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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 7510200
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Muscle Spasm(s) (1966); Loss of Range of Motion (2032); Depression (2361); Neck Pain (2433); Neck Stiffness (2434)
Event Type  Injury  
Manufacturer Narrative
(b)(6).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.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that on: (b)(6) 2010: patient presented with c1-c2 instability post ehlers-danlos syndrome and underwent c1-c2 posterior spinal instrumentation and fusion using auto and allograft.As per operative report: ".A straight midline incision was made over c1 and c2, skin and fascia was incised.Arch of c1 and c2 was exposed.Using high speed burr, starting point for c1 isthmus screw was made.The screw hole was tapped and medtronic vertex screw was placed in the isthmus of c1 bilaterally.Next lateral mass of c2 was identified in inferior one-third.Similarly screw was placed into pedicles of c2.The lamina of c1 and c2 were decorticated and then packed with auto and allograft.The c1-c2 screws were then connected using a small rod and set screws were placed and torqued.Intra-operative cervical spine x-rays shows posterior screw and rod fixation of c1 and c2 in satisfactory position and alignment.The patient was taken out of the operating room in stable condition." on (b)(6) 2010: patient presented for pain consultation.Patient is having headaches, some pain and mobility issues.Impression: status post c1-c2 fusion due to neck pain with decreased mobility in adl¿s.On (b)(6) 2010: patient presented for office visit and complains of increase pain ever since he was brushing his teeth and bent over to split and rinsing.Patient underwent c spine x-ray showing stable postsurgical changes.On (b)(6) 2010: patient presented for post op evaluation and is having lot of issues controlling his pain.Patient has shooting pain across the back of his head.His shoulders are tight on both sides and is having muscle spasms.On (b)(6) 2010, (b)(6) 2010, (b)(6) 2011, (b)(6) 2011, (b)(6) 2011, (b)(6) 2011, (b)(6) 2011 : patient presented for office visit.Examination shows little cervical range of motion and he¿s triggering spasm from even minor paracervical palpation.Palpation of c7 causes tremors in spine and hands.On physical examination of cervical spine there is no movement from occiput to c3, severe full spinal diffuse tenderness over posterior disc spaces.Diagnosis: major reversal of curve in cervical spine without disc disease, c4-5 mild spur, c1-2 instability repaired.On (b)(6) 2010: patient underwent x-ray of cervical spine.Impression: examination demonstrates reversal of the cervical curvature.Surgical fusion is noted at c1 and c2.On (b)(6) 2011: patient presented with chief complaint of pain.Review of system is positive for ehlers-danlos syndrome and neck pain.On physical examination, patient has limited range of motion of cervical spine because of pain mainly on extension.Patient has tenderness over cervical paraspinal area and some mild tenderness over cervical facet area mainly at c6-c6 and c7-t1.X-ray of cervical spine show stable fusion at c1-c2.Impression: neck pain, cervical facet joint disease.On (b)(6) 2011; (b)(6) 2011, (b)(6) 2011, (b)(6) 2011: patient presented to pain medicine center for consultation regarding the morphine pump trial.On (b)(6) 2011: patient presented for office visit after (b)(6) and new films were ordered which were (b)(6).Diagnosis: motor vehicle accident.On (b)(6) 2011: patient was admitted.Patient presented with pre operative diagnosis of intractable neck pain status post spinal fusion at c1-c2, cervical facet joint disease, degenerative disk disease and underwent intrathecal pump trial tunneled catheter placement in the intrathecal space.Patient tolerated procedure well.On (b)(6) 2011, (b)(6) 2011: patient presents for im toradol injection for complains of neck and back pain.Diagnosis: major reversal of curve in cervical spine without disc disease, c4-5 mild spur, c1-2 instability repaired.On (b)(6) 2011: patient was discharged.(b)(6) 2011, (b)(6) 2011,(b)(6) 2011, (b)(6) 2011, (b)(6) 2011, (b)(6) 2011, (b)(6) 2011,(b)(6) 2012, (b)(6) 2012, (b)(6) 2012, (b)(6) 2012, (b)(6) 2012, (b)(6) 2012, (b)(6) 2012, (b)(6) 2012, (b)(6) 2012: patient presented for office visit.Diagnosis: major reversal of curve in cervical spine without disc disease, c4-5 mild spur, and c1-2 instability partially repaired.On (b)(6) 2011, (b)(6) 2012, (b)(6) 2012, (b)(6) 2012,: patient presents for im toradol injection.Diagnosis: major reversal of curve in cervical spine without disc disease, c4-5 mild spur, c1-2 instability partially repaired.On (b)(6) 2012: patient presented for office visit.Diagnosis: fall with head injury, possible concussion, left scrotal abscess.Patient underwent ct of cervical spine due to fall.Impression: there is no acute osseous injury.There are stable post surgical changes of fusion of c1-c2.Paravertebral soft tissue is unremarkable.Patient also underwent brain ct without contrast.Impression: unremarkable.On (b)(6) 2013: patient presented with chief complaint of swollen leg and underwent left lower extremity venous duplex scan due to pain.Impression: no evidence of acute deep vein thrombosis of left lower extremity.On (b)(6) 2013; (b)(6) 2014: patient presented for office visit with chief complaint of neck pain.Review of systems is positive for neck stiffness, neck pain, limitation of joint movement, muscle pain.On musculoskeletal examination patient abnormal neck flexion, extension, rotation and lateral bending of neck to left and right.Patient has tenderness to palpation over occipital and c1 region.Pain with passive rom testing in all directions of neck.On (b)(6) 2014; (b)(6) 2014; (b)(6) 2014: patient presented with chief complaint of left hand pain and left hand 3/4/5 digit swelling.Assessment: carpal tunnel syndrome, left flexor synovitis of index/long/ring fingers.On (b)(6) 2014: patient presented with chief complaint of neck pain.Patient underwent x-ray of cervical spine due to c1-2 fusion neck pain.Impression: stable appearance of posterior fusion of the c1-c2.No hardware complication.Mild diffuse degenerative change of cervical spine.On (b)(6) 2014: patient underwent ct of cervical spine with and without contrast due to cervical spine pain.Impression: ct show superior top of right sided c1 screw appears to extend into the oa joint.Left sided c1 screw contacts the cortex but doesn't appear to extend into oa joint.No disc herniation or narrowing.Patient underwent mri of cervical spine without contrast.Impression: degenerative spondylosis notably at right at c5-c6.On (b)(6) 2014: patient presented with chief complaint of neck pain and underwent x-ray of cervical spine: impression: status post posterior fusion c1/2 with 4 screws and stabilization.Loss of lordosis postural in nature.No abnormal motion with flexion/extension.Mild scoliosis cervical spine.On (b)(6) 2014: patient presented for office visit: diagnosis: depression, misplacement of right c1 screw into atlanto occipital joint, major reversal of curve in cervical spine without disc disease, c4-5 mild spur, c1-2 instability partially repaired.On (b)(6) 2014: patient presented for office visit with chief complaint of neck pain intractable in nature.On physical examination patient has limited range of motion of cervical spine on rotation.Extension produces pain.Patient has impoverished movement of left hand and diagnosed with some arthritic changes in hand.Plain x-rays show c1-c2 fusion.On the right side, the upper screws goes through the atlanto-occipital joint.Interpretation: other mechanical complication of other internal orthopedic device, implant and graft.Depression.On (b)(6) 2015: patient presented with pre operative diagnosis of probable pseudoarthrosis c1-2 and underwent removal of c1-2 screws.There was some difficulty removing the screws because they had been stripped.There were no complications.On (b)(6) 2015: patient underwent x-ray of cervical spine.There is some subcutaneous gas present posteriorly upper cervical spine consistent with recent surgery.On (b)(6) 2015: patient presented with chief complaint of neck pain intractable in nature.Patient reports substantial increase in neck pain.Patient¿s flexion-extension x-rays of cervical spine shows very subtle spondylolisthesis at c2-3 that is stable without any signs of dynamic instability.Slight reversal of normal cervical curvature.
 
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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 USA, INC
4340 swinea rd
memphis TN 38118
Manufacturer Contact
stacie ziemba
1800 pyramid place
memphis, TN 38132
9013963133
MDR Report Key6692182
MDR Text Key79229977
Report Number1030489-2017-01687
Device Sequence Number1
Product Code NEK
UDI-Device Identifier00681490843782
UDI-Public00681490843782
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
Report Date 06/12/2017
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 Date11/01/2012
Device Catalogue Number7510200
Device Lot NumberM110905AAG
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 06/12/2017
Initial Date FDA Received07/07/2017
Was Device Evaluated by Manufacturer? No
Date Device Manufactured04/21/2010
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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