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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 Headache (1880); Muscle Spasm(s) (1966); Neuropathy (1983); Swelling (2091); Tingling (2171); Stenosis (2263); Arachnoiditis, Spinal (2390); Palpitations (2467); Shaking/Tremors (2515); Sleep Dysfunction (2517); Ambulation Difficulties (2544); Abdominal Distention (2601)
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.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.
 
Event Description
It was reported that (b)(6) 2004: the patient presented with complaints of depression, forgetfulness, numbness, nervousness, constipation, poor circulation.He also complained of back, feet, hips and legs pain.(b)(6) 2005: the patient presented with the following pre-operative diagnosis: lumbar l4-l5 and l5-s1 degenerative disc disease and left lumbar l5 pars interarticularis defect without spondylolisthesis.Secondary diagnosis: mild acute blood loss anemia, constipation, sinus infection, and preputial edema.He underwent the following procedures: 1.An anterior lumbar interbody fusion at l4-l5 and l5-s1 with lt cages instrumentation and bone morphogenic protein fusion.2.Lumbar laminectomy from l4 through l5 with posterolateral fusion at l4 through s1 with pedicle screw instrumentation at l4 through s1 (360-degree spinal fusion).3.Intraoperative fluoroscopy less than one hour.Other implants: cancellous cubes 30 cc of regeneration technologies.Per op notes, with care the l5-s1 disc space was identified and using intraoperative fluoroscopy, the discectomy was performed and then the lt cage apparatus was used to place cages at the l5-s1 level as well as the l4-l5 level.There was noted to be degenerative changes and disc space narrowing at the l5-s1 level with significant abnormality and change in the disc at l4-l5 level.With the cages appropriately placed by intraoperative fluoroscopy, they were then packed with bone morphogenic protein to perform the fusion at l4-l5 and l5-s1.With the paraspinous muscles widely elevated, a lateral lumbar x-ray was used to confirm the l4 through s1 levels.The laminectomy was performed at l4, l5, and s1 using the double-action rongeur as well as the kerrison punches.The bone was saved and later used along with allograft bone graft to perform the posterolateral fusion with the bone morsellized.At this point with the decompression completed and the exiting nerve roots noted to be completely decompressed, then pedicle screws were identified at l4, l5, and s1.With the pedicle screws identified, a lateral lumbar x-ray was used to confirm their alignment and then pedicle screws were placed at each level and then rods were cut and secured to the pedicle screws.With this in place, a good purchase bone noted at all levels.A lateral lumbar x-ray was used to confirm the alignment.With the alignment confirmed, the transverse processes at l4, l5, and the sacrum were decorticated with the high-speed drill and then bone was placed bilaterally to perform the posterolateral fusion.The instrumentation was then tightened with the torque wrench and then the wound was thoroughly irrigated with antibiotic solution and closure begun.No patient complications were reported.The patient also underwent x-ray of the abdomen, intra-operatively, to rule out foreign body.Impression: no evidence for an unexplained radiopaque foreign body object; pedicle screws and interconnecting rods are seen at l4, l5 and s1; postlaminectomy changes seen on l4 and l5; posterolateral fusion grafts are noted from l4 to s1.X-ray of the lumbar spine was also done, which revealed metallic cages at l4-l5 and l5-s1.(b)(6) 2005: the patient underwent x-rays of the abdomen due to abdominal distension, difficulty taking a big breath and penis was edematous.Impression: pedicle screws and interconnecting rods are seen at l4, l5 and s1; postlaminectomy changes seen on l4 and l5; posterolateral fusion grafts are noted from l4 to s1.(b)(6) 2005: the patient was discharged.(b)(6) 2005: the patient underwent "ext lowr venous duplex uni lt" test due to leg pain.Impression: negative study.(b)(6) 2005: the patient presented for an office visit.(b)(6) 2005: the patient presented with complaints of upper back pain and bilateral radicular symptoms.The pain was described as shooting, stabbing.He also reported of increasing spasm and tremors in the legs and left calf, numbing and tingling in left foot.Assessment: 1.Low back pain with bilateral l5-s1 radicular symptoms, left greater than right.2.Reactionary depression.3.Insomnia.4.History of diverticulosis.(b)(6) 2005: the patient presented with the following pre-operative diagnosis: postlaminectomy syndrome of lumbar spine with continued low back and bilateral l5-s1 radicular symptomology.He underwent the following procedure: bilateral l5-s1 selective nerve root block under fluoroscopic guidance.No patient complications were reported.(b)(6) 2005: the patient presented for an office visit with chronic back pain with bilateral l5-s1 radicular symptoms.Assessment: 1.Low back pain with bilateral l5-s1 radicular symptoms, left greater than right.2.Reactionary depression.3.Insomnia.4.History of diverticulosis.(b)(6) 2005: the patient presented with the following pre-operative diagnosis: postlaminectomy syndrome of lumbar spine with continued low back and bilateral l5-s1 radicular symptomology.He underwent trans-laminar lumbar epidural steroid injection procedure.There were no patient complications.(b)(6) 2005: the patient presented with significant low back pain with bilateral radicular pain.Any type of activity seemed to make this pain a great deal worse.(b)(6) 2005: the patient underwent lumbar myelography due to severe low back pain.Impression: post-surgical changes; no evidence visualized for any spondylolisthesis.(b)(6) 2005: the patient underwent nerve conduction test and "emg" study.Impression: normal study.(b)(6) 2005: the patient presented with bilateral lower extremity pain and low back pain, left greater than right.The patient underwent lumbar epidural steroid injection procedure, under fluoroscopy.No patient complications were reported.(b)(6) 2005: the patient presented with the following pre-operative diagnosis: post-laminectomy failed back surgery syndrome.He underwent the following procedure: spinal cord stimulator trial.Per op notes, a 14-gauge introducer epidural needle was advanced under direct fluoroscopic guidance on a paramedian approach to the left until loss of resistance.Proper epidural placement was confirmed with 3 ml of lsovue m-200 in both anterior and posterior views.Then a 33 cm quad lead, lot number 389 lead was advanced under direct fluoroscopic guidance until the top zero lead was the superior edge of the t9 intervertebral body slightly off to the left.No patient complications were reported during needle placement or withdrawal.The patient underwent x-rays of the lumbodorsal spine due to spinal cord placement.Impression: spot image of spinal stimulator placement.(b)(6) 2005: the patient presented with the following pre-operative diagnosis: post-laminectomy failed back surgery syndrome.He underwent the following procedure: spinal cord stimulator implant.Per op notes, two lead were placed, both of which had 8 positive and negative anode configuration.The lead kits were 3778-75 x 2.Rechargeable patient programmer was placed, which was 37742.It was a rechargeable kit charging system 37752.A 14 gauge introducer, epidural was inserted under direct fluoroscopic guidance x2 into the epidural space l2-l3.There were no patient complications.The patient underwent x-ray of thoracic spine due to low back pain and spinal stimulator.Findings: two spinal stimulator tips overlying the t7-t8 vertebral body level; an overlying metallic rod overlying the t9 vertebral body level obliquely.Fluoroscopy was also provided during the spinal stimulator procedure.(b)(6) 2006: the patient presented with the following diagnosis: motor vehicle accident.He had pain with mobility activities.(b)(6) 2006: the patient presented with low back pain, radiating to left buttocks and left leg.(b)(6) 2006: the patient presented with difficulty in locomotion.He complained of low back pain radiating down right leg.(b)(6) 2006: the patient presented with complaints of depression, forgetfulness, numbness, nervousness, constipation, poor circulation.He also complained of back, feet, hips and legs pain.(b)(6) 2006: the patient underwent doppler lower extremity arterial examination due to leg pain.Impression: normal bilateral lower extremity arterial doppler; no focal areas of stenosis.(b)(6) 2006: the patient presented with failed back surgery syndrome and neuropathic pain.He also complained of severe headache.He underwent lumbar epidural steroid injection procedure.There were no patient complications.On an unknown date in 2007, the patient underwent prior surgery pain pump.(b)(6) 2007: the patient with the following preoperative diagnosis: postlaminectomy syndrome residual radiculopathy.The patient underwent the following procedure: removal of dorsal column pulse generator and removal of dorsal column electrodes times two.No patient complications were reported.He also underwent intra-operatively fluoroscopy.Impression: interval removal of spinal cord stimulator.(b)(6) 2007: the patient underwent mri of lumbar spine due to low back pain.Impression: 1.Postoperative changes with orthopedic hardware at l4, l5 and s1.2.Decompression of osseous elements posteriorly at l4-l5 and l5-s1.3.No focal disc herniation, significant central spinal canal stenosis or abnormal contrast enhancement.4.Osseous structures appear to be maintained.(b)(6) 2007: the patient presented with chronic back pain.Tenderness to palpation over the mid thoracic area with soft tissue swelling was noted.X-rays of the cervical, thoracic and lumbar spine were reviewed which showed no acute fractures.Chest x-rays revealed elevated right diaphragm.Assessment: 1.Status post fall.2.Neck and back pain.(b)(6) 2008: the patient underwent mri of thoracic cord due to severe back pain.Impression: 1.No evidence to suggest granuloma at the tip of the pain pump catheter.2.Spidural collection from t11 to l1.The etiology and composition is uncertain.3.No acute osseous abnormalities appreciated.On an unknown date in 2009, the patient underwent right shoulder surgery.(b)(6) 2009: the patient underwent the following procedures: 1.Pump refill by physician of intrathecal pump.2.Reprogramming of intrathecal pump.There were no complications.(b)(6) 2009: the patient presented with postlaminectomy failed back surgery syndrome.He had a recent exacerbation of his pain radiating from the tailbone down into his legs bilaterally.He underwent a lumbar epidural steroid injection under direct fluoroscopic guidance.Morphine was increased from 8.5 mg to 9 mg per day.On an unknown date in 2010, the patient underwent left shoulder surgery.(b)(6) 2010: the patient presented with lower back and buttock pain.He also complained of bilateral leg pain.Impression: postlaminectomy syndrome.He underwent lumbar epidural steroid injection on a caudal approach under direct fluoroscopic guidance with iv conscious sedation.There were no complications.(b)(6) 2010: the patient presented with the following preoperative diagnosis: postlaminectomy failed back surgery syndrome.He underwent the following procedures: reprogramming of intrathecal pump as well as pump refill by a physician.(b)(6) 2011: the patient presented with the following preoperative diagnosis: postlaminectomy failed back surgery syndrome.He underwent the following procedures: refill of the intrathecal pump by a physician.There were no complications.(b)(6) 2010, (b)(6) 2011: the patient presented with lower back, buttock and leg pain.He underwent a fluoroscopic guided lumbar epidural steroid injection on the caudal approach as well as at l2-3 above and below his fusion sites to give him better relief.The steroid dose was split and conducted under iv conscious sedation.There were no patient complications.(b)(6) 2010: the patient underwent mri of lumbar spine due to back pain.Impression: 1.Postoperative changes consistent with laminectomy and fusion at l4, l5 and s1.2.Dural ectasia at the l4-l5 level.3.Fluid within the paraspinal musculature at l5 and s1 levels.4.Osseous structures intact without recent fracture.5.No focal disc herniation significant central spinal canal stenosis or neuroforaminal narrowing.(b)(6) 2010: the patient presented with sinus problems.The patient also had the following complaints: loss of sleep, numbness, constipation, hemorrhoids, back pain, feet pain, hips pain and legs pain.The pain was worsened by bending, lifting, sitting, standing and strain.(b)(6) 2010: the patient presented with the following pre-operative diagnosis: 1.Postlaminectomy failed back surgery syndrome.2.Arachnoiditis.He underwent the following procedures: 1.Iv conscious sedation.2.Thoracic and lumbar epidural steroid injections.There were no complications.(b)(6) 2010: the patient presented with following pre-operative diagnosis: acute pain, status post left rotator cuff repair in a patient who is opioid tolerant.He underwent posterior cervical paravertebral brachial plexus block.There were no complications.(b)(6) 2010: the patient presented with chronic pain syndrome as well as postlaminectomy surgery syndrome, which caused him have chronic pain and tolerance to opioid.He underwent left posterior cervical paravertebral block in order to afford him relief from his rotator cuff repair.There were no complications.He also underwent refill of intrathecal pump by physician.(b)(6) 2011: the patient presented with the following preoperative diagnosis: postlaminectomy failed back surgery syndrome.He underwent the following procedures: refill of the intrathecal pump by a physician.There were no complications.(b)(6) 2012: the patient for an office visit for postlaminectomy syndrome and arachnoiditis.He underwent fluoroscopic-guided lumbar epidural steroid injection at the l2-l3 space just cephalad to his fusion under iv conscious sedation.He also had caudal epidural steroid injection to cover the entire area.There were no complications.(b)(6) 2012: the patient presented with postlaminectomy syndrome.He was also diagnosed for arachnoiditis.He underwent refill of intrathecal pump.There were no complications.(b)(6) 2012: the patient presented with lower back, thoracic, bilateral back pain, as well as right leg pain.Diagnoses: 1.Arachnoiditis.2.Postlaminectomy syndrome.He also underwent a caudal epidural steroid injection under iv conscious sedation.On an unknown date in (b)(6) 2012: the patient underwent stenting of left anterior descending and diagonal branch of lad.(b)(6) 2012: the patient presented for an office visit with pain.He underwent refilling of intrathecal pump by the physician.(b)(6) 2012: the patient presented with postlaminectomy failed back surgery syndrome.He underwent the following procedures: refill of the intrathecal pump by a physician.(b)(6) 2012: the patient underwent mri of right shoulder without contrast due to history of bilateral rotator cuff repair, left shoulder pain also involving the neck and mid back area and motor vehicle accident.Impression: osteophytosis of the acromioclavicular joint.Post-surgical change at the greater tuberosity; no evidence for a re-torn supraspinatus portion of the rotator cuff.(b)(6) 2012: the patient underwent mri of thoracic spine due to back pain, which revealed lower thoracic area where there was a fluid collection/pocket, the pain catheter went in at the bottom part of the fluid collection.He also underwent mri of cervical spine due to neck and mid back pain.Impression: no herniated disc or central spinal canal stenosis.(b)(6) 2012: the patient presented for an office visit and was evaluated for possible pump dysfunction.He also underwent unknown radiology exam of the lumbodorsal spine due to failed back syndrome and pain pump catheter injection.Impression: 1.Opacification of the lower thoracic epidural space with pain pump injection.He also underwent image intensifier intraoperatively for one hour.(b)(6) 2012: the patient presented with pain to the midscapular region for about 3-4 months and it has gotten worse.He had intermittent headaches and numbness/tingling generalized to his arms and legs.He had constant dizziness and headache.He also had difficulty sleeping.Review of symptoms revealed chest pain or discomfort and fast palpitations.Musculoskeletal examination revealed tenderness to palpation of the thoracic spinous process and thoracolumbar spine pain was elicited by flexion.There was also decreased response to tactile stimulation to left anterior forearm.Right posterior thigh, bilateral feet and toes.Assessment: mid back pain.On an unknown date in (b)(6) 2012: the patient underwent repeat coronary angiogram which showed previously placed stents to be widely patent and no significant coronary artery atherosclerosis in the remaining coronary.He had preserved lv systolic function with an ejection fraction estimated at 60%.Although the patient has had episodes of chest pain intermittently, these were thought to be atypical and not to represent angina.(b)(6) 2012: the patient presented with the following preoperative diagnosis: 1.Postlaminectomy failed back surgery syndrome.He underwent the following procedures: refill of the intrathecal pump by a physician.(b)(6) 2013: the patient presented with the following pre-operative diagnosis: 1.Postlaminectomy failed back surgery syndrome.2.L eft-sided shoulder bursitis.He underwent the following procedures: 1.Refill of intrathecal pump by a physician.2.Left shoulder intra-articular injection.No patient complications were reported.No patient complications were reported.(b)(6) 2013: the patient presented with the following preoperative diagnosis: 1.Postlaminectomy failed back surgery syndrome.He underwent the following procedures: 1.Replacement of intrathecal pump.2.Dye contrast study.3.Refill and reprogram of intrathecal pump.No patient complications were reported.He also underwent single fluoroscopic view of the thoracic spine to evaluate catheter pain pump location.Impression: pain pump catheter appears to terminate at the level of t7-t8.(b)(6) 2013: the patient presented with the following preoperative diagnosis: postlaminectomy failed back surgery syndrome.He underwent the following procedure: reprogramming and refill of intrathecal pump.No patient complications were reported.(b)(6) 2013: the patient presented with the following preoperative diagnosis: 1.Postlaminectomy failed back surgery syndrome.2.Phantom limb pain.He underwent the following procedure: reprogramming and refill of intrathecal pump.No patient complications were reported.(b)(6) 2013: the patient presented with the following diagnosis: postlaminectomy failed back surgery syndrome.He underwent the following procedure: refill of intrathecal pump.No patient complications were reported.(b)(6) 2013: the patient presented with the following diagnosis: postlaminectomy failed back surgery syndrome.He underwent the following procedures: 1.Caudal epidural.2.Lumbar epidural.The patient underwent fluoroscopy of lumbar spine for needle placement at l2-l3 level.He also underwent fluoroscopy for needle placement for caudal injection.No patient complications were reported.(b)(6) 2014: the patient presented with the following diagnosis: postlaminectomy failed back surgery syndrome.He underwent the following procedure: refill of intrathecal pump.No patient complications were reported.
 
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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 NEUROMODULATION
7000 central avenue ne rcw215
minneapolis MN 55432
Manufacturer Contact
diane wolf
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263987
MDR Report Key5049327
MDR Text Key24879566
Report Number1030489-2015-02179
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
Report Date 08/03/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number7510600
Device Lot NumberM111003AR
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received09/02/2015
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 Weight93
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