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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 Abrasion (1689); Arthritis (1723); Asthma (1726); Chest Pain (1776); Cyst(s) (1800); Diarrhea (1811); Dry Eye(s) (1814); Dyspnea (1816); Edema (1820); Fatigue (1849); Fever (1858); Headache (1880); Hearing Loss (1882); Nausea (1970); Pain (1994); Pneumonia (2011); Loss of Range of Motion (2032); Swelling (2091); Thrombosis (2100); Vomiting (2144); Weakness (2145); Dizziness (2194); Myalgia (2238); Hernia (2240); Stenosis (2263); Sinus Perforation (2277); Distress (2329); Discomfort (2330); Malaise (2359); Pharyngitis (2367); Neck Pain (2433); Chest Tightness/Pressure (2463); Fibrosis (3167)
Event Type  Injury  
Event Description
It was reported that on (b)(6) 2008, the patient presented with low back pain and leg pain.X-rays indicated ¿degenerative disk disease of the lumbar spine l4-5 and l5-s1.¿ on (b)(6) 2008, patient underwent caudal epidural steroid injection.On (b)(6) 2008, patient underwent caudal epidural steroid block.On (b)(6) 2008, patient presented with back pain and cough.On (b)(6) 2008, patient underwent caudal epidural steroid injection.On (b)(6) 2008, patient presented for an office visit.Reported that the epidural steroids did not alleviate his symptoms.On (b)(6) 2008, patient presented with degenerative disk disease.The patient underwent a redo l4-l5 laminectomy,discectomy and foraminotomy followed by bilateral decompression at l4-l5 and bilateral decompression at l5-s1, interbody arthrodesis, l4-5 and l5-s1, and posterolateral fusion l4-s1.There were no noted complications.Interfix, rhbmp-2/acs, autologous bone, and posterior instrumentation were used.On (b)(6) 2008, patient presented for post-op follow up.Reported a lot of pain, but has made some improvement.Radiographs indicated ¿previous surgery at l4-l5 and l5-s1 with no acute abnormality demonstrated.¿ on (b)(6) 2008, patient presented with increasing back pain radiating to the lateral aspect of both legs.On (b)(6) 2008, patient presented with complaints of significant back pain and burning into both legs.Lyrica has not helped much.On (b)(6) 2008, nerve conduction study indicated ¿examination of both lower limbs and back is abnormal.There are features of a chronic left l5-s1 radiculopathy superimposed upon a minimal mainly axonal polyneuropathy of the lower limbs.The latter may relate to the patient¿s know diabetic state and may explain some of the continued sensory/pain complaints.There are no signs of other muscle or nerve injury including no evidence for more acute motor root injury.¿ on (b)(6) 2008, patient presented with signs of radiculopathy on the left at l5-s1.Also, a diabeting neuropathy is identified.On (b)(6) 2008, patient presented with lower back pain radiating to the left leg.Cat scan indicated ¿no significant disc herniation or acquired canal stenosis identified.There is mild-to-moderate bony ingrowth into the exiting neuroforaminal at the level of l5-s1 bilaterally, left greater than right.I am unsure of the actual significance of these findings with the presence of any actual nerve root compression.There is considerable amount of soft tissue density seen elevating the thecal sac, startinga t the level of l4, extending to s1, off the posterior walls of the vertebral bodies, most likely representing scar material from previous laminectomies and fusion.¿ on (b)(6) 2008, sonographic imaging of the kidneys indicated ¿no hydronephrosis.Bilateral renal cysts.¿ on (b)(6) 2008, patient underwent reexploration of l5-s1 nerve roots.Per the operative report ¿¿ there was a large amount of scar tissue and compression of the l5 root before it exited around the pedicle¿ there were no signs of instability and no signs of infection.¿ there were no noted complications.On (b)(6) 2008, patient presented for an office visit with complaints of leg pain.The pain is ¿a little bit better, but not that much.¿ on (b)(6) 2008, patient presented with testicular pain.Ultrasound indicated ¿possible slight heterogenous echotexture to both testes¿ minimal hydroceles¿ normal color-flow to both testes.Epididymis not seen.¿ patient reported shortness of breath occurring in a persistent pattern for 5 weeks.On (b)(6) 2008, patient presented with complaints of leg pain.X-rays indicated ¿no acute abnormality demonstrated.¿ on (b)(6) 2009, patient underwent percutaneous lysis of epidural adhesions, l5-s1.On (b)(6) 2009, patient presented with exacerbation of l4-5-s1 failed laminectomy syndrome with epidural fibrosis, t7-8 discogenic disease, l4-s1 granulation tissue, l3-s1 facet arthropathy, diabetic polyneuropathy ,bilateral l5-s1 radiculopathy, bilateral l5-s1 nerve root compression, and l4-s1 discogenic disease.Patient underwent percutaneous lysis of epidural adhesions, l5-s1.On (b)(6) 2009, patient underwent a pain block.On (b)(6) 2010, patient presented with chest pain and difficulty breathing.Patient was admitted to the hospital.Cardiac workup was negative.Patient was discharged on (b)(6) 2010.On (b)(6) 2011, patient presented with lightheadedness, dizziness, headaches, and falls.An mri of the brain indicated ¿no acute intracranial process or intracranial mass lesion.Minimal supratentorial white matter disease is a nonspecific finding with numerous possible etiologies but possibly representing a small vessel vascular disease is chronic white matter ischemic change.Minimal cerebral which is age-appropriate.Mucosal inflammatory disease the ethmoid air cells.Nonenhancing small scalp lesion on the right posteriorly possibly representing sebaceous-type cyst.¿ on (b)(6) 2011, the patient presented with increasing disequilibrium.Patient was diagnosed with movement/ambulation related disequilibrium.On (b)(6) 2011, pathology results of right scalp mass indicated ¿benign epidermal inclusion cyst.¿.
 
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.
 
Manufacturer Narrative
(b)(4).
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that on: (b)(6) 2003: the patient underwent x-ray of chest due to chest pain.On (b)(6) 2003: the patient presented for an office visit for a cardiology consultations that also had some left arm discomfort.Impressions: possible coronary artery disease with, fixed defect by nuclear study but no evidence of ischemia at the present time and very atypical arm discomfort; hypertension; hyperlipidemia.On (b)(6) 2008: the patient underwent for lumbar myelogram, myelogram injection status post l4-5-s1 fusion due to lower back pain.On (b)(6) 2008: patient presented with some compression of the root at the left l5-s1 level.On (b)(6) 2009: patient underwent percutaneous lysis of epidural adhesions, l5-s1.On (b)(6) 2009: the patient underwent ct of lumbar spine w/o contrast due to history of chronic back pain.Conclusion: previous laminectomies from l4 down to the 81 with orthopedic hardware and spacers seen in place.Extensive granulation tissues were noted at these levels which extended into the spinal canal.On (b)(6) 2009: patient underwent x-ray of the cervical spine which revealed degenerative change of the lower cervical spine without ev idence of fracture.Also, x-ray of the bilateral knees with no evidence of fracture.On (b)(6) 2009: patient underwent x-ray of chest which revealed stable degenerative change of the thoracic spine.On (b)(6) 2009, (b)(6) 2011: the patient underwent bilateral lumbar sympathetic nerve block under fluoroscopy.On (b)(6) 2009: the patient underwent ct of chest with contrast due to pulmonary eosinophilia.Impressions: improved appearance lo right lower lobe infiltrate; thickening of the heart septum and left ventricular wall; hypodensities in the bilateral kidneys, likely representing cysts.On (b)(6) 2009: the patient was scheduled for caudal epidurogram, epidural steroids, and percutaneous neuroplasty.On (b)(6) 2009: the patient presented with complaint of abdominal pain and diarrhea.The pain did not radiate.The symptoms have been associated with bloating, diarrhea and nausea.On (b)(6) 2009: the patient presented with chief complaint of increased pain and was scheduled for pain procedure for (b)(6) 2009.Location of pain was low back, left hip, left thigh and left calf.On (b)(6) 2009: the patient presented complaint of return of pain after pain procedure relief wore off.Patient got renewal of medications and was scheduled for (b)(6) 2009.On (b)(6) 2009: the patient presented with complaint of testicular pain and dyspnea.On (b)(6) 2010: the patient presented with complaint of moderate neck pain and back pain in the lower back.Assessment: herniation of i ntervertebral disc, cervicalgia.On (b)(6) 2010: the patient presented with complaint of increased pain in low back, mid back, upper back, neck.For which patient underwent facet joint injections right and left l3-l4.L4-l5, ls-s1.On (b)(6) 2010: the patient underwent left l5 transforaminal epidurogram injection under fluoroscopy.On (b)(6) 2010: the patient was admitted with diagnoses of: chronic back pain; history of hypertension; diabetes mellitus, type 2; hyperlipidemia; depression.The final diagnoses were: atypical chest pain; disk syndrome; diabetes mellitus, type 2; hyperlipidemia (b)(6) 2010: the patient underwent for stress persantine myoview study due to indication of chest pain.Impression: persantine myoview study performed.No clinical or ekg evidence of ischemia.The patient also underwent m-mode and 2-d echocardiogram.Conclusion: normal m-mode study of the heart and normal 2-d study of the heart.The patient underwent x-ray of chest due to chest pain and difficulty breathing.Impression: cardiomegaly with mild pulmonary vascular congestion.On (b)(6) 2011: the patient presented for a physical exam and for red spot on face under right eye with additional complaint of dizziness.On (b)(6) 2011: the patient presented to discuss consultation paperwork.On (b)(6) 2011: the patient presented with a complaint of common cold and underwent evaluation of general x-ray due to indications of cough.Impression: normal chest with no significant change from (b)(6) 2007.Assessment: dyspnea; edema; herniation of intervertebral disc (b)(6) 2011: the patient underwent x-ray of ankle due to pain.Impression: no evidence of fracture; small plantar calcaneal spur.Patient also underwent x-ray of knee due to pain and swelling.Impression: no evidence of fracture; possible suprapatellar joint effusion; no evidence of fracture.On (b)(6) 2011: the patient presented with atypical chest tightness and heaviness which may last for a few minutes.Sometimes epigastric distress, moderate shortness of breath, occasional light headedness, diaphoresis.Patient denied any syncopal episode.Impression: recurrent chest pain, question angina; normal persantine myoview study done last year, question false-negative; moderate exertional shortness of breath; diabetes mellitus; hypertension; dyslipidemia.On (b)(6) 2011: the patient presented for an office visit with his usual atypical chest pain.His cardiac catheterization was done recently and it showed normal coronary arteries, normal left ventricular contractility and function.On (b)(6) 2011: the patient presented with severe swelling and redness of the right leg with some pustular discharge from the abrasion and leg pain impression: acute cellulitis of the right leg; extensive abrasion right leg; ecchymosis right leg.Patient also underwent right lower extremity venous duplex study due to lower extremity edema and pain.Conclusion: somewhat limited study for the calf area.No evidence of deep vein thrombosis in the visualized veins.On (b)(6) 2011: the patient presented for consultation on wound culture positive for oxacillin resistant coagulase-negative staphylococcus.The patient underwent bilateral lower extremity ankle brachial index with segmental pressures.Conclusion: right lower extremity with no evidence of any significant disease.Left lower extremity could not give any conclusion because of non-compressibility of the vessels.However, the waveforms do not indicate any significant disease.There are diffusely calcified vessels bilaterally.On (b)(6) 2011: the patient underwent x-ray of chest due to cough, congestion, difficulty breathing and history of asthma.Impression: minimal asymmetric elevation right hemi diaphragm and minimal cicatrizing atelectatic changes bilaterally.Stable appearance compared to prior study; no new intrathoracic abnormality evident.On (b)(6) 2011: the patient underwent x-ray of chest single view with history of repositioning of picc line and picc line placement.Conclusion: left picc line is in the superior vena cava.It is in good position.On (b)(6) 2011: the patient presented for a follow up visit for cellulitis and leg pain.The patient underwent x-ray of tibia and pibula due to pain.Impression: soft tissue swelling right calf and right ankle with no acute fracture-dislocation.On (b)(6) 2011: the patient presented for a pre-procedure reevaluation, for increased pain, to schedule pain procedures, for medications prescribed, to go over results of previous testing ordered; for testing ordered, for inadequate analgesia, for a new pain and to request different medication.Diagnosis: other chronic pain; pain in joint involving lower leg; other and unspecified disc disorder of lumbar region; unspecified arthropathy involving lower leg.On (b)(6) 2011: the patient underwent ct of cervical spine due to history of radiculopathy.Conclusion: central disc protrusion at c4-c5 indenting into the ventral surface of the thecal sac; spondylitic changes at c5-c6 and c6-c7.Patient also underwent ct of lumbar spine.Conclusion: status post-surgical fusion of l4-s1 with the orthopedic hardware and interbody spacers in good position; neuroforaminal stenosis at l4-l5 and ls-s1 due to degenerative changes.Patient underwent x-ray of chest due to history of swelling, asthma.Impression, stable appearance of the chest; no evidence of acute airspace disease.On (b)(6) 2012: the patient presented with complaint of chest pain.Impression: chest pain, possible unstable angina; coronary artery d isease; history of gastroesophageal reflux disease; history of hiatal hernia; hypertension.On (b)(6) 2012: the patient presented with complaint of leg pain.Symptoms included leg pain, swelling, stiffness, instability, decreased range of motion and calf tenderness.Assessment: edema; vascular disease ¿ peripherial; deep vein thrombosis.On (b)(6) 2012: the patient presented for an office visit complaining of pain in the both mammary area and bilateral parasternal region.Examination of the chest showed tenderness in the left precordial and right precordial region which is similar to the pain he is complaining.Ekg is unremarkable.On (b)(6) 2012: the patient underwent electromyography which revealed chronic denervation approximately in the left l4-l5 and s1 nerve root distribution.On (b)(6) 2012: the patient presented for an annual eye exam.Assessment: presbyopia, dry eye syndrome, diabetes.On (b)(6) 2012: the patient presented with complaint of leg pain.Symptoms included leg pain, swelling, stiffness, instability, decreased range of motion and calf tenderness for which patient underwent venous duplex scan of the left lower extremity due to left calf tenderness and swelling.Conclusion: no evidence of deep or superficial vein thrombosis in the visualized veins.Behind the left knee there was non-color flow cystic mass which may represent a baker's cyst.On (b)(6) 2012: the patient presented with complaint of elevated d dimer and underwent ct ¿ angio chest for pulmonary embolism.Impression: no pulmonary embolism as above; question groundglass like densities bilateral lower lobes may be infectious or inflammatory.Positive d dimer.On (b)(6) 2012: the patient presented with complaint for shortness of breath.Symptoms include fatigue, weakness, chest tightness, cough and wheezing, while symptoms do not include dyspnea, exercise intolerance, lightheadedness, palpitations, orthopnea, chest pain or choking sensation.On (b)(6) 2012: patient underwent imaging due to history of hypertension, diabetes, and hyperlipidemia.Impression: mild interventricular septal thickening and slight sigmoid contour.Lv was hyper dynamic with an ef 70%; mild left atrial dilatation; sclerotic aortic root with borderline prominence.Mitral and aortic motions normal; minimal tricuspid and minimal mitral regurgitation.Normal aortic flow; no pericardial effusion.Same day patient also underwent bilateral carotid duplex study due to indication of diabetes.Impressions: normal carotid duplex study.On (b)(6) 2012: patient presented for a follow up visit, lab test results.Assessment: deep vein thrombosis (suspected diagnosis); herniation of intervertebral disc; diabetes insulin- type ii.On (b)(6) 2012: the patient presented for medication issues, new pain: knee pain - left, knee pain - right, low back pain, mid back pain, neck pain, shoulder pain - left, shoulder pain - right, upper back pain.Assessment: bilateral l5, s1 nerve root compression.On (b)(6) 2012: patient presented with complaint of knee pain.Symptoms include knee pain, swelling, locking and difficulty bearing weight.Assessment: knee derangement; myalgia ¿ traumatic, hearing loss.On (b)(6) 2012: the patient underwent mri of the right knee without contrast due to internal derangement, arthritis right knee.Impression: no evidence of meniscal or ligamentous pathology; small joint effusion.Moderate baker's cyst; degenerative changes and cartilage abnormalities are identified.Patient also underwent mri of left knee without contrast.Impression: radial type posterior horn medial meniscal tear; small subchondral incomplete fracture along the medial femoral condyle with reactive edema.Perhaps related to recent axial load type injury; large joint effusion and baker's cyst.I cannot exclude an underlying synovitis; early developing arthropathy of the medial compartment.Same day patient underwent mri of brain due to recent hearing loss in left ear.Impression: no acute intracranial findings, mild ischemic white matter disease similar to prior examination.Internal auditory canals are appropriate.Right parietal scalp lesion has been removed.New periosteal new bone within the skull adjacent that region.Significance uncertain.On (b)(6) 2012: the patient presented with pre-op diagnosis of bronchiectasis of the bilateral lower lobes, rule out underlying maligna ncy.For which patient underwent: bronchoscopy with transbronchial biopsy of the right lower lobe and left lower lobe under fluoroscopy; bronchial washing.The patient tolerated the procedure well and left the operating room in satisfactory condition.On (b)(6) 2012: the patient presented with medication issues, medication refill and low back pain, neck pain, upper back pain.On (b)(6) 2012: the patient was diagnosed with viral syndrome; gastroenteritis; hemarthrosis; diabetes mellitis type ii.On (b)(6) 2012: the patient presented with medication issues, pain and drug counselling.On (b)(6) 2012: the patient presented with pre-op diagnosis of: tear of the left medial meniscus; osteoarthritis, left knee.For which patient underwent diagnostic arthroscopy, partial left medial meniscectomy.On (b)(6) 2012: the patient presented with chief complaint of acute abdominal pain, nausea, vomiting, generalized weakness, swollen left knee and was admitted due to fever.Impression: possible acute viral syndrome; acute gastroenteritis; dehydration; status post knee arthroscopy, status post left medial meniscectomy; rule out underlying postoperative infection; history of coronary artery disease; history of hypertension; history of chronic obstructive pulmonary disease (copd); history of diabetes mellitus.Patient also underwent cr of chest.Impression: normal examination.On (b)(6) 2012: the patient was discharged with discharge diagnosis of: acute viral syndrome; gastroenteritis; hemarthrosis; diabetes mellitus, type ii; hypertension.On (b)(6) 2012: the patient presented with leg pain, swelling and stiffness.On (b)(6) 2012: the patient presented for pain, scheduling pain procedure and counselled for spinal cord stimulator trial.On (b)(6) 2012: the patient presented for spinal cord stimulator trial.On (b)(6) 2012: the patient underwent ct of head with and without contrast.Impression: normal non-enhanced ct of the brain.On (b)(6) 2012: the patient presented with complaint of headache, sore throat.Assessment: acute pharyngitis; sinusitis- acute; knee de rangement.On (b)(6) 2012: the patient presented with complaint for new pain and pain returned after pain procedure relief wore off.Assessment: chronic pain syndrome, leg pain, sympathetically mediated neuropathic pain syndrome.Dvt.L4-l5, ls-s1 discogenic disease, arthritis of the knees.Mrsa of right leg, peripheral neuropathic pain syndrome.L4, l5 radiculopathy.C5-c6 discogenic disease.L3-l4, l4-l5, l5-s1 facets syndrome failed laminectomy syndrome with epidural fibrosis.L4-l5, l5-s1 failed laminectomy syndrome with epidural fibrosis.Diabetic polyneuropathy.Degenerative arthritic changes of thoracic spine.Infiltrates in right lower lobe, t7-t8 discogenic disease.L4-l5, ls-sl granulation tissue.L3-l4, l4-l5, l5-s1 facet arthropathy.Bilateral l5, si nerve root compression.The patient also underwent blood culture, hematology.On (b)(6) 2012: the patient presented with need of antibiotic post spinal cord stimulator trial.On (b)(6) 2012: the patient presented for a follow up visit of type ii diabetes.On (b)(6) 2012: the patient underwent x-ray of complete lumbar spine and thoracic spine.On (b)(6) 2012: the patient underwent mri of lumbar spine without and with contrast due to worsening of chronic low back pain which revealed no significant degree of stenosis.On (b)(6) 2012: the patient received medical clearance for undergoing following procedures: thoracic laminotomy, stimulator implantation- left, lead insertion to t8.On (b)(6) 2012: the patient was admitted due to hospital due to because of chronic back pain.The patient underwent pain management and in spite of this, the symptoms were persistent, so the patient was admitted for thoracic laminotomy stimulator implantation, left lead insertion t8.The patient tolerated the procedure hell and postoperatively the patient was doing well.On (b)(6) 2013: the patient presented with bacterial pneumonia.Symptoms include productive cough, cough, and general malaise, dyspnea at rest and dyspnea on exertion.Patient also underwent x-ray of chest due to cough.Impression: no visualized abnormalities.On (b)(6) 2013: the patient presented for surgical clearance to have left knee replacement.On (b)(6) 2013: the patient presented with complaint of left knee pain and was admitted for surgical intervention due to history of osteoarthritis of the knee which was manifested by chronic pain and discomfort.On (b)(6) 2013: the patient underwent cr- chest due to cough.Impression: no evidence of interval change or acute process.On (b)(6) 2013: the patient presented for one month follow-up left total knee arthroplasty.Patient¿s x-ray revealed satisfactory alignment and fixation of the implant with no signs of osteolysis or other complicating factors.On (b)(6) 2013: the patient presented for two month follow-up left total knee arthroplasty.On (b)(6) 2013: the patient presented for three month follow-up left total knee arthroplasty with reporting of swelling, mild effusion.On (b)(6) 2013: the patient underwent ct of chest with contrast.Conclusion: essentially normal ct chest.On (b)(6) 2013: the patient presented with complaint of left knee pain, four-month follow-up on a left total knee arthroplasty.On (b)(6) 2013: the patient presented with chief complaint of chest, jaw and neck pain.Diagnoses: left jaw pain, probably secondary to musculoskeletal strain versus the possibility of dentalgia; history of coronary artery disease; history of diabetes mellitus type ii; history of lesion in the scalp.On (b)(6) 2013: the patient presented with complaint of leftknee pain.On (b)(6) 2013: the patient presented for 9-month follow-up on a left total knee arthroplasty.Diagnosis: satisfactory nine-month follow-up left total knee arthroplasty.
 
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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 Key3899608
MDR Text Key19767690
Report Number1030489-2014-02953
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,consumer
Reporter Occupation Attorney
Type of Report Initial
Report Date 07/31/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/27/2014
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 Received07/31/2015
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) Required Intervention;
Patient Weight109
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