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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 7510600
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Chest Pain (1776); Edema (1820); Fatigue (1849); Headache (1880); High Blood Pressure/ Hypertension (1908); Muscle Spasm(s) (1966); Nausea (1970); Neuropathy (1983); Pain (1994); Loss of Range of Motion (2032); Swelling (2091); Weakness (2145); Injury (2348); Numbness (2415); Sleep Dysfunction (2517); Weight Changes (2607); No Code Available (3191)
Event Type  Injury  
Event Description
It was reported that the patient underwent percutaneous posterior spinal fusion.The patient presented with preop diagnoses of l5-s1 disc degeneration with back pain recalcitrant to conservative measures.The patient underwent l5-s1 posterior spinal fusion; segmental instrumentation l5-s1.As per op notes, the patient back was prepped and draped in sterile fashion.Sequential dilators in the metric system were used to dilate over each of the facet joints.Doctor placed a bone morphogenic protein sponge into each of the facet joints and then removed the working cannulas.The screw extenders were hooked together using implantable segmental hardware.A rod was then advanced into the screws without difficulty.On (b)(6) 2007 the patient presented for office visit complaining of back pain.The patient underwent lumbar 2/3 views.X-ray shows the hardware and grafts to be in good position and alignment.Her pain is in the mid-back on the left hand side above the level of fusion.On (b)(6) 2008 the patient presented for office visit.The patient underwent lumbar without contrast followed by conta spine, lumbar.Impression: l4-5: progressive facet arthrosis without neural displacement of foraminal compromise.Clinical correlation for facet s yndrome; l5-s1: discectomy with fusion has been performed.Canal and foramina patent.Pedicle screws present only on the right side at l5 and s1.Clinical correlation required to determine significance of the position of the right l5 pedicle screw.On (b)(6) 2008 the patient underwent x-ray of chest.Impression: no acute abnormality detected.Eleven months post-op, the patient underwent x-ray of lumbar spine.Impression: localization of films.The patient underwent 2-views of lumbar spine.Impression: post operative changes.On (b)(6) 2008 the patient presented with indications as postlaminectomy syndrome, lumbar; chronic, refractory low back pain; postlaminectomy syndrome, lumbar; degenerative disc disease.The patient underwent bilateral l3 dorsal ramus medial branch nerve block; bilateral l4 dorsal ramus medial branch nerve block; bilateral l5 dorsal ramus nerve block; fluoroscopic guidance.As per op notes, after patient brought to operating room her low back was prepped.Quincke-type spinal needles were directed toward the target nerve location: bilateral l4 and l5 transverse process superior articular process junctions; bilateral sacral alar notch.Following gentle negative aspiration through each needle, 0.75 ml of injectate was slowly administered.The needles were restyletted and removed.On (b)(6) 2008 the patient presented for office visit.Patient medications noted.Reportedly, the patient underwent revision surgery due to non-union of her l5-s1 vertebrae.The patient continues to experience pain that radiates into her lower extremities.The patient cannot sit, stand, walk, or recline for more than a few minutes at a time, making it impossible for her to find lasting comfort.
 
Manufacturer Narrative
(b)(4).Neither the device nor applicable imaging study films 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/used 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
Additional information.
 
Event Description
It was reported that on, (b)(6) 2008 ;(b)(6) 2006 ; (b)(6) 2005, the patient presented for follow up.(b)(6) 2008, per medical bills, the patient was admitted for anterior / posterior lumbar or lumbosacral fusion.The patient had removal of implant device and fusion/refusion of 2-3 vertebrae.Recombitant bmp was used for insert.Billing records confirm used of set screws , rhbmp/2 , lined rod.(b)(6) 2009 the patient presented for routine check and underwent bilateral mammograms.Impression: category 2.Benign findings.(b)(6) 2012 the patient presented to the office for her annual exam.(b)(6) 2014 the patient presented to the office for her annual exam and hormone refills.(b)(6) 2014:.The patient underwent digital bilateral mammography.Impression: benign mammograms, category 2 (b)(6) 2015 the patient presented to the office for her annual exam.(b)(6) 2015 the patient presented to the office to undergo lab tests.
 
Manufacturer Narrative
(b)(4).Image review report: (b)(6) 2014 lumbar spine series with myelography initial ap c-arm is taken during injection of contrast into the l5 interspace.Pedicle screws with rods are seen l4-l5-s1 on the right, l4-l5 on the left.Spacer is seen within the l5 disc space.Multiple c-arm views show contrast within the thecal sac without signs of nerve root cut off in the surgical area.Subsequent lateral shows contrast within the thecal sac.Possible stenosis is suggested at l3/4.(b)(6) 2014, postmyelogram lumbar ct shows construct as described above.Large peek ring interbody spacer is seen at l5.Fusion is clearly solid.Facet arthropathy is noted at l3/4.High grade stenosis is noted at l3/4 both central and foraminal.Clips are seen on the right consistent with previous cholecystectomy.No evidence of heterotopic bone is detected on any films.Instrumentation is in satisfactory position.
 
Manufacturer Narrative
(b)(6).(b)(4).
 
Event Description
It was reported that on, on (b)(6) 2007 the patient presented for follow-up.On (b)(6) 2007, patient presented for office visit and reported back pain and hip pain which gets worse with activity and with protracted sitting or standing.On (b)(6) 2007 the patient presented for follow-up with back pain.On (b)(6) 2007: the patient presented with nausea.On (b)(6) 2007: the patient presented with back pain.On (b)(6) 2007, patient presented for office visit and reported back pain and hip pain which gets worse with activity and with protracted sitting or standing.On (b)(6) 2007: the patient presented for office visit for back pain.On (b)(6) 2008: the presented with back pain, muscle spasm.On (b)(6) 2008, patient presented for office visit and reported back pain and hip pain which gets worse with activity and with protracted sitting or standing.Patient reported getting awake by pain and chronic fatigue.On (b)(6) 2008, (b)(6) 2007: the patient presented for office visit.On (b)(6) 2008 the patient presented for follow-up.On (b)(6) 2008 the patient presented for office visit.The patient underwent lumbar w/out contrast followed by conta spine, lumbar.Impression: no disc herniation, canal or foraminal stenosis.On (b)(6) 2008, patient underwent following procedure: bilateral l3 dorsal ramus medial branch nerve block; bilateral l4 dorsal ramus medial branch nerve block; bilateral l5 dorsal ramus nerve block; fluoroscopic guidance.For indications: postlaminectomy syndrome, lumbar; chronic refractory low back pain; postlaminectomy syndrome, lumbar; degenerative disc disease, lumbar.No complications were reported during the procedure.On (b)(6) 2008: the patient presented with hip and leg pain.On (b)(6) 2008, patient presented for office visit and reported back pain and hip pain which gets worse with activity and with protracted sitting or standing.On (b)(6) 2008: the patient admitted with preoperative diagnosis of adjacent segment of breakdown status post l5-s1 fusion with facet pain at l4-5.And underwent removal of hardware l5 and s1 on the right, lumbar decompression at l4, segmental instrumentation at l4 to s1, posterior spinal fusion at l4 to s1, exploration of fusion at l5-s1.On (b)(6) 2008: the patient presented with back and leg pain.On (b)(6) 2008 the patient presented for office visit.Patient reported pain down left leg.On (b)(6) 2008: the patient presented with cough, congestion in chest.On (b)(6) 2009: the patient admitted with chief complaint of low back and right hip pain secondary to failed back syndrome/ lumbar spondylosis.The patient admitted for placement of temporary epidural catheter for narcotic infusion trial.The patient underwent physical examination.Impression: low back and radiating right leg pain secondary to failed back syndrome/ lumbar spondylosis.The patient diagnosed with failed back syndrome and underwent ¿adsdip¿.On (b)(6) 2009: the patient was discharged.On (b)(6) 2009: the patient presented with chronic low back and right hip pain secondary to failed back syndrome and lumbar spondylosis.The patient underwent placement of indwelling intrathecal pump and implantation of programmable subcutaneous pump reservoir.On (b)(6) 2009: the patient presented for office visit with pain.On (b)(6) 2009: the patient underwent xr- c-arm pain management.On (b)(6) 2009 the patient was presented for office visit with nausea, headache and some back pain.Impressions: posterior puncture cephalgia; history of chronic low back and right hip pain secondary to failed back syndrome and lumbar spondylosis.On (b)(6) 2009 the patient was presented for office for follow up.Impressions: post dural puncture headache; chronic low back and right hip pain secondary to failed back syndrome and lumbar spondylosis.On (b)(6) 2009 the patient presented for follow-up.On (b)(6) 2009, (b)(6) 2010 the patient was presented for office visit with low back, right hip and right leg pain, with a history of lumbar radiculitis secondary to failed back syndrome and lumbar spondylosis, now status post intrathecal pain pump placement.Impressions: low back, right hip and right leg pain with lumbar radiculopathy secondary to failed back syndrome and lumbar spondylosis.On (b)(6) 2010 the patient was presented for office visit with chronic low back pain secondary to failed back syndrome, now status post intrathecal pump placement.On (b)(6) 2010 the patient presented for follow-up and reported swelling in ankles and back pain.On (b)(6) 2010 the patient underwent chest x-ray.Impression: cardiomegaly with a small left pleural effusion.On (b)(6) 2010: the patient underwent anesthesis procedure.On (b)(6) 2010: the patient underwent ct arteries w/calcium scoring.Impression: normal extra cardiac exam.On (b)(6) 2010 the patient underwent ct arteries.Impression: normal extra cardiac exam.On (b)(6) 2010 the patient presented for follow-up post catheterization.The patient presented for follow-up.On (b)(6) 2010 the patient presented for follow-up with complaints of dizziness and chest pain.On (b)(6) 2011, (b)(6) 2010 the patient presented for follow-up for chest pain.On (b)(6) 2009 the patient presented for follow-up on (b)(6) 2011 the patient was admitted to the hospital with dehydration and viral gastroenteritis.On (b)(6) 2011 the patient was admitted to the hospital with recurrent abdominal pain, nausea, vomiting and diarrhea.She was hypotensive on presentation.On (b)(6) 2011 the patient presented for follow-up with complaints of persistent nausea.On (b)(6) 2011 the patient presented for follow-up after an episode of gastroenteritis and suspected intestinal dismotility.On (b)(6) 2010: the patient presented with follow up visit with complaint of back pain, numbness left leg.On (b)(6) 2010: the patient presented with back pain and refill.On (b)(6) 2010: the patient presented with check up refils.On (b)(6) 2011: the patient presented with pain for office visit.On (b)(6) 2011: the patient presented with sinus congestion and for check up.On (b)(6) 2011 the patient was presented for office visit with low back and bilateral lower extremity pain, left greater than right, and history of bilateral l5 radiculitis secondary to postlaminectomy back syndrome.Physical examination: straight leg raises are negative bilaterally.She did had some lower lumbar spinous and paraspinous tenderness.Impressions: low back, mainly left lower extremity pain, occasional right lower extremity pain, with l5 radiculitis, probably secondary to post laminectomy back syndrome, status post lumbar fusion, now with flare of pain.On (b)(6) 2011 the patient underwent removal of indwelling intrathecal catheter with explantation of the synchromed ii programmable sub cutaneous pump reservoir.Preoperative diagnosis: desires removal of intrathecal catheter and pump reservoir due to non-use and mild discomfort.Perop notes: pressure points were sufficiently padded and proper positioning was noted.Next, the area overlying the pumo reservoir as well as back and right hemi-abdomen were prepped in the usual sterile fashion and draped including ioban draping.Next, beginning over the programmable subcutaneous pump reservoir approximately an 8cm to 10cm incision was made over the previous inc ision area and carried down to the pump reservoir which was sitting over the rectus fascia.Bovie cautery was used to achieve hemostasis.Blunt dissection was preformed around the pump reservoir.The pump reservoir was removed from the pocket and from the capsule after clipping the permanent sutures which appeared to be ethibond.The pump reservoir was explanted.At this point we attempted to remove the catheter from the abdomen being careful for the catheter not to break.The catheter was removed in its entirely and confirmed by everyone with the marking on the end of the catheter at the end area that the catheter had been removed intact.On (b)(6) 2011: the patient presented with chief complaint of low back and right leg pain, possible failed back syndrome/post laminectomy syndrome.Ros revealed: impression: low back and occasionally right lower extremity pain with lumbar radiculitis secondary to probable post laminectomy syndrome/ failed back syndrome.The patient underwent ¿adsdop¿.On (b)(6) 2011: the patient presented with nausea, vomiting.Ros revealed: musculoskeletal: back stiffness, neurological: numbness, tremors, weakness, psych: depression, insomnia, memory concentration anxiety (b)(6) 2011: the patient admitted with diagnoses of dehydration and viral gastroenteritis.The patient underwent dx chest portable.Impression: satisfactory appearance of the picc line, no acute cardiopulmonary process.On (b)(6) 2011: the patient underwent us upr abdomen.Impression: prior cholocystectomy, no biliary ductal dilatation, normal sonographic appearance of the liver.The patient underwent dx abd series w/pa cheat.Impression: post operative changes nonspecified bowel gas pattern, satisfactory posi tioning of the picc line.No acute cardiopulmonary pathology (b)(6) 2011: the patient presented with chief complaint of abdominal pain.On (b)(6) 2011: the patient presented with flu.Ros revealed: musculoskeletal: back stiffness, neurological: numbness, tremors, weakness, psych: depression, insomnia, memory concentration anxiety.On (b)(6) 2011: the patient underwent endoscopy.Findings: mucosal inflammation noted from the eg junction to the antrum with bile staining.On (b)(6) 2011: the patient presented with chief complaint of flu.Ros revealed: musculoskeletal: back stiffness, neurological: numbness, tremors, weakness.Psych: depression, insomnia, memory., anxiety.On (b)(6) 2011: the patient presented with chief complaint of check up and labs, general health maintenance and back pain.Ros revealed: musculoskeletal: arthralgias, myalgias, back pain, stiffness, psychiatric: depression, insomnia.The patient underwent physical ex amination: musculoskeletal: diminished range of motion, tender to palpation over lower back, psychiatric: depression, flattened.On (b)(6) 2011: the patient presented with chief complaint of djd.On (b)(6) 2011 the patient presented for follow-up after experiencing rectal bleeding.On (b)(6) 2011 the patient presented for follow-up after experiencing chest pain.On (b)(6) 2011 the patient presented for follow-up after experiencing nausea, cardiomyopathy, hypertension and epigastric discomfort.On (b)(6) 2011 the patient presented for follow-up after experiencing nausea, cardiomyopathy, hypertension and epigastric discomfort.On (b)(6) 2011, the patient underwent x-ray chest.Impression:cardiomegaly with no evidence for congestive failure.On (b)(6) 2011: the patient presented for office visit.The patient underwent x-ray of the chest.Impression: cardiomegaly with no evidence for congestive failure.On (b)(6) 2012: the patient presented for follow ¿up visit and reported occasional heart skipping.On (b)(6) 2012, the patient presented for follow ¿up visit.The patient underwent physical examination.Impression: gastroparesis, gerd, gastritis.On (b)(6) 2012: the patient admitted for physical examination.Assessment cardiumyopathy severe, anomalous left vein, moderate to svere mitral regurgitation, hypertension, ventricle ectopy, moderate pulmory hypertension.On (b)(6) 2012: the patient underwent x-ray of the chest.Impression: mild cardiomegaly with no acute pulmonary process.On (b)(6) 2012, the patient underwent implantable cardioverter defibrillator implantation with acute placement of a right ventricular defibrillator lead.On (b)(6) 2012: the patient presented for follow-up.On (b)(6) 2012: the patient presented for office visit for wound check.On (b)(6) 2012, the patient presented for follow-up.On (b)(6) 2012, the patient presented for wound check.On (b)(6) 2012, the patient presented for follow-up and reported weakness.On (b)(6) 2012, the patient presented for follow-up and reported 9 pound weight gain and weakness.On (b)(6) 2012: the patient presented for office visit.On (b)(6) 2012, the patient presented for follow-up and reported dizziness with fear of falling, lack of energy, and sinus drainage.On (b)(6) 2012, the patient presented for follow-up and reported skipping of the heart and occasional episodes of tiredness and poor energy.On (b)(6) 2013 the patient presented for follow-up and reported brief fluttering of the heart and occasional weakness.On (b)(6) 2013 the patient presented for follow-up and reported fatigue.On (b)(6) 2013 the patient presented for follow-up after experiencing nausea and vomiting and epigastric discomfort.On (b)(6) 2013, the patient presented for follow-up with chronic gastroparesis.And reported nausea and vomiting of undigested food p roducts of last night's meal.On (b)(6) 2013 the patient presented for follow-up and reported brief fluttering of the heart and occasional weakness.On (b)(6) 2013 the patient presented for follow-up and reported fatigue.On (b)(6) 2013 the patient presented for follow-up after experiencing nausea and vomiting and epigastric discomfort.On (b)(6) 2014 the patient presented for follow-up after experiencing nausea and vomiting and epigastric discomfort.On (b)(6) 2014 the patient presented for follow-up.On (b)(6) 2014, patient underwent ct myelogram of lumbar spine which showed disk bulge and degeneration above the level of her previous fusion.On (b)(6) 2014, patient presented for office visit and reported back pain and bilateral hip pain.Patient underwent x-ray of lumbar spine 2/3 views.Patient was diagnosed with lumbago.On (b)(6) 2014, patient presented for follow-up evaluation of low back pain radiating down lateral aspects of both legs.Ct myelogram showed right-sided l3-l4 degeneration and disc bulge, above level of her fusion.Past injection gave two weeks of relief.On (b)(6) 2014 the patient presented for follow-up and reported mild edema and dyspnea.On (b)(6) 2015 the patient presented for follow-up after experiencing nausea and vomiting while on a cruise.On (b)(6) 2014 the patient presented for follow-up with nausea.On (b)(6) 2014 the patient underwent x-ray chest.Impression: cardiomegaly.Mild interstitial opacity most prominent in the upper lob es which most likely represents fibrosis.On (b)(6) 2014 the patient presented for follow-up and reported edema.On (b)(6) 2015, patient reported with complaint of knot on back, and soreness in upper thoracic region which had flattened out.On (b)(6) 2015 the patient underwent x-ray chest.Impression: probable confluence of shadows overlying the right apex.Additional images are necessary.The patient presented for follow-up and reported edema.On (b)(6) 2015 the patient underwent x-ray chest.Impression: cardiomegaly; no acute pathology; the focus of density previously described at the right apex is favored to represent a confluence.On (b)(6) 2015 the patient presented for follow-up and reported nausea and vomiting due to flared gastroparesis.On (b)(6) 2015 the patient presented for follow-up and reported edema up and down with pain in feet.On (b)(6) 2015 the patient presented for follow-up.On (b)(6) 2015 the patient presented for follow-up and reported flared gastroparesis with vomiting.On (b)(6) 2015 the patient presented for follow-up and reported some edema on left side and had some trouble with her back.On (b)(6) 2015 the patient presented for follow-up and reported some edema on left side and had some trouble with her back.
 
Event Description
It was reported that on (b)(6) 2005 the patient underwent routine bilateral mammograms.Impression: benign mammograms.On (b)(6) 2005 patient underwent ct scan of head without contrast.Impression: minimal nonspecific white matter low densities most likely related to small vessel disease.On (b)(6) 2005 the patient underwent abdominal ultrasound due to pain.Impression: normal upper abdominal ultrasound.On (b)(6) 2005 the patient underwent cholescintigram with ejection fraction due to pain.Impression: normal exam with normal gallbladder ejection fraction calculated at 92% (b)(6) 2007 the patient presented with nausea with vomiting.On (b)(6) 2007 patient presented with constipation.Patient also underwent ct scan of abdomen.On (b)(6) 2007 patient presented with abdominal pain, nausea with vomiting and anxiety.On (b)(6) 2007 the patient underwent upper abdominal ultrasound due to pain.Impression: normal upper abdominal ultrasound.The patient also underwent gallbladder cholescintigram with ejection fraction.Impression: unremarkable gallbladder cholescintigram with normal ejection fraction.On (b)(6) 2007 the patient underwent ct abdomen with and without contrast due to abdominal pain.Findings: the biliary ductal system is at the upper range of normal in size.No space occupying mass is seen in the liver, spleen, pancreas, adrenals, or kidneys.A few unopacified loops of bowel are present adjacent to the pancreatic tail.There is a large amount of stool throughout the colon.The patient also underwent ct pelvis with contrast.Impression: constipation.On (b)(6) 2007 the patient underwent gastric emptying study due to abdominal pain.Impression: markedly prolonged plateau phase with su bsequent gastric emptying.On (b)(6) 2007 the patient underwent ultrasound of the gallbladder.Impression: negative gallbladder ultrasound.On (b)(6) 2007 patient presented with abdominal pain, nausea with vomiting and anxiety.On (b)(6) 2007 patient underwent cholangiogram due to pain.Impression: normal intraoperative cholangiogram.The patient presented to the office for murmur.Finding: mild mitral regurgitation, post anesthesia follow-up, pain in upper belly suspicious for gallbladder trouble, underwent dx cholangiogram in or with c-arm due to dx ruq pain n/v.Impression: normal intraoperative cholangiogram.On (b)(6) 2007 the patient presented for lap chole, chronic cholecystitis (gallbladder).
 
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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 Key4471397
MDR Text Key5566666
Report Number1030489-2015-00218
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 02/22/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/30/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date09/01/2007
Device Catalogue Number7510600
Device Lot NumberM114003AAK
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received02/22/2016
Was Device Evaluated by Manufacturer? No
Date Device Manufactured12/09/2004
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 Weight75
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