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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
Device Problem Insufficient Information (3190)
Patient Problem Injury (2348)
Event Type  Injury  
Event Description
It was reported that the patient sustained unspecified injuries following the use of rhbmp-2/acs in an unspecified spinal fusion surgery.No additional information was reported.
 
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.
 
Manufacturer Narrative
(b)(4).
 
Event Description
The patient underwent thoracic laminectomy t1-t8 and fusion with synthes posterior instrumentation, floseal, mtf tissue, and rhbmp-2/acs.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that on (b)(6) 2007 patient presents to emergency department with c/o back pain.X-ray indicates posterior fusion with osteoporosis without evidence of an acute fracture.On the date of (b)(6) 2008 patient presents to er with complaints of pain.Per medical record patient is an opiate addict consuming 100mg of methadone daily.On the date of (b)(6) 2008 patient presented with c/o chronic pain.Per medical record mri scan of the lumbar spine today without and with gadolinium.Hypoplasia is noted.There is a small fluid collection in the dead space created by the laminectomy.It is a confined fluid collection causing absolutely no compression of the dural sac.There is minimal-to-no enhancement around it.On the date of (b)(6) 2008 patient present for mri lumbar.W/wo gadollnium indicates: unchanged appearance of the lumbar vertebral bodies, posterior pedicle fusion, soft tissues and appearance of the disc spaces as discussed in the full body of the report on file.No evidence of interval disc herniation, nerve root displacement or abnormal enhancement on the post-gadolinium sequences to suggest discitis or osteomyelitis.On the date of (b)(6) 2008 patient presented with complaints of pain and soreness in his lower sacral area.He also complains of deep burning pain in the lateral side of both hips along with left breast tenderness since surgery.Spine x-rays shows excellent placement of the hardware and a fusion mass.There is stability with flexion, and the patient's scoliotic curvature is largely resolved.On the date of (b)(6) 2010 8 views of the cervical spine including flexion and extension reveal cervical spondylosis and smooth kyphosis.On the date of (b)(6) 2010 mri-spine, there is evidence of a compression deformity of t4; this.Is not as well seen on the mri-spine but is identified.Subtle and end plate depression identified, thoracic spondylosis of the mid and lower thoracic spine, s/p thoracolumar fusion, pulmonary emphysema bullous changes, uncomplicated appearing cholelithiasis and signs of an exophytic cyst of the superior pole of the left kidney.On the date of (b)(6) 2010 mri of the thoracic spine indicates there does not appear to be a significant interval change.Again noted is a moderate chronic compression deformity of t4 and mild compression deformity of t5.There is no retropulsion.No other compression fracture is detected.Minimal central disk protrusion at the t8¿9 level is again noted and does not appear changed.The spinal cord appeared intrinsically normal.Para-spinal soft tissues are normal mild osteophyte production is noted.On the date of (b)(6) 2010 exploration of t1 through t8, bilateral lumbar laminectomies for decompression, t1 through.T8 osteotomies for local autograft harvest.T1 through t8 placement of bilateral synthes universal spinesystem ii, pedicle screw, and vertical fixation rod stabilization system, placement of 2 low-profile crosslink trans connectors for nonsegmental rotation, and translational stabilization, use of the stealth flame with stereotactic spinal neuro navigation system, use of the o-arm intraoperative fluoroscopic virtual ct scanning guidance system, allograft graft preparation with crushed cancellous bone md trinity evolution adult stem cell preparation, and t1 through t8 posterior and posterolateral thoracic fusion with autograft and allograft bone and bone morphogenic protein, and use of intraoperative electrophysiological spinal cord monitoring.On the date of (b)(6) 2010 per imaging the skull base and cervical vertebral bodies appear to be adequately aligned.Then is forward inclination of the cervical vertebrae in general.No spondylolisthesis or abnormal posterior element splaying is appreciated.The intervertebral disc space: relatively preserved.The prevertebral soft tissues are normal in thickness, as is the predental space.The included airway is patent the patient appears to be edentulous.There has been prior thoracic fusion with the use of parallel spinal rods and screws.Suspected there has been posterior decompression laminectomy.On the date of (b)(6) 2010 patient states 숅 presented to er at 2:00am today complaining of pain, received rx for lortab.Patient already has rx for same.Patient has not taken pain medication as prescribed today.Encouraged to lake medication as they ant ordered.Patient noted to have incision thoracic spine, healed with no infection present.Patient grimaces to touch, moans.Patient is not wearing brace secondary to pain." on the date of (b)(6) 2010 patient arrived by ambulance with cane and c/o burning pain at the incision level.Per medical record patient has slouching posture and cervical lordosis is noted.Per medical record "the patient has a focal area of pain in the left t 1-t2 area that gets worse during the day as he fatigues and bends his neck forward.There is no protrusion of hardware; however, it is around the site of the head of the pedicle screws on that side." on the date of (b)(6) 2011 dx of thoracic spine findings indicate the patient has had multi-level thoracic and multi-level lumbar fixation of the spine.No evidence of orthopedic hardware failure.The examination demonstrates eight pairs of pedicle screws for fixation of the upper thoracic spine.On the dates of (b)(6) 2011 patient underwent physical therapy for cervical pain on the date of (b)(6) 2011 patient presented with c/o low back pain and lower extremity pain, burning and paresthesia's on left greater and right.On the date of (b)(6) 2011 patient presented for mri of the spine w/o contrast which revealed kyphosis on the date of (b)(6) 2011 patient presents for follow-up and states he is better and declines tpi and states he is getting adequate pain relief.On the date of (b)(6) 2011 patient arrived with c/o pain at the incision level.Per medical record patient has poor posture and has been instructed to use plate and brace to improve posture.On the date of (b)(6) 2011 trigger point injections given.On the date of (b)(6) 2011 patient arrived by ambulance with c/o pain in the upper thoracic at the area of upper hardware construct.Per medical record "unable to remove hardware (per patient request) too unstable if removed." on the date of (b)(6) 2011 2 views of the thoracic spine indicate no interval change in the appearance of the thoracic spine since previous exam.Extensive spinal fusion has been performed extending from approximately t1 through t7.Chronic partial compression fracture of t3 is again noted and is stable.Anterior and lateral views of the cervical spine show normal position and alignment t1 through t7 without evidence fracture or sublaxation.Mild disc space narrowing is noted at c6-7.On the date of (b)(6) 2011 patient is here today for a 1 month follow up.He continues on methadone as issued.Pain is unchanged from loy.He states it seems to be getting worse with the weather changes.Meds do ease the pain.On the date of (b)(6) 2012 patient underwent injection per record symptoms improved.On the date of (b)(6) 2012 patient presents for routine follow up to the left -sided thoracic rf injection.Per medical record patient states 숅 obtained some improvement, however, he does remain symptomatic with pain.Continues on issued medication of methadone.Last refilled on os (b)(6) 2012.Last reported dosage was this afternoon." on the date of (b)(6) 2012 patient present with c/o pain.Patient states "the cause of his pain is due to a birth defect.The current problem began on or about sometime in childhood.The symptoms were gradual in onset.Pain location: lower lumbar.The patient describes the pain as nagging, miserable, unbearable, sharp, aching, burning and throbbing.The pain is made worse by standing, walking and sitting." on the date of (b)(6) 2013 patient presented for routine follow-up.Patient is here for routine office visit and medication refills.Doing well on current medications.No negative side effects and pain is adequately controlled, allowing the patient to participate in normal daily activities of living.On the date of (b)(6) 2013 patient presented for routine follow-up.Patient is here for routine office visit and medication refills.Doing well on current medications.No negative side effects and pain is adequately controlled, allowing the patient to participate in normal daily activities of living.On the date of (b)(6) 2013 patient presented for routine follow-up.Patient is here for routine office visit and medication refills.Doing well on current medications.No negative side effects and pain is adequately controlled, allowing the patient to participate in normal daily activities of living.On the date of (b)(6) 2013 patient presented for routine follow-up.Patient is here for routine office visit and medication refills.Doing well on current medications.No negative side effects and pain is adequately controlled, allowing the patient to participate in normal daily activities of living.On the date of (b)(6) 2013 patient presented for routine follow-up.Patient is here for routine office visit and medication refills.Doing well on current medications.No negative side effects and pain is adequately controlled, allowing the patient to participate in normal daily activities of living.On the date of (b)(6) 2013 patient presented for routine follow-up.Patient is here for routine office visit and medication refills.Doing well on current medications.No negative side effects and pain is adequately controlled, allowing the patient to participate in normal daily activities of living.
 
Manufacturer Narrative
Review of radiographic images found as follows: (b)(6) 2010 thoracic spine x-rays dorsal segmental fixation is seen in the mid and upper thoracic areas.This appears to extend from t1 to t8.This is thought to be bilateral and symmetrical.
 
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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 Key3604570
MDR Text Key4154446
Report Number1030489-2014-00361
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,Followup,Followup
Report Date 03/24/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/03/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received04/21/2015
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 Weight66
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