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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 Abdominal Pain (1685); Biliary Cirrhosis (1736); High Blood Pressure/ Hypertension (1908); Pain (1994); Swelling (2091); Vomiting (2144); Weakness (2145); Dizziness (2194); Ulcer (2274); Ascites (2596)
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
It was reported that on (b)(6) 1993: patient got injured.On (b)(6) 1993: the patient presented with the following impression: slight fracture of the head of the "fifth" metacarpal.On (b)(6) 1993: patient presented with box fall on his right, sustaining a fairly complex fracture of the 5th metacarpal neck.On (b)(6) 1994: the patient went for an office visit due to pain in his right hand.On (b)(6) 1994: the patient presented with the following procedure emg <(>&<)> nerve conduction velocity report and impression: today's electrodiagnostic evaluation reveals the presence of a lesion of the right median nerve at the wrist, consistent with a clinical diagnosis of right carpal tunnel syndrome.This process was demyelinating in nature, with no evidence of an axonal component.Evidence for this diagnosis consists of both absolute and relative prolongation of both the distal motor latency and the distal sensory latencies of the right median nerve.There was no denervation.Today's electrodiagnostic valuation reveals the presence of a lesion of the left median nerve at the wrist, consistent with a clinical diagnosis of left carpal tunnel syndrome.This process was demyelinating in nature, with no evidence of an axonal component.Evidence for this diagnosis consists of both absolute and relative prolongation of both the distal motor latency and the distal sensory latencies of the left median nerve.There was no denervation.Except for the above two noted abnormalities, today's emg and nerve conduction velocity study of both upper extremities and the cervical region was otherwise within normal limits and fails to provide evidence for the electrodiagnosis of radiculopathy, myelopathy, peripheral neuropathy, or other focal/entrapment neuropathies.On (b)(6) 1997: the patient presented with the injury.On (b)(6) 1997: patient presented with low back pain.On (b)(6) 1997: patient underwent lumbar mri.Impression: moderately large soft disc protrusion to the right at l3-4, impressing slightly on the anterior right lateral aspect of the thecal sac and pushing the thecal sac slightly to the left.Degenerative changes of the l4-5 disc with mild diffuse bulging.Small central disc protrusion at l5-s1.On (b)(6) 1997: patient present with the following impression: fecal incontinence possibly secondary to diabetic neuropathy versus lumbar disc impingement syndrome.On (b)(6) 1997: patient present with the following procedure flexible sigmoidoscopy, anorectal manometry.Impression: normal sigmoidoscopy.Normal resting pressure of the internal anal sphincter.Normal contraction but early fatigue of the external anal sphincter.Abnormal rectal sensation with his sensory threshold being at 40 ml but the patient did have a normal anal inhibitory reflex.Normal defecatory urge at appropriate volumes.Inability to expel 50 ml balloon.On (b)(6) 1997: patient went for an office visit for follow up.Diagnosis: herniated nucleus pulposus with associated stenosis.On (b)(6) 1997: patient presented with following preoperative diagnosis: herniated nucleus pulposus, l3-4.Procedure: bilateral laminotomy and discectomy, l3-4.Impression: two portable lateral intraoperative x-rays, the first showing surgical clamp on the lamina of l2, the second showing a probe in the l3-4 disc space.On (b)(6) 1997: the patient underwent ap and lateral views of the lumbar spine were obtained.Impression: minor degenerative spurring.On (b)(6) 1997: patient presented with back pain.Impression: acute low back strain with radiculitis.On (b)(6) 1997: patient went for follow up with a diagnosis of superficial wound infection.On (b)(6) 1997: patient presented with the following diagnosis-acute lumbar contusion secondary to fall.On (b)(6) 1998: patient presented with following diagnosis: herniated disc and infection, wound.On (b)(6) 1998: patient underwent mri of lumbar spine.Impression: postoperative fibrotic changes at the l3-4 level.Size of the sac was markedly reduced from a combination of surrounding enhancing fibrotic change and short pedicles at l3 and l4.On (b)(6) 1998: patient presented with the following impression: subacromial impingement, plus or minus ac joint arthritis.On (b)(6) 1998: patient presented with left shoulder pain.On (b)(6) 1998: patient underwent left shoulder mri.Impression: hypertrophic degenerative disease of the ac joint which projects downward and could cause impingement syndrome.There was some tendinosis of the rotator cuff and on a couple of slices one tiny bright spot that could represent a small incomplete tear along the humeral surface of the cuff.On (b)(6) 1998: patient presented with low back pain radiating to bilateral lower extremities.Impression recurrent stenosis.On (b)(6) 1998: patient underwent the following procedure: lumbar myelogram and post myelogram ct scan.Impression: there was severe spinal stenosis atl3-4 that appears to be secondary to a combination of bulging disc and epidural scarring and probably some ligamentum flavum hypertrophy, although cannot separate the ligamentum flavum from the epidural scar.Review of the mri suggests that a relatively large anterior defect represents scarring but there was still a possibility that there was a recurrent disc protrusion.I have seen a couple of recurrent disc protrusions which did enhance a fair amount if not completely on a gadolinium mri study, probably secondary to a significant amount of granulation tissue in and around the protrusion.Mild diffuse bulging of the disc annulus at l4-5.Small chronic calcified central disc protrusion at l5-s1.On (b)(6) 1998: patient presented with low back pain.Impression: recurrent stenosis.At this time, patient remains markedly symptomatic.We discussed in great detail treatment options.He has failed conservative therapy and his two options would be to live with this problem or undergo surgical intervention which would be re-do lumbar laminectomy and associated fusion and instrumentation, iliac crest bone graft.On (b)(6) 1998: patient presented with history of back problems and a history of disk herniation.Impression: acute exacerbation of chronic lower back pain.On (b)(6) 1998: patient presented for follow up with the following diagnosis of spinal stenosis, recurrent, at the l3-4 level and wishes the possibility of surgical intervention.On (b)(6) 1998: patient presented with upper respiratory infection with significant headache.Assessment: bronchitis.Migraines.On (b)(6) 1998: patient presented with back pain extending down the leg.On (b)(6) 1998: patient presented with following impression: spinal stenosis l3-4 and l4-5.The patient presented with following preoperative diagnosis: recurrent spinal stenosis l3 through l5.Procedure: lumbar laminectomy, partial facetectomy and foraminotomy l3, l4 and l5, posterior lateral fusion l3-4, l4-5, pedicle screw instrumentation l3-4, right posterior iliac crest bone graft.Perop: dissection was then taken out laterally bilaterally over the transverse process of l3, l4 and l5.A horsley bone cutter was utilized to resect the spinous process of l3, l4 and l5.A rongeur was then utilized to thin the lamina.A kerrison punch was utilized to perform a midline laminectomy from l3 through l5.This was taken out laterally bilaterally.Taylor retractor was placed in such a way to avoid the notch and associated contents.The outer table and middle cancellous layers of pelvis reamed using the acetabular reamer.The reamings were saved for bone graft.The bone graft was not noted to be adequate in volume and 5 cc of interpore hydroxyapatite corallin artificial bone graft substitute was mixed in with bone graft.Bone graft was divided in two and then all bony surfaces of l3, l4 and l5 including pars and transverse process were burred using an electric burr.Bone graft was divided in two and packed out laterally bilaterally.On (b)(6) 1998: the patient presented with backpain.Assessment: postoperative lumbar spine pain.On (b)(6) 1999: patient went for an office visit for follow up.On (b)(6) 1999: patient went for an office visit due to headaches.On (b)(6) 1999: patient presented with headache and back pain.Assessment: a patient with a chronic headache and backache here requesting narcotic pain medication.On (b)(6) 1999: patient presented with chronic recurrent headache and lower back pain.Complaining of his typical migraine headache and also some increasing lower back pain.On (b)(6) 1999: patient presented with acute back strain.On (b)(6) 1999: patient presented with exacerbation of chronic back pain.On (b)(6) 1999: patient went for an office visit for follow up.Have significant post laminectomy radiculopathy.On (b)(6) 2000: patient underwent cervical spine 4 views and lumbar spine 3 views.Impression: no evidence of cervical spine fracture, there was calcification in the posterior soft tissues of the lower neck, likely due to old trauma.No fractures or destructive lesions were noted.Note was made of mild diffuse degenerative changes.On (b)(6) 2000: patient presented with worsening pain radiating into the bilateral lower extremities.Xrays impression: ap, lateral, flexion/ extension of the lumbar spine show a possible halo effect around the left side of the l3 screw.On (b)(6) 2000: patient presented with mri of lumbosacral spine.Impression: postoperative changes were identified at l3-4.There was a little enhancing mass lesion centrally and towards the right which probably represents some minimal fibrosis.No recurrent disease was identified.On (b)(6) 2000: patient presented for evaluation of his left shoulder.Impression: chronic left shoulder impingement syndrome with ac joint arthrosis.On (b)(6) 2000: patient underwent ct scan of the lumbar spine.Impression: stable appearing fusion at l3-4.Some postoperative scarring changes at l4-5.On (b)(6) 2003: patient underwent limited lumbar spine.Impression: no interval change in the osteopenia.No malalignment or acute fracture.Unchanged fusion hardware at l3- l.4.On (b)(6) 2004 the patient presented with complaint of left shoulder pain.Assessment: chronic pain.On (b)(6) 2004: patient underwent lumbar spine mri.Impression: protruding disc l3-4 to the left but with some enhancing scar present at this level also.Minimal central disc bulge at l4-5 not contacting the thecal sac.A moderate central bulge was seen at l5-s1 and also does not contact the thecal sac.Post-surgical changes l3-4 and l4-5.On (b)(6) 2004: patient presented with low back pain with left sciatica.On (b)(6) 2004: patient presented with acute increase in back pain.Impression: possible pseudoarthrosis, now indicated for myelogram post myelogram cat scan to further delineate extent above of associated neurologic impingement.On (b)(6) 2004: patient underwent post myelogram ct.Impression: there appears to be a moderate degree of spinal stenosis at l3-4.Prominent epidural defect was seen as well as hypertrophic changes from the posterior elements and prominent ventral spurring off the end plates, particularly the inferior end plate of l3.The myelogram does show some slight dynamic impressions upon the posterior aspects of the thecal sac.Additionally, there appears to be separation of the right vertical rod from the head of the right l4 pedicular screw, and there was radiolucency surrounding the left l4 pedicular screw, suggesting loosening.Findings were suggestive of a left paramedian disc herniation at l4-5.There appears to be a chronic small central disc herniation at l5-s1 with minimal impression upon the ventral aspect of the thecal sac of questionable clinical significance.The size of the bony canal appears to be generally slightly small, but the thecal sac was even smaller, explaining the extreme difficulty in obtaining "c.S.F.As there was very little "c.S.F." surrounding the "conus" and roots of the cauda equina due to the small size of the sac.On (b)(6) 2004: patient underwent persantine myoview myocardial perfusion imaging.Impression: the persantine electrocardiogram was negative.Normal persantine myoview myocardial perfusion imaging study.Normal left ventricular side wall thickness and motion.Preserved left ventricular function.On (b)(6) 2004 the patient underwent chest x-ray ap and lateral.Impression: degenerative changes of the t-spine.On (b)(6) 2004, (b)(6) 2005 the patient presented with complaints of chronic low back pain with the radicular symptoms in the left leg.Musculoskeletal: there was some paraspinous muscle spasming in the left lumbosacral region and at the left si notch.Assessment: chronic low back pain with radiculopathy.On (b)(6) 2005: patient presented with low platelet counts and thrombocytopenia.On (b)(6) 2005: patient presented with itp that was immune related.On (b)(6) 2005 the patient presented with complaints of migraine type headache.Assessment: acute cephalgia related to diabetes, poorly controlled; related to decadron therapy and urinary hesitancy, suspect related to narcotic usage; idiopathic thrombocytopenic purpura.On (b)(6) 2005: patient presented with fairly significant hyperglycemia.On (b)(6) 2005, patient went for an office visit for follow up.On (b)(6) 2005 the patient underwent ct of head due to headache.Impression: normal unenhanced c.T.Brain.On (b)(6) 2005 the patient presented with complaints of low back pain radiating to the lower extremity.On (b)(6) 2005 the patient presented with the following pre-op diagnosis: pseudoarthrosis with recurrent stenosis and retained hardware, l3-4.Herniated nucleus pulposus, l4-5.The patient underwent: lumbar laminectomy and partial facetectomy and foraminotomy, l3-l4.Removal non-segmental pedicle screw instrumentation.Reinsertion of non-segmental pedicle screw instrumentation.Posterolateral fusion at l3-4.Left posterior iliac crest bone graft.As per op notes, there was noted to be obvious pseudoarthrosis bilaterally and hardware at l3-4.The locking screws were removed outer and inner, and then the rod was removed and the screws were removed.Intra-op, no gross disc herniation was noted and adequate decompression of the neurologic structures was obtained.Then attention turned to placing pedicle screws through the previous pedicle screw sites on the patient's right side.The pedicle screws were placed using the multiaxial titanium pedicle screws.On the left side we used the same hole at l3.However, at l4 a new hole was drilled.Intraoperative lateral x-rays documented good position and good length of screws.The appropriate-sized rod was placed, bent to the appropriate lordosis.It was placed between the screws.Locking screws were then placed using torque-anti-torque device to tighten down and snap the heads off.Bone graft divided in two and packed out laterally bilaterally the left posterior iliac crest bone.A titanium crosslink was placed between the rod and tightened down for added stability.The patient tolerated the procedure well without complications.On (b)(6) 2005 the patient underwent c-arm intra-op.Findings: metal screws were seen through the posterior aspects of l3 and l4.Alignment appears to be close to anatomic.No acute fractures of the vertebral bodies were noted.There was some disc space narrowing at the l3-4 disc space.On (b)(6) 2005 the patient underwent x-rays which reveal post-op changes l4-5 and l3-4.Myelogram and post-myelogram cat scan was significant for spinal stenosis at the l3-4 level and herniated nucleus pulposus left l4-5.Impression: pseudoarthrosis, recurrent stenosis.On (b)(6) 2005: patient went for an office visit for follow up of his lumbar spine.On (b)(6) 2005 the patient presented with following pre-op diagnosis: degenerative disc disease l3-4.The patient underwent: left retro peritoneal exploration and exposure of l3-4 interspace.08 mar 2005 the patient with history of low back pain presented with following preoperative diagnosis: pseudoarthrosis l3-4, status post redo lumbar laminectomy and fusion.The patient underwent: anterior lumbar interbody fusion l3-4, lumbar interbody fusion cage l3-4, anterior instrumentation lumbar spine, left anterior iliac crest bone graft.As per op notes, gross diskectomy was performed.Then an appropriate sized fusion cage trial was impacted.The peek fusion cage was opened which was packed with rhbmp-2/acs bone morphogenic protein.The cage was then impacted and placed and noted to have excellent purchase in the bone.Both ap and lateral fluoroscope image documented good position on the lateral aspect of the cage and anteriorly.The morselized autograft bone graft was then placed.Next, using a starting awl a titanium screw and buttress washer was placed in the body of l3 buttressing the fusion cage cover.The patient tolerated the procedure well and without complication.On (b)(6) 2005: patient presented with pseudoarthrosis of the lumbar spine.Impression: single view lateral lumbar spine showing status post lumbar interbody fusion with fusion cage and buttress screw and washer.On (b)(6) 2005: patient presented for follow up of his lumbar spine.X-rays show good position of hardware and bone graft.On (b)(6) 2005: patient underwent lumbar spine two to three views.Impression: previous l3-4 laminectomy and fusion with an anterior lag screw within the inferior aspect tithe l3 vertebral body.Callus formation at the anterior aspect of the endplate of l4 suggests healing fracture injury.Narrowed l3-4 intervertebral disc space.Mild to moderate l4-5 and l5-s1 facet arthropathy.On (b)(6) 2005: patient underwent mri of the lumbar spine.Impression: evaluation of the neuroforamina.In addition, post-contrasted evaluation in this patient status post bilateral l3 and l4 pedicle screws was also not performed because of the patients inability to complete the examination, due to back pain.Fusion cage at l3-4, without disc space ankylosis.Sequence 4, #6.Probable mild bilateral neuroforaminal narrowing at l2-3, with mild to moderate hypertrophic facet changes bilaterally.Sequence 7, #6, 5.Mild posterior broad-based bulge at l3-4 with difficulty in assessing neuroforaminal patency.There may be mild left neuroforaminal narrowing, or perhaps bilateral foraminal narrowing.Sequence 7, #10.Mild posterior broad-based bulge, with a mild, superimposed, left paracentral protrusion, which does not efface the anterior thecal sac, and questionably narrows the neuroforamina bilaterally.Sequence 7, #14, 13.Mild posterior broad-based bulge, with central, superimposed disc protrusion, which minimally effaces the anterior thecal sac.There may be mild left neuroforaminal narrowing.On (b)(6) 2005: patient underwent mri lumbar spine with and without contrast.Impression: chronic postoperative findings related to anterior and posterior fusion at l3-4.There was degenerative facet arthrosis at l2-3 and l4-5.There was only a minor degree of lateral recess narrowing at the l4-5 level.There were no new disc protrusions causing focal neural compromise.There were no findings of intradural fibrosis/arachnoiditis.On (b)(6) 2007: patient went for an office visit for follow up.On (b)(6) 2010 the patient had following final diagnosis: chronic back pain.On (b)(6) 2010 the patient presented with gi bleeding/vomiting.He also has had some diffuse abdominal pain and bowel movements have become darker and darker with time.Impression: probable repeat esophageal variceal bleed.The patient denies alcoholism vehemently.Airway compromise secondary to continued bleeding.Uncontrolled diabetes mellitus.Hypertension.History of disability.Incomplete data base.The patient underwent diagnostic studies.Abdominal ultrasound which shows course liver echogenicity suggesting diffuse hepatocellular disease such as cirrhosis.Patent right middle hepatic veins with normal directional flow.The portal vein was also patent.Gallbladder was not identified.Egd that was done a bedside with banding of esophageal varices.Final diagnosis: acute gi hemorrhage.Ros neurological: headache, dizziness.On (b)(6) 2010 the patient underwent x-ray of chest 1 view.Conclusion: the endotracheal tube and right internal jugular central venous catheter were in satisfactory position.Borderline to mild cardiomegaly.Clear lungs.On (b)(6) 2010 the patient underwent: emergent esophagogastroduodenoscopy in the icu.Endoscopic variceal ligation times 6.Impression: esophageal varices, grade iv with an active venous jet on the largest varix at the ge junction, treated with endoscopic variceal ligation in a patient who had been previously stabilized with excellent iv access and airway protection.On (b)(6) 2010 the patient underwent chest x-ray 1 view due to respiratory distress.Conclusion: no change since the prior afternoon's exam.On (b)(6) 2010 the patient underwent chest x-ray 1 view due to sepsis, dyspnea.Ventilation management.Findings: endotracheal tube and right internal jugular central line were unchanged.The heart size was normal for this ap technique.There was mild accentuation of the interstitial markings, but no overt edema pattern.No appreciable effusions or focal consolidation seen.On (b)(6) 2010 the patient underwent chest x-ray 1 view due to picc line placement.Conclusion: interval extubation with improved aeration of the left lung base and decrease in basilar atelectasis.On (b)(6) 2010 the patient underwent chest x-ray 1 view due to sepsis, fever.Conclusion: the right upper extremity picc remains in place.The patient was rotated to the left and there was opacity at the left lung base, which obscures the left diaphragm.This could be atelectasis or pneumonia.On (b)(6) 2010 the patient underwent chest x-ray pa and lateral due to chest and fever.Conclusion: borderline cardiomegaly and low lung volumes without acute cardiopulmonary process identified.On (b)(6) 2010 the patient underwent chest x-ray 1 view due to chest pain.Conclusion: no acute cardiopulmonary process and no significant change since the previous study.On (b)(6) 2010 the patient presented with complaints of persistent weakness and swelling.The patient was diagnosed for: ascites.Cirrhosis secondary to fatty liver.Hypomagnesemia.Hypokalemia.Abdominal pain.The patient underwent paracentesis.The patient was discharged in stable condition.Final diagnosis: nausea and vomiting.The patient underwent chest x-ray.Conclusion: normal two view chest.The patient underwent ultrasound abdomen.Conclusion: small nodular liver with increased echogenicity, consistent with cirrhosis.Splenomegaly.Moderate abdominal ascites.On (b)(6) 2010 the patient underwent chest x-ray 2 views due to weakness and shortness of breath.Conclusion: osteoporosis and compression injuries of the mid thoracic spine.The patient underwent ct of brain.Conclusion: normal non-contrast ct of the brain.The patient underwent ct of head due to weakness.Impression: no acute intracranial abnormality.On (b)(6) 2010 the patient presented with altered mental status, headache and confusion.Ct of head for the patient was negative.Musculoskeletal ros: mild edema of the lower extremity.Neuro ros: dull headache with intermittent confusion.The patient was discharged with the following diagnosis: altered mental status, hepatic encephalopathy.Cirrhosis secondary to (nash) nonalcoholic steatohepatitis syndrome.History of esophageal variceal bleeding.Type 2 diabetes.Hypertension-chronic back pain.On (b)(6) 2011 the patient came for a follow-up of end-stage liver disease and varices.Musculoskeletal ros: complains of back pain and fibromyalgia.Neuro ros: complains of paralysis.Assessment: cirrhosis of liver without mention of alcohol portal hypertension.On (b)(6) 2011 the patient presented with right lateral rib cage pain.On (b)(6) 2011 the patient presented with complaints of pain, redness and swelling of the left leg.An ultrasound of his leg was done and shows no deep vein thrombosis.Assessment: patient has an acute cellulitis of his right leg with his diabetes and liver disease.On (b)(6) 2011 the patient presented with pain in left lower extremity.Assessment: cellulitis of the left leg.Diabetes type 2 insulin dependent with current hyperglycemia.Hypertension well controlled at this time.End-stage liver disease.Hypothyroidism.Chronic pain.Dvt prophylaxis.Stress ulcer prophylaxis screening.On (b)(6) 2011 the patient underwent esophagogastroduodenoscopy.Findings: normal vocal cords and hypopharynx.Esophagus demonstrated 3 channels of grade 1 esophageal varices in the distal 1/3 of the tubular esophagus.No stigmata.They readily flattened out with insufflation.The z line was at 39 cm.Stomach demonstrated changes of mild portal hypertensive gastropathy with a lenticular or mosaic mucosa pattern.No junctional or "fundic" varices seen.Pylorus was patent.Duodenum to second portion was unremarkable.On (b)(6) 2011 the patient presented with abdominal pain.The patient underwent x-ray of abdomen 3 ways due to nausea and vomiting.Conclusion: senescent changes of the chest without an acute cardiopulmonary process identified.No bowel obstruction or perforation.Post-surgical changes of the lumbar spine.
 
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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 Key5229022
MDR Text Key31450870
Report Number1030489-2015-03030
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
Type of Report Initial
Report Date 10/19/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/17/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number7510400
Device Lot NumberM114001AAC
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received10/19/2015
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;
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