• Decrease font size
  • Return font size to normal
  • Increase font size
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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 Arthritis (1723); Asthma (1726); Bronchitis (1752); Chest Pain (1776); Contusion (1787); Dyspnea (1816); Embolus (1830); Headache (1880); High Blood Pressure/ Hypertension (1908); Muscle Spasm(s) (1966); Neuropathy (1983); Pain (1994); Swelling (2091); Shock, Traumatic (2268); Distress (2329); Injury (2348); Depression (2361); Numbness (2415); Neck Pain (2433)
Event Type  Injury  
Manufacturer Narrative
(b)(4).Neither device nor applicable imaging studies returned to manufacturer for evaluation.
 
Event Description
It was reported that on (b)(6) 2006, patient presented with following pre-operative diagnosis: grade 1 spondylolisthesis at l5/s1.Patient underwent the following procedure: l5/s1 decompressive laminectomies and foraminotomies with posterolateral fusion using bone auto graft, rh-bmp2/acs and pedicle screw instrumentation.Per op notes: the transverse processes were decorticated using the drill.The morselized bone and chopped up sponges soaked with rh-bmp2/acs was packed over the transverse processes bilaterally.No patient complications.On (b)(6) 2006, patient presented with remove sutures from lower back area.On (b)(6) 2006, patient presented with numbness/burning in left fore-arm.Suspect mild trauma with venepuncture at site.X-ray - posterior fusion with l5-s1 with spondylitic spondylolisthesis of l5 on s1.On (b)(6) 2007, patient presented with "under stress", headaches.On (b)(6) 2007, patient presented with back pains and traumatic left median neuropathy.On (b)(6) 2007, patient presented with neck pain.X-ray impressions: bilateral spondylosis of l5 with spondylolisthesis of l5 on s1 of grade i.Comparison is made to a prior lumbar spine mri examination dated (b)(6) 2005.No evidence for significant new neuroanatomic pathology.Posterior fusion l5 s1 with spondylitic spondylolisthesis.On (b)(6) 2007, patient underwent djd cervical spine examination.Impression: no abnormality seen.On (b)(6) 2007, patient underwent for prosthetics because of cervical collar, neck pain.X-ray impression: no abnormality seen.On (b)(6) 2007, patient underwent x-ray due to djd lumbar and neck.Impression: the bone mineral density in the lumbar spine is suggestive of osteopenia and mild fracture risk.The mean bone mineral density of bilateral femoral neck is normal.On (b)(6) 2007, patient presented for "emg" because of pain in lt calf area, djd lumbar, cervical spine pain, left calf pain.On (b)(6) 2007, patient presented to psychiatry because of feeling depressed, esp, disability to work and pain.Examined impressions: mri cervical spine reveals no significant neuroanatomic pathology for patient age.Chief complaint: depression, lower back pain.Lle and joint pain.On (b)(6) 2007, patient presented with chronic illness-compressed nerves and severe back pain.On (b)(6) 2007 patient presented with "mhc" intake.Patient underwent following tests ncs, emg.Conclusion: these findings are indicative of a polyradiculopathy, involving left lumbosacral as well as bilateral thoracic levels.There is evidence of a superimposed mild peripheral neuropathy.On (b)(6) 2007, patient underwent radiology.Impression: posterior fusion l5 s1 with spondylitic spondylolisthesis.No acute abnormality seen.On (b)(6) 2007, patient presented with pain in lower c-spine resulting in muscle spasm in back of neck, with pain.Has mild tenderness in lower spine.On (b)(6) 2007, patient underwent mri examined.Impression: no focal lesions seen in the liver.On (b)(6) 2007, patient underwent bp check.Followed up by neurologist for back pain, chronic neck pain, headache and has been on pamelor.On (b)(6) 2007, patient called and complaint significant pain into legs.Pain with djd.On (b)(6) 2007, patient was admitted with complaint of not feeling well, having following diagnosis: psychotic disorder, deferred, shoulder pain and spondylolisthesis, hyperlipidemia and degenerative joint disease, lower back pain, hypertension.On (b)(6) 2007, patient discharged with following diagnosis: psychotic disorder, deferred, lower back pain, hypertension.On unknown date (b)(6) 2007 patient presented with mania/psychosis.On (b)(6) 2008, the patient was admitted having complaint of chest wall pain, hypertension.Pertinent findings: pulmonary embolus.Underwent ecg, normal ecg.Examined impressions: bilateral pulmonary emboli.Right basal atelectasis.On (b)(6) 2008, patient discharged with following diagnosis: primary pulmonary embolus, venous thromboembolic disease, hypertension, dyslipidemia.On (b)(6) 2008, the patient presented with left leg dvt and bilateral pe.On (b)(6) 2008, the patient presented for follow-up for low back pain with history of prior lumbar surgery with polyradiculitis with probable arachnoiditis, and peripheral neuropathy, burning pains in buttocks area and paresthesias in left foot over sole and left foot cooler than right leg.Physical examination showed spontaneous "restless toe" movements and limping left leg.On (b)(6) 2008, the patient presented with complaints of neck pain and spasm in posterior neck muscles with "ha." on (b)(6) 2008, the patient presented with complaints of sharp pain and difficulty in initiating urination.On (b)(6) 2008, the patient presented with complications of infection in his cavity and swelling on his face.The patient underwent dental filling in 2nd last molar right upper gum.On (b)(6) 2009, the patient was admitted.On (b)(6) 2009, the patient presented with complaints of lower l-spine pain.On (b)(6) 2009, the patient presented for psychiatric evaluation with complaints of lower back pain.On (b)(6) 2009, patient discharged, having following admission diagnoses: psychotic disorder, marijuana abuse/dependence, deferred, hypertension, pulmonary embolus, hyperlipidemia, chronic back pain, chronic illness.Patient discharged with following diagnosis: psychotic disorder, marijuana abuse/dependence, deferred, hypertension, pulmonary embolus, hyperlipidemia, chronic back pain, and chronic illness.On (b)(6) 2009, the patient presented with complaints of pain between shoulder blades, ha and back pain.On (b)(6) 2009, patient examined.Impression: the thoracic spine reveals no significant bony or soft tissue abnormalities for patientage.On (b)(6) 2009, the patient presented for psychiatric evaluation.On (b)(6) 2009, the patient presented with complications of hypertension, hyperlipidemia, neck pain, chronic low back pain, neuropathy.On (b)(6) 2010, the patient called with complications of chronic back pain.On (b)(6) 2010, the patient presented with complications of neck and back spasms.Musculoskeletal examination revealed that the patient used cane, spas city neck and back and slow gait.On (b)(6) 2011, patient underwent ecg, normal ecg.The patient presented with complaint of wheezing and coughs with minimal white sputum.On (b)(6) 2011, patient underwent pulmonary function test, result: addenda.Presented with asthma.On (b)(6) 2011, patient examined.Impression: osteopenia and minimal degenerative change.On (b)(6) 2011, the patient called and reported that his knee hurt more due to a lot of walking.On (b)(6) 2011, the patient underwent x-ray imaging.Impression: osteopenia and minimal degenerative changes.On (b)(6) 2011, the patient called with complaint of pain in right hip and upper leg, sharp pain in middle of noc and worsening since jumping out of bed.On (b)(6) 2011, the patient's x-ray was performed due to complication of lower back pain to the right hip and the pain had worsened by walking, calf pain on the right side.The physical examination result showed no tenderness in palpating lower back, mild tenderness in right lateral hip.Patient underwent radiology.Impression: osteopenia, spondylolisthesis at l5-s1 level and postsurgical changes.On (b)(6) 2012, patient was examined.Impression: musculoskeletal pain, doubt cardiac cause.Underwent ecg, result: abnormal ecg.On (b)(6) 2012, patient presented to psychiatry.On (b)(6) 2012, presented with chief complaint of depression.Result: serious depression.On (b)(6) 2012, patient visited for diagnosis of chronic low back pain, neuropathy, and neck pain.On (b)(6) 2012, patient presented with following problems: veteran with long standing chronic pain, neck-low back pain complicated with dvt has ls radiculopathy.On (b)(6) 2012, patient underwent x-ray.Impression: no significant abnormality seen.On (b)(6) 2013, patient underwent "ncs" and "emg" conclusion: there is no electro physiologic evidence of a right cervical radiculopathy.There is evidence of mild peripheral neuropathy in the upper extremities.There is also evidence of persistence of active and chronic denervation in the left t10/t12 thoracic paraspinal muscles tested today, but not appear as active as prior study in 2007.On (b)(6) 2013, patient presented with chief complaint "pain at the right upper quad." result: chest contusion.Responses: abdominal pain, chest pain, chest injury, dyspnea, trunk wound, skin penetration.On (b)(6) 2013, patient underwent rheumatology.Impressions: articular pain as well in hands/wrists.Ddx could be an inflammatory arthritis vs an underlying hypercoag d/o or even c spine pathology.On (b)(6) 2013, patient was admitted with following diagnoses: 1.Unspecified schizophrenia spectrum and other psychotic disorder.2.Rule out bipolar disorder and cannabis use disorder.Complaint "to smoke weed." on (b)(6) 2013 patient discharged with following diagnoses: 1.Psychotic disorder not otherwise specified (rule out secondary to prednisone secondary to underline rheumatologic disorder secondary to cannabis versus primary psychotic disorder).2.Cannabis use disorder.Patient had following problems: sleeplessness, paranoid.On (b)(6) 2013, patient complaint chronic bronchitis on call.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key5027060
MDR Text Key23936351
Report Number1030489-2015-02064
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
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/25/2015
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
-
-