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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
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Wound Dehiscence (1154); Pulmonary Embolism (1498); Adhesion(s) (1695); Anemia (1706); Aspiration/Inhalation (1725); Atherosclerosis (1728); Infarction, Cerebral (1771); Chest Pain (1776); Coagulation Disorder (1779); Cyst(s) (1800); Death (1802); Dyspnea (1816); Edema (1820); Pulmonary Emphysema (1832); High Blood Pressure/ Hypertension (1908); Low Blood Pressure/ Hypotension (1914); Inflammation (1932); Laceration(s) (1946); Left Ventricular Hypertrophy (1949); Nausea (1970); Pain (1994); Pleural Effusion (2010); Pneumonia (2011); Pulmonary Edema (2020); Renal Failure (2041); Urinary Tract Infection (2120); Vomiting (2144); Tingling (2171); Chronic Obstructive Pulmonary Disease (COPD) (2237); Ulcer (2274); Distress (2329); Depression (2361); Numbness (2415); Post Operative Wound Infection (2446); Respiratory Failure (2484); Ambulation Difficulties (2544); Hemorrhage, Subgaleal (2603)
Event Type  Injury  
Manufacturer Narrative
(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.
 
Event Description
Date of death: (b)(6) 2012 per medical records, it was reported that on, (b)(6) 2010: patient underwent chest x-ray due to central line placement.Impression: 1.Right jugular central line positioned in the mid superior vena cava, no evidence of pneumothorax or other acute abnormality.Pre-operative diagnosis: l1 fracture with loose hardware.Patient underwent following procedures: 1.Removal of hardware, l1, l2, l4, l5, and s1.2.Onlay fusion using bone morphogenic protein and bone graft, l1-2, l2-3, l3-4, l4-5 and l5-s1.Per op notes, hardware was then removed.The cross link was removed first.Next, the top-tightening connector screws were removed.The two rods were removed followed by the connectors, and finally the pedicle screws at l1, l2, l4, l5, and s1 were removed.The patient had no pedicle screws at l3.The transverse processes of t12, l1, l2, l3, l4, l5, and the sacral ala were decorticated bilaterally.Earlier in the case, two kits of bone morphogenic protein had been opened.Bone morphogenic protein was applied to the collagen sponge within each kit, and the sponges were then cut in half, resulting in a total of four sponges.Bone graft was placed over each collagen sponge.These were then rolled into cylindrical shapes.Two sponges were placed end to end on the right and two on the left side, spanning between the transverse processes of t12 and the sacral ala.No complications reported.Post-op diagnoses: l1 fracture with loose hardware; superficial wound infection.(b)(6) 2010: patient underwent chest x-ray due to picc line placement.Impression: 1.Left picc tip in the distal superior vena cava.2.Right internal jugular catheter in place with the tip in the distal superior vena cava.No pneumothorax.(b)(6) 2010: it was reported through call that patient's;back was draining and it was not slowing down and was getting worse.It was yellow with blood but no odor.(b)(6) 2010: patient called and reported severe pain.Patient was crying and was upset and asked for stronger medicine.(b)(6) 2010: patient underwent mri lumbar spine with <(>&<)> without contrast due to back pain.Impression: status post removal of hardware from extensive bilateral posterior pedicle screw and metal rod fusion; there is a comminuted fracture to the body of l1 with diffuse marrow edema.Marrow edema is also present at l2 and l3, which could be reactive due to the pedicle screw or could be inflammatory.Similar changes are seen along the superior endplate of s1.There is narrowing of the ap dimension of the spinal canal behind l1 and also behind the l2-l3 disc level due to the rather marked retrolisthesis of l2 in relation to l3.There is considerable granulation tissue present posterior to the lumbar spine and there is elongated serpiginous fluid collecting tracking down the entire length of the paraspinous soft tissues behind the lumbar region, which certainly could be infected.This involves the paraspinous musculature bilaterally and the sub-q soft tissues in the midline.Patient underwent lumbar spine x-ray due to back pain.Impression: 1.Removal of the pedicle screw infusion rods with a comminuted fracture of the l1 vertebral body.2.At least 1 cm of retrolisthesis of l2 with respect to l3.3.Bone graft and laminectomy material again noted.(b)(6) 2010: patient was discharged with following discharge diagnosis: 1.Lumbar wound infection.2.Status post removal of hardware and abscess drainage just last week.3.Anemia.4.Hypoalbuminemia.5.Anasarca which improved.6.History of gastric bypass.7.Osteoporosis.8.Fibromyalgia.9.Bipolar disorder and depression.(b)(6) 2010: patient presented for post operative follow up.Patient was having her wound packed on daily basis.Patient was in moderate amount of distress and was ambulating extremely slow.Examination of wound revealed that the top part of the wound was healing well.(b)(6) 2010: patient underwent sp venous access procedure as patient no longer needed the picc; picc removal.Impression: successful left picc removal by special procedures technologist doug hendricks.(b)(6) 2010: patient presented for post operative follow up.Assessment: satisfactory postoperative course.(b)(6) 2010: patient underwent lumbar spine x-ray.Impression: little change in the alignment, subluxation and fractures of the upper lumbar spine as described, when compared to (b)(6) 2010.(b)(6) 2010: patient presented for evaluation.Patient underwent chest x-ray due to chest pain.Impression: blunting of the right costophrenic angle.Patient underwent cta chest with and without contrast.Impression: 1.Positive study for pulmonary emboli in the proximal left lower lobe branch arteries.2.Resolved bibasilar infiltrates with residual right pleural thickening and right basilar scarring.3.Mild emphysema.(b)(6) 2010: patient underwent chest x-ray due to picc line placement.Impression: picc line at the junction of the superior vena cava and right atrium.(b)(6) 2010: patient was discharged with following discharge diagnosis: 1.Pulmonary embolism.2.Chronic low back pain with history of recurrent lumbar surgeries.3.Chronic postop lumbar wound , 4.Fibromyalgia.5.Hypertension.6.Bipolar disorder.(b)(6) 2010: patient presented status post hardware removal l1 to s1.After being admitted, she was found to have pulmonary embolus and fungal wound infection.(b)(6) 2010: patient underwent lumbar spine x-ray.Impression: post surgical changes.There is fracture involving the inferior posterior aspect of the l1, this has been mentioned previously.There is forward displacement of l3 with respect to l2.There are degenerative changes.(b)(6) 2010: patient presented for post operative follow up.(b)(6) 2010: patient underwent myocutaneous rotational flap closure of her chronically diseased lumbar surgical wound.(b)(6) 2010: patient underwent chest x-ray due to shortness of breath.Impression: hazy right lung base opacity may represent small right pleural effusion with layering and associated atelectasis, developing pneumonia cannot be excluded.Linear left lung base opacity is consistent with atelectasis.(b)(6) 2010: patient underwent chest x-ray due to respiratory distress.Impression: picc line no longer present.No evidence of acute disease in the chest.(b)(6) 2010: patient underwent chest x-ray due to picc line insertion.Impression: 1.Left picc is in satisfactory position.2.Bibasilar opacities with small bilateral pleural effusions.Differential diagnosis includes atelectasis, aspiration or pneumonia.(b)(6) 2010: patient was discharged.(b)(6) 2010: patient underwent right lower leg x-ray due to fall, laceration.Impression: orthopedic device with a staple into the anterior tibial region.Lucency along the cortex that the emergency room felt might be a fracture.I do not believe this is a definite fracture of the tibia at that location.It is only seen in its one projection.Degenerative changes of the knee.(b)(6) 2010: patient underwent g/colon tube check with contrast.Impression: j tube in good position in the jejunum with no extravasation or obstruction seen.(b)(6) 2011: patient underwent g/colon tube check with contrast due to history of malnutrition.Impression: lateral placement of the j tube which appears to have been pulled out of the jejunum and resides lateral to the jejunum with contrast extending into the jejunum following injection of the j tube.The catheter should be replaced.(b)(6) 2011: patient underwent lumbar spine x-ray due to back pain.Impression: post surgical changes.Retrolisthesis of l2 with respect to l3.Patient underwent ct thoracic spine without contrast due to back pain.Impression: multilevel degenerative disk changes.No evidence for acute compression fracture.Patient underwent ct lumbar spine without contrast due to back pain.Impression: 1.Retrolisthesis of l2 on l3.2.No evidence for acute fracture.3.Multilevel postoperative changes of the posterior elements.(b)(6) 2011: patient underwent hip x-ray due to pain.Impression: unremarkable left hip.Patient underwent lumbar spine x-ray.Impression: post surgical change.There is scoliosis to the left.There are degenerative changes.There is spondylolisthesis most pronounced at l2-3, less pronounced at l3-4.(b)(6) 2011: patient underwent chest x-ray due to pain.Impression: prominent pulmonary hila bilaterally.Patient underwent ct head without contrast due to pain.Impression: mild bilateral proptosis.No ct evidence of acute intracranial process.(b)(6) 2011: patient was admitted foe following: 1.Rule out sepsis.2.Hypocalcemia.Patient underwent mri lumbar spine without contrast due to numbness and tingling.Impression: 1.Incomplete evaluation of the draining wound with in the posterior lumbar subcutaneous tissue.Post contrast sagittal and axial t1 fat sat images to the lumbar spine should be obtained.2.No evidence of diskitis.3.Improved bone marrow edema is present with in the l1 vertebra.4.Increased degenerative endplate changes noted within the l2, l3 and l4 vertebral bodies.5.Extensive post operative change with stable acute kyphosis centered at l1.Patient underwent mri t spine without contrast due to numbness and tingling.Impression: extensive postsurgical change is present within the lumbar spine with acute angle kyphosis centered at l1.Please see the mri lumbar spine without contrast report for further details.Otherwise, mild degenerative disc disease is present within the lower thoracic spine.Patient underwent xr abdomen with chest due to nausea.Impression: 1.Trace right pleural effusion.2.Non-obstructive bowel gas pattern.(b)(6) 2011: patient presented with abdominal pain, nausea, vomiting, numbness and tingling in her legs.Patient presented with following pre-op diagnoses: gastrointestinal bleeding, abdominal pain, intractable nausea and vomiting, with previous gastric bypass.Patient underwent esophagogastroduodenoscopy with biopsy and clipping.No complications reported.Post-op diagnosis: 1.Status post gastric bypass.2.Giant anastomotic ulceration just distal to the gastrojejunostomy, with oozing of blood identified.(b)(6) 2011: patient underwent chest x-ray due to picc line insertion.Impression: 1.Picc line in the right atrium and it could be pulled back 4 cm.2.No pneumothorax.Patient underwent chest x-ray due to picc line placement.Impression: picc line in the distal superior vena cava.No pneumothorax.(b)(6) 2011: patient was discharged with following discharge diagnosis: 1.Hypocalcemia, corrected.2.Decubitus ulcer.3.Large anastomotic ulcer.4.Ventricular bigeminy.5.History of gerd.6.History of bipolar disorder.7.History of chronic low back pain.8.History of copd.(b)(6) 2011: pre-op diagnosis: history of anatomotic ulceration with hemorrhage <(>&<)> returns for follow up.Patient underwent eso phagogastroduodenoscopy with biopsy.No complications reported.Post-op diagnoses: status post partial gastrectomy with an inflammation ulceration just distal to the anastomosis without evidence of visible vessel or active bleeding, clips identified, biopsies obtained.(b)(6) 2012: patient presented for follow up evaluation to assess for healing with history of anastomotic ulceration.Patient underwent esophagogastroduodenoscopy with biopsy.No complications reported.Post-op diagnoses: 1.Anastomotic ulceration, mildly improved.2.Evidence of previous gastric bypass procedure.(b)(6) 2012: patient presented with following pre-op diagnoses: 1.Abdominal distress.2.History of gastric ulceration.Patient underwent esophagogastroduodenoscopy with biopsy.No complications reported.Post-op diagnoses: 1.Large ulceration in the proximal stomach, possibly a gastroenterostomy.2.Otherwise negative upper exam.(b)(6) 2012: patient presented with back pain.(b)(6) 2012: patient underwent cta chest due to chest pain.Impression: positive for pulmonary thromboembolism.(b)(6) 2012: patient underwent ct abdomen/pelvis with and without contrast due to abdominal pain.Impression: 1.Small right effusion.2.Left renal cyst.3.Inferior vena cava filter.4.Previous gastric bypass.5.Mild dilatation common bile duct measuring 8.0 to 9.0 mm in maximum diameter.No significant intrahepatic biliary dilatation.No calcified gallstones are noted.(b)(6) 2012: patient underwent vena cavagram due to history of pulmonary emboli as well as deep venous thrombosis.Impression: 1.Relatively unremarkable inferior vena cava showing extensive collateral vessels.2.No intraluminal thrombus is seen within the inferior vena cava at this time.3.Post surgical changes within the abdomen.4.No specific abnormalities are identified.Pre-op diagnoses: intense nausea and vomiting, history of known chronic gastric ulceration.Patient underwent esophagogastroduodenoscopy with biopsy.No complications reported.Post-op diagnoses: 1.Status post gastric partitioning with narrowed area in the proximal stomach with large ulceration.2.Rule out malabsorption.(b)(6) 2012: patient underwent xr ugi with kub due to pain.Impression: postsurgical change consistent with the clinical history of partial gastrectomy and billroth anastomosis.In the mid portion of the stomach in the location of the anastomosis, there are findings felt to represent thickened mucosal folds with a persistent collection of barium, ulceration is considered.(b)(6) 2012: patient was discharged with following discharge diagnoses: 1.Gastric ulcer.2.Pulmonary embolism.3.Deep venous thrombosis.4.Chronic pain syndrome.5.Stage 4 lumbar wound.6.Major depressive disorder.7.Anxiety disorder.8.Fibromyalgia.(b)(6) 2012: patient underwent lumbar spine x-ray as patient fell.Impression: 1.I do not detect any acute fracture or change in alignment at this time in this patient with marked post operative changes and deformity.Patient underwent hip x-ray.Impression: negative pelvis and left hip.Patient underwent chest x-ray.Impression: 1.Port catheter present.2.Lungs clear.(b)(6) 2012: patient underwent chest x-ray due to shortness of breath.Impression: right lower lobe infiltrate.Patient underwent chest x-ray post intubation.Impression: 1.Endotracheal tube in satisfactory position.2.Right lower lobe infiltrate and small effusion.(b)(6) 2012: patient underwent xr abdomen for gi tube placement due to kub, nasogastric tube placement.Impression: nasogastric tube, proximal stomach.Patient underwent chest x-ray post intubation.Impression: 1.Endotracheal tube in satisfactory position.2.Right lower lobe infiltrate and small effusion.Patient underwent xr abdomen for gi tube placement due to nasogastric tube placement.Impression: nasogastric tube curled in the gastroesophageal junction with the tip extending proximally into the distal esophagus.Patient underwent xr abdomen for gi tube placement due to orogastric tube placement.Impression: orogastric tube extends into the proximal stomach.Pre-op diagnoses: 1.Acute renal failure.2.Aspiration pneumonia.3.Mucous plugs.Patient underwent bronchoscopy.No complications reported.Post-op diagnoses: copious amount of secretions and mucous plugs, removed from the right lower lobe.(b)(6) 2012: patient presented with large wound dehiscence in the lumbosacral area with hypotension, coagulopathy.Patient underwent chest x-ray post intubation.Impression: 1.Mild chronic obstructive pulmonary disease changes.2.Tubular devices appear to be in good position.Patient underwent echocardiogram which showed ejection fraction 60-65%.(b)(6) 2012: patient was discharged with following discharge diagnoses: 1.Acute respiratory failure.2.Acute exacerbation of chronic obstructive pulmonary disease.3.Right lower lobe pneumonia.4.Opiate dependence, probable overdose.5.Bipolar disorder.6.Urinary tract infection.7.Sacral wound.8.Medical noncompliance.9.Chronic pain syndrome.10.Personal history of pulmonary embolism.It was reported that per the autopsy report that the patient was found deceased on (b)(6) 2012.Per the report it was stated that cause of death was: acute combined toxic effects of methadone, hydromorphone, temazepam, clonazepam, promethazine and meprobamate.Manner of death was reported as accident.Per autopsy report: the thoracic and lumbar vertebrae have prominent osteophytes.Autopsy findings and diagnoses: 1.Presence of methadone, hydromorphone, temazepam, oxazepam, clonazepam, 7-aminoclonazepam, promethazine and meprobamate in blood.2.Left lower lung lobe edema and congestion.3.Remote thrombi of bilateral branches of pulmonary artery.4.Right pleural fibrous adhesions.5.Pericardial effusion.6.Sparse, acute and chronic epicardial inflammation (histologic finding).7.Moderate to severe coronary atherosclerosis.8.Left ventricular hypertrophy.9.Myocardial scar.10.Nephrosclerosis.11.Left renal cyst.12.Remote infarct of left basal ganglion.13.Status post remote gastric bypass surgery.14.Pigmented thyroid gland.15.Marked curvature of thoracic and lumbar spine.16.Port within left subclavian vein.17.Filter within inferior vena cava.18.Edema of lower legs.19.Left temporal subgaleal hemorrhage.20.Dehisced wound of back.
 
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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 Key5049259
MDR Text Key24957128
Report Number1030489-2015-02170
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 Attorney
Report Date 08/03/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/02/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received08/03/2015
Was Device Evaluated by Manufacturer? No
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 Weight98
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