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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); Cancer, Other (1760); Fatigue (1849); Inflammation (1932); Nerve Damage (1979); Neurological Deficit/Dysfunction (1982); Pain (1994); Swelling (2091); Injury (2348); Malaise (2359); Numbness (2415)
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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 posterior lumbar interbody fusion at l5-s1 using a peek interbody cage and a posterolateral fusion at l5-s1.The peek cage was packed with bmp, which was soaked into a collagen sponge.Bmp was also placed in the anterior disc space prior to insertion of the cage, and along the transverse process.It is alleged that following surgery, the patient experienced disabling pain and numbness in his legs, loss of mobility, ectopic bone growth, inflammatory reaction, non-union, cancer, neuro-deficit, nerve injury, and neurological injury.
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Manufacturer Narrative
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(b)(6).(b)(4).Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.
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Manufacturer Narrative
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(b)(4).
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Manufacturer Narrative
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Per image review: (b)(6) 2010 chest x-rays pa and lateral views are provided.Pulmonary scaring is seen in the right lower lobe seen adjacent to the right heart border.Cardiac shadow is of normal configuration.Ribs, clavicles and diaphragmatic shadows are all normal.Early degenerative disc disease of the thoracic spine is visible on lateral view.On (b)(6) 2010 lumbar x-rays copies of 5 films are provided.Ap, lateral, spot lateral and two oblique views are reviewed.These show advanced disc collapse, sclerosis and osteophytes at l5, narrowing at l3 and l2 as well.Facet arthrosis accompanies the collapse of l5.Lordosis is straightened by the anterior column shortening.No subluxation, tumor or fractures are apparent.On (b)(6) 2011 chest x-rays pa and lateral views are provided.Pulmonary scaring is seen in the right lower lobe seen adjacent to the right heart border.Cardiac shadow is of normal configuration.Ribs, clavicles and diaphragmatic shadows are all normal.Early degenerative disc disease of the thoracic spine is visible on lateral view.On (b)(6) 2012 chest x-rays pa and lateral views are provided.Pulmonary scaring is seen in the right lower lobe seen adjacent to the right heart border.Cardiac shadow is of normal configuration.Ribs, clavicles and diaphragmatic shadows are all normal.Early degenerative disc disease of the thoracic spine is visible on lateral view.On (b)(6) 2014 lumbar spine x-rays copies of 5 films are provided.Ap, lateral, spot lateral and two oblique views are reviewed.Interval tlif has been performed at l5 with pedicle screws bilaterally at l5 and s1 and interbody peek spacer that appears to be a crescent.Rods are rounded suggesting open technique.Narrowing at l3 and l2 is unchanged facet arthrosis accompanies the collapse of l5.Lordosis is straightened by the anterior column shortening.No subluxation, tumor or fractures are apparent.Laminectomy has been performed at l5.Heterotopic bone with nerve involvement cannot be diagnosed from these films.On (b)(6) 2015 chest x-rays pa and lateral views are provided.Pulmonary scaring is seen in the right lower lobe seen adjacent to the right heart border.Cardiac shadow is of normal configuration.Ribs, clavicles and diaphragmatic shadows are all normal.Early degenerative disc disease of the thoracic spine is visible on lateral view.
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Event Description
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On (b)(6) 2007: patient underwent x-ray of chest.Impression: normal portable chest.Patient presented with pre-op diagnosis gerd and underwent egd.On (b)(6) 2007 patient presented for follow-up for diarrhea and history of polyps.On (b)(6) 2007: patient underwent nm gastric emptying study.Impression: normal gastric emptying.On (b)(6) 2010 patient presented for routine follow up for med refills and for flu vaccine.And complained of back pain.Patient underwent x-rays of lumbar spine with oblique.Impression: 1+ l4-l5 degenerative disc disease; 3+l2-l3 and l3-l4 degenerative disc disease.; 5+ l5-s1 degenerative disc disease; muscle spasm; moderate l3 through si facet joint arthritis (b)(6) 2014: patient presented for health maintenance visit and requested medication refill.On (b)(6) 2014: patient presented for health maintenance visit.Patient complained of difficulty with breathing and shortness of air.On (b)(6) 2015: patient underwent x-ray of chest.Impression: no acute cardiopulmonary process.On (b)(6) 2012: patient presented with shortness of breath.On (b)(6) 2012: patient presented with shortness of breath issue.On (b)(6) 2012: patient presented with diagnosis of chronic airway obstruction not elsewhere classified.On (b)(6) 2013: patient presented with diagnosis of major depressive affective disorder recurrent episode mild degree.On (b)(6) 2013: patient presented with diagnosis of chronic prostatitis.On (b)(6) 2013: patient presented with benign essential hypertension.On (b)(6) 2014: patient presented with diagnosis of chronic airway obstruction not elsewhere classified.On (b)(6) 2014: patient presented with diagnosis of coronary atherosclerosis of unspecified type of vessel native or gr.On (b)(6) 2014: patient presented with diagnosis of chronic airway obstruction not elsewhere classified.(b)(6) 2014: patient presented with diagnosis of pneumonia organism unspecified.On (b)(6) 2014: patient presented with diagnosis of chronic airway obstruction not elsewhere classified, lumbago.On (b)(6) 2014: patient presented with diagnosis of hypertrophy (benign) of prostate without urinary obstruction and "ot".On (b)(6) 2014: patient presented with diagnosis of hemoptysis unspecified.On (b)(6) 2014: patient presented with diagnosis of non-dependent tobacco use disorder.
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Event Description
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On (b)(6) 2010 patient presented for routine follow up for med refills and for flu vaccine.On (b)(6) 2011 patient presented for health maintenance visit and medication refill request.The doctor's diagnoses were asthma, unspecified, coronary atherosclerosis of unspecified vessel, native or graft, benign hypertension, esophageal reflux, pain in joint of shoulder, depressive disorder not elsewhere classified, lumbago.On (b)(6) 2011 patient presented for health maintenance visit and medication refill request.Patient underwent depression screening and scored 24 which indicated a major depressive disorder.Doctor's diagnosis were pain in joint of shoulder, lumbago, esophageal reflux.On (b)(6) 2012 patient presented for follow up and health maintenance visit.The doctor's diagnosis were acute bronchitis, lumbago <(>&<)> tobacco use disorder, asthma, unspecified.Tobacco use disorder, chronic airway obstruction not elsewhere classified, coronary atherosclerosis of unspecified vessel, native or graft, benign hypertension, esophageal reflux, hyperlipidemia not elsewhere classified and not otherwise specified.On (b)(6) 2012 the patient underwent x-rays of chest, 2 views, due to cough which demonstrated bilateral lower lobe bronchitis.On (b)(6) 2014 patient presented with the complaint of cough and medication refill request.Cough described as productive and reported sputum as yellow in color.Associated symptoms included chest tightness, hemoptysis and headache.Diagnosis: chronic airway obstruction not elsewhere classified; b12 deficiency anemia not elsewhere classified; tobacco use disorder; abnormal blood chemistry not elsewhere classified; cough; body mass index between (b)(6), adult; special screening examination for pulmonary tuberculosis.
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Manufacturer Narrative
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(b)(4).
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Event Description
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On (b)(6) 2005: the patient presented with right hip pain and underwent mri of the right lower extremity joint.Impression: non-specific mri scan findings of the hip.On (b)(6) 2005: the patient presented with dyspnea and a history of smoking.The patient underwent ct of the chest.Impression: nonspecific ct scan findings of the chest.On (b)(6) 2005: the patient presented with the following preoperative diagnoses: questionable ganglion cyst, dorsum, left wrist; ganglion cyst, lateral aspect, right foot.The patient underwent a single compartment extensor tenosynovectomy of the left hand and wrist and aspiration of ganglionic cyst, right foot.Postoperative diagnosis changed to extensor tenosynovitis of the 3rd dorsal extensor compartment, left wrist, and right foot ganglion cyst.No patient complications were noted.On (b)(6) 2005: the patient presented with preoperative diagnoses of questionable recurrent ganglion cyst, dorsum left wrist.The patient¿s post-operative diagnosis was extensor tenosynovitis, 3rd and 4th dorsal extensor compartments, left wrist.The patient underwent a single compartment extensor tenosynovectomy of left hand and wrist.No patient complications were reported.On (b)(6) 2007: the patient presented with an admitting diagnosis of c6-7 disc lesion.On (b)(6) 2007: the patient underwent mri of the cervical spine due to c6-7 disc lesion, neck pain, and radiculopathy.Impression: mild degenerative changes with mildly bulging disks at c3-4 and c6-7.No significant stenoses or herniations other than a mild right lateral recess stenosis at the c3-4 level.On (b)(6) 2007: the patient presented with an admitting diagnosis of dysphagia.The patient underwent a barium swallow procedure.Impression: negative on (b)(6) 2007: the patient presented with admitting diagnosis of fainting, syncopic episode.On (b)(6) 2008: the patient underwent x-ray of the right hip due to leg pain.Impression: degenerative joint disease.On (b)(6) 2008: the patient presented with dark brown urine.Urine culture had no growth.On (b)(6) 2008: the patient underwent echocardiogram and stress test due to angina and difficulty walking.Conclusion: no cardiac symptoms were reported during stress or recovery.Normal test.On (b)(6) 2009: the patient underwent mri of the head due to headaches, sinusitis and abdominal pain.Impression: stable chronic white matter changes involving both cerebral hemispheres that are probably related to chronic microangiopathic ischemic disease.No evidence of acute areas of ischemia, hemorrhage or mass.There is stable chronic mucosal disease noted in a hypoplastic right maxillary sinus (b)(6) 2009: the patient presented with shortness of breath.On (b)(6) 2010: the patient presented for bloodwork and to follow up on his (b)(6).On (b)(6) 2010: the patient underwent ct of the chest due to cough and congestion.Impression: stable basilar pulmonary nodules, likely representing granulomas.On (b)(6) 2011: the patient presented with lumbago.Diagnoses: lumbosacral spondylosis; lumbar disc degeneration; on (b)(6) 2011: the patient presented with shortness of breath.On (b)(6) 2011: the patient presented with nausea and vomiting.On (b)(6) 2011/ (b)(6) 2012: the patient presented with malaise and fatigue.On (b)(6) 2012 the patient underwent ct scan of the abdomen with contrast, which demonstrated that there was no mass or adenopathy.The patient presented with shortness of breath.The patient underwent ct scan of the chest with and without contrast, which demonstrated stable very small pulmonary nodules bilaterally which appear unchanged from previous exams and no evidence of active disease.On (b)(6) 2012: the patient underwent a pulmonary function interpretation.Impression: spirometry is normal; lung volumes revealed increased residual volume and rv/tlc ration indicating that there could be small airway disease; dlco is mildly decreased.On (b)(6) 2012: the patient presented with (b)(6) infection and secondary diagnoses of: anal and rectyl polyp; mixed hyperlipidemia; depressive disorder; tobacco use disorder; on (b)(6) 2014: the patient presented to the er with flu like symptoms.Final diagnoses: community-acquired pneumonia; copd; (b)(6); hypertension; hyperlipidemia; benign prostatic hypertrophy; encephalopathy secondary to fever; anxiety and depression; hypokalemia and hypomagnesemia.The patient¿s x-rays showed moderate-sized right lower lobe infiltrate.On (b)(6) 2014: the patient consulted with an infectious disease doctor.Impression: right lower lobe pneumonia in an immunocompromised patient.On (b)(6) 2014: the patient underwent ct of the chest.Impression: bilateral infiltrates with small right-sided pleural effusion and right hilar adenopathy.The patient underwent right upper extremity venous ultrasound.Impression: negative study.On (b)(6) 2014: the patient underwent lab-work.Potassium and calcium were low; chloride was high; total protein was low; albumin was low; alkaline phosphatase was high; ast high; bun high; on (b)(6) 2014: the patient underwent x-rays of the chest.Impression: consolidative infiltrate seen throughout the right lung similar in appearance to the prior exam; small bilateral pleural effusions; mediastinal and right hilar adenopathy.On (b)(6) 2014: the patient presented with shortness of breath.The patient underwent x-rays of the chest.Impression: interval decrease in previously described partially consolidative infiltrate throughout the right hemithorax.On (b)(6) 2014: the patient presented to have lab-work conducted.The patient underwent x-rays of the chest.Impression: interval improvement with decreased right infiltrate right lower lobe.On (b)(6) 2014: the patient presented for follow up due to tobacco use disorder.The patient underwent x-rays of the chest.Impression: normal chest.On (b)(6) 2014: the patient presented with an admitting diagnosis of hymothesis.The patient had labwork done.On (b)(6) 2007: patient underwent x-ray of chest.Impression: normal portable chest.Patient presented with pre-op diagnosis gerd and underwent egd.On (b)(6) 2007 patient presented for follow-up for diarrhea and history of polyps.(b)(6) 2007: patient underwent nm gastric emptying study.Impression: normal gastric emptying.
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Event Description
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It was reported that on (b)(6) 2001 the patient presented complaining of dysuria and frequency.The patient also reported that he has had suprapubic pressure and discomfort intermittently for the past two months and also pain with ejaculation and some intermittent gross hematuria.On digital rectal exam, the patient's prostate was found to be boggy and tender.Impression: 1.Acute prostatitis.2.History of gross hematuria.3.Right flank pain.On (b)(6) 2001 the patient underwent nephrotomography for right flank pain.Impression: negative ivp.On (b)(6) 2001 the patient presented complaining of dysuria, frequency and lower pelvic pain.The patient also had gross hematuria.Impression: 1.Acute prostatitis, resolving.2.History of gross hematuria.On (b)(6) 2001 the patient underwent office cystoscopy to evaluate the bladder for any lesions or tumors due to his extensive use of tobacco and recent gross hematuria.No abnormalities were found.Impression: 1.Acute prostatitis, resolved.2.Normal cystoscopy with history of gross hematuria.On (b)(6) 2002 the patient presented for follow up of his urinary retention.He states recently he has been feeling more bloated.Im pression: urinary retention.On (b)(6) 2004 the patient underwent the following procedures: 1.Left heart catheterization 2.Selective coronary angiography 3.Left ventriculography.Conclusions: 1.Non obstructive coronary artery disease 2.Low normal left ventricular systolic function.No patient complications were reported.On (b)(6) 2005 the patient underwent echocardiogram.Impression: 1.Left ventricular chamber size is normal.2.Estimated ejection fraction is 50%.3.Right ventricle is dilated.4.Septal hypertrophy is noted.5.Left atrium is dilated.6.Doppler reveals mild mitral insufficiency.On (b)(6) 2005 the patient underwent ultrasound echography, left extremity due to mass left hand.Impression: no evidence of sonographic abnormality.On (b)(6) 2005 the patient underwent mri of the brain with and without contrast due to headache.Impression: right maxillary inflammatory sinus disease.Otherwise within the range of normal.The patient underwent x-rays of the chest due to cough.Impression: mild right middle lobe infiltrate.Also the patient underwent ct scan of the facial area due to chronic sinusitis.Impression: completely opacified right maxillary sinus consistent with sinusitis.On (b)(6) 2005 the patient presented with pre-op diagnosis of rectal bleeding and chronic diarrhea.The patient underwent colonoscopy to the cecum with snare polypectomy x 1.No patient complications were noted.The post-op diagnoses are polyp at 20 cm and external hemorrhoids.The pathological diagnosis showed tubular adenoma with some metaplastic change, no dysplasia is seen.On (b)(6) 2005 the patient presented with a mass in the dorsum of his left hand and the lateral aspect of his right foot over a period of approximately 8-12 months.X-rays demonstrated mild degenerative changes of the foot.On (b)(6) 2005 the patient presented with difficulties in his left wrist and right foot.On (b)(6) 2005 the patient underwent x-rays of the chest.Impression: normal chest.On (b)(6) 2005 the patient underwent dilated exam.Impression: 1.Blurry vision secondary to dry eyes and early cataracts 2.Dry eyes 3.Bilateral cataracts 4.Refractive error- change in glasses maybe secondary to fluctuating blood sugar from borderline diabetes.If blood sugar too high, would make the prescription of the glasses too weak.5.No ocular manifestation of (b)(6).On (b)(6) 2006 the patient underwent ultrasound study of the gallbladder due to abdominal pain right upper quadrant.Impression: nonspecific evaluation of the gallbladder by ultrasound.No evidence of cholelithiasis.On (b)(6) 2006 the patient underwent x-rays of the chest due to cough.Impression: normal chest.On (b)(6) 2007 the patient underwent ct scan of the thorax due to increased sob.Impression: two small non calcified pulmonary nodules noted in the left lower lobe.They measure 2-3 mm in size.On (b)(6) 2007 the patient presented with heartburn and dysphagia.Assessment: 1.Dysphagia 2.Atypical chest pain due to heartburn.On (b)(6) 2007 the patient underwent upper gastrointestinal endoscopy with dilatation due to dysphagia.Assessment: 1.Gastroesophageal reflux disease status post dilatation.2.Hiatal hernia.3.Gastritis status post biopsy.On (b)(6) 2007 the patient underwent ct scan of the chest due to sob, small nodules lung & chest.Impression: there are multiple tiny nodules present in both lung bases.These represent tiny granulomas.The appearance of new nodules is probably due to the improved technique as compared to the previous exam.On (b)(6) 2007 the patient presented with heartburn and swallowing difficulty as well as atypical chest pain.Assessment: 1.Diarrhea and history of polyps.2.Persistent heartburn.On (b)(6) 2007 the patient underwent esophagogastroduodenoscopy due to gerd.Impression: positive study.The patient also underwent colonoscopy due to history of polyp with occasional diarrhea.Impression: 1.Grossly normal colon.2.Hemorrhoid.On (b)(6) 2007 the patient underwent ph monitoring study.Conclusion: gastroesophageal reflux disease with atypical chest pain.On (b)(6) 2007 the patient underwent ct scan of the chest.Impression: stable tiny pulmonary nodules in the lung bases which are likely to represent granulomas.On (b)(6) 2007 the patient underwent ultrasound study of the gall bladder.Impression: no evidence of gallstones.Mild dilation of the renal collecting systems bilaterally.On (b)(6) 2007 the patient underwent mri of the head due to head aches, sinusitis and abdominal pain.Impression: stable chronic white matter changes involving both cerebral hemispheres that are probably related to chronic micro angiopathic ischemic disease.No evidence of acute areas of ischemia, hemorrhage or mass.On (b)(6) 2008 the patient underwent ct scan of the chest.Impression: stable small bilateral pulmonary nodules, likely representing granulomas.On (b)(6) 2008 the patient underwent x-rays of the lumbar spine.Impression: levoscoliosis with degenerative disk disease.He also u nderwent x-rays of the chest which was normal.On (b)(6) 2008 the patient was admitted to er because of an injury.X-rays were normal.On (b)(6) 2008 the patient presented with episode of chest pain and weakness.Impression: angina; dyslipidemia.On (b)(6) 2008 the patient presented for a follow-up on chest pain.Impression: coronary artery disease, and dyslipidemia.On (b)(6) 2008 the patient presented complaining of chest pain.He also reported occasional dizziness and fatigue.The patient铠medication metoprolol was increased to 25 mgs twice a day.Impression: coronary artery disease, stable.On (b)(6) 2009 the patient presented with coronary artery disease and reported that his chest is so much better, but he is still having orthopnea and palpitations.On (b)(6) 2009 the patient underwent ultrasound study of the gall bladder due to head aches, sinusitis and abdominal pain.Impression: nonspecific evaluation of the gallbladder by ultrasound.No evidence of cholelithiasis.The patient also underwent ct scan study of the paranasal sinuses.Impression: hyperplastic right maxillary sinus with opacification with mucosal thickening.Mild mucosal thickening involving a few of the right anterior ethmoid air cells in the floor of the left sphenoid sinus.On (b)(6) 2009 the patient underwent ct of abdomen with iv contrast, which demonstrated no evidence of active intra-abdominal pathology.On (b)(6) 2009 the patient had an episode of chest pain that woke him up in the middle of the night with associated severe shortness of breath, nausea and presented for a follow-up visit.On (b)(6) 2009 the patient underwent ct of chest with contrast, which demonstrated stable tiny nodules in the lung bases which were likely to represent granulomas.There was no evidence of active disease.On (b)(6) 2009 the patient underwent myocardial perfusion imaging, which demonstrated 1.Myocardial perfusion imaging was normal (negative for ischemia), 2.Overall left ventricular systolic function was normal, 3.There was a small bowel attenuation artifact of the inferior wall.The patient presented for a follow-up visit.The patient had still occasional episodes of palpitations and fatigue.Impression: 1.N oncritical coronary artery disease.2.Dyslipidemia.On (b)(6) 2010 the patient presented with pre-op diagnosis of gastroesophageal reflux disease and underwent esophagogastroduodenoscopy with biopsies.The findings were 1.Mild distal esophagitis with a normal z-line.2.Mild gastritis.3.No hiatal hernia.4.Mild duodenitis.On (b)(6) 2010 the patient presented with acid reflux/gerd.On (b)(6) 2010 the patient presented with pre-op diagnosis of gerd and underwent a biopsy procedure.Diagnosis: 1.Duodenum biopsy: no pathologic abnormalities.No helicobacter identified.2.Stomach biopsy: minimal chronic gastritis.No helicobacter identified.3.Mild chronic esophagitis.On (b)(6) 2010 the patient underwent ct scan of the neck with and without iv contrast, which demonstrated that it was within normal limits.On (b)(6) 2010 the patient underwent mri scan of the lumbosacral spine, which demonstrated diffuse degenerative change.Right paracentral disk protrusion at l2-l3 and central disk protrusion at l4-l5.On (b)(6) 2010 the patient presented with low back pain, pain in right hip and numbness in left leg.On (b)(6) 2010 the patient underwent x-rays of pa and lateral views of chest, which demonstrated a normal chest.On (b)(6) 2010 the patient presented with pre-operative diagnosis of degenerative disk disease with instability and radiculopathy, l5-s1.The patient underwent the following procedures.1.Posterior lateral fusion using structural arthrodesis, compression resistant matrix, and bmp and localized bone graft, l5-s1 2.Posterior interbody fusion using structural arthrodesis, peek cage, bmp, and local bone graft, l5-s1 3.Posterior non-segmental instrumentation using pedicle screws, l5-s1 4.Decompression at l5-s1 to decompress the l5 nerve root 5.Lumbar decompression at l5-s1 to decompress the l5 nerve root after the patient was prepared, an incision was made in the lower lumbar area.The deep dermal tissue was dissected using the bovie and a retractor was placed.Attention was then turned to the lumbosacral fascia, which was divided in a subperiosteal fashion exposing the spinous processes of l4, l5, and the sacrum.This dissection was then undertaken in a more lateral direction exposing the transverse processes of l5 and the sacral ala.The pedicle screws were placed in position and the wound was irrigated.Decompression was then begun at l5-s1 starting with a large biting rongeur to take down spinous process followed by a 3-mm kerrison punch for the decompression.The l5-s1 disk space was cleared of disk and annulus material using a combination of pituitary rongeur and angle and straight bone rasp.Once this was completed, there was no disk or anulus remaining and the exiting l5 nerve root and the traversing 51 nerve root were both decompressed.An appropriately sized trial graft was placed into the disk space.It was found that an 8 mm trial had a good fit.An 8 mm peek cage was then brought into the field.It was filled with bmp soaked sponge and previously morselized bone, which had been obtained from the decompression.Another construct of morselized bone and bmp sponge was placed into the anterior disk space and tapped down.The interbody graft, the peek cage was then inserted in a transforaminal fashion ensuring that there was no injury to the exiting or traversing nerve root.Once this was in a position, it was rotated into its correct orientation and then tapped anteriorly.Another lateral radiograph was taken, which showed good position of the interbody graft.A construct of compression resistant matrix, bmp sponge, and morselized local bone graft were then placed into the lateral gutters spanning the transverse processes of l5 to the sacral ala.This was done bilaterally.Then, 40 mm rods were placed into the screw heads.Screw caps were placed and then the guides were removed.The wound was then closed using 0 vicryl in interrupted fashion for the deep fascia.A suprafascial drain was placed and deep dermal tissue was reapproximated using a 2-0 vicryl and the skin was closed using a 3-0 vicryl in a subcuticular fashion.The sponge and needle counts were correct at the end of the c ase.The drain was secured using a 2-0 silk.Dermabond was applied to the skin for watertight closure.The patient was rotated onto the hospital bed and extubated without complication.It was noted that sponge and needle counts were correct at the end of the case and there was no abnormal discharge during pedicle screw placement.The patient was taken to recovery room in good condition.On (b)(6) 2010 the patient underwent x-rays of lumbar spine cross-table lateral view, which demonstrated l5-s1 spinal fusion.The patient underwent x-rays of the lumbar spine.Surgical screws and brackets are now seen in projection with the l5 and s1 vertebra.On (b)(6) 2011 the patient underwent ct scan of lumbosacral spine, which demonstrated diffuse degenerative change.The patient was status post previous fusion procedure at l5-s1.On (b)(6) 2011 the patient underwent x-rays of the chest.Impression: normal exam.On (b)(6) 2011, (b)(6) 2011, (b)(6) 2011, (b)(6) 2012, (b)(6) 2012 the patient complains of pain in ears, headache, sore throat, cough, diarrhea, fatigue/tiredness, nasal congestion.The doctor's diagnosis was acute upper respiratory infection not otherwise specified, lumbago and anxiety state not otherwise specified.The doctor prescribed blaxin, erythromycin eye ointment, proventil hfa and zyrtec as medication.On (b)(6) 2011 the patient underwent ct scan of the chest with contrast, which demonstrated stable tiny pulmonary nodules and no ev idence of active disease.On (b)(6) 2011 the patient underwent ultrasound of thyroid, which demonstrated a 5mm cyst within the left thyroid lobe.Otherwise, unremarkable thyroid ultrasound.On (b)(6) 2011 the patient underwent nm biliary function study, whi9ch demonstrated negative hepatobiliary scan.On (b)(6) 2011 the patient presented for a follow up ofcoronary artery disease.He stated that he has being having some more frequent episodes of chest pain.The pain sometimes radiated to his left arm.Impression: cad, dyslipidemia, htn, palpitations.On (b)(6) 2011 the patient underwent ap portable upright view of the chest, which demonstrated a normal chest.On (b)(6) 2011 the patient underwent echocardiography, which demonstrated 1.The left ventricle was normal in size and function with an ejection fraction of 67%.2.Mildly dilated left atrium.3.Mild pulmonic regurgitation was seen.4.Trivial pericardial effusion identified.The patient underwent x-rays of abdomen series with chest 1 view, which demonstrated no active disease.The patient presented for a follow up of coronary artery disease.Impression: coronary artery disease, stable; dyslipidemia.The patient underwent abdominal ultrasound, which demonstrated no pathologic findings.The patient underwent x-rays of chest single view, which demonstrated a mild right basilar atelectasis.The patient underwent the following procedures: 1.Left heart catheterization.2.Selective left coronary angiogram.3.Selective right coronary angiogram.4.Left ventriculogram.Impression: critical left anterior descending bifurcating lesion.On (b)(6) 2011 the patient underwent right lower extremity arterial doppler sonography, which demonstrated no evidence of deep vein thrombosis of the right lower extremity.The patient underwent the following procedures 1.Left-sided cardiac catheterization, on (b)(6) 2011, via the radial approach, in which the patient was found to have obstructive disease in the proximal lad with an approximate 80% to 90% lesion with no other significant disease noted in any of the other arteries with estimated ejection fraction of 60%.Decision was made that this would need elective pci via an 8-french sheath through the groin and this procedure was terminated at that time to proceed with elective pci the next day.2.Left-sided cardiac catheterization on (b)(6) 2011, per doctor with drug-eluting stent placement to the lad with a 3.5 mm x 18 mm xience stent.3.Transthoracic echocardiogram with estimated ejection fraction of 67% mildly dilated left atrium, mild pulmonic regurgitation, trivial pericardial effusion.The patient underwent ptca and stent of the lad procedure due to angina with stenosis of the lad, which demonstrated coronary artery disease.On (b)(6) 2012 the patient underwent ct scan of the abdomen with contrast, which demonstrated that there was no mass or adenopathy.The patient underwent ct scan of the chest with and without contrast, which demonstrated stabke very small pulmonary nodules bilaterally which appear unchanged from previous exams and no evidence of active disease.On (b)(6) 2012 the patient underwent x-rays of chest, 2 views, which demonstrated bilateral lower lobe bronchitis.On (b)(6) 2012 the patient complains of cough.He described the cough as productive and reported sputum as brownish color.Associated symptoms include nasal congestion and deny ear pain has itching in ears.On (b)(6) 2012 the patient presented with increased sob about 3 to 4 weeks.Associated symptoms include dyspnea, fatigue, nausea, night sweats and vomiting.Assessment: cad, native vessel; shortness of breath; (b)(6); anal and rectal polyp; depression; unspecified hy perlipidemia.On (b)(6) 2012 the patient underwent x-rays of pa and lateral chest, which demonstrated no acute cardiopulmonary process.On (b)(6) 2012 the patient underwent ct angiography of chest with contrast, which demonstrated negative for pulmonary embolus and stable subcentimeter, very pulmonary nodules in the lung bases bilaterally.The patient underwent ct scan of the thorax.Impression: 1.Negative for pulmonary embolus.2.Stable sub centimeter, very pulmonary nodules in the lung bases bilaterally.On (b)(6) 2013, (b)(6) 2013, (b)(6) 2013, (b)(6) 2013,(b)(6) 2014, (b)(6) 2014, (b)(6) 2014, (b)(6) 2014 the patient presented for health maintenance visit with complaints of difficulty in breathing and shortness of air after treatment for pneumonia.The doctor's diagnoses were asthma, unspecified.Tobacco use disorder, chronic airway obstruction not elsewhere classified, coronary atherosclerosis of unspecified vessel, native or graft, benign hypertension, esophageal reflux.On (b)(6) 2012 the patient presented for insomnia.On (b)(6) 2012 the patient presented with crawling sensation in left lower leg near artery.Assessment: shortness of breath; (b)(6); anal and rectal polyp; depression; mixed hyperlipidemia.On (b)(6) 2012 the patient presented for a follow-up on (b)(6).Assessment: (b)(6); anal and rectal polyp; depression; mixed hyperlipidemia; anxiety; gastritis; tobacco abuse.On (b)(6) 2013 the patient presented for a follow-up on (b)(6).On (b)(6) 2013 the patient presented for a follow-up on (b)(6).Assessment: (b)(6); anal and rectal polyp; anxiety; urinary frequency.On (b)(6) 2013 the patient presented complaining of daytime frequency, dysuria, hematuria, intermittent stream and nocturia.The symptoms began 4 months ago and have been episodic.He has been experiencing achy pain in the abdomen, groin and perineum.Associated symptoms include hematuria, low back pain, pelvic pain, bladder pressure, slow stream, suprapubic pain, urgency, frequent urination and urinary hesitancy.Assessment: prostatitis, chronic; benign prostatic hypertrophy; nocturia.On (b)(6) 2013 the patient presented complaining of daytime frequency, dysuria and nocturia.He has been experiencing achy pain in the abdomen, groin, low back, perineum and bilateral testicles.On (b)(6) 2013 the patient presented for a follow-up on (b)(6).Assessment: (b)(6); anxiety; gastritis, special screening for malignant neoplasms.On (b)(6) 2013 the patient presented with prostatitis, abdominal pain which radiates toback.He also complained of bilateral lower abdominal pain with bright red rectal bleeding.Assessment: hemorrhage of rectum and anus; abdominal pain in right and left lower quadrant.On (b)(6) 2014 the patient presented complaining of frequent urination.Associated symptoms include frequency, nocturia- 3 times per night and urgency.Assessment: urinary frequency; benign prostatic hypertrophy; nocturia.On (b)(6) 2014 the patient presented for a follow-up on (b)(6).Assessment: (b)(6), gerd, and anxiety.On (b)(6) 2014 the patient underwent x-rays of lumbar spine with oblique, 5 views due to back pain.Impression 1.Status post ls-s1 discectomy and laminectomy with posterior fusion.There were no acute or chronic complications.2.Moderate l2 through ls degenerative disc disease.3.Otherwise, unremarkable exam.There were no acute findings or suspicious bone lesions.On (b)(6) 2014 the patient underwent ct of lumbar spine without contrast, which demonstrated 1.Multilevel degenerative type changes and stenosis of the lumbar spine.Evaluation of degenerative type change was limited on the ct and correlation with mri was suggested as clinically warranted.2.Posterior lumbar fusion and laminectomy changes involving the l5-s1 level with no evidence of acute hardware complication.On (b)(6) 2014 the patient underwent x-rays of chest pa and lateral views, which demonstrated interval improvement with decreased infiltrate right lower lobe.
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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) 2015: patient presented for health maintenance visit and medication refill.Diagnosis: chronic airway obstruction not elsewhere classified, abdominal or pelvic swelling.On (b)(6) 2015: patient presented for routine follow-up on knots in lt.Side of chest.Diagnosis: coronary atherosclerosis of unspecified vessel, native or graft, abdominal or pelvic swelling, mass or lump site not otherwise specified, tobacco use disorder, b12 deficiency anemia (b)(6) 2015: patient presented for his health maintenance visit, medication refill and to have thyroid checked.Diagnosis: benign hy pertension, esophageal reflux, anxiety state not otherwise specified, hyperlipidemia not elsewhere classified and not otherwise specified, goiter not otherwise specified, b12 deficiency anemia not elsewhere classified, anemia not elsewhere classified (macrocytic), mild major depression, recurrent episode, coronary atherosclerosis of unspecified vessel, native or graft, chronic airway obstruction not elsewhere classified, special screening examination for malignant neoplasm of prostate.On (b)(6) 2015: patient presented for his health maintenance visit and medication refill.Diagnosis: other dietary vitamin b12 deficiency anemia, other hyperlipidemia, major depressive disorder, recurrent, mild, nicotine dependence, cigarettes, uncomplicated, primary hypertension, atherosclerotic heart disease of native coronary artery without angina pectoris, gastro-esophageal reflux disease without esophagitis.
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Event Description
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It was reported that on: (b)(6) 2010: patient underwent x-ray of chest due to cough.Impression: right lower lobe bronchitis versus mycoplasma pneumonia.
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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) 2000, (b)(6) 2000: as per billing records, patient presented for screening (b)(6).On (b)(6) 2001: as per billing records, patient presented for radiological exam joint pain shoulder.On (b)(6) 2001: as per billing records, the patient presented with ganglion unspecified.On (b)(6) 2001: as per billing records, patient presented with ganglion of tendon sheath.On (b)(6) 2001: as per billing records, patient presented with ganglion of joint.On (b)(6) 2001: as per billing records, patient presented with allergic rhinitis.On (b)(6) 2001: as per billing records, patient presented with generalized anxiety disorder.On (b)(6) 2001: as per billing records, patient presented with depressive disorder.On (b)(6) 2001, (b)(6) 2002: as per billing records, patient presented with gastritis.On (b)(6) 2001: as per billing records, patient presented with chronic rhinitis.On (b)(6) 2001: as per billing records, patient presented with hematuria.On (b)(6) 2001: as per billing records, patient presented with presbyopia.On (b)(6) 2001: as per billing records, patient presented with high risk sexual behavior.On (b)(6) 2001: as per billing records, patient presented with chronic sinusitis.On (b)(6) 2002: as per billing records, patient presented with mycoplasma infection, esophageal reflux.On (b)(6) 2002: as per billing records, patient presented with deviated nasal septum.On (b)(6) 2002: as per billing records, patient presented with depressive disorder.On (b)(6) 2002: as per billing records, patient presented to office for depressive disorder.On (b)(6) 2002: as per billing records, patient presented with allergic rhinitis.On (b)(6) 2002: as per billing records, patient presented to office for esophageal reflux.On (b)(6) 2002: as per billing records, patient presented with poisoning and antidepressant.On (b)(6) 2002: the patient underwent radiological exam.On (b)(6) 2002: the patient presented with depressive disorder.On (b)(6) 2002: as per billing records, patient presented with esophageal reflux.On (b)(6) 2002: as per billing records, patient presented with cough.On (b)(6) 2002, on (b)(6) 2003: as per billing records, patient presented with nasal cavity/sinus.On (b)(6) 2003: the patient presented with unspecified joint pain.On (b)(6) 2003: as per billing records, the patient presented with joint leg pain.On (b)(6) 2003: as per billing records, patient presented with nasal cavity/sinus.On (b)(6) 2004: as per billing records, patient presented with angina pectoris unspecified.On (b)(6) 2004: as per billing records, patient presented to office for unspecified chest pain and angina pectoris.On (b)(6) 2004: as per billing records, patient presented to office for chest pain.On (b)(6) 2004: as per billing records, the patient presented for unspecified allergic rhinitis.On (b)(6) 2004: as per billing records, patient presented for joint pain in leg.On (b)(6) 2004: as per billing records, patient presented with tear medicine meniscus knee cur.On (b)(6) 2004: as per billing records, patient presented with urethritis.On (b)(6) 2004: as per billing records, patient presented with acute cystitis.On (b)(6) 2004: as per billing records, patient presented with hematuria.On (b)(6) 2004: as per billing records, patient presented for follow up on stricture of ureter.On (b)(6) 2005: as per billing records, patient presented with enthesopathy of hip.On (b)(6) 2005: as per billing records, patient presented with bipol i depressed severe.On (b)(6) 2005: as per billing records, patient presented with (b)(6)disease.On (b)(6) 2005: as per billing records, patient presented with (b)(6) disease.On (b)(6) 2005: as per billing records, patient presented for screening pulmonary tb.On (b)(6) 2005: as per billing records, patient presented with diarrhea.On (b)(6) 2005: as per billing records, patient presented with pneumonia.On (b)(6) 2005: as per billing records, patient presented with (b)(6) disease.On (b)(6) 2005: as per billing records, patient presented with (b)(6) disease.On (b)(6) 2005 as per billing records, patient presented with shortness of breath.On (b)(6) 2006: as per billing records, patient presented with coronary athrscl uns vessel.On (b)(6) 2006: as per billing records, patient presented with joint pain in pelvis, palpitation.On (b)(6) 2006: as per billing records, patient presented with unspecified chest pain.On (b)(6) 2006: as per billing records, patient presented with esophageal reflux.On (b)(6) 2006: as per billing records, patient presented fro elbow enthesopathy.On (b)(6) 2006: as per billing records, patient presented with allergies.On (b)(6) 2006: as per billing records, patient presented with (b)(6) disease.On (b)(6) 2007: as per billing records, patient presented with acute bronchitis.On (b)(6) 2007: as per billing records, patient presented with acute uri.On (b)(6) 2007: as per billing records, patient presented with (b)(6) disease.On (b)(6) 2007: as per billing records, patient presented to office for (b)(6) disease and hyperlipidemia unspecified.On (b)(6) 2007 as per billing records, patient presented with shortness of breath, esophageal reflux, unspecified chest pain and heartburn.On (b)(6) 2007: as per billing records, patient presented to office for (b)(6) disease.On (b)(6) 2007: as per billing records, patient presented with shortness of breath.On (b)(6) 2007: as per billing records, patient presented to office for (b)(6) disease.On (b)(6) 2007: as per billing records, patient presented to office for esophageal reflux.On (b)(6) 2007: as per billing records, patient presented for psychomotor ep not intract.On (b)(6) 2007:as per billing records, the patient presented for office due to common migraine.On (b)(6) 2008: as per billing records, patient presented to office for esophageal reflux.On (b)(6) 2008: as per billing records, patient presented with shortness of breath.On (b)(6) 2008: the patient presented with diarrhea.On (b)(6) 2008: as per billing records, patient presented to office for esophageal reflux.On (b)(6) 2008: as per billing records, patient presented with back ache.On (b)(6) 2008: as per billing records, the patient presented for office visit for (b)(6) disease.On (b)(6) 2008: as per billing records, patient presented with diarrhea.On (b)(6) 2008: as per billing records, patient underwent routine venipuncture for malaise/fatigue.On (b)(6) 2008, the patient presented with episode of chest pain and weakness.Impression: angina; dyslipidemia.On (b)(6) 2008: as per billing records, patient presented for routine venipuncture for artheroscler native coronary artery.On (b)(6) 2009: as per billing records, patient presented for office visit due to osteoarthrosis at unspecified site.On (b)(6) 2009: as per billing records, the patient presented for office visit for (b)(6) disease.On (b)(6) 2009: as per billing records, patient presented to office for (b)(6) disease.On (b)(6) 2009: as per billing records, patient presented to office for unspecified asthma.On (b)(6) 2009: as per billing records, patient presented for office visit due to (b)(6) disease.On (b)(6) 2009: as per billing records, patient presented with acute sinusitis.On (b)(6) 2010: as per billing records, the patient presented for office visit due to migraine.On (b)(6) 2010: as per billing records, patient presented with gastritis with duodenitis.On (b)(6) 2010: as per billing records, the patient presented for office visit for (b)(6) disease.On (b)(6) 2010: as per billing records, patient also presented with enlargement of lymph nodes.On (b)(6) 2010: as per billing records, patient presented to office for (b)(6) disease.On (b)(6) 2010: as per billing records, patient presented to office for esophageal reflux.On (b)(6) 2010: as per billing records, patient underwent diagnostic laryngoscopy.On (b)(6) 2010: as per billing records, the patient presented with acute bronchitis.On (b)(6) 2010: as per billing records, patient presented with pneumonia.On (b)(6) 2010: as per billing records, patient presented with shortness of breath.On 2011: as per billing records, the patient presented for office visit for (b)(6) disease.On (b)(6) 2011 as per billing records, patient presented with shortness of breath.On (b)(6) 2011: as per billing records, the patient presented for office visit for lumbar/sacral disc degeneration.On (b)(6) 2011: as per billing records, the patient presented for office visit for (b)(6) disease.On (b)(6) 2011: as per billing records, patient presented with abdominal pain.On (b)(6) 2011: as per billing records, patient presented with unspecified chest pain.On (b)(6) 2011: as per billing records, the patient underwent electrocardiogram of coronary vessel.On (b)(6) 2011: as per billing records, patient presented for hyperlipidemia.On (b)(6) 2011: as per billing records, patient presented with benign hypertension.On (b)(6) 2011, on (b)(6) 2012: as per billing records, the patient presented for office visit for (b)(6) disease.On (b)(6) 2011, on (b)(6) 2012: as per billing records, patient underwent acute uri unspecified.On (b)(6) 2012: on (b)(6) as per billing records, patient underwent ¿atheroscler native cor art.¿ on (b)(6) 2011/ (b)(6) 2012: also presented for regular venipuncture for (b)(6) disease.On (b)(6) 2012: patient presented with shortness of breath.On (b)(6) 2014: as per billing records, patient presented for routine venipuncture for asymptomatic (b)(6) status.On (b)(6) 2015: as per billing records, the patient presented for office visit for (b)(6) disease.On (b)(6) 2015: the patient also presented with benign hypertension.On (b)(6) 2015: as per billing records, patient underwent breast ultrasound due to lump or mass in breast.On (b)(6) 2015: as per billing records, the patient presented for office visit for routine venipuncture of (b)(6) disease.On (b)(6) 2015: as per billing records, the patient underwent electrocardiogram.On (b)(6) 2015: as per billing records, the patient underwent removal of breast lesion.On (b)(6) 2015: as per billing records, patient presented with unspecified hypertension.On (b)(6) 2015: as per billing records, the patient underwent screening of mal neo colon.On (b)(6) 2015 : patient presented for routine follow-up on knots in lt.Side of chest.Diagnosis: coronary atherosclerosis of unspecified vessel, native or graft, abdominal or pelvic swelling, mass or lump site not otherwise specified, tobacco use disorder, b12 deficiency anemia.On (b)(6) 2015: as per billing records, the patient presented with benign hypertension.On (b)(6) 2015: as per billing records, patient underwent ultrasound exam of head and neck.On (b)(6) 2015: as per billing records, patient underwent chest x-ray 2 views, frontal and lateral.
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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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Search Alerts/Recalls
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