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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET

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MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET Back to Search Results
Catalog Number 7510400
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Biliary Cirrhosis (1736); Bronchitis (1752); Chest Pain (1776); Nausea (1970); Neuropathy (1983); Loss of Range of Motion (2032); Swelling (2091); Vomiting (2144); Weakness (2145); Dizziness (2194); Depression (2361); Numbness (2415); Neck Pain (2433)
Event Type  Injury  
Manufacturer Narrative
(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.
 
Event Description
Patient demographics: height: (b)(6).It was reported that on: (b)(6) 2007: the patient presented for an office visit.He had sharp and burning pain.On (b)(6) 2007: the patient presented for an office visit with lower back pain and sciatic type symptoms in his right leg.He had failed conservative therapy including activities modifications, medicines, physical therapy or epidural injections.On (b)(6) 2007: the patient presented for an office visit with chief complaint of low back pain with pain radiating down right leg and some numbness to right foot.Reported pain since (b)(6) 2007 when he twisted his back.The patient was diagnosed with abnormalities in the following areas: back, neck and neuro.Impression: degenerative disk disease l5-s1.The patient underwent x-rays of chest with pa and lateral views technique.Findings: the cardiac silhouette and pulmonary vasculature are within normal limits.The lungs were free of infiltrates.There are no significant pleural effusions.The bony structure was unremarkable.No mediastinal or hilar contour abnormalities are seen.Surgical clips were seen in the upper abdomen.On (b)(6) 2007: the patient was admitted with the diagnosis: lumbar degenerative disk disease, l5, s1 with significant disk herniation and right leg sciatica.The patient underwent following procedure: posterior spinal fusion, instrumentation l5, s1 with transforaminal lumbar interbody fusion, transpedicular decompression of far lateral disk bulging nerve roots l5-s1, placement of interbody peek cage, placement of local bone and bmp sponges for spine surgery.There were no complications through the patient's stay in the hospital.As per-op notes: jamshidi needle was placed through the incision on the left-hand side approx.3cm up to the midline overlaying the l5-s1 disk space and facet joint and through the pedicle of l5 using the aid of fluoroscopy.A 6.5x45mm screw was placed at l5.A 6.5x40 mm screw was placed at s1 over the guide wires.The sextant system was used to place a rod through the multiaxial heads of the screw.Appropriate sizing maneuvers were performed and a 12mm x 32mm interbody fusion peek cage packed with local bone and bone morphogenic protein sponges was placed as an interbody fusion device.This was done as a transforaminal lumbar interbody fusion.Fluoroscopy x-ray was used to confirm appropriate placement of this interbody fixation device.The transverse process of l5 and sacral "ala" of s1 were identified on the right-hand side.Local bone and bmp sponges were placed in posterolateral gutters for an intertransverse fusion.Pedical screws were placed through this right-sided incision as previously described.Sextant system was again used to place rod to bone through the multiaxial heads of screws.The wound was copiously irrigated.Patient went to recovery room in good condition.Fluoroscopy of cross-table lateral view of the lumbosacral junctions was performed during the intraoperative procedure which showed bilateral interpedicular screws in place overlying the l5 and s1 vertebral bodies.Disk markers over lie the l5-s1 disk.On (b)(6) 2007: the patient was discharged from the facility.On (b)(6) 2007: the patient underwent ap and lateral x-rays which showed well placed position of the pedicle screws, except for the right sacral screw was positioned slightly lateral because that pedicle was blown at the time of surgery.On (b)(6) 2007: the patient presented for an office visit with complaint of some stiffness in the morning and eases about noon.The ap and lateral x-ray of the lumbar spine showed well placed pedicle screws at l5-s1.The interbody fusion cage was still in good condition.On (b)(6) 2008: patient presented for an office visit with chief complaint of worsening back pain after 2 months of the surgery and leg pain after 4 months of the surgery.Patient stated the pain was as bad as it was before the surgery.The ap and lateral x-ray of the lumbar spine shows the patient had well placed pedicle screws at l5-s1.The fusion cages were in good condition.The patient was forming bone.On (b)(6) 2011: the patient presented for an office visit with complaint of low back pain.Musculoskeletal review revealed low back pain and presence of paraspinal muscle tenderness with motion restriction of the left lower extremity and hip pain with motion.Assessment: coronary artery disease, diverticulosis of colon, chronic pain in back.On (b)(6) 2011: the patient presented for a follow up visit with chief complaint of chronic problems.The patient underwent radiograph examination of lumbar spine with ap lateral views due to low back pain and degenerative joint disease (djd).(b)(6): the patient presented for a follow up visit with chief complaint of chronic problems.Patient complains of facial pain which started the previous night after the patient hit the right side of the face.Patient was not able to eat and drink anything in pain.Assessment: acute pain due to trauma.On (b)(6) 2011: the patient was admitted with complaint of chest pain and diagnosis of chest pain with negative workup for acute coronary syndrome by electrocardiograms and biochemical markers, history of coronary artery disease, moderate, best treated medically, chronic thrombocytopenia, chronic pain.Signs and symptoms: sob, radiation to the left jaw, weakness, positive diaphoresis, pain in left arm, back of the head and neck, dizziness, lightheadedness, nausea, vomiting.On (b)(6) 2011: the patient presented for a follow up visit with chief complaint of chronic problems.Er follow up revealed numbness of arm, hot flashes.Er states patient had a blockage in arteries and had tightness in chest pain.Assessment: shortness of breath, chronic pain.On (b)(6) 2011: the patient presented with abdominal pain.Patient underwent ct of abdomen which revealed liver with slight marginal mi cronodular contour raising the possibility of cirrhosis, marked splenomegaly measuring up to 19 cm in cephalocaudal dimension, vague areas of low attenuation are again noted along the margin of the upper spleen suggestive of splenic infarcts.Bilateral posterior spinal fixation at l5-s1 was again noted.Impression: persistent marked splenomegaly, up to 19 cm cephalocaudal dimension, with slight increase in low attenuation along the dome of the spleen suspicious for increasing splenic infarctions.Persistent findings of mesenteric congestion and probable portal venous collateral vasculature, particularly prominent in the anterior pelvis.Again, slight micronodular appearance of the liver was noted suggesting cirrhosis and unchanged appearance of a large ventral abdominal hernia mesh repair.On (b)(6) 2011: the patient presented for a follow up visit with chief complaint of chronic problems.Patient complains of having an accumulation of fluid under the pancreas, shortness of breath with weakness.Musculoskeletal review revealed low back pain.Assessment: foot pain.The patient also underwent radiographic examination for lateral foot with ap view.On (b)(6) 2011: the patient presented with complaint of seizure and headache began after seizure.His pain was shooting and throbbing and felt numbing.On (b)(6) 2011, (b)(6) 2013: the patient presented for an office visit to get the pain medications changed.Patient was also having a lot of headache.Assessment: abdominal pain and chronic pain.Diabetes running around 185-210, hypertension.Assessment: arthritis.On (b)(6) 2011, (b)(6) 2012: the patient presented for a follow up visit with chief complaint of chronic problems.Patient also complains of back pain which radiates to left leg, shoulder pain and chest pain.Musculoskeletal review revealed low back pain, myalgias, and stiffness.Assessment: high risk medication, tobacco use disorder, pain in joint: shoulder region, ins omnia.The patient also underwent radiographic exams of left shoulder and lumbar spine due to djd, evidence of fused lumbar spine l5-s1.On (b)(6) 2012: the patient presented for a follow up visit with chief complaint of chronic problems.Patient also complained of hernia with low blood cell count.Assessment: anxiety disorder, rectal bleeding.On (b)(6) 2012: the patient presented for a follow up visit with complaint of rectal bleeding getting worse.On (b)(6) 2012: the patient presented for a follow up visit with complaint of hip pain.The patient also had radiographic exam of lumbar spine 3 views due to pain and djd.On (b)(6) 2012: the patient presented for a follow up visit with complaint of cramps, nausea and vomiting, back pain.Patient also underwent radiographic examination of "cxr".On (b)(6) 2012: the patient presented for a follow up visit with complaint of pancreatitis.On (b)(6) 2012: the patient underwent ct of abdomen and pelvis with contrast due to pancreatitis, abdominal pain, history of diverticulitis with bowel resection after rupture.Impression: 1 morphologic change of the liver suggestive of cirrhosis and massive enlargement of the spleen with multiple enlarged veins or varices of the abdomen noted consistent with portal hypertension, currently there is contrast enhancement of the portal vein with no visible portal venous thrombus, mild wall thickening and enhancement of the right colon and proximal transverse colon suggestive of some nonspecific colitis, postsurgical changes of prior abdominal wall hernia repair with mesh devices.There appears to be a recurrent, fat-filled abdominal wall hernia between the upper and lower mesh devices as described above.On (b)(6) 2012: the patient presented for a follow up visit with complaint of back and leg pain and bronchitis.Assessment: biliary cirrhosis.On (b)(6) 2012: patient underwent radiographic examination of "cxr" due to cough.On (b)(6) 2012: the patient presented for a follow up visit with complaint of neck pain which radiates down left side of the back and left leg and left shoulder pain, back and shoulder pain i.E.Pain all over.Psychiatric tests revealed: anxiety and depression.Assessment: vitamin d deficiency, fatigue, depression.Patient also underwent radiographic examination of lumbar spine and shoulder ap views.On (b)(6) 2012: the patient presented for a follow up visit with severe pain, anxiety and cirrhosis.Patient stated to have completely ran out of pain medication.Musculoskeletal review revealed knee pain.Assessment: obstructive sleep apnea.Patient also underwent radiographic exam.On (b)(6) 2012: the patient underwent radiographic examination of knee/left limited (2 views).Impression: no acute fracture or joint effusion.On (b)(6) 2012: the patient presented for office visit due to pain in stomach, back and left leg.His pain was sharp.On (b)(6) 2012: the patient presented for office visit.Impression: osteoarthritis, gastritis, chronic abdominal pain, anxiety with depression disorder.On (b)(6) 2012: the patient presented for a follow up visit with chief complaint of anxiety depression and diabetes.On (b)(6) 2012: the patient presented for office visit.On (b)(6) 2012: the patient presented for a follow up visit with chief complaint of cirrhosis of liver and (b)(6).On (b)(6) 2013: the patient presented for an office visit with low back pain and leg pain.Patient fell on grass that morning and has pain in the lower back.The pain radiates in the upper legs and becomes worst with jarring and movement.Patient also had muscle spasms and mild distress.On (b)(6) 2013: the patient presented for a follow up visit with pain management, low back pain, abdominal pain and leg pain.On (b)(6) 2013: the patient presented for a follow up visit with chief complaint of abdominal pain, neck pain, leg pain, ear pain, hip pain and low back pain.Patient stated he had been diagnosed with cancer.Assessment: cervical pain, etiology unclear, newly diagnosed cancer, sacroiliac joint pain, low lumbar pain, lumbar radiculopathy, acute left lumbar pain, coagulopathy, esophageal varices, hematuria, nausea.On (b)(6) 2013: patient presented for an office visit with abdominal pain and underwent ct of abdomen and pelvis impression: no acute process in the abdomen or pelvis.Morphologic changes or cirrhosis.Clinical correlation is recommended.Splenomegaly as above.No focal hepatic lesion is identified.Pulmonary findings as detailed above in the chest section.An 8 mm right middle lobe and approximately 1 cm spiculated region within the subpleural region in the left lower lobe.Assessment: fever, shortness of breath, swelling, mass, or lump in chest, diabetes mellitus type ii.On (b)(6) 2013: the patient was admitted upper gi bleed and underwent an egd which revealed esophageal varices which were banded, portal gastropathy and duodenitis.
 
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Brand Name
INFUSE BONE GRAFT
Type of Device
FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
Manufacturer (Section D)
MEDTRONIC SOFAMOR DANEK USA, INC
4340 swinea rd
memphis TN 38118
Manufacturer (Section G)
MEDTRONIC SOFAMOR DANEK
1800 pyramid place
memphis TN 38132
Manufacturer Contact
greg anglin
1800 pyramid place
memphis, TN 38132
9013963133
MDR Report Key5030623
MDR Text Key24150137
Report Number1030489-2015-02090
Device Sequence Number1
Product Code NEK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P000058
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Other
Report Date 07/27/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/26/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date01/31/2010
Device Catalogue Number7510400
Device Lot NumberM110609AAG
Was Device Available for Evaluation? No
Date Manufacturer Received07/27/2015
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/11/2007
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Weight99
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