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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 Anemia (1706); Cyst(s) (1800); Dyspnea (1816); Unspecified Infection (1930); Muscle Spasm(s) (1966); Nausea (1970); Neuropathy (1983); Pain (1994); Swelling (2091); Tachycardia (2095); Vomiting (2144); Stenosis (2263); Anxiety (2328)
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) 2012: patient presented with right leg pain and back pain.Patient presented with following pre-op diagnosis: l5-s1 spondylol isthesis with spondylolysis with l5 right sided nerve root compression with disk herniation and severe right l5 radiculopathy with pain and weakness.Procedure: 1) aspiration of bone marrow from right anterior iliac crest.2) removal of abnormal articular processes at the l5-s1 level, with extensive foraminotomies over the l5 and s1 nerve roots bilaterally, with aggressive for lateral discectomy at l5-s1 on the left with decompression of the right l5 nerve root out to the distal pedicle.3) harvesting of local autologous bone graft.4) right sided transforaminal lumbar interbody fusion at the l5-s1 level, using vitoss and locally harvested autograft, with bilateral posterior lateral fusion using vitoss and locally harvested autograft.5) placement of l5-s1 peek 9mm interbody cage.6) l5-s1 non segmental pedicle screw instrumentation using pedicle screws.Per-op: bone aspiration needle was advanced 3 cm into the right anterior iliac crest.The interspinous attachments were removed at l4-5 and l5-s1.The ligamentum flavum was removed with the 1 mm kerrison punch between l4-5 and l5-s1 and then the posterior elements were removed a block with the periosteal elevator.The l5 transverse process, sacral ala was decorticated bilaterally with the high speed drill.The gearshift was used to identify the l5-s1 pedicle.Pedicles were tapped checked with a check probe and under fluoroscopic guidance appropriate sized screws were placed.5.5 x 40 mm screws were placed in the l5 pedicle.And 6.5 x 40 mm screws were placed in the s1 pedicle.Rods were placed in the s1 pedicle and the reduction device was used to reduce the subluxation.A series of trials was used to determine that a 9 mm spacer would be appropriate.The graft bed was packed with vitoss and locally harvested autograft.The space and position checked fluoroscopically and appeared to be acceptable.(b)(6) 2012: patient underwent lumbar spine series 3 views.Impression: interval l5-s1 plif with reduction in degree of previously documented grade 1 anterolisthesis.Stable appearing lumbar dextroscaliosis.Nephrolithiasis, radiographically more conspicuous on the right.(b)(6) 2012: patient underwent lumbar spine ct scan.Impression: status post l5-s1 fusion for bilateral l5 pars defects.L5-s1 anterolisthesis appears improved post fusion comparison with preoperative ct scan.Large amount fecal material in the colon.Bilateral nephrolithiasis.(b)(6) 2013: patient presented with following discharge diagnoses: back pain and superficial back infection.Patient underwent 2 chest views front and lateral.Impression: no radiographic evidence of acute cardiopulmonary disease.(b)(6) 2013: patient underwent lumbar spine mri without iv contrast.Impression: 1) stable postsurgical changes of plif l5-s1 with minimal anterolisthesis of l5 on s1.Fluid and edema tracks superiorly along the subcutaneous soft tissues of the midline back from the level of the surgical incision superiorly to the lower thoracic spine without any well-defined fluid collection.Patchy enhancement along the incision is likely within normal limits for post-surgical change without any suspicious fluid collection or evidence of abscess.(b)(6) 2013: patient underwent 1 view portable chest for pioc plc.Impression: satisfactory position of the right arm picc catheter.No radiographic evidence of an acute chest process.(b)(6) 2012, (b)(6) 2013, (b)(6) 2013, (b)(6) 2013, (b)(6) 2013, (b)(6) 2013, (b)(6) 2013: patient went for an office visit due to right leg pain and back pain.(b)(6) 2013: patient presented with right flank pain which radiates to the right groin.Patient underwent ct scan of abdomen and pelvis without iv contrast.Impression: 1) non obstructing intrarenal calculi bilaterally.2) incidental probable small follicular cysts noted within the right ovary.There is trace free pelvic fluid, most likely physiologic in nature.3) moderate stool and gas content noted within the colon.The appendix is not identified with certainty at this time.If clinically concerning for etiology of patient's abdominal pain.Repeat study with iv contrast may be of use.(b)(6) 2013: patient presented with severe back pain.Patient underwent spine lumbosacral 2/3 views.Impression: status post lower lumbar spine surgery.No change from the previous study.(b)(6) 2013: patient underwent 4 views of lumbosacral spine.Impression: 1) l5-s1 postsurgical changes without acute fracture or mal-alignment.Overall appearance is unchanged from recent lumbar spine radiograph.(b)(6) 2013: patient underwent four views of lumbar spine.Impression: 1) no acute osseous or acute alignment abnormality of the lumbar spine.2) postsurgical changes appear stable.(b)(6) 2013: patient presented with severe leg and back pain.Impression: patient underwent mri of lumbar spine without contrast.Impression: 1) stable postoperative changes at l5-s1.2) stable mild posterior broad based disc protrusion at l5-s1.3) evaluation of the neural foramina is somewhat limited at this level.However no significant neural foraminal narrowing is felt present.4) no new findings from previous study.(b)(6) 2013: patient underwent x-ray of spine lumbosacral min 4 views.Impression: 1) stable appearance status post posterior and interbody fusion at l5-s1.2) mild dextroscoliosis.3) right nephrolithiasis.(b)(6) 2013: patient underwent noncontrast ct axial images through the lumbar spine of sagittal and coronal.Impression: posterior lumbar interbody fusion at l5-s1 with stable grade 1 anterolisthesis l5 on s1.No evidence of hardware loosening.Mild to moderate bilateral foraminal stenosis l5-s1 similar to previous.Bilateral nephrolithiasis.(b)(6) 2013: patient presented with following pre-op diagnosis: leg pain on the right and back pain status post l5-s1 fusion with retained hardware.Procedure: removal of retained hardware at l5-s1 level.2) exploration of fusion.3) posterolateral fusion from l5-s1 using rhbmp-2/acs and allograft.Perop: set screws were removed and the rods were removed uneventfully.The l5 pedicle screw was partially removed on the left and it is clear that it was fractured less than a centimeter from the polyaxial head.The screw from the s1 level on the right was removed and it was also fractured in the same location.At this point, the screwdriver was attached to the l5 pedicle screw on the left and the screw was logged cephalad and caudad to attempt to assess the side of the fusion, but the screw did not appear to be completely solid and it was impossible to tell whether the fusion was solid or not.This was done in the same fashion on the right hand side and the screw appeared to be slightly loose and it was impossible to ascertain whether the fus ion was solid or not.Both the screws were removed completely and then the high speed drill was used to drill down the lateral mass where fusion had been performed or the right and the left.There was evidence of bone growth, but it was again impossible to tell after this exercise whether the fusion was robustly solid or not.The bone around the pedicle on the left was drilled down to decorticate it thoroughly and decorticate more of the transverse process at the l5 level and the s1 level.Rhbmp-2/acs was then placed over the decorticated bone from l5 to s1 bilaterally and then allograft was placed over this as well.Rods and end caps were explanted.(b)(6) 2014: patient went for an office visit for follow up of removal of her hardware due to right leg pain and some back spasm.Patient underwent x-ray of left spine 2 views (ap and lateral).Impression:1) removal bilateral pedicle screws at l5.Partial removal bilateral pedicle screws at s1.2) residual grade 1 spondylolisthesis at l5-s1 with bilateral pars defects.Patient status post anterior fusion.3) discogenic degenerative changes of the lumbar spine are most prominent l4-5.(b)(6) 2014: patient presented with back pain.(b)(6) 2014: patient underwent x-ray of left spine 4 views (ap, lat, flex, ext).Impression: 1) stable appearing 10 degree dextrotoscoliosis, curvature apex l2-3.2) postoperative features as detailed above l5-s1.(b)(6) 2014: patient presented with following impression: nausea of uncertain etiology, cholelithiasis without evidence of cholecystitis.Status post lumbar fusion with infected abdominal wall seroma, completed three weeks of treatment, no evidence of recurrent infection.(b)(6) 2014, (b)(6) 2014: patient presented with chronic back pain, headache, anemia, tachycardia.The patient underwent transfusion.(b)(6) 2014: patient underwent ultrasound of abdomen complete.Impression: patient status post cholecystectomy.The liver is mildly enlarged in size.The liver is increased in size as compared to the previous study.There is no evidence of intrahepatic biliary duct dilatation.(b)(6) 2014: patient underwent right lower pelvic pain, eval ovary.Impression: suspected hemorrhagic cysts in both ovaries.Intrauterine device in place in an otherwise unremarkable uterus.(b)(6) 2014: patient underwent x-ray of lumbar spine 2 views.Impression: mild anterolisthesis of l5 on s1 which is stable to perhaps minimally progress from prior study.There is no gross fracture.X-ray pelvis 1 view (ap) impression: no acute osseous abnormally.X-ray femur (min 2 views)-right.Impression: no acute or significant chronic osseous abnormality.(b)(6) 2014: patient presented with right flank pain and "rlq" abdominal pain.Patient underwent ultrasound of renal complete.Impression: small bilateral renal calculi.Both kidneys are negative for hydronephrosis.No current evidence of obstructive uropathy.Diffusely increased echogenicity of the medullary aspect of both kidneys may reflect underlying medullary nephrocalcinosis.(b)(6) 2015: patient presented with shortness of breath and dehydration.Patient underwent ultrasound of abdomen.Impression: cholecystectomy, no hydronephrosis.(b)(6) 2015: the patient was diagnosed for chronic low back pain, anxiety, renal calculi, lumbago, status post lumbar spinal fusion, sacroiliac joint pain, piriformis syndrome of the right side lumbar radiculopathy post op infection, chronic calculous cholecystitis, kidney stone, ida, intractable low back pain.The patient presented with the following pre-op diagnosis: intrauterine pregnancy, intractable back pain, bilateral lower extremity neuropathy, acuter exacerbation, undesired fertility.The post-op diagnosis were: status post repeat low transverse cesarean section (rltcs).2.Status post total salpingectomy.The patient underwent the following procedure: 1.Rltcs.2.Total bilateral salpingectomy.(b)(6) 2015: the patient presented with bilateral lower extremity pain.X-ray of the lumbar spine dated (b)(6) 2014, showed mild arterolisthesis of l5-s1.Assessment: chronic back pain exacerbated during pregnancy, possibility of irreversible nerve compression.
 
Manufacturer Narrative
(b)(4).(leg pain), (pseudoarthrosis).
 
Event Description
It was reported that on, (b)(6) 2013, patient underwent ct of pelvis/abdomen.Impression: ventral abdominal wall abscess, incrementally decreased size since prior exam.Second, smaller adjacent compression has also decreased in size.Assymetric enlargement of left abdominal rectus muscle at the level of the abscess is suspicious for infectious extension into the muscle; decreased foci of gas within the left retroperitoneum.Likely resolving postsurgical gas.No diascrete retroperitoneal fluid collection; stable nonobstructing right nephrolithiasis and subcentimenter hypodensity, likely a simple cyst; stable non-specific hypodense lesion in the posterior right hepatic lobe.This may be further characterized with ultrasound on nonemergent basis; stable mild intrahepatic bile duct dilation.Normal gallbladder.No extrahepatic bile duct dilatation.On (b)(6) 2013 patient presented for office visit with following present problems: chronic low back pain, anxiety, renal calculi, lumbago, sacroiliac joint pain, piriformis syndrome of right side, lumbar radiculopathy, post of infection, chronic calculous cholecystitis, kidney stone, and iron deficiency anemia.On (b)(6) 2014: patient presented for office visit with following present problems: chronic low back pain, anxiety, renal calculi, lumbago, sacroiliac joint pain, piriformis syndrome of right side, lumbar radiculopathy, post of infection, chronic calculous cholecystitis, kidney stone, intractable low back pain, postoperative nausea and vomiting and iron deficiency anemia.Patient had paint in the right side of her low back started immediately following the birth of her 3rd son.Pain in the right side of back and down right leg posteriorly to right calf, heel and right lateral foot to small toe continued despite physical therapy and injection.Patient underwent right sacroiliac joint injection.On (b)(6) 2014: patient presented for office visit.On (b)(6) 2014: patient presented for follow up visit for back pain with diagnoses of lumbago, lumbar radicular pain, lumbar radiculopathy, lumbar degenerative disc disease and pseudoarthrosis after fusion or arthrodesis.On (b)(6) 2014: patient presented for office visit for pre-operative examination and diagnoses: screening examination for unspecified i nfectious disease.Problem list includes: chronic low back pain, anxiety, renal calculi, lumbago, sacroiliac joint pain, piriformis syndrome of right side, lumbar radiculopathy, post of infection, chronic calculous cholecystitis, kidney stone, intractable low back pain, postoperative nausea and vomiting and iron deficiency anemia.Patient complains of pain from right si joint and radiculopathy from l5-s1.To address these issues patient today presented for discussing revision fusion l5-s1.Mri of lumbar spine shows the l4-5 region and superiorly in normal standing.Posterior l5-s1 revision fusion and anterior l5-s1 fusion.Assessment: low back pain, l5-s1 ddd; status post lumbar spinal fusion.It was reported that she does not note any improvement in her original type of pain(right sided low back and right leg).She has some mild incisional pain midline low back.Pain is constant in right low back with radiation of dull pain to right leg in s1 distribution to right lateral foot and small toe and heel.Describes as a dull constant pain.Right si joint injection right sided gave 4 days of good relief of low back pain and less relief of the right leg pain, however pain r eturned after having a right piriformis injection procedure which she states took multiple sticks and was traumatic and aggravated pain again.Mri from (b)(6) 2014 shows the l4-5 disc without degeneration and facet joints on this mri are normal in appearance.X-rays of (b)(6) 2014 of lumbar spine shows remnants of screws at s1 bilaterally, disc height at l4-5 proximally are well maintained.On (b)(6) 2014, patient presented for follow-up visit on pregnancy.On (b)(6) 2014, patient was admitted for scoliosis and kyphoscoliosis.Patient underwent l5-s1 ap fusion.On (b)(6) 2014, patient underwent following procedure: anterior exposure of lumbar spine, l5-s1; neural monitoring; fluoroscopy; for pre-op diagnosis of: spondylolisthesis, l5-s1; failed previous surgery with implant failure and non-union; persistent pain and recurrent deformity.No complications were reported.On (b)(6) 2014, patient underwent following procedure: anterior surgical approach, l5-s1; complete revision discectomy, l5-s1, anterior; removal of bony overgrowth and partial corpectomy at l5 for anterior spinal fusion, l5-s1; complete decompression at l5-s1 bilaterally; placement of a synthetically machined structural allograft bone cage, l5-s1; use of bmp for anterior spinal fusion, l5-s1; use of allograft bone powder for anterior spinal fusion, l5-s1; posterior revision surgical approach, l5-s1; removal of broken screw tips, s1, bilaterally; placement of pedicle screws, l5 and s1, bilaterally; use of stealth intraoperative computer assisted surgical navigation for placement of pedicle screws, l5 and s1, bilaterally; neural monitoring; fluoroscopy; revision partial laminectomy at l5, bilaterally; posterior spinal fusion, l5-s1; use of allograft bone powder and residual bmp for posterior spinal fusion, l5-s1, posterior; for pre-op diagnosis of: previous attempted lumbar spinal fusion, l5-s1, with wound infection and broken hardware and residual hardware removal with tips of broken screws imbedded in the bone and rem aining in place, and now with nonunion and residual stenosis and instability.Per-op notes: once exposure was obtained, anterior disc was removed.Partial corpectomy was done at l5 to remove the scar tissue and previous fusion material.After this decompression of spinal canal and nerve root was carried out.After this synthetically machined structural allograft filled with bmp and artificial bone powder was placed in the interbody space.Under fluoroscopy cage appeared in good position.Additional bmp and bone powder was placed next to the cage.For posterior approach incision was made from l4 to s1.Pedicle screws were placed bilaterally at l5 and s1.Once screws were in place they were locked together with titanium rods.Residual bmp and allograft bone powder were placed, especially over the left side, the screws and rods were locked using set screws and torque locking mechanism.No complications were reported.On (b)(6) 2014, patient underwent o-arm x-ray.Impression: intra-op o-arm acquisition demonstrating appropriate position of l5-s1 femoral allograft ring, l5 and s1 paired pedicle screws.On (b)(6) 2014, patient underwent x-ray of lumbar spine.Impression: no evidence of hardware failure.On (b)(6) 2014, patient was discharged with following diagnosis: spinal stenosis; degeneration of lumbar intervertebral disc; acquired spondylolisthesis; acquired muscoskeletal deformity; chronic pain; disorders of sacrum; thoracic or lumbosacral neuritis or radiculitis, unspecified; dysthymic disorder.On (b)(6) 2014, patient presented in emergency department due to increasing back pain.Patient underwent ct of abdomen/pelvis without contrast.Impression: a 9.8cm fluid and gas collection in the anterior abdominal wall is suspicious for abscess.There is a second 3cm fluid collection within the musculature in the left ventral abdominal wall that may be sterile or infected; post surgical changes of l5-s1 corpectomy and posterior fusion.Ill-defined presacral soft tissue/edema with scattered foci of gas could be post surgical, although infection cannot be entirely excluded.No organized fluid collection to suggest abscess; scattered foci of gas in the left retroperitoneum are presumably post surgical.Small amount of pelvic free fluid; non-obstructing right renal stones.Patient underwent ultrasound of bilateral lower extremity.Impression: no evidence of deep vein thrombosis in the lower extremities.Prominent bilateral inguinal lymph nodes.On (b)(6) 2014, patient underwent procedure for incision debridement and washout of wound infection, anterior lumbar incision.No complications were reported.The patient also underwent ct scan of the abdomen.Impressions: ventral abdominal wall abscess, incrementally decreased in soze since the prior exam.Second, smaller adjacent compression has also decreased in size.Asymmetric foci of ags within the left retroperitoneum.Likely resolving postsurgical gas; stable non obstructing right nephrolithiasis and subentimeter hypodensity, likely a simple cyst; stable non specific hypodense lesion in the posterior right hepatic lobe; stable mild intrahepatic bile duct dialation.The patient was also presented for office visit with following problem list: anxiety, renal calculi, lumbago, status post lumbar spinal fusion, sacroiliac joint pain, piriformis syndrome of right side, lumbar radiculopathy, post op infection, chronic calculous choleccytitis, kidney stone, iron deficiency anemia.On (b)(6) 2014: patient underwent chest x-ray ap portable.Impression: right tip projects in the lower svc.On (b)(6) 2014: patient admitted in hospital due to diarrhea, nausea and vomiting.On (b)(6) 2014 patient presented due to wound infection, abscess of abdominal wall, myrositis, leukocytosis, thrombocytosis, picc (peri pherally inserted central catheter) in place.Patient underwent chest x-ray.Patient underwent x-ray of lumbar spine.Per records, radiology studies independently visualized and are pertinent for ap and lateral of the lumbar spine demonstrated stable alignment of the anterior interbody space, as well as the hardware which was in place at l5-s1.There is no evidence of fusion across the interbody graft.The patient presented with diagnosis of s/p lumbar spine and underwent x ray spine : lumbar spine 2 views.On (b)(6) 2014, the patient was admitted in the facility.Final diagnosis included ; lumbago; nausea with vomiting ; anemia ; calculus of gallbladder w/o mention of cholecystitis.The patient underwent us abdomen.Impression : large gallbladder.Cholelithiasis.No bile duct dilatation.Impression.Imaging study of ct abdomen / pelvis shows intact l5-s1 psf and asf hardware but also shows b/i nonobstructing intrarenal collecting systems as wells and small hyperdense foci in the gallbladder and finally almost resolved anterior wall fluid.The patient was discharged next day.On (b)(6) 2014, the patient was admitted to the facility.Reason for visit was back pain.The patient underwent x-ray of lumbar spine.Impression : l5-s1 decompression and fusion with early bony incorporation across interbody graft.The patient was also referred to physical therapy.On (b)(6) 2015, the patient presented with chronic low back pain.On (b)(6) 2015, the patient presented for follow up.The patient diagnosis were low back pain; s/p lumbar fusion and bilateral low back pain w/o sciatica.On (b)(6) 2015, the patient visited the facility requesting medicine refill.On (b)(6) 2015, the patient presented for f/u on back after child birth on (b)(6) 2015.Patient diagnosis was sacroiliac dysfunction.The patient underwent x ray of lumbar spine.Impression : l5-s1 bilateral posterolateral fusion without acute abnormality.On (b)(6) 2015, the patient requested for medicine refill.On (b)(6) 2015, the patient visited for medicine refill.
 
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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 Key5323538
MDR Text Key34270171
Report Number1030489-2015-03567
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,Followup
Report Date 01/18/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/23/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/01/2015
Device Catalogue Number7510400
Device Lot NumberM111302AAB
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received01/18/2016
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/17/2013
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 Weight54
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