• 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
Catalog Number 7510400
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Arthritis (1723); Calcium Deposits/Calcification (1758); Chest Pain (1776); Cyst(s) (1800); Dysphagia/ Odynophagia (1815); Edema (1820); Fatigue (1849); Gastritis (1874); Headache (1880); Hypersensitivity/Allergic reaction (1907); High Blood Pressure/ Hypertension (1908); Incontinence (1928); Unspecified Infection (1930); Nausea (1970); Neuropathy (1983); Pain (1994); Loss of Range of Motion (2032); Skin Discoloration (2074); Swelling (2091); Thyroid Problems (2102); Weakness (2145); Burning Sensation (2146); Tingling (2171); Chills (2191); Myalgia (2238); Stenosis (2263); Sinus Perforation (2277); Discomfort (2330); Injury (2348); Depression (2361); Fasciitis (2375); Sore Throat (2396); Numbness (2415); Neck Pain (2433); Nerve Proximity Nos (Not Otherwise Specified) (2647)
Event Type  Injury  
Event Description
It was reported that the patient underwent anterior fusion l4-l5 using rhbmp-2/acs.Post-op, the patient developed increasing low back pain, cramping, associated radiculopathy and numbness in her right leg and foot, and neck pain.The patient continues to experience radiating pain in her low back along with pain, numbness, tingling, and weakness in her right leg.She continues to have severe neck pain with accompanying and debilitating headaches.These serious injuries prevent patient from practicing and enjoying the activities of daily life that she enjoyed pre-operatively.
 
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.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that on (b)(6) 2012, the patient presented with pre-op diagnosis of l4-5 adjacent segment degenerative disk disease , degenerative scoliosis and left disk herniation with foraminal stenosis.The patient underwent stage- 1 total discectomy l4-5 with left foraminal disk herniation reduction and foraminal decompression , intraspinal fusion l4-5 using bmp combined with local autogenous bone graft and peek interbody cage , anterior instrumentation using lumbar plate.Per op-notes, ¿.The interbody device was then packed with bmp soaked sponge pieces combined with local bone graft.The surgeon then placed peek interbody device eccentric to the left to correct the scoliosis.The cage was packed with autogenous local bone graft combined with the bmp soaked sponge ¿.¿ later, the patient underwent stage -2 posterior spinal fusion l4-5 using a putty combined with the local autogenous bone graft , l5-s1 fusion mass exploration , l4-5 non-segmental instrumentation , implantation of indwelling pain catheter.On (b)(6) 2012, the patient got discharged.On (b)(6) 2012: patient presented with back pain.Assessment: low back pain (acute and chronic).On (b)(6) 2012: patient presented for post-op recheck.Diagnoses: two weeks status post l4-5 fusion with challenging pain management with probable opioid tolerance given a history of chronic opioid use.Some urinary incontinence postop of uncertain etiology.On (b)(6) 2012: patient presented with back pain.Assessment: low back pain, neck pain, cervicalgia, fibromyalgia.On (b)(6) 2012: patient presented with low back pain and neck pain.On (b)(6) 2012: patient came for followup after lumbar cervical and lumbar fusion.Diagnoses: status post cervical and lumbar fusion.History of chronic narcotic use and opioid tolerance/dependency.Sedated and slurred speech pattern.On (b)(6) 2012: patient presented with complaint of left shoulder pain.Assessment: rotator cuff injury of the left shoulder.Patient also underwent x-ray of complete shoulder.Impression: negative.On (b)(6) 2012: patient underwent therapeutic exercise.On (b)(6) 2012: patient presented with complaint of chronic pain.Assessment: pain disorder related to psychological fact; esophageal reflux, hyperlipidemia, hypertension.On (b)(6) 2012: patient presented for review of cervical mri.It showed no herniations or stenosis.Patient underwent mri of cervical spine.Impressions: foraminal compromise at c5-6 to the right due to uncinated spur.Protruding disk centrally atc4-5 without significant foraminal compromise.Central broad based angular bulge at c6-7 without significant stenosis.On (b)(6) 2012: patient presented with complaint of possibly a delayed union five months post extension of lumbar fusion to l4-5 and 11 month post acdf at c3-4.Patient also had pain both cervical and thoracic and lumbar regions.Patient also underwent ct of cervical spinal fusion due to neck and bilateral; upper extremity pain.Conclusion: solid interbody fusion at c3-4 and solid interbody and facet fusion at c5-6 without instrumentation loosening.Erosive osteoarthritis involving bilateral c2-3 facet joints with accompanying 2mm degenerative spondylolisthesis.Also erosive and hypertrophic left c7-t1 facet arthropathy and hypertrophic nonerosive osteoarthritis on the right at c4-5 and c6-7.C2-3 bulge/protrusion and c4-5 central protrusion.Residual chronic moderate right c5-6 foraminal stenosis.On (b)(6) 2012, the patient presented with complaint of left shoulder pain with decreased range of motion.The patient underwent shoulder mri.On (b)(6) 2012: patient presented with left arm pain.Assessment: chronic intermittent left arm pain.Patient also underwent chest x-ray.Impression: no failure or pneumonia.Patient also underwent ultrasound of left arm.Impression: normal left arm venous ultrasound.No evidence of ¿dvt¿.On (b)(6) 2012: patient underwent mri of upper extremity joint without contrast.Impression: subtle arthrosis glenohumeral joint with degenerated or torn labrum most suspicious inferior and posterior aspect.Subscapularis tendinosis with possible lateral intrasubstance tearing but no disruption.Supraspinatus tendinosis without significant focal partial or full-thickness tear.Degenerative subcortical cysts posterior humerus at the infraspinatus margin.Mild degenerative changes acromioclavicular joint with subacromial subdeltoid bursitis.On (b)(6) 2012: patient was diagnosed with shoulder pain.On (b)(6) 2012: patient presented with complaint of shoulder pain.Assessment: patient presented with decreased strength, decreased range of motion, increase pain associated with left shoulder pain of multiple pathologies.On (b)(6) 2012: patient presented with complaint of cervical, thoracic and low back pain.Patient¿s lumbar spine x-rays revealed delayed union and possibly going onto a nonunion at l4-5.On (b)(6) 2012: patient presented with complaint of depression and chronic pain.Assessment: dysthymic disorder.On (b)(6) 2012: patient presented with complaint of neck pain with facet arthropathy and degenerative changes at c4-5 with prior fusions at c3-4 and c5-6 and suspect facet-related pain at the c4-5 level.For which patient underwent intraarticular zygapophyseal joint injections at c4-5 on both right and left sides.On (b)(6) 2013: patient presented with complaint of headaches with occipital neuralgia bilaterally.Posterior element pain at the c4-5 level status post fusions at c3-4 as well as c5-6.Pain in the shoulder girdle with trigger points in the rotator cuff region and a labral tear.For which patient underwent right and left sided greater occipital nerve blocks.On (b)(6) 2013: patient presented for pain management follow up with adjacent segment degenerative changes at c4-5 status post acdf at both c5-6 and c3-4 with suspected posterior element pain at c4-5.For which patient underwent medial branch facet nerve blocks bilaterally at the c4 and c5 levels under fluoroscopy.On (b)(6) 2013: patient presented with complaint of headaches, sinus infection with history of cervical facet arthropathy and greater o ccipital neuralgia.On (b)(6) 2013: patient presented with pre-op diagnosis of neck pain with facet arthropathy at c4-5 status post c3-4 and c5-6 fusion.For which patient underwent: percutaneous radiofrequency neurolysis of the left c4, right c4, and right c5 medial branch nerve.On (b)(6) 2013: patient presented with complaint of neck pain.Patient¿s ct scan review revealed c2-3 facet joint erosions.At c7-t1 there was also facet joint arthritis.On (b)(6) 2013: patient presented with complaint of some mild disc degeneration between c3-4 and c5-6 acdfs.Patient also underwent ct of lumbar spine.Conclusion: solid interbody fusion at l4-5 and l5-s1, solid dorsal fusion at l5-s1 and non solid dorsal fusion at l4-5.Intact anterior screw plate instruments and l5 transfacet screws.L4 transfacet screws appear loose especially distally on the left side.Mild central spinal stenosis and right facet hypertrophy at l4-5 due to bulging disc and mild central stenosis at l2-3 also due to bulging disc.No fractures or destructive lesions.On (b)(6) 2013: patient presented with complaint of low back and right leg pain.On (b)(6) 2013: patient presented with complaint of recurrent bilateral right greater than left posterior hip/upper buttock and intermittent leg pain with si joint-related symptoms including pseudo-sciatica.(transfer syndrome).For which patient underwent: intraarticular injection of the right sacroiliac joint following confirmatory arthrogram.Infiltration of the interosseous ligament overlying the right sacroiliac joint (completing treatment of the si joint complex on the right side).On (b)(6) 2013: patient presented with complaint of right leg weakness, status post si injection.On (b)(6) 2013: patient presented with complaint of some residual lower right lumbosacral pain greater than left.On (b)(6) 2013: patient presented with right lower extremity complex regional pain syndrome type 1 for which patient underwent lumbar sympathetic block using a paravertebral approach at the l2 level with fluoroscopically monitored needle placement, injection of contrast and local anesthetic.On (b)(6) 2013: patient has developed a right leg rsd.Patient had some mild swelling in right leg and some mild discoloration to right foot.On (b)(6) 2013: patient presented with complaint of right lower extremity complex regional pain syndrome type 1 (rsd) with a history of postlaminectomy syndrome and chronic l5 radiculopathy.Assessment: transforaminal needle placement at the l5 level on the right under fluoroscopy followed by selective epidural steroid injection.On (b)(6) 2013: patient had developed a right l5 radiculitis.With this dysesthetic pain and hypersensitivity patient had developed ¿rsd¿ on (b)(6) 2013, and (b)(6) 2014: patient presented for smoking cessation.Assessment: nicotine dependence.On (b)(6) 2013: patient presented with complaint of chronic pain, anxiety, stressed.On (b)(6) 2013: patient presented with chronic pain.On (b)(6) 2013: patient presented with acupuncture and main issue of quitting smoking.On (b)(6) 2014: patient was seen today for her cervical, thoracic and lumbar spinal conditions as well as her ¿rsd¿.On (b)(6) 2014: patient presented with complaint of spine discomfort, difficulty in concentrating, feelings of guilt and loss of appetite.Assessment: chronic pain; thoracic spine pain; reflex sympathetic dystrophy (rsd).On (b)(6) 2014: patient presented with complaint of chills, cough, fatigue, generalized weakness, headache and myalgia, ¿uri¿ and cold symptoms.Patient underwent mammogram screening.Impression: no interval change.No evidence of malignancy.On (b)(6) 2014: patient presented with cold symptoms, sore throat.Assessment: sore throat.On (b)(6) 2014: patient presented with gastroesophageal reflux disease (gerd).On (b)(6) 2014: patient presented with complaint of recurrent symptoms of left-sided buttock and leg pain in the setting of postlaminectomy changes with chronic recurrent radiculopathy complicated by complex regional pain syndrome.For which patient underwent, transforaminal needle placement on the left at the l5-s1 level under fluoroscopy followed by selective epidural steroid injection.On (b)(6) 2014 patient presented with complaint of abdominal pain.Assessment: ¿gerd¿, dysphagia, epigastric abdominal pain, obesity.On (b)(6) 2014: patient underwent x-ray of upper gi air contrast and esophagus.Impression: minimal primary stripping wave dysmobility with good clearing of barium from the esophagus.No spontaneous reflux identified.No esophagitis or gastritis with duodenum appearing normal.On (b)(6) 2014: patient presented with pre-op diagnoses as: abdominal pain, gerd, chest pain.For which patient underwent esophagogastroduodenoscopy.On (b)(6) 2014: patient underwent ct of chest abdomen pelvis with contrast due to chest and abdomen pain.Impression: atherosclerotic vascular calcification.No masses or evidence of malignancy.Breast augmentation implants.Spinal surgical changes with hardware fixation.Absent appendix with no diverticular disease evident.On (b)(6) 2014: patient presented with concern of hot flashes, sweats, changes in nails and followup of thyroid issues.On (b)(6) 2014: patient underwent x-ray of abdomen due to bloating.Impression: normal tight upper quadrant ultrasound with no evidence of cholelithiasis or ductal dilation.On (b)(6) 2014: patient presented with complaint of upper neck pain and headaches with advanced spondylosis at the c2-3 level and suspected posterior element pain.For which, patient underwent: medial branch facet nerve blocks c2 and c3 and the c3 primary rami bilaterally (covering the c2-3 zygapophyseal joints and third occipital nerve bilaterally).On (b)(6) 2014: patient presented with complaint of back pain, leg pain and feeling out of control.Assessment: flank pain; hypothyroidism.On (b)(6) 2014: patient underwent nm hepatobiliary imaging with ef.Impression: abnormal exam.Subnormal responses to nepro.On (b)(6) 2014: patient presented with preop diagnosis as: gallbladder dysfunction.For which patient laparoscopic cholecystectomy.Patient tolerated the procedure well with no complications reported.On (b)(6) 2014: patient visited clinic for evaluation of generalized aches and pains.On (b)(6) 2014: patient presented for follow up post cholecystectomy.Assessment: still having regurgitation and pain not improved after the surgery.On (b)(6) 2014: patient presented with bilateral leg pain, generalized muscle weakness and pain.On (b)(6) 2014: patient presented with complaint of shoulder pain and left sided knee pain.Assessment: shoulder pain; osteoarthritis of knee.On (b)(6) 2014: patient presented with complaint of cough.Assessment: chronic cough, esophageal reflux, allergic rhinitis.On (b)(6) 2014: patient underwent x-ray of chest due to chronic cough.Impression: negative exam.On (b)(6) 2014: patient came for a recheck of hypothyroidism.Assessment: hypothyroidism.On (b)(6) 2015: patient presented with complaint of flank pain, right side.Assessment: rib pain on right side; fibromyalgia, hyperlipidemia.Patient underwent x-ray of chest and ribs due to right rib pain.Impression: no acute findings.On (b)(6) 2015: patient presented for a pap smear, breast exam and to discuss hormone therapy.Assessment: cervical cancer screen, other screening mammogram, hot flashes.On (b)(6) 2015: patient underwent mammogram screening.Impression: there is no radiographic evidence for malignancy.On (b)(6) 2015: patient presented lab results and for medical recheck.Assessment: diabetes mellitus, hypothyroidism, depression, hype rlipidemia, ¿rsd¿ lower limb.On (b)(6) 2015, the patient presented was diagnosed with chronic low back pain and underwent ct scan of lumbar spine.On (b)(6) 2015: patient presented with complaint of cough, headache and body aches.Assessment: influenza like illness.On (b)(6) 2015: patient presented with complaint of cough.Assessment: sore throat.On (b)(6) 2015, the patient presented for ct scan of lumbar spine due to chronic low back pain with radiculopathy.Conclusion: moderate circumferential disc bulge at l2-3 & l3-4 with moderate central spinal canal stenosis.There is severe left neural foraminal narrowing and mild right neural foraminal narrowing at l2-3.There is moderate left and mild right neural foraminal narrowing at l3-4.On (b)(6) 2015: patient presented with general low back and spine discomfort.Assessment: history of cervical, lumbar spine fusion; lumbar spine degenerative joint disease, chronic pain management, fibromyalgia.On (b)(6) 2015: patient presented for recheck and refill request.Assessment: type 2 diabetes mellitus without complication; hyperlipid emia; chronic back pain; chronic neck pain; renal insufficiency; creatinine; depression with anxiety; reflex sympathetic dystrophy of right lower extremity; hypothyroidism.On (b)(6) 2015: patient presented with complaint of significant pain across her low back, down to her buttocks upper thigh area.On (b)(6) 2015: patient was diagnosed with low back and si joint pain.On (b)(6) 2015: patient presented with complaint of aching pain in bottom of her heels.Assessment: foot pain, bilateral; plantar fasciitis, reflex sympathetic dystrophy.On (b)(6) 2015: patient presented with complaint of upper respiratory symptoms, including: nasal congestion, runny nose, rhinitis, facial pain, teeth hurt.Assessment: sinusitis, acute.On (b)(6) 2015, the patient presented for left transforaminal l3-4 epidural steroid injection.
 
Event Description
It was reported that on: (b)(6) 2012: patient underwent x-ray, ap/pa and lateral chest.Conclusion: no acute pulmonary disease apparent.On (b)(6) 2013: patient underwent x-ray, left knee, 3 views.Findings: mild degenerative changes in the medial joint space and the lateral patellofemoral joint space.On (b)(6) 2013: patient underwent x-ray chest pa/ap and lateral views.Impression: negative chest.On (b)(6) 2013: patient underwent mri lumbar spine.Impression: small extruded disk at l2-3 the left and also at l3-4 to the left.Previous anterior, posterior fusion of l4-5, l5-s1.On (b)(6) 2015, (b)(6) 2014, (b)(6) 2013, the patient presented for left transforaminal l3-4 epidural steroid injection.
 
Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that on: (b)(6) 2013: patient underwent bilateral full field digital screening mammogram.Findings: the breasts have scattered fibroglanular densities.There is no radiographic evidence of malignancy.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that on: (b)(6) 2012: the patient presented for follow-up.Diagnosis: chronic neck and back pain, chronic anxiety.On (b)(6) 2012: the patient presented for an office visit with chief complaint of left shoulder pain.The patient's condition was complicated due to significant neck pain and a cervical neck fusion with poor healing.On (b)(6) 2012 patient presented for an office visit due to chronic pain.On (b)(6) 2012: the patient presented for follow-up of depression and anxiety.On (b)(6) 2012: the patient presented for an office visit concerned about cough.Patient reported that her tonsils were sore.On (b)(6) 2012: patient presented for follow up of chronic neck and back pain.On (b)(6) 2012: patient presented to clinic to discuss about a fish oil supplement.Impression: shoulder pain.On (b)(6) 2012: patient presented for a preventive health examination.Patient has a hot burning sensation on top of her feet, legs elbows and shoulder blades.Assessment: burning sensation, major depressive disorder.On (b)(6) 2013: patient presented for office visit for follow up on chronic pain.Patient reports intermittent pain and swelling symptoms in her tongue and continues to have a lot of pain in her neck and her lower back which has not fused yet.On (b)(6) 2013: patient presented to clinic concerned about lumps in her inner upper thighs.Impression: folliculitis, gerd, anxiety, hyperlipidemia.On (b)(6) 2013: patient presented for follow up of chronic back pain.Patient reports increased pain in her neck.Patient has received a bone graft stimulator for her lower spine recently.On (b)(6) 2013: patient presented for follow up visit of chronic spinal pain.On (b)(6) 2013: patient presented with chief complaint of left knee pain and general pain syndrome.On examination, left knee is swollen with visible edema.Tenderness at patella and posterior.Mild instability.Increased posterior pressure with flexion suspect related to fluid on knee.Assessment:pain in knee joint with effusion.On (b)(6) 2013: patient presented with complaints of pain and swelling in her left knee.On examination, patient is tender to palpation over the medial femoral condyle and medial tibial condyle.Radiology: mild degenerative changes in the medial joint space and the lateral patella-femoral joint space.Assessment: oa of knee, knee pain.(on b)(6) 2013: patient presented for office visit to discuss her hot flashes.Assessment: menopause syndrome, fatigue.On (b)(6) 2013: patient presents with shoulder pain(left shoulder, torn labrum).Pain started after lifting a heavy object.Patient had a mri which sowed a torn labrum, tendinopathy and generalized oa of the ghj.Assessment: rotator cuff sprain, labral tear of shoulder, tendonitis of shoulder.On (b)(6) 2013: patient presents for follow up of chronic spinal and joint pain.On (b)(6) 2013: patient presented with flare of chronic neck and back pain which started about a week ago.Pain is located in the posterior neck shoulder area and upper back on both sides and is non radiating.Patient has decreased range of motion with rotation flexion and extension of her neck equally bad to all sides.Patient is tender along the paraspinal muscles from the base of the skull through the scapular area.On (b)(6) 2013: patient presents with complaints of continued pain in her left shoulder.Assessment: shoulder arthritis, labral tear of shoulder.On (b)(6) 2013: patient presented for flare of pain in her right leg likely related top chronic low back pain.Patient now has pain on the top and bottom of her foot, around the ankle and up the back of lower leg to the knee.She has numbness on the bottom of her foot.Patient recently had right joint injections that resulted in bilateral leg weakness for several days which is improving but bothersome.On (b)(6) 2013: patient presented for routine health maintenance.Patient has concerns regarding night sweats and sleeping problems due to menopause.Assessment: preventive health care, sinusitis, menopausal hot flushes.On (b)(6) 2013: patient presented with chief complaint having cold with sinus congestion, headache and productive cough.Assessment: bronchitis.On (b)(6) 2013: patient presented for follow up for chronic pain medications and is recently ill with respiratory symptoms including na sal and sinus congestion, chest congestion, productive cough, fatigue and feverish feeling.On (b)(6) 2013: patient presented for medication refills and presents with severe hot flashes.Assessment: major depressive disorder, menopausal hot flushes, nicotine dependence.On (b)(6) 2014: patient presented for follow up of chronic joint and back pain.Patient continues to have significant pain recently especially in her hands.On (b)(6) 2013, (b)(6) 2014: patient presented for follow up visit.On (b)(6) 2014: as per the billing records, the patient underwent x-ray of shoulder.On (b)(6) 2014: patient with history of chronic neck and back from degenerative spine disease comes for follow up.On (b)(6) 2014: patient presented for follow up of chronic degenerative spine and joint disease.On (b)(6) 2014: patient presented for annual health examination.On (b)(6) 2014: patient with history of chronic spine and joint pain and chronic anxiety comes in for follow up and is bothered by constant nausea in the past month.On (b)(6) 2015: patient with history of chronic spine and joint pain presented for follow up.Patient still has lot of pain which is bothersome especially with sciatica lately.She is also having arthritis changes or pain in her hands.Assessment: chronic spine and joint pain.On (b)(6) 2015: patient presented for follow up on gastroesophageal reflux.Impression: patient has gerd and it appears to be responding well to current acid suppressive therapy and behavioral modifications.On (b)(6) 2015, assessment: chronic degenerative spine and joint disease.On (b)(6) 2015: patient with history of chronic neck and back pain and joint pain presented for follow up.Patient is currently having a flare of pain in her lower back.Recent ct scan show moderately severe central and foraminal stenosis above her fusion in mid lumbar spine.Assessment: chronic neck and back pain.On (b)(6) 2015 patient presented for an office visit due to chronic spine and joint diseases.On (b)(6) 2015: as per the billing records, the patient underwent ultrasound.On (b)(6) 2015: as per the billing records, the patient underwent x-ray of knee.On (b)(6) 2015: as per the billing records, the patient underwent x-ray of foot.On (b)(6) 2015: per billing records, patient underwent right and left sacroiliac joint injection.On (b)(6) 2015 patient presented for an office visit due to chronic joint and spine pain.On (b)(6) 2015: per billing records, patient underwent sacroiliac joint injection.On (b)(6) 2015: per billing records patient underwent lumbar transforaminal epidural steroid injection.On (b)(6) 2015 patient presented for an office visit due to degenerative spine disease causing significant neck and low back pain.On (b)(6) 2015 patient presented for an office visit due to degenerative spine disease.On (b)(6) 2015: as per the billing records, the patient underwent x-ray of chest.On (b)(6) 2016 patient presented for an office visit due to bilateral knee pain.On (b)(6) 2016 patient presented for an injection of synvisc into the left knee.On (b)(6) 2016 patient presented for an office visit due to chronic spine pain, chronic anxiety, hypothyroidism.On (b)(6) 2016: as per the billing records, the patient underwent mammogram screening.On (b)(6) 2016: as per the billing records, the patient underwent x-ray of shoulder.On (b)(6) 2016 patient presented for a follow-up visit due to left knee pain.On (b)(6) 2016 patient presented for an office visit due to chronic neck and back pain.
 
Event Description
It was reported that on: (b)(6) 2014: the patient presented with upper respiratory systems including: nasal congestion, runny nose, rhinitis, facial pain, teeth hurt and tired.On (b)(6) 2014, patient presented for follow-up for pain management procedures performed.On (b)(6) 2014: the patient presented with chief complaint of pain everywhere.On (b)(6) 2014: the patient presented with pre-op evaluation and dysfunctional gall bladder.On (b)(6) 2014: the patient underwent 1.4 mci technetium 99m sulfur colloid administered in oatmeal.Impression: normal gastric emptying kinetics.No evidence of gastro paresis or outlet obstruction.On (b)(6) 2015: the patient presented with low back and sacroiliac joint pain.On (b)(6)2015: the patient presented with sinus problem, diabetes and rechecking for lab results.On (b)(6) 2015: the patient presented with sweating symptoms.On (b)(6) 2015: the patient presented with hot flashes.On (b)(6) 2015: the patient presented with chief complaint of uri, cough, head ache and diarrhea.On (b)(6) 2015: as per the billing records, the patient underwent x-ray of chest.Impression: no acute airspace disease.On (b)(6) 2016: the patient presented with increased pain and numbness in hands and fingers.On (b)(6) 2016: the patient presented with complaint of diabetes.On (b)(6) 2016: as per the billing records, the patient underwent mammogram screening.Impression: prostatic margins intact.No internal change.No evidence of malignancy.
 
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
huzefa mamoola
1800 pyramid place
memphis, TN 38132
9013963133
MDR Report Key4555049
MDR Text Key5459086
Report Number1030489-2015-00379
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,Followup,Followup,Followup,Followup
Report Date 08/24/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/27/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date10/31/2014
Device Catalogue Number7510400
Device Lot NumberM111101AAT
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received08/24/2016
Was Device Evaluated by Manufacturer? No
Date Device Manufactured02/02/2012
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 Weight103
-
-