrasound of the right breast.Impression: probably benign-follow up recommended.On (b)(6) 2014: the patient had trouble in sleeping.The patient also experienced pain in left leg, neck stiffness.On (b)(6) 2014: the patient had fever, chills, coughing, sinusitis.On (b)(6) 2014: the presented with problem of sleep disorder.On (b)(6) 2014: the patient presented with irregularity to thyroid gland.On (b)(6) 2014: patient was presented with hurting neck.On (b)(6) 2014: the presented with neuropathy.Patient could not move left arm.On (b)(6) 2014, the patient had left arm weakness, tremors left arm and left leg strength decrease worse than right.Patient had a gait: walking with limp, balance was unsteady and left knee tends to give out.On (b)(6) 2014, the patient presented for follow up.On (b)(6) 2014: the patient presented with neck and back pain.On (b)(6) 2014: the patient presented for mobility exam.On (b)(6) 2015: patient presented for severe pain.On (b)(6) 2015; the patient underwent screening mammogram.On (b)(6) 2013, (b)(6) 2014, (b)(6) 2015: the patient presented for medications and laboratory tests.On (b)(6) 2015: the patient underwent x-ray of c spine due to pain.Impression: no acute fracture.Hardware is intact.Overall decreased bone mineralization with degenerative changes throughout.The patient also underwent xray of thoracic spine.Impression: no acute bony findings.The patient also underwent xray of shoulder completely.Impression: no acute bony findings.The patient also underwent xray of lumbosacral spine.Impression: no acute bony findings.Mild degenerative changes and mild to moderate facet arthropathy, more prominent at the lower lumbar spine.On (b)(6) 2015: the patient underwent bilateral digital diagnostic mammogram with cad.Impression: there is no mammographic evidence of malignancy.On (b)(6) 2015: the patient presented for pain in groin going up both sides.On (b)(6) 2015: patient underwent ultrasound of abdomen completely.Impression: no acute sonographic abnormalities.Single liver cyst.There are 2 simple right renal cysts.On (b)(6) 2015: the patient underwent xray pelvis due to pain.Impression: moderate degenerative osteoarthritis in the hip joints.Patient also underwent xray of lumbosacral spine 2-3 views.Impression: no significant interval change.No acute fracture, spondylolysis or spondylolisthesis.Multilevel degenerative disc disease, worse at l5-s1.On (b)(6) 2015: patient presented for tremors in left hand which were getting more frequent.Patient had crunch in neck.Patient experienced weakness in right leg because of pain.On (b)(6) 2015: patient called to a visit for medication.On (b)(6) 2015 the patient underwent x-ray of the skull due to history of lumps.Ap, left and right lateral and towne¿s views of the skull were obtained.Impression: questionable areas of sclerosis within the skull.This is somewhat nonspecific but may reflect paget¿s disease.This could be better evaluated with dedicated ct scan as deemed clinically appropriate.On (b)(6) 2015: the patient presented for neuropathy, hyperlipidemia.The patient underwent physical exam.
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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) 2005: impression: status post anterior and posterior cervical spine fusion without acute abnormality.There was no incorporation of the anterior bone graft seen.
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Search Alerts/Recalls
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