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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 7510800
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cyst(s) (1800); Headache (1880); Neuropathy (1983); Pain (1994); Scar Tissue (2060); Vomiting (2144); Weakness (2145); Stenosis (2263); Injury (2348); Neck Pain (2433); Ambulation Difficulties (2544)
Event Type  Injury  
Event Description
It was reported that on (b)(6) 2005 the patient underwent spine fusion surgery on the lumbar region at levels l5- s1.The patient was implanted with select parts of rhbmp-2/acs (i.E.Only the rhbmp-2 and collagen sponge) which was applied from a transforaminal and posterior approaches.The rhbmp-2 collagen sponge was placed outside a cage (i.E., in the disc space, facet joint and over the transverse processes).Post-op, the patient complained of progressively worsening pain in his low back pain and radiculopathy into his lower extremities.Patient continues to experience severe and unrelenting pain in his low back, and radiculopathy in his bilateral lower extremities.Patient experiences difficulty sitting, standing and walking,and requires assistance with ambulation.These serious injuries prevent patient from practicing activities of daily life and reportedly the patient has suffered serious and permanent injuries.
 
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.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that on: (b)(6) 2002: patient underwent chest one view x-ray.Impression: normal chest examination.(b)(6) 2003: patient visited the facility due to low back pain for follow up.(b)(6) 2003: patient underwent lumbar spine series 3 views.Impression: normal lumbosacral spine.(b)(6) 2003: patient underwent the following procedure: septoplasty.Bilateral inferior turbinate reduction.(b)(6) 2003: patient underwent ultrasound of abdomen.Impression: no evidence of hernia is seen.(b)(6) 2003: patient presented for follow up due to pain.(b)(6) 2003: patient presented with the following preop diagnosis: bilateral inguinal hernias.Procedure: bilateral inguinal herniorrhaphy with mesh repair using a bard mesh inlay and plug.(b)(6) 2003: patient underwent right knee x-ray.Impression: normal knee.(b)(6) 2004, (b)(6) 2005: patient visited the facility for follow up due to pain.(b)(6) 2004: patient presented with the following impression: degenerative disc disease at l5-s1 with bulging disc and foraminal encroachment predominantly left sided.Mild disc bulging at l4-5.Patient underwent mri of lumbar with and without contrast.Impression: degenerative disc disease at l5-s1 with bulging disc and foraminal and encroachment predominantly left sided.Mild disc bulging at l4-5.(b)(6) 2004: patient underwent thoracic spine x-rays.Impression: normal thoracic spine.Patient underwent lumbar spine two or three views x-rays.Impression: diastasis right si joint.Patient underwent cervical spine one view.Impression: normal single view cervical spine.Chest single view impression: no clinically significant findings.Pelvis one view impression: symphysis and right si joint diastasis.Ct of the abdomen with contrast impression: normal ct abdomen.Ct of the pelvis with contrast impression: apparent reduction of diastasis across symphysis, right sacroiliac joint.Normal ct pelvis at this time.Pelvis owe or two views impression: pubic symphysis and right si joint diastasis with findings suggestive of pelvic hematoma.Right femoral fractures.Patient presented with following preop diagnosis: segmental fracture, right femur, pelvic ring disruption, multiple fractures.Procedure: intramedullary nailing, right femur fracture, using a gamma nail.Open reduction and internal fixation, pelvic fractures, using a symphyseal plate.(b)(6) 2004: patient underwent single inspiratory view of the chest.Impression: there is an endotracheal tube in good position.The lungs are clear.There is no pneumothorax.(b)(6) 2004, (b)(6) 2005: patient visited the facility for post-op follow up.(b)(6) 2005: patient presented with the following impression: lumbago secondary to degenerative disc disease, lumbar disc displacement, l5-s1, lumbar myofasiitis, sensory radiculopathy.(b)(6) 2005: patient presented with following preop diagnosis: lumbago secondary to degenerative disc disease, lumbar disc displacement, l5-s1, lumbar myofasiitis, sensory radiculopathy.Procedure: lumbar epidural steroid injection, use of the image intensifier, lumbar epidurogram l5-s1.(b)(6) 2005, (b)(6) 2005 : patient went for the office visit due to right lower extremity pain.(b)(6) 2005: patient underwent right knee series and right femur series impression: status post intramedullary rod placement, right femur, with healing oblique fractures noted.2) osteopenia, likely secondary to disuse.Very mild medial compartment narrowing right knee.(b)(6) 2005: patient presented with following pre-op diagnosis: 1) right- sided l5 disk herniation with degenerative disk disease and intractable low back pain.2) status post polytrauma with open reduction internal fixation of the pelvis and rod to the femur.Procedure: 1) l5-s1 laminectomy and discectomy (right side).2) posterior fusion l5-s1.3) transverse lumbar interbody fusion l5-s1.4) insertion of prosthetic device (12mm height).5) posterior non segmental instrumentation l5-s1.6) rhbmp-2/acs mixed with local autograft for transverse lumbar interbody fusion and posterior fusion.7) retractor system used for the above procedures for less invasive spine surgery.Intra-op findings: degenerative disk l5-s1 with bilateral degenerative facet disease of l5-s1.Perop: a muscle sling approach was used to access the facet joints at l5-s1 and l4-5 and the pars.The quadrant retractor was used.The superior facets of l5 and s2 were exposed along with part of the transverse process of l5 and sacral alae.A herniation was noted at the l5-s1 level.After the inferior facet of l5 was removed, the superior facet down to the pedicle was removed.Bone that was taken from the laminectomy was then cleaned of soft tissue and morselized and then packed into the disk space along with a strip of bmp.The 12mm cage was then packed with rhbmp-2/acs and impacted into the disk space.Pedicle screws were then placed on the right side.Screws of 6.5 mm size were inserted at l5 and s1, 15 mm in length at l5, and 45 mm in length at s1.A rod was inserted and compressed.(b)(6) 2005, (b)(6) 2006: patient visited the facility for follow up due to low back pain.Diagnosis: displacement of lumbar intervertebral disc without myelopathy.Fracture of the pelvis, fracture of the femur.(b)(6) 2005: patient visited the facility for postop follow up.(b)(6)2006: patient visited the facility due to low back pain.(b)(6) 2006: patient underwent ct scan of the pelvis.Impression: status post placement of a richardson type threaded stabilization bar through an intramedullary rod within the proximal and mid right femur.An l-shaped presumed heterotopic bony density is seen in the lateral soft tissues at the level of the junction of the right femoral shaft and right femoral neck.No acute bony abnormalities are detected.The visualized portions of the aeminal vesicles and the prostate gland are grossly normal.Phleboliths are seen in the pelvis.No acute bony abnormalities are seen.Additional note is made of a bone island in the left iliac bone and increased bony sclerosis previously described in the anterior aspect of the right iliac bone adjacent to the right superior si joint.(b)(6) 2006: patient underwent mri of right shoulder.Impression: inflammatory and degenerative type changes at the acromioclavicular joint.(b)(6) 2006: patient underwent mri overread of the right knee.Impression: status post l5-s1 interbody fusion.No recurrent disc herniation seen.No additional level of disc herniation or spinal stenosis.(b)(6) 2006: patient underwent mri of the lumbar spine with and without contrast.Impression: status post l5-s1 interbody fusion.No recurrent disc herniation seen.No additional level of disc herniation or spinal stenosis is seen.(b)(6) 2006, (b)(6) 2007: patient presented with following impression: status post orif right proximal femur fracture orif pelvic fracture.(b)(6) 2006: patient visited the facility for follow up due to lower backpain, right leg pain secondary to old leg injury.(b)(6) 2007: patient underwent xray of pelvis and right hip series.Impression: status post multiple femur fractures with internal fixation and no evidence of complication.Likely heterotopic bone formation surrounding the intertrochanteric region.No evidence of "avn" (b)(6) 2009: patient underwent lumbar spine mri.Impression: status post plif at l5-s1.There is right foraminal fluid.This may be related to the previous surgical pathway.It was confidently identified that a focal mass occupying abnormality on the axial sequences.Mri of the pelvis impression: status post right hip nailing with early sclerosis in the superolateral aspect of the acetabulum consistent with early osteoarthritis.Post operative changes at l5-s1 as described in the lumbar spine report.(b)(6) 2009: patient underwent ap pelvis one view impression: no significant change is appreciated in the bony structures and orthopedic hardware since the preceding image.(b)(6) 2006, (b)(6) 2007,(b)(6) 2008, (b)(6) 2009: patient presented in the facility for follow up due to low back pain, stiffness, a clicking sensation, hip joint stiffness, knee joint pain, knee joint swelling and knee redness.(b)(6) 2009: patient underwent 3 views of right foot.Impression negative right foot.Three views of left impression: negative left foot.Two views right tibia and fibula impression: negative right tibia and fibula.Three views of right knee impression: medullary rod distal femur otherwise negative right knee.Three views right hand impression: negative right hand.(b)(6) 2009: patient underwent two views of the left leg show normal mineralization and alignment without fracture stress fracture or other bony abnormality.The soft tissues appear intact.(b)(6) 2010 as per medical records, chronic pain syndrome involving chronic lumbalgia s/p failed back surgery; chronic cervicalgia w radicular features and migraines: pain control suboptimal at this point.There is a significant level of non compliance.(b)(6) 2011: patient underwent ct of the abdomen with contrast.Impression: no evidence of acute diverticulitis.Fatty infiltration of the liver versus hepatocellular disease.Patient underwent ct of the pelvis with contrast.Impression: no evidence of acute diverticulitis.Fatty infiltration of the liver versus hepatocellular disease.(b)(6) 2011: patient underwent mri of the brain.Impression: normal brain mri scan.Patient presented with chronic low back pain.Patient underwent mri of the lumbar spine.Impression: postsurgical changes at l5-s1 with heterogenous signal slightly indenting the traversing s1 nerve root, probably representing a combination of scar tissue and a slightly buckled ligament as described.Mild to moderate foraminal stenosis at l4-5 with a laterally extending disc bulge and facet arthropathy.(b)(6) 2011 the patient presented with uncontrolled headaches for seven years.Described as right side of head, starts like something pushing the eye then throbbing sensation on right temporal, it slowly gets to 10/10, with associated nausea, loss of appetite, usually last 8-10 hours but now they are lasting 2-3 days.Associated photo/phonophobia.Perfumes, candles, incense trigger- mostly smells.Approximately everyday.Patient has scintillating lights on his vision before getting the headache.Assessment: uncontrolled migraines, radicular pain.(b)(6) 2011 the patient presented for evaluation of rhinitis.(b)(6) 2011: the patient presented for an office visit for management of chronic pain in low back and right hip.Complained of new pain in left knee and left calf for past week.Indications: chronic lumbalgia s/p failed back surgery; chronic cervicalgia w radicular features, uncontrolled migraines, radicular pain.Patient underwent x-ray of hip.Impression: right femoral rod with dynamic nail and good healing of proximal femoral fractures.Views of the femur are recommended to evaluate in dilated length of the rod.Prior fixation of pubic diastasis and probable left pubic fractures.Prior posterior lumbar pedicular fixation.(b)(6) 2011 the patient presented with back pain.The chronic pain resulting from multiple pelvic, hip, and knee injuries sustained in motorcycle accident.(b)(6) 2011, (b)(6) 2012 the patient complained of headache (moderate intensity) around the left temporal area and also some tightness of neck pain.No relieving factors similar to previous episodes.Sensitivity to light.(b)(6) 2011: patient presented in the facility with headache.(b)(6) 2011 the patient came for follow up of chronic pain located in the lower back radiating down, right pelvic area and posterior thigh.(b)(6) 2011 the patient presented with right temple area migraine and nausea.Assessment: head injury, headaches.(b)(6) 2011: the patient complaint of left hand pain s/p landing on the hand wrong when getting into bed.Patient underwent x-ray of the hand.Impression: no abnormality noted.(b)(6) 2011 the patient presented with knee pain x 5 days.While getting out of recliner he twisted his right knee.(b)(6) 2012 the patient complained for recurrence of his typical migraine headache onset 3 days ago.(b)(6) 2012, : patient visited the facility for follow up for having problems with knees, pain and swelling, migraine, nausea, vomiting.(b)(6) 2012 the patient came for a follow-up of chronic pain.(b)(6) 2012: patient underwent bilateral knee x-ray.Impression: mild bilateral degenerative joint disease.Patient underwent x-ray of the knee.Impression: minimal "djd" (b)(6) 2012, (b)(6) 2013, the patient presented for head/headache, knee, right hip and leg, low back, neck, pelvis, foot pain.(b)(6) 2012 patient complained of left frontal headache intermittently, + nausea and photophobia.(b)(6) 2012 the patient underwent mri for cervical spine.Impression: mild multilevel degenerative changes are noted throughout cervical spine with degenerative disc disease most pronounced at the c3-4 level where there is a disc bulge with small central protrusion resulting in mild spinal canal stenosis.Otherwise, multiple levels of mild foraminal narrowing secondary to mild uncinate spurring and mild facet arthropathy are demonstrated.(b)(6) 2012: patient underwent mri of the cervical spine without contrast.Impression: mild multilevel degenerative changes are noted throughout cervical spine with degenerative disc disease most pronounced at the c3-4 level where there is a disc bulge with small central protrusion resulting in mild spinal canal stenosis.Otherwise, multiple levels of mild foraminal narrowing secondary to mild uncinated spurring and mild facet arthropathy are demonstrated.(b)(6) 2012 the patient presented with low back pain.The pain was aching, heaviness, pressure, sharp, shooting, soreness, stabbing, tightness.(b)(6) 2012 the patient came for a follow-up for headache "it worked from (b)(6)".(b)(6) 2012 as per medical records, assessment: migraine.(b)(6) 2012 the patient presented with migraine headaches with headache at the left temporoparietal region since earlier today, no triggers, pain is sharp and localized, its similar to his regular migraine episodes.(b)(6) 2012: patient underwent mri of the cervical without contrast.Impression: mild multilevel degenerative changes are noted throughout cervical spine with degenerative disc disease most pronounced at the c3-4 level where there is a disc bulge with small central protrusion resulting in mild spinal canal stenosis.Otherwise, multiple levels of mild foraminal narrowing secondary to mild uncinate spurring and mild facet arthropathy are demonstrated.(b)(6) 2012 the patient was diagnosed for scars on right lower extremity.Non-linear, vertical scar to lateral right hip, on anterior trunk.Linear, horizontal scar to lower abdominal, mid-pelvis area.Scars on posterior trunk.Linear, parallel, vertical scars to lower lumbar spine area, #1 is to the left of the spine and #2 is to the right of the spine.The patient was diagnosed for migraine, headache, pulsating and throbbing pain, on both side of the head, nausea, vomiting and intolerant to smell, erectile dysfunction, cervical spine degenerative disc disease, loss of rom.The patient was diagnosed for patella femoral syndrome.The patient had increased pain and edema to his knees and increased difficulty bending, kneeling, walking long distances.The patient was diagnosed for pelvic fracture, hip fracture.(b)(6) 2012 the patient underwent mri of cervical spine.Impressions: mild multilevel degenerative changes are noted throughout cervical spine with degenerative disc disease most pronounced at the c3-4 level where there is a disc bulge with small central protrusion resulting in mild spinal canal stenosis.Otherwise, multiple levels of mild foraminal narrowing secondary to mild uncinate spurring and mild facet arthropathy are demonstrated.(b)(6) 2012 as per medical records, bmi: (b)(6).The patient presented for a follow-up of htn, ptsd, chronic low back/chronic pain syndrome, chronic opioids and related constipation, migraines and other concerns.(b)(6) 2012 the patient presented with complaints of migraine headaches here for persistent migraine since yesterday.Complains of photophobia, aural sensitivity and nausea.(b)(6) 2012 the patient was diagnosed as follows: axis i: ptsd (mixed noncombat/combat) r/o depressive disorder nos axis ii: deferred axis iii: low back pain, treatment compliance problem, diverticulitis of colon, constipation, unspecified hypertension, chronic pain syndrome, migraine, unspecified, without "meant" axis iv: problems with primary support group axis v: gaf = 59 (b)(6) 2012 the patient presented with complaints of migraine headache for three days.The patient reported pain in his left temple, photophobia, sensitivity to smells, and nausea for three days.Typical migraine symptoms.He had a normal mri on (b)(6) 2011.Pain is throbbing in nature.(b)(6) 2013 the patient came for a follow-up.Assessment: axis i: ptsd (mixed noncombat/combat), r/o depressive disorder nos axis ii: deferred axis iii: low back pain, treatment compliance problem, diverticulitis of colon, constipation, unspecified hypertension, chronic pain syndrome, migraine, unspecified, without "meant" axis iv: problems with primary support group axis v: gaf = 61 (b)(6) 2013 as per medical records, impression: constipation, intractable, seems to be r/t chronic pain/narcotic use.S/p diverticulitis (osh) nausea/vomiting.Impression for ct: no evidence of acute diverticulitis.Fatty infiltration of the liver versus hepatocellular disease.Assessment: uncontrolled headaches, right arm weakness.(b)(6) 2013: patient underwent ct of the head without contrast.Impression: no ct secondary signs of an acute intra-cranial process.Nonacute incidental findings as noted above.If symptoms persists and there is continued high clinical index of suspicion for an early acute ischemic event, a more sensitive noncontrast mri of the brain could be considered for further assessment if clinically warranted.Patient presented with temporal headache wit nausea and photophobia, migraines.(b)(6) 2013: patient presented with neck pain.Has hx of "bulged disks" in the cervical region and s/p fusion of lower back.Impression : subacute neck/back pain- msk etiology.(b)(6) 2013: patient presented with pain in neck and back.Patient also has growths under his skin in l fingers.(b)(6) 2013: patient presented with neuro pain, chronic low back pain, lower extremity radiculopathy, chronic pain.(b)(6) 2013: patient underwent x-ray of the hand.Impression: increasing focal areas of soft tissue prominence along the dorsal a spects of the left second and fifth digits proximally.Findings may represent underlying ganglion cyst.No bony involvement.(b)(6) 2013: patient presented for follow-up of unspecified depressive disorder.(b)(6) 2014: patient presented with persistent migraine, nausea, vomiting, headache.(b)(6) 2014: patient underwent x-ray of the chest.Impression: there is no acute cardiopulmonary disease.Patient presented with cyst on left fingers.Musculoskeletal: no significant findings verbalized.Neurological: no significant findings verbalized.Psychiatric: no significant findings verbalized.(b)(6) 2014: patient presented with pre-op diagnosis: lump dorsal aspect left index and little finger.Procedure: exploration excision.Patient underwent ambulatory surgery.(b)(6) 2014: patient underwent ct of the head without contrast.Impression: no acute intracranial abnormality.Recommend follow-up mri as clinically indicated.Musculoskeletal: denies any new arthralgia, myalgia, weakness or joint swelling.Psych: denies depression, tearfulness, suicidal ideation, homicidal ideation or anxiety (b)(6) 2014: patient underwent x-ray of the knee.Impression: superior patellar enthesophytes with otherwise stable appearance of the knees.Prior femoral fracture fixation with intramedullary rod.(b)(6) 2014: patient underwent x-ray of the knee.Impression: superior patellar enthesophytes with otherwise stable appearance of the knees.Prior femoral fracture fixation with intramedullary rod.(b)(6) 2014: patient presented with knee pain.(b)(6) 2014: patient presented with right foot pain since 2009.Patient states pain feels like pins and needles and burns to his right hallux.Patient stated he was referred from ortho to help his knee pain.(b)(6) 2014: patient underwent ct of the head without contrast.Impression: no acute intracranial abnormality or change from prior studies.Recommend follow-up mri as clinically indicated.Patient presented with migraine headache.(b)(6) 2014: patient presented with pain.(b)(6) 2014: patient presented for follow-up.Patient presented with lower back, knees, neck pain.(b)(6) 2014: patient underwent following procedure: l5-s1 laminectomy and diskectomy (rt side).Posterior fusion l4-s1.Transvers lumbar interbody fusion l5-s1.Insertion of prosthetic device (12mm height).Posterior on-sgemental instrumentation l5-s1 (pedicle screw system).Rhbmp ii mixed with local autograft for transverse lumbar interbody fusion and posterior fusion.Retractor system used for the above procedure for less invasive spine surgery.(b)(6) 2014: patient presented with migraine, nausea, photophobia.(b)(6) 2014: patient underwent aspiration and/or injection of joint, bursa, cyst, or periarticular structure.(b)(6) 2015: patient underwent ct of the head without contrast.Impression: no acute intracranial pathology.Stable ct examination of the head.(b)(6) 2015: patient presented with increased neck pain, pain behind lateral eyes, nausea and migraine.(b)(6) 2015, (b)(6) 2014: patient underwent physical therapy.Patient presented with swelling of limb, neck pain, low back pain, chronic pain syndrome, migraine, hypertension, ganglion of joint.Patient presented with lower back, knees, neck pain.(b)(6) 2015: patient underwent physical therapy.Assessment: patient presented with bilateral chondromalacia patella.Pt with surgical "hx" (rod in r femur, pubic symphysis and l5/s1 pedicle fixation).Pt reports decreased pain with tape application.Improved tolerance for exercise.Remains motivated.Weakness in hips (unable to keep knees inline with higher resistance during squats) but remains very motivated.(b)(6) 2015, (b)(6) 2014, (b)(6) 2013, (b)(6) 2012: patient presented with lower back, knees, neck pain.(b)(6) 2015: patient presented with chronic pain.
 
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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 Key4890887
MDR Text Key6021945
Report Number1030489-2015-01361
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
Report Date 02/22/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/06/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number7510800
Device Lot NumberM115004AAC
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received02/22/2016
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;
Patient Weight77
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