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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 Headache (1880); Nausea (1970); Neuropathy (1983); Pain (1994); Vomiting (2144); Weakness (2145); Depression (2361); Sore Throat (2396); Sleep Dysfunction (2517)
Event Type  Injury  
Event Description
It was reported that the patient underwent a spine fusion surgery on the lumbar region of her spine from l4-l5 using rhbmp-2/acs.It was reported that the patient's post-operative period has been marked by increasingly severe pain and weakness in her legs.It was reported that the patient developed pain that radiates into her lower extremities and legs.
 
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).
 
Event Description
It was reported that on (b)(6) 2006 the patient was diagnosed with disk disruption at l4-5 and underwent anterior approach to l4-l5 interbody fusion using lt-cages with rh-bmp2/acs.On (b)(6) 2006 the patient was diagnosed with disc disruption, post laminectomy syndrome l4-5.The patient underwent l4-5 lumbar interbody fusion with lt/peek cages and rh-bmp2/acs.Fluoroscopy in the ap position confirmed excellent position of the screw in the mid-line.A complete discectomy was carried out utilizing curettes and pituitary rongeurs.The disc was markedly degenerative and narrowed.Once the discectomy was completed, the disc space was distracted to size 10 and a double barrel distractor was inserted.The disc space was then reamed bilaterally.A size 10x23 lt/peek cage was then packed with rh-bmp2/acs carrier and inserted under fluoroscopic control, one on each side.An additional amount of rh-bmp2/acs carrier was inserted between the cages and laterally to them.Fluoroscopy in both the ap and the lateral position confirmed the excellent position of the cages.On (b)(6) 2008 the patient underwent cr spine lumbar 2 or 3 views.The ap and cone-down views of the lumbar spine were compared to prior study dated (b)(6) 2007.Impression: suspicion of an acute mild compression fracture of the superior endplate of t12.Post surgical changes at l4-5.On (b)(6) 2009 the patient presented for an office visit.On (b)(6) 2009 the patient presented with epigastric pain.The patient underwent sequential axial contrast enhanced ct scans of the abdomen and pelvis.The ct scan was compared.Impression: retained stool.No evidence for colitis or bowel thickening at this time.No bowel obstruction.Schmorl¿s node with t12 with apparent minimal central loss of height needs clinical correlation.Post surgical changes at l4-l5.As per plaintiff factsheet: patient had fusion surgery with anterior approach.Currently patient complaints of extreme pain in lower back.Pain radiating from back to left leg following on-the-job injury.2005-2006: patient was diagnosed with extreme back pain,radiating pain, osteoarthritis and depression,radiating pain in legs, hospitalized 3 times for severe depression, difficulty sleeping 2012: patient underwent surgery due to breaking of 2 bones in left wrist.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that on, on (b)(6) 1986, patient presented in emergency department for complaint of banged toe nail.On (b)(6) 1986, patient presented in emergency department for complaint of head congestion, fever, sore throat and bilateral earache since morning with nausea.On (b)(6) 1986, patient presented in emergency department for complaint of bilateral headache going to the temporal area.On (b)(6) 1986, patient presented in emergency department for complaint of lump on right areola.On (b)(6) 1986, patient presented in emergency department for complaint of bitemporal throbbing headache since waking up in morning.On (b)(6) 1987, patient presented in emergency department for complaint of right sided headache.On (b)(6) 1987, patient presented in emergency department for migraine headache.On (b)(6) 1987, patient presented in emergency department for sore throat which radiates to left ear.On (b)(6) 1987, patient presented in emergency department for headache.On (b)(6) 1987, patient presented in emergency department with injury to right side of face after an altercation.Patient underwent x-ray of facial bones which didn't show any abnormalities, right zygomatic arch was normal as well.On (b)(6) 1987, patient presented in emergency department for complaint of severe left sided migraine headache associated with nausea.On (b)(6) 1987, patient presented in emergency department for complaint of severe left sided frontal headache associated with nausea and some photosensitivity.On (b)(6) 1988, patient presented in emergency department for complaint of severe right sided frontal headache associated with nausea.On (b)(6) 1988, patient presented in emergency department for complaint of left sided throbbing headache associated with nausea.On (b)(6) 1988, patient underwent bilateral mammography.Impression: benign bilateral mammograms without radiographic evidence of malignancy.On (b)(6) 1988, patient presented in emergency department for complaint of migraine headache.On (b)(6) 1988, patient presented in emergency department for complaint of severe left sided headache.On (b)(6) 1988, patient presented in emergency department for complaint of right temporal headache for a couple of days.On (b)(6) 1988, patient presented in emergency department.Patient reported back pain after slipping on concrete and landing on back.Patient underwent x-ray of ls spine which showed no fracture or boney abnormalities.On (b)(6) 1989, patient presented in emergency department for complaint of left sided headache.On (b)(6) 1991, patient presented in emergency department for complaint of migraine headache with nausea for two days.On (b)(6) 1993, patient presented in emergency department for complaint of bilateral headache and nausea.On (b)(6) 1993, patient presented in emergency department for complaint of migraine headache.Patient reported 3-day history of left retro-orbital headache and nausea.On (b)(6) 1993, patient presented in emergency department for complaint of recurrent migraines.On (b)(6) 1996, patient presented in emergency department for complaints of pain and swelling behind right ear.Patient underwent x-ray of right mastoid which was negative.On (b)(6) 1996, patient presented in emergency department for abdominal pain.On (b)(6) 2005 as per billing records patient underwent x-ray exam of wrist, 2 views.Impressions: right carpal tunnel syndrome.Ulnar sided wrist pain with likely ecu tenosynovitis.Patient was injected with therapeutic, carpal tunnel.On (b)(6) 2005 patient presented due to the following diagnosis: bilateral carpal tunnel syndrome.On (b)(6) 2005 as per billing records patient presented for an office visit due to the following diagnosis: right carpal tunnel syndrome with negative electrical studies.Ulnar sided wrist pain with likely edc tenosynovitis.Possible sensory branch of radial nerve neuritis.Impression: the patient is having difficulty with carpal tunnel syndrome symptoms on the right side.On (b)(6) 2005 patient underwent the following surgery: right carpal tunnel release to treat the following diagnosis: right carpal tunnel syndrome.Impression: right carpal tunnel syndrome.The patient had failed conservative treatment including cortisone injections.The nature of the problem was explained to the patient.Various treatment options were outlined.The patient now desires to proceed with operative treatment.On (b)(6) 2005 patient presented due to the following diagnosis: bilateral carpal tunnel syndrome with negative electrical studies, status post right carpal tunnel release, ulnar sided wrist pain likely edc tenosynovitis, possible sensory branch radial nerve neuritis.Impression: the patient had noted some difficulty with symptoms of carpal tunnel syndrome on the left side on (b)(6) 2009, patient presented in emergency department for complaint of blood in stool, nausea, vomiting and headache.Patient underwent ct scan of abdomen and pelvis.Impression: long segment narrowing of the transverse colon.Further characterization with virtual or endoscopy colonoscopy may be helpful.Thickening of the sigmoid colon this can be due to underdistention.Chronic diverticulitis not excluded.On (b)(6) 2010, patient underwent x-ray of chest.Impression: negative examination.On (b)(6) 2011, patient presented in emergency department for complaint of back pain, left leg pain.Patient had broken back one year ago and had spinal fusion two years ago.On (b)(6) 2011, patient presented for office visit and reported low back pain.On (b)(6) 2012, patient presented in emergency department for complaint of left wrist pain.Patient underwent x-ray of left wrist.Impression: no acute abnormality.On (b)(6) 2012, (b)(6) 2014, patient presented in emergency department due to crisis.On (b)(6) 2012, patient presented in emergency department for complaint of broken left arm and dislocated shoulder.Patient was in extreme pain.On (b)(6) 2012, patient presented for follow-up on left shoulder.On (b)(6) 2013, patient presented for follow-up on back pain.On (b)(6) 2013, patient presented in emergency department for complaint of migraine headache.Patient underwent ultrasound of abdomen.Impression: unremarkable examination.On (b)(6) 2014, patient presented for follow-up on anxiety.On (b)(6) 2014, patient presented in emergency department for complaint of back pain.On (b)(6) 2014, patient presented in emergency department for a wasp sting.On (b)(6) 2014, patient presented for follow-up on bipolar disorder, smoking and chronic back pain.On (b)(6) 2014, patient presented for follow-up on chronic back pain and bipolar disorder.On (b)(6) 2015, patient presented in emergency department due to pain in left hip because of a fall.On (b)(6) 2015, patient presented for follow-up on back pain and frequent falls.
 
Event Description
It was reported that on (b)(6) 1997, patient underwent x-ray of chest.Impression: normal chest.Patient underwent x-ray of abdomen.Impression: there are multiple calcifications in the pelvis compatible with pelvic phleboliths.A single calcification with apparently lucent center is seen to the left of l4 which may be vascular or representing a calcified lymph node although the possibility of a uretral calculus cannot be unequivocally excluded.Patient underwent x-ray of ribs bilateral.Impression: probable healing fracture of right "lith" rub.No acute fracture is identified.On (b)(6) 1997, patient underwent x-ray of elbow.Impression: normal elbow.Patient underwent x-ray of chest.Impression: normal chest.On (b)(6) 1999, patient underwent x-ray of right ribs unilateral and chest two views.Impression: undisplaced healing fracture of the right posterior 9th rib.No evidence of acute cardiopulmonary disease, including no evidence of right pneumothorax.On (b)(6) 1999 patient underwent x-ray of chest.Impression: essentially unremarkable chest exam.Patient underwent x-ray of ribs bilateral.On (b)(6) 1999, patient underwent x-ray of wrist.Impression: no evidence of acute bony injuries.On (b)(6) 1999, patient underwent ct of lumbar spine.Impression: question of scarring vs a right lateral herniation of the disc material compressing the l4 nerve root on the right.Post-operative changes in the right lamina at l4.Degenerative facet and ligamanetous changes at l4-5 and lesser extent l5-s1.On (b)(6) 2004, patient presented for office visit due to injury to right hand.Patient underwent x-ray of right hand.Impression: no fracture.On (b)(6) 2005, patient underwent mri of lumbar spine without intravenous contrast due to complaint of back pain.Impression: mild to moderate levoscoliosis of the lower lumbar spine with the apex at the l4-5 level, multi-level degenerative changes of the lumbar spine worst at l4-5 with associated circumferential broad-based disc bulge resulting in narrowing of the bilateral neural foramen and compression of the exiting l4 nerve roots, post-operative right sided laminotomy defect at l4-5 level.On (b)(6) 2005, patient underwent mri of cervical spine due to complaint of neck pain and right arm numbness.Impression: mild osteophyte disc complexes within the mid cervical spine with mild ventral ridging of the thecal sac.No evidence of cord compression or significant foraminal stenosis.Only mild right sided foraminal stenosis revealed at c5-6.On (b)(6) 2006, patient presented with complaint of neck and back pain.On (b)(6) 2006 the patient underwent x-rays of the lumbar spine.Impression: stable degenerative changes in the lumbar spine with l4-5 disc replacement.On (b)(6) 2006 the patient underwent x-rays of the lumbar spine.Impression: unremarkable post-operative spine.Stable since the previous.On (b)(6) 2007 the patient underwent x-rays of the lumbar spine.Impressions: stable post op changes at the l4-5 level.No fracture or subluxation.On (b)(6) 2008 the patient underwent cr spine lumbar 2 or 3 views.The ap and cone-down views of the lumbar spine were compared to prior study dated (b)(6) 2007.Impression: suspicion of an acute mild compression fracture of the superior endplate of t12.Post-surgical changes at l4-5.The patient was presented for office visit with chest pain and neck pain.The patient underwent x-rays of the left forearm.Impression: comminuted, mildly foreshortened fracture through the distal radius.Non displaced ulnar stynoid fracture.Also underwent left hand x-rays.Impressions: comminuted, mildly foreshortened, mildly angled fracture through the distal radius.Non displaced fracture through ulnar styloid.The patient underwent chest x-rays.No complication reported.On (b)(6) 2009 patient presented for on office visit due to abdominal pain and diarrhea.Impression: the constellation of crampy abdominal pain, diarrhea with some blood, nausea and vomiting and weight loss with normocytic anemia.Gradually increasing with a long segment of transverse coloric narrowing and segmental sigmoid mural thickening, evokes the strong possibility of crohn's disease.On (b)(6) 2009 patient underwent upper gastrointestinal endoscopy due to recurrent gastroesophageal reflux disease.On (b)(6) 2009 patient discharged from hospital.
 
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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 Key3598237
MDR Text Key4092664
Report Number1030489-2014-00289
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
Report Date 03/17/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/29/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number7510400
Device Lot NumberM115005AAE
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received03/17/2016
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; Required Intervention;
Patient Age00047 YR
Patient Weight59
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