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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); Bradycardia (1751); Chest Pain (1776); Dyspnea (1816); High Blood Pressure/ Hypertension (1908); Nausea (1970); Nerve Damage (1979); Neuropathy (1983); Pain (1994); Vomiting (2144); Burning Sensation (2146); Excessive Tear Production (2235); Stenosis (2263); Sinus Perforation (2277); Depression (2361); 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 tlif surgery from l5-s1 using rhbmp-2/acs.The patient reportedly experiences severe pain that radiates into his lower extremities.The patient also reportedly experienced unanticipated bone growth from the implant site.
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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 on (b)(6) 2007: the patient presented with following admission and discharge diagnosis: left gluteal abscess with skin necrosis.Following procedures were performed: incision and drainage of abscess; excisional debridement of necrotic skin and subcutaneous tissue.On (b)(6) 2009: the patient presented with complaint of back and left leg pain.Impression: left lumbar radiculopathy secondary to recurrent lumbar disk l5-s1.On (b)(6) 2009: the patient underwent lab test.Patient also underwent x-ray of chest.On (b)(6) 2009: the patient presented with following admission and discharge diagnosis: left lumbar radiculopathy secondary to recurrent lumbar disk herniation of l5-s1.Patient underwent x-ray of lumbar spine.Impression: orthopedic intervention l5-s1.On (b)(6) 2009: the patient presented for office visit.On (b)(6) 2009: the patient underwent following procedures: colonoscopy; esophagogastroduodenoscopy (b)(6) 2009: the patient presented for an office visit.On (b)(6) 2009: the patient presented due to pain.On (b)(6) 2009: the patient presented for office visit with diagnosis of rotator cuff tear right shoulder.On (b)(6) 2009: the patient underwent blood test.On (b)(6) 2009: the patient underwent x-ray of chest.On (b)(6) 2009: patient presented with chief complaint of right shoulder pain.On (b)(6) 2009: the patient underwent mri of left knee.Impression: interbody degenerative signal in the posterior horn of the medial meniscus and a small peripheral tear which extends to the inferior articular surface; small knee effusion; early changes of chondromalacia involving the lateral facet of the patella and the articular surface of the medial femoral condyle.On (b)(6) 2009: the patient underwent mri of shoulder.Assessment; rotator cuff tear right shoulder.On (b)(6) 2009: the patient presented with the following preoperative diagnosis: internal derangement, torn medial meniscus.Following p rocedures were performed: partial meniscus menisectomy; parapatellar synovectomy; chondroplasty of medial femoral condyle.Patient had the following preoperative diagnosis: torn medial meniscus, chondronecrosis, medial femoral condyle.On (b)(6) 2009: the patient presented due to hypertension, chest pain.Assessment: hypertension, suboptimal control; dyslipidemia; exertional chest discomfort suggestive of angina.Conclusion: mild mitral insufficiency with somewhat dilated left atrium.On (b)(6) 2009: the patient underwent lab test.On (b)(6) 2009: the patient was admitted and discharged with following diagnosis: bilateral cervical radiculopathy secondary to cervical spondylosis, c5-6 (b)(6) 2009: the patient was discharged.On (b)(6) 2009: the patient presented due to hypertension.Assessment; hypertension, suboptimal control; dyslipidemia.On (b)(6) 2010: the patient underwent x-ray of abdomen due to pain.Impression: mild splenomegaly on (b)(6) 2010: the patient presented due to chest pressure, pain, new-onset atrial fibrillation.Assessment: new-onset atrial fibrillation associated with an epinephrine injection.Patient experienced chest tightness during that episode; coronary artery disease history with a positive stress test with apical scar; hypertension; hypercholestrolemia; left rotator cuff tear.The patient underwent following procedures: ptca and stent replacement of the mid right coronary artery (bare metal stent); left heart catheterization with left ventricular angiography; coronary angiography conclusion: normal left ventricular function with an estimated ejection fraction of 55%; difuse disease of the left anterior descending artery; ostial left main 30%; ostial stenosis 50%, of the second diagonal branch; extremely small circumflex with very limited distribution; 90% diameter stenosis of the mid right coronary artery.The patient underwent x-ray of chest.On (b)(6) 2010: the patient presented for an office visit.He had chest pain, shortness of breath, nausea, vomiting.On (b)(6) 2010: the patient presented for office visit due to palpitations, chest discomfort.Assessment: transient atrial fibrillation (b)(6) 2015: the patient presented for office visit due to chest pain.Review of systems: neck pain, chronic back pain.The patient underwent ekg study.The patient also underwent x-ray of chest due to congestion.On (b)(6) 2015 the patient underwent x rays of the chest and ct scan of the blood vessels in chest due to chest pain.Impression of x-ray: no active disease.Impression of ct: no acute pulmonary process.No ct evidence of pulmonary embolism; splenomegaly; 50% left subclavian artery stenosis.The patient also underwent ecg study.Abnormal ecg.The patient also underwent blood tests and urine analysis, bacteriology.On (b)(6) 2015: the patient presented for unstable angina.Procedures performed: ptca and stent replacement of the proximal lad; ptca and stent placement of the distal left main and ostial lad.Conclusions: previous rca stent - patent; proximal and mid -lad lesions; no aortic gradient; mildly elevated lvedp: 28 mm hg; normal lv systolic function.Results: the 80-90% diameter stenosis of the proximal lad was reduced to 0% following stent replacement.The 70-80% diameter stenosis of the distal left main/ostial lad was reduced to 0% following stent replacement.Impression: lv ejection fraction is estimated to be less than 20%; severely dilated left ventricle; severe global hypokinesis; severely reduced rv systolic function; mild to moderate mitral valve regurgitation; mild tricuspid regurgitation; mild to moderate aortic valve sclerosis/calcification without any evidence of aortic stenosis; trivial aortic regurgitation.On (b)(6) 2015: the patient was discharged home.On (b)(6) 2015: the patient presented for office visit.On (b)(6) 2015: the patient presented for cardiopulmonary rehabilitation.On (b)(6) 2015: the patient presented for stents.On (b)(6) 2015: the patient underwent coronary angioplasty.On (b)(6) 2015: the patient presented for rehabilitation process.
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Manufacturer Narrative
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Add'l info: (b)(4).
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Event Description
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It was reported that on, (b)(6) 2009, the patient underwent lumbar surgery at l5-s1.(b)(6) 2009, the patient presented for follow up due to neck pain and pain in scapular area.Impression: moderate bilateral cervical radiculopathy secondary to disk bulge at c5-6 was disk protrusion.On (b)(6) 2010, the patient presented with left shoulder pain and underwent left shoulder mri w/o contrast.Impression : ac joint arthrosis and the undersurface of the acromion produce subacromial impingement.There is a partial high-grade tear of the subscapularis and tendinopathy in the proximal biceps tendon.There is an 8-mm segment of full-thickness tear in the anterior fibers of the supraspinatus, and there is fraying and fibrillation of the undersurface insertional fibers of the remainder of the supraspinatus extending into the anterior fibers of the infraspinatus.(b)(6) 2014, the patient presented for office procedure due to right shoulder pain.Assessment and procedure: right acromioclavicular joint injection.(b)(6) 2010, the patient presented for follow up.09/24/2014: the patient presented for a follow up.Assessment : myofascial pain syndrome.
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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 per medical records on (b)(6) 2009 the patient underwent mri of the lumbar spine.Impressions: previous l5-s1 surgery.Recurrent disc herniation affecting the left lateral recess at l5-s1 versus large eccentric dorsa; osteophyte.Mild annular disc bulging at l2-3.On (b)(6) 2009 the patient underwent left l5-s1 minimally invasive excision recurrent disk/ transforaminal lumbar interbody fusion (a llograft) and left l5-s1 pedicle screw internal fixation.Preoperative diagnosis: left lumbar radiculopathy secondary to recurrent lumbar disk herniation l5-s1.Preop notes: dilating the disc space utilizing the hourglass scrapers and began with an 8-dilator and progressed up to 10 mm in height.We chose bone graft 10 x 26 in size.The center portion was packed with a small amount of bone morphogenetic protein as well as fragments of bone from the laminectomy.This was placed in the disk space and noted to be in satisfactory position in both the ap and the lateral projection as well as visually.Placed a guided wire followed by the tap at both the l5 and s1 levels.This was 65mm tap abd this was followed by placement of pedicle screws at l5-s1.These were connected with a rod utilizing the equipment.The locking screws were tightened utilizing slight compression.On (b)(6) 2009, (b)(6) 2009 the patient underwent xrays of the lumbar spine.No complication was reported.On (b)(6) 2009 the patient underwent ct scan of the lumbar spine.Impressions: postoperative changes at l5-s1 as above.Soft tissue changes in the left canal at this level most likely residual epidural postoperative changes.Mild degenerative disc disease at other levels.On (b)(6) 2009 the patient presented for an office visit due to chief complaint of side of lower back mild pain.On (b)(6) 2009 the patient underwent mri of the lumbar spine.Impressions: ls-sl there has been a left laminectomy and there are left pedicle screws.There is left paracentral focal epidural defect.The majority of this does not enhance post-administration of contrast and the appearance is consistent with a recurrent persistent disc.There is peridural enhancement around the posterior and left lateral aspect of the sac.There is residual bulge of annulus, which does protrude into the right foramen.He also underwent mri of the thoracic spine.Impressions: dorsal spondylosis with multilevel degenerative disc change.There is a small focal central disc protrusion at t7-t8 and there are anterior osteophytes, greatest at t8, t9 and t10.There is also a disc bulge at t11-t12, but there is no significant spinal foraminal stenosis.On (b)(6) 2009 the patient underwent mri of bilateral hips.Impression: orthopedic metal device in the proximal right femur which casts metal artifact.Incidental note is made of a 1.4 cm hyperintense nodule in the superior aspect of the prostate gland.No abnormalities identified in the hips.The patient underwent mri of lumbar spine.Impressions: l5-s1 there has been a left laminectomy and there are left pedicle screws.There is left paracentral focal epidural defect.The majority of this did not enhance post-administration of contrast and the appearance is consistent with a recurrent persistent disc.The patient underwent mri of thoracic spine.Impression:dorsal spondylosis with multilevel degenerative disc change.There was a small focal central disc protrusion at t7-t8 and there were anterior osteophytes, greatest at t8, t9 and t10.The was also a disc bulge at t11-t12 but there was no significant spinal foraminal stenosis.On (b)(6) 2009 the patient presented for an office visit to talk about the mri which showed some changes in the thoracic area and lumbar area.On (b)(6) 2009 the patient underwent xrays of the lumbar spine.Impressions: l5-s1 interbody fusion left-sided pedicle screw fixation.On (b)(6) 2009 the patient underwent xrays of the cervical spine.Impressions: small disc protrusion centrally at c5-6, with small to moderate left paracentral protrusion / osteophyte at c7-t1.There are less pronounced areas of spondylosis in the upper cervical spine.On (b)(6) 2009, the patient underwent fusion c5-c6.On (b)(6) 2009 the patient presented for an office visit to recheck his sugar.Patient complained of some chest pain.On (b)(6) 2009 the patient underwent anterior cervical disc excision, allograft fusion, internal fixation, c5-c6.Preoperative diagnosis: bilateral cervical radiculopathy secondary to cervical disk bulge, c5-c6.Preop notes: a disk space was enlarged slightly with a high-speed drill.We chose a 6-mm bone graft for fusion.This was placed in the disk space and noted to be in satisfactory position visually as well as with x-ray.The distraction pins were removed.We chose an plate measuring 25 mm in length.This was secured to the cervical spine with 40 x 13-mm bone screws.We used fixed-angle screws at c6 and variable-angle screws at cs.The locking nuts were tightened.The graft was checked and noted to be snugly in place.Final fluoroscopic x-rays were performed in both the ap and lateral projections.On (b)(6) 2009 the patient underwent x-rays of the cervical spine.Impressions: cervical spine status post anterior cervical disk excision and fusion otherwise unremarkable.On (b)(6) 2009, the patient underwent right rotator cuff surgery.On (b)(6) 2010, (b)(6) 2010 the patient presented for an office visit.Patient was disabled because of his back.On (b)(6) 2010 the patient presented with chief complaint of back pain and medication refills.On (b)(6) 2011 the patient presented with chief complaint of back pain and trouble sleeping.On (b)(6) 2011 the patient presented with chief complaint of insomnia.On (b)(6) 10 the patient presented with chief complaint of abdominal pain and medication refills.On (b)(6) 2011 patient presented for re-evaluation of chronic medical conditions.On (b)(6) 2011 the patient was presented for office visit with chronic medical conditions.Assessments: insomnia, bradycardia, hypertension, chronic pain, hyperlipidemia.On (b)(6) 2012, the patient was presented for office visit with hypertension, hyperlipidemia, lumbago and the acute pain of nocturia.Assessments: lumbago, nocturia, chronic prostatitis, insomnia, bradycardia, hypertension, chronic pain, hyperlipidemia on (b)(6) 2012, (b)(6) 2012 the patient was presented for office visit for the medical wellness exam and chronic pain.On (b)(6) 2012 the patient was presented for office visit with sore throat, cough, sinus pain, congestion and fevers.Impressions: pharyngitis, sinusitis, chronic back pain, insomnia, hyperlipidemia, hypertension on (b)(6) 2012, (b)(6) 2012 the patient was presented for office visit for re-evaluation of the sinusitis.On (b)(6) 2013, (b)(6) 2013 the patient presented for the follow up and prescription refill.On (b)(6) 2013 the patient underwent mri of lumbar spine.Abnormal study on the left at l5-s1.On (b)(6) 2014 the patient presented for the follow up and prescription refill.On (b)(6) 2014 the patient underwent mri of lumbar spine.Impression: postoperative changes at l5-s1 with enhancing scar exerting moderate mass effect on the left s1 nerve root and also resulting in the mild mass effect on the left ventral aspect of the thecal sac.Since the infuse surgery, the patient has been suffering from bone overgrowth; difficulty swallowing; nerve injuries; radiating pain to legs and arms; significant pain in hip and both legs; extreme back pain; pain is more frequent and severe than before the infuse surgery; burning and stinging in both legs and mainly in the left leg; numbness in feet; erectile dysfunction; mental anguish; depression.He also had the following symptoms: pain in right and left leg; left leg is very bad; burning and stinging in both legs; severe back pain; pain in hips; pain in arms; difficulty swallowing and he has to eat very slowly.
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Manufacturer Narrative
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Event Description
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It was reported that on (b)(6) 2008 patient had right shoulder pain.On (b)(6) 2009 patient presented for right shoulder pain.Mri of the shoulder shows a very small but what appears be a full thickness tear the supraspinatus at the insertion.Assessment: diagnosis: rotator cuff tear right shoulder.On (b)(6) 2009 patient had pain in right ankle, left knee, and left hip.On (b)(6) 2009 patient presented due to arthroscopy sad, rcr -right shoulder.Patient presented for mri of right shoulder showed rotator cuff tear right shoulder.On (b)(6) 2009 patient presented due to left knee pain medially and underwent mri without contrast.Impression: interbody degenerative signal in the posterior of the medial meniscus and a small peripheral tear which extends to the inferior articular surface.Small knee effusion.Early changes of chondromalacia involving the lateral facet of the patella and articular surface of the medial femoral condylc.On (b)(6) 2009 patient presented due to the rotator cuff tear, right shoulder and underwent the following procedures: right shoulder arthroscopic subacromial decompression.Rotator cuff repair.On (b)(6) 2009 the patient presented due to internal derangement, torn medial meniscus.Patient had the following procedures: partial medial meniscectomy.Parapatellar synovectomy.Chondroplasty of medial femoral condyle.On (b)(6) 2009 patient presented due to rotator cuff rear, right shoulder.On (b)(6) 2009 patient had little redness of the medial incision with no drainage.On (b)(6) 2009 the patient presented right shoulder arthroscopic subacromial decompression and rotator cuff repair.On (b)(6) 2009 the patient presented post right shoulder arthroscopic subacromial decompression.On (b)(6) 2009 the patient presented post right shoulder arthroscopy subacromial decompression.On (b)(6) 2010 patient stated that he had some discomfort of the left knee.On (b)(6) 2010 patient presented postop after right shoulder arthroscopic subacromial decompression and rotator cuff repair.On (b)(6) 2010 the patient presented with chief compliant of left shoulder pain.Assessment: diagnosis: -left shoulder pain possible rotator cuff tear.On (b)(6) 2010 patient underwent left shoulder mri without contrast.Ac joint arthrosis and the undersurface of the acromion produce subacromial impingement there was a partial hig-grade tear of the "subscapularis and tendinopathy" in the proximal biceps tendon.There was an 8mm segment of full thickness tear in the anterior fibres of the supraspinatus there was fraying and fibrillation of the underspace insertional fibers of the reminder of the supraspinatus extending into the anterior fibers of the infraspinatus.On (b)(6) 2010 the patient presented with chief compliant of left shoulder pain.X-ray: left shoulder shows a small tear at the anterior aspect of the supraspinatus insertion.Assessment :diagnosis: -rotator cuff tear left shoulder.On (b)(6) 2010 the patient presented pre-operative examination.Assessment : diagnosis: rotator cuff tear left shoulder.On (b)(6) 2010 patient presented due to palpitations/chest discomfort.Assessment: transient atnal fibrillation probably related to administration or intervenous epinephrine.Patient was back in sinus rhythm and had no complaints.(b)(6) 2009: the patient presented with pain in the left scapular area.(b)(6) 2010: the patient presented with left sided low back pain.(b)(6) 2010: the patient underwent left l5-s1 transforaminal epidural steroid injection under fluoroscopy with contrast.(b)(6) 2010: the patient underwent left l5-s1 transforaminal epidural steroid injection under fluoroscopy with contrast.(b)(6) 2014: patient presented for evaluation and treatment of left-sided mid thoracic back pain.(b)(6) 2014: the patient presented for a follow up.(b)(6) 2014: the patient presented with right shoulder pain.(b)(6) 2014: the patient presented with pain in his left shoulder.On (b)(6) 2009 patient underwent mri of left knee without contrast.Impression: interbody degenerative signal in the posterior horn of the medial meniscus and an small peripheral tear which extends to the inferior articular surface.Small knee effusion.Early changes of chondromalacia involving the lateral facet of the patella and the articular surface of the medial femoral condylc.(b)(6) 2009 patient presented post right shoulder arthroscopic subacromial decompression and rotator cuff repair.(b)(6) 2009 patient underwent physical therapy.On (b)(6) 2009 the patient underwent physical therapy.On (b)(6) 2009 patient had arthroscopic subacromial decompression.Right shoulder and rotator cuff repair for postop follow-up.On (b)(6) 2010 patient underwent mri of left shoulder without contrast.Impression: ac joint arthrosis and the undersurface of the acromion produce subacromial impingement there was a partial high-grade tear of the subscapularis and tendinopathy in the proximal biceps tendon.There was an 8mm segment of full-thickness tear in the anterior fibers of the supraspinatus.And there is fraying and fibrillation of the undersurface insertional fibers of the remainder of the supraspinatus extending into the anterior fibers of the infraspinatus.On (b)(6) 2010 patient underwent the following procedures: left heart catherization with left ventricular angiography, coronary angiography.Conclusion: normal left ventricular function with an estimated ejection fraction of 55%.Diffuse disease of the left anterior descending artery, but no focal stenosis greater than 40%.Ostial left main 30%.Ostial stenosis, 50%,of the second diagonal branch(estimated 2.5 mm in diameter).Extremely small circumflex with very limited distribution.A 90% diameter stenosis of the mid right coronary artery.7.Large left ventricular branch and posterior descending artery showing no significant disease.On (b)(6) 2012 the patient was presented for office visit and underwent routine ekg check up.On (b)(6) 2012 the patient underwent blood tests for lipids, cholesterol and triglycerides.On (b)(6) 2012 the patient was presented for office visit and underwent routine ekg check up on (b)(6) 2012 the patient was presented for office visit and underwent routine ekg check up on (b)(6) 2012 the patient underwent blood tests for lipids, cholesterol and triglycerides.On (b)(6) 2012 the patient was presented for office visit and underwent routine ekg check up on (b)(6) 2013 the patient underwent blood tests for lipids, cholesterol and triglycerides.On (b)(6) 2012 the patient underwent comprehensive blood check up.On (b)(6) 2013 the patient was presented for office visit and underwent routine ekg check up on (b)(6) 2013 the patient was presented for office visit and underwent routine ekg check up on (b)(6) 2013 the patient underwent pathological examination of tissue.On (b)(6) 2013 the patient was presented for office visit.On (b)(6) 2013 the patient underwent removal of foreign body, external eye, conea with slit lamp examination.On (b)(6) 2013 the patient was presented for office visit.On 11/01/2103 the patient underwent blood tests.On (b)(6) 2013 the patient was presented for office visit and underwent methylprednisolone injection.On (b)(6) 2013 the patient was presented for office visit.On (b)(6) 2014 the patient was presented for office visit and underwent routine ekg check up on (b)(6) 2014 the patient was presented for office visit.On (b)(6) 2014 the patient presented for the follow up and prescription refill.On (b)(6) 2014 the patient was presented for office visit and underwent urinalysis test.On (b)(6) 2014 the patient was presented for office visit and underwent routine ekg check up on (b)(6) 2014 the patient was presented for office visit for annual check up.On (b)(6) 2014 the patient was presented for office visit.On (b)(6) 2014 the patient was presented for office visit.On (b)(6) 2014 the patient was presented for office visit.On (b)(6) 2014 the patient was presented for office visit and underwent methylprednisolone injection.On (b)(6) 2014: the patient presented with pain in his left shoulder.The patient also underwent injection procedure into sacroiliac joint with steroid.On (b)(6) 2014 the patient underwent removal of foreign body, external eye, conea with slit lamp examination.On (b)(6) 2015 the patient was presented for office visit.Also the patient underwent pathological examination of tissue.On (b)(6) 2015 the patient was presented for office visit.On (b)(6) 2015 the patient was presented for office visit.On (b)(6) 2015 the patient was presented for office visit and underwent urinalysis test.On (b)(6) 2015 the patient was presented for office visit and underwent routine ekg check up on (b)(6) 2015 the patient was presented for annual wellness check up.On (b)(6) 2015 the patient was presented for office visit.On (b)(6) 2015 the patient underwent prostate cancer screening.On (b)(6) 2015 the patient underwent x rays of the chest.On (b)(6) 2015 the patient was presented for office visit.On (b)(6) 2015 the patient underwent x rays of the chest and ct scan of the blood vessels in chest.On (b)(6) 2015 the patient was presented for office visit.
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