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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET

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MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET Back to Search Results
Catalog Number 7510400
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Headache (1880); Hyperventilation (1910); Neuropathy (1983); Loss of Range of Motion (2032); Weakness (2145); Stenosis (2263); Discomfort (2330); Numbness (2415); Neck Pain (2433)
Event Type  Injury  
Manufacturer Narrative
(b)(4).Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.Products from multiple manufacturers were implanted during the procedure.Although it is unknown if any of the devices contributed to the reported event, we are filing this mdr for notification purposes.
 
Event Description
Patient demographics: height- (b)(6), race- white.It was reported that (b)(6) 2007: patient presented with cervical spine axial discomfort and bilateral upper extremity radiculopathy left greater than right and underwent c6-c7 epidural steroid injection under fluoroscopic guidance with epidurogram procedure.Patient presented with following diagnosis- 1.C5-c6, c6-c7 herniated disc.2.Left upper extremity c6-c7 radiculopathy.3.Left upper extremity motor weakness.On (b)(6) 2007: patient underwent x-ray examination of cervical spine.Impressions: 1.At c5-c6, a 3.00 mm disc bulge seen flattening the thecal sac.Moderate narrowing of the left neuroforamin present.2.At c6-7, a 4.00 mm left parasagittal and foraminal disc herniation noted compressing the left c7 nerve root sleeve with severe narrowing of the left and mild narrowing of the right neuroforamin.On (b)(6) 2007, (b)(6) 2008: patient presented with follow-up visit due to cervical spine axial discomfort and neck pain.Patient diagnosed with c5-c6, c6-c7 herniated disc.On (b)(6) 2008: patient presented with follow-up visit due to cervical pain radiating down to shoulder.On (b)(6) 2008: patient presented with an office visit.10 sept 2008: patient presented with follow-up visit due to cervical spine axial discomfort with upper extremity motor weakness and pain.Patient also diagnosed with c5-c6, c6-c7 herniated disc.11 sept 2008: patient presented with x-ray of cervical spine due to neck pain.Impressions- lower cervical spondylosis changes with very little motion from c5 or c6 to t1.On (b)(6) 2008: patient underwent an mri of cervical without contrast.On same day, patient also presented with a follow-up visit and following diagnosis- 1.C4-c5 segmental instability.2.C5-c6 segmental instability with herniated nucleus pulposus.3.C6-c7 herniated nucleus pulposus.4.Left c6 and left c7 motor weakness and radiculopathy.On (b)(6) 2008: patient underwent home health evaluation and daily dressing changes using ¿primapous¿.On same day, patient underwent x-ray of the chest.Impressions- 1.No acute pulmonary disease.2.Bilateral pulmonary parenchymal hyperaeration.On (b)(6) 2008: the patient was admitted with the following diagnosis- 1.Cervical spine radiculopathy with herniated nucleus pulposus.2.Smoking and chronic obstructive pulmonary disease stage i.The patient underwent following procedures: 1.Major discectomy with partial corpectomy at c4-5.2.Anterior interbody arthrodesis at c4-5.3.Insertion of intravertebral device at c4-6.4.Major discectomy with partial corpectomy at c5-6.5.Osteotomy with major discectomy at c6-7.6.Anterior interbody arthrodesis at c5-6.7.Insertion of intravertebral device at c5-6.8.Anterior interbody arthrodesis at c6-7.9.Insertion of intravertebral device at c6-7.10.Anterior plate fixation at c4-7.11.Use of operative microscope.12.Use if intraoperative fluoroscopy.The following implants were also used with rhbmp-2/acs in the surgery- dupuy swift plate measuring 57 mm and eight 12mm screws, self-tapping at c4-5, 7x9mm intravertebral graft by lifenet.C5-6 intravertebral graft by lifenet and c6-7 8 x 10-mm intravertebral graft by lifenet.Per op-n otes, the trial sizer was used to ensure the appropriate size at the levels c5 and c6, noting a 6 x 8 mm to be appropriate.The graft was subsequently hydrated for the appropriate period of time.A small trough was created cranially and caudally and a small 1/20 strip of the bmp saturated sponge was placed within this trough, subsequently covered with dbm putty and cancellous mixed allograft.The graft was gently tapped into place and slightly recessed.The patient was counseled pre-operatively regarding the off-label use of bmp and the risk of post-operative swelling and also that they would be using a minimal amount to ensure minimal risk.The patient was noted to have a history of smoking and was able to stop 2 weeks prior to surgical intervention.The graft in appropriate position on anterior, posterior and lateral images was examined at the c4-5 level where the caspar pin was placed and distraction was placed on c4-5 interval.The exact same procedure was performed at this level, requiring no removal of the inferior aspect of c4 and no partial corpectomy.However, only smoothing of the inferior aspect was required with a 4mm cutting and diamond burr.A footplate was created along the cranial aspect of c5, c6 and c7 to prevent graft extrusion into the canal after removal of our cartilages endplate at each level.The trial sizer again was used at this level.After this, foraminotomy, uncinectomy and discectomy was ensured with a nerve hook to ensure no impingement upon the c5 nerve roots, the trial sizer was used at this level, noting a 7x9mm to be appropriate, was prepared in the same manner as performed at c5-6, and gently tapped into place.No patient complications were reported.On (b)(6) 2008: the patient was discharged with the following diagnosis- 1.Status post c4, c7 anterior cervical discectomy and fusion plus plating.2.Chronic obstructive pulmonary disease i, smoking cessation advised.3.Reactive lymph nodes, no evidence of malignancy.Patient was stable at the time of discharge.On (b)(6) 2008: patient presented with a follow-up visit due to anxiety and hyperventilation.Patient also underwent following diagnosis- status post anterior cervical discectomy and fusion at c4-c5, c5-c6, c6-c7 segments with anterior locking plate.On (b)(6) 2008, (b)(6) 2009: patient presented with a follow-up visit due to cervical spine axial discomfort with progressive left upper extremity motor weakness and radiculopathy.Patient also presented with following diagnosis- status post c4-5, c5-6, and c6- 7 anterior cervical discectomy and fusion with anterior plating.On (b)(6) 2009: patient presented with a follow-up visit due to cervical spine axial discomfort with upper extremity pain and paraspinal discomfort.Patient also presented with following diagnosis- status post anterior cervical discectomy and fusion at c4 through c7.On (b)(6) 2009: patient presented with a follow-up visit due to cervical spine axial discomfort with upper extremity pain.On (b)(6) 2009: patient underwent a ct scan of cervical spine.Impressions: 1.Solid anterior fusion and fixation of c4-c7.Expected postoperative appearance.2.Mild right foraminal stenosis at c34 the could affect the right c4 nerve root.On (b)(6) 2009, (b)(6) 2010: patient underwent x-ray examination due to swollen neck and arm.Impressions- herniated nuc pul cerv, cervicalgia- neck pain, facet syndrome.On (b)(6) 2010: patient presented with whole body bone scan due to history of c4-c7 anterior cervical fusion and bilateral c3-4 facet joint arthropathy.Findings- 1.Expected uptake in the area of the previous anterior c4-c7 fusion.2.Increased uptake in region of the atlanto occipital facet joints and base of the clivus.3.No abnormal uptake identified in the region of the c3-4 facet joints.4.Mildly increased uptake both hip joints, both patellofemoral joints and right great toe mtp joint consistent with mild arthrosis.On (b)(6) 2010: patient presented with x-ray due to cervical pain.Impressions- 1.Minimal motion-induced listhesis at c3-4 and c7-t1 above and below the multilevel cervical fusion.2.Mild spondylosis change.On (b)(6) 2010: patient presented with x-ray of cervical spine due to cervical pain postsurgery.Impressions- stable examination with anterior plate and screw fusion from c4 through c7, with very slight anterolisthesis of c3 on c4 during flexion and slight 1 mm retrolisthesis of c3 on c4 during extension.On (b)(6) 2010, (b)(6) 2011: patient presented with follow-up visit due to neck pain occurred due to motor vehicle accident on (b)(6) 2010.On same day, patient underwent a cervical spine examination which revealed tenderness to palpation bilateral cervical paraspinal musculature and diminished range of motion for cervical flexion, extension, axial rotation and right and left lateral bend.Patient also underwent x-ray of the cervical spine consisting of ap lateral flexion and extension views which revealed normal anterior posterior alignment with a cervical spine plate placed c4-c7.Lateral projections revealed consolidated interbody fusion c4-7.Flexion versus extension views revealed hypermobility at the c3-4 level.Impressions- sprains/ strains neck, herniated nuc pul cerv, cervicalgia- neck pain.Neurological examination revealed numbness and headaches/ migraines.On (b)(6) 2010: patient presented with x-ray of cervical spine with lateral flexion/ extension due to neck pain.Findings- 1.Status post anterior cervical fusion of c4-c7 with expected postoperative appearance.2.Segmental instability at c2-3 andc3-4.On (b)(6) 2010: patient presented with following diagnosis- cervical hnp i disc displacement without myelopathy and postlaminectomy cervical region.Assessment- patient developed neck pain which was described as continuous aching.Repeat mri and x-rays showed disc protrusion above the level of fusion.Patient also underwent physical examination which revealed tenderness on the left lower cervical facets c4-s-s 6 and 67 with positive quadrant loading signs increasing pain and left rotation of the neck.On (b)(6) 2011: patient presented with following diagnosis- postlaminectomy cervical region and cervical hnp i disc displacement without myelopathy.On (b)(6) 2011: patient underwent emg/ncv bilateral upper extremities revealed patient to have bilateral c4 and c5 radiculopathy.On (b)(6) 2011: patient underwent an mri of cervical spine which revealed a 2.5 mm paracentral disc herniation at c3-4 level.There was a 2.5 mm broad-based disc herniation resulting in moderate to severe right foraminal stenosis compressing the right c8 nerve root.There was also moderate left foraminal stenosis.Patient also underwent x-ray of cervical spine with lateral flexion/ extension due to neck pain.Findings- no significant change.On (b)(6) 2011: patient presented with following diagnosis- encounter for therapeutic drug monitoring, encounter for long-term use of other medications, cervical hnp i disc displacement without myelopathy and postlaminectomy cervical region.Patient underwent a physical examination which revealed no significant change.On (b)(6) 2012: patient presented with following diagnosis- status post anterior cervical fusion, chronic posterior neck pain, chronic pain syndrome, and encounter for medication management.Patient also underwent physical examination which revealed that the cervical spine showed preserved range of motion.Tenderness to palpation in the left facets upper and lower with quadrant loading signs were observed.On (b)(6) 2012: patient presented with following diagnosis- status post anterior cervical fusion, posterior neck pain, cervical facet joint arthropathy, chronic pain syndrome, and encounter for medication management.Patient also underwent a physical examination of the cervical spine revealed range of motion unchanged, tenderness to palpation in the left cervical facets at c4-c5 and c5-c6 level mostly and possibly c3-c4 as well with quadrant loading signs.Anterior cervical fusion scar was well healed.No major changes on exam of the upper extremities either sensory or motor.On (b)(6) 2013: patient presented with following diagnosis- status post anterior cervical fusion multilevel, worsening of posterior neck pain to interscapular area and thoracic area, and worsening of radicular symptoms.Patient also underwent physical examination which revealed decreased range of motion in both flexion and extension.There was tenderness to palpation posteriorly at c4-c5, c5-c6, c6-c7 into interscapular area, posterior shoulders, and upper arms.Deceased sensitivity to light touch and pinprick in bilateral c6 distribution.On (b)(6) 2013: patient underwent a ct scan of the cervical spine for flexion and extension conditions due to neck injury post a motor vehicle accident.Impressions- 1.Anterior cervical diskectomy and fusion c4 through c7.2.Mild segmental instability at the c3-c4 level.3.No motion of the fused levels on flexion or extension.On same day, patient again underwent a ct scan without contrast due to neck pain.Impressions: anterior cervical and fusion c4 through c7 in near anatomic alignment.On (b)(6) 2013: patient presented with following diagnosis- status post anterior cervical fusion, three level, with c3-c4 mild instability and persistent neck pain.Patient also presented with physical examination which revealed decreased range of motion in both flexion and extension.There was tenderness to palpation posterity at c4-c5, c5-c6, c6-c7 into interscapular area, posterior shoulders, and upper arms.Deceased sensitivity to light touch and pinprick in bilateral c6 distribution.On (b)(6) 2013: patient presented with the following diagnosis- status post anterior cervical fusion, thoracic spondylosis and chronic pain syndrome.On (b)(6) 2013: patient presented with ct scan of thoracic spine without contrast due to back pain.Impressions- mild right foraminal stenosis at t9-10 and t10-t11.Patient also underwent a physical examination which revealed tenderness to palpation in the midthoracic area around t5- t6 on the right subscapularis area and also pain.Patient has persistent paresthesias in the left upper extremity in the c6 and c7 distribution.On (b)(6) 2013: the patient presented with following diagnosis- status post anterior cervical fusion, thoracic spondylosis, and chronic encounter for medication management.Physical examination of the cervical and thoracic spine revealed some tenderness to palpation mostly at the t7- t8 level left more than right-sided that seems to be facetogenic.On (b)(6) 2013: the patient presented with the following diagnosis- status post anterior cervical fusion, thoracic spondylosis, and encounter for medication management.Physical examination of the cervical spine revealed tenderness to palpation in the cervical facets with quadrant loading signs on the right more than left.Some chronic pain radiated into the interscapular area.
 
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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 Key5028478
MDR Text Key23990026
Report Number1030489-2015-02083
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 Other
Report Date 07/27/2015
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 Expiration Date01/31/2010
Device Catalogue Number7510400
Device Lot NumberM110609AAG
Was Device Available for Evaluation? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/25/2015
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/11/2007
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 Weight51
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