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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 7510050
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bronchitis (1752); Chest Pain (1776); Edema (1820); Headache (1880); High Blood Pressure/ Hypertension (1908); Incontinence (1928); Muscle Spasm(s) (1966); Nerve Damage (1979); Neuropathy (1983); Pain (1994); Pneumonia (2011); Scarring (2061); Seroma (2069); Swelling (2091); Weakness (2145); Tingling (2171); Dizziness (2194); Chronic Obstructive Pulmonary Disease (COPD) (2237); Stenosis (2263); Pressure Sores (2326); Depression (2361); Arachnoiditis, Spinal (2390); Numbness (2415); Ambulation Difficulties (2544); Nervous System Injury (2689); Fibrosis (3167)
Event Type  Injury  
Manufacturer Narrative
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.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.If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the patient underwent a spinal fusion surgery on the lumbar region of her spine from l4-s1.Reportedly, rhbmp-2 was used in this surgery.Reportedly, the patient's post-operative period has been marked by increasingly severe pain in her legs and nerve injury.It was reported that the patient continues to experience radiating pain to the legs, nerve injury, numbness in both legs, and constant lower back pain.This prevents her from practicing and enjoying the activities of daily life that she enjoyed pre-operatively, and she has otherwise suffered serious injuries.It was reported that on (b)(6) 2008 the patient mri of the lumbar spine with and without contrast.Impression: unilateral pars intra-articularis defect on the left at l5 with minimal grade i anterior spondylolisthesis l5 on sl.Left posterior focal disc extrusion at l4-l5 and right posterior.On (b)(6) 2008 the patient presented with low back pain and bilateral leg pain.On (b)(6) 2008: the patient admitted to hospital.The patient underwent x-ray of lumbar spine 2/3 views.The patient underwent the surgery.Preoperative diagnosis: l4-l5 and l5-s1 degenerative disc disease with disc herniation and l5-s1 spondylolisthesis.The patient underwent the following operations: l4-l5 and l5-s1 decompressive laminectomies bilaterally.L4-l5 and l5-sl posterior lateral spinal fusion bilaterally.L4-l5 and l5-sl interbody fusion using a transforaminal approach.Pedicle screw instrumentation at l4-l5 and l5-sl, bilaterally with globus revere pedicle screw system.Use of interbody fusion cages using the revere oblique cage.Autologous local bone graft plus allograft cancellous chips.Use of vitoss bone graft substitute and rhbmp-2.Per op notes: autologous bone graft which had been obtained from the spinous processes and the lamina and had been cleaned and morselized, this was now mixed with the vitoss bone graft substitute.It was packed into the anterior aspect of the disc space.A piece of rhbmp-2 -soaked sponge was also used.This was followed by an oblique fusion cage which was packed with vitoss bone graft substitute.Autologous bone graft which had been mixed with vitoss bone graft substitute was used to pack in the lateral gutters over the decorticated transverse processes.A sheet of rhbmp-2 protein was placed first and then packed with the bone graft.This was done bilaterally.On (b)(6) 2008 the patient underwent x-rays of lumbar sacral spine.Impression pedicle screw fixation from l4 through s1 with disc spacers.On (b)(6) 2008 the patient presented for the follow up of l4-5, l5-s1 laminectomy and fusion.Patient complained of leg pain.X-rays of lumbar spine ap <(>&<)> lateral showed good position of her pedicle screw instrumentation and bone grafting at l4-5 and l5-si.Interbody spacer were in good position.On (b)(6) 2008 the patient presented for follow up.She complained of leg pain.Mri of the lumbar spine appeared to be consistent with any type of infection or abscess.On (b)(6) 2008 patient complained of some pain in back of her leg radiating down the leg.On (b)(6) 2008 the patient presented for refill of pain med.On (b)(6) 2008 the patient presented for follow up.Patient complained of recurring back and leg pain.X-rays of the lumbar spine showed good position of instrumentation.Bone graft appeared to be consolidating in the lateral gutters.On (b)(6) 2008.The patient was hospitalized due to lower back pain.Patient discharged on (b)(6) 2008.Assessment: post-op low back pain.The patient underwent mri of lumbar spine w and w/o contrast.Impression: interval laminectomy and instrumentation of fixation l4-5 and l5-s1 since the previous examination of (b)(6) 2008.The l4-5 level has a typical postoperative appearance.The l5-s1 level exhibits fairly significant epidural enhancement and some enhancement of the right posterior lateral margin of the operative disc space.In addition, a posterior epidural rim-enhancing fluid collection is present, with a slight mass effect along the posterior aspect of the thecal sac.Patient presented with chief complaint of chronic back pain.Patient underwent x-ray of left great toe.Impression: comminuted fracture of the distal phalanx of the great toe.Patient underwent x-ray of chest.Impression: negative chest.On (b)(6) 2008 the patient presented for the follow up of l4-5, l5-s1 laminectomy and fusion.On (b)(6) 2008 the patient presented for the follow up of l4-5, l5-s1 laminectomy and fusion.On (b)(6) 2008 the patient was presented for office visit with low back pain, leg pain and foot pain.Assessments: lumbar post laminectomy, lumbar radiculopathy, muscle spasms.On (b)(6) 2008: the patient presented for the follow up due to pain.Patient complained of back pain, leg pain and numbness in the foot.X-rays of the lumbar spine showed good position of instrumentation.Bone graft appeared to be consolidating in the lateral gutters.On (b)(6) 2008 the patient was presented for office visit with low back pain.Assessments: lumbar post laminectomy.On (b)(6) 2008 the patient complained of swollen back and having pain.On (b)(6) 2008: the patient presented for leg pain and low back pain.On (b)(6) 2008 the patient underwent the mri of the lumbar spine.Impression: postoperative and degenerative changes., findings at the l4-5 and l5-s1 disc with minimal increased signal and slight enhancement.Contact of exiting nerves most pronounced l4-5 and l5-s1.Possible impingement at the exiting left nerve at l5-s1.On (b)(6) 2008 the patient presented for an office visit.Mri scan showed some epidural fibrosis posteriorly at the l5-s1 level.The patient complained of some numbness in leg.On (b)(6) 2008 patient presented with chief complaint of cough, sinus pain, chills and runny nose.The patient underwent x-ray of chest.Impression: mild interstitial pulmonary edema.On (b)(6) 2008, (b)(6) 2009 the patient was presented for office visit with low back pain, buttocks pain, leg pain and foot pain.Impressions: lumbar post laminectomy, muscle spasms.On (b)(6) 2009 the patient presented for the follow up of l4-5, l5-s1 laminectomy and fusion.Patient complained of back pain.On (b)(6) 2009 the patient underwent lexiscan myocardial perfusion scan.On (b)(6) 2009 the patient presented for the follow up of l4-5, l5-s1 laminectomy and fusion.Patient complained of soreness in lower back.X-rays showed instrumentation in good position along with interbody cages.Consolidating bone graft was noted in both the lateral gutters.On (b)(6) 2009 the patient presented for the follow up of l4-5, l5-s1 laminectomy and fusion.X-rays of lumbar spine showed good position of instrumentation.Bone grafting was noted in the lateral gutters.Some mild lucency around the s1 screws.On (b)(6) 2009: as per the billing records, the patient underwent mammogram screening.On (b)(6) 2009 the patient complained of numbness in both feet.On (b)(6) 2009 the patient underwent mri of the lumbar spine.Impression: the degree of central spinal stenosis at l5-s1 was noted and anterolisthesis of l5 on s1.There is slight tethering of a few of the posterior spinal nerve roots at the l4 level and a partially empty sac sign.There is no significant enhancements of the nerve roots at this level and this suggests the sequel of burnt out or remote arachnoiditis.No convincing evidence for active arachnoiditis.Mild adhesions suspected at this level.No significant interval change from prior study dated (b)(6) 2008.On (b)(6) 2009, patient presented with complaints of back pain.Patient reported moderate pain left mid, mid, left lower and lower lumbar spine which radiates to left hip, thigh, knee, calf and foot.On (b)(6) 2009 patient presented for an office visit due to swelling in her ankles and of back pain.Mri showed residual stenosis at 5-1 although that had improved.Epidural fibrosis posteriorly at canal level, mild clumping of the nerve at 4-5 which had indicated some arachnoiditis.On (b)(6) 2009 the patient was presented for office visit with hip pain, leg pain, low back pain and mid back pain.Assessments: lumbar post laminectomy, muscle spasms, opioid-induced bowel dysfunction disuse.Atrophy of muscles.On (b)(6) 2009 the patient was presented for office visit with low back pain, leg pain and foot pain.Assessments: lumbar post- laminectomy, lumbar radiculopathy, muscle spasms, opioid-induced bowel dysfunction.On (b)(6) 2009 the patient presented for office visit due to lower back pain.X-rays revealed the mild lucency around the screws at s1.On (b)(6) 2009 patient presented with injury to left ankle which happened three days ago.Patient reported moderate pain.The patient presented with lower back pain.On (b)(6) 2009 the patient underwent mri of spine lumbar.On (b)(6) 2009, (b)(6) 2010 the patient was presented for office visit with low back pain, hip pain, leg pain.Assessments: lumbar post laminectomy, lumbar radiculopathy, muscle spasms.On (b)(6) 2009 the patient presented for an office visit.X-rays revealed pedicle screws were intact l4 to s1.On (b)(6) 2009 the patient underwent mri of lumbar spine without and with intravenous contrast.Impression: overall similar appearance to the lumbar spine other than maturation of epidural fibrosis, postsurgical changes, and endplate changes at l4-l5 and l5-si.Non recurrent disc herniation or significant stenosis at these levels and no stenosis in the upper lumbar spine through the l3-l4 level.On (b)(6) 2009 the patient presented for follow up due to back pain.Patient complained of back pain and numbness in feet.On (b)(6) 2009: patient presented with following mri impression: degenerative disc disease, status post compression and fusion.L4-s1 2) probable postoperative arachnoiditis with epidural fibrosis and residual radiculopathy.On (b)(6) 2010 the patient was presented for office visit with low back pain and leg pain.Assessments: lumbar post laminectomy, lumbar radiculopathy, muscle spasms, opioid- induced bowel dysfunction.On (b)(6) 2010 the patient was presented for office visit with low back pain and leg pain.Assessments: lumbar post laminectomy.Muscle spasms.Lumbar radiculopathy.On (b)(6) 2010 the patient was presented for office visit with diagnosis: difficulty in walking and lumbago.On (b)(6) 2011, patient presented for office visit for chronic headache, left eye red since last week and back pain.On (b)(6) 2011, patient presented for office visit due to dry cough for three weeks.On (b)(6) 2011, patient presented for follow-up on pneumonia.On (b)(6) 2011, patient presented for office visit due to pneumonia.On (b)(6) 2011, on (b)(6) 2012, patient presented for follow-up visit.On (b)(6) 2012 the patient underwent ct scan of the chest.Impressions: emphysema and 6 mm right lower lobe and 5 mm right middle lobe pulmonary nodules.Groundglass opacities throughout especially in the right lower lobe.On (b)(6) 2012, patient presented for office visit for bronchitis.On (b)(6) 2012, patient presented for office visit.Patient reported intermittent swelling in feet and occasional dizziness while standing.On (b)(6) 2012, patient presented for office visit.Assessment: chest pain.Solitary pulmonary nodule.On (b)(6) 2012, patient presented for office visit for cough and chest congestion.Patient reported worsening chronic back pain.On (b)(6) 2012, patient presented for office visit.Patient reported left knee pain and worsening pain in back and legs.On (b)(6) 2012, patient presented for office visit.Patient reported worsening chronic back pain.On (b)(6) 2012, patient presented for follow-up on chest congestion.On (b)(6) 2013: patient presented for an office visit.Assessment: benign, hypertension; acute bronchitis; copd; other and unspecified hyperlipidemia; lumbar disc disease; edema; lumbar radiculopathy; other screening mammogram.On (b)(6) 2013 the patient presented with diagnosis of lumbar spondylosis, postlaminect synd-lumbar.On (b)(6) 2013 the patient underwent x rays of the chest due to chest pain and hypertension.Impressions: frontal upright portable radiograph of the chest.No complication was reported.The patient was also presented for office visit with chest pain.On (b)(6) 2014 the patient presented with chief complaint of lower back problem.The patient underwent mri of lumbar spine.On (b)(6) 2014 the patient underwent mri of lumbar spine.Impression: status-post l5-s1 operative intervention.No recurrent/residual protrusion, though l4-5 osteophyte complex causes moderate right exit crowding of l4.Recess scar at both levels may affect l5s and right greater than left s1.The l3-4 disc bulge is slightly more prominent than on the prior exam, without change in stenotic effect.L2-3 left foraminal disc bulge is also more prominent with new slight deflection of left l2.No other significant interval change.On (b)(6) 2014, patient presented for follow-up on low back pain and for medication refill.On an unknown date, the patient was implanted with spinal cord stimulator.On (b)(6) 2014 the patient presented with chief complaint of pain in lumbar spine.On (b)(6) 2014, patient presented for follow-up on cough and chest congestion.Patient had chronic back pain since 2008.On (b)(6) 2014 the patient presented with chief complaint of chronic pain syndrome.On (b)(6) 2014 the patient presented with chief complaint of lower back pain.Since the rhbmp-2 surgery, the patient has been suffering from: constant pain in lower back and left leg; the pain is more severe than before the rhbmp-2 surgery; radiating pain to legs; neck pain; numbness and tingling in both feet; numbness and tingling in left leg; nerve injury; disc bulge; stenosis; foraminal narrowing; spondylolisthesis; bladder incontinence; bowel incontinence; constipation; localized edema; mental anguish.The patient also had difficulty walking any distance; extreme difficulty standing for any length of time.On (b)(6) 2014, patient presented for office visit due to cough.On (b)(6) 2015 the patient underwent mri of lumbar spine due to degenerative disc degeneration, herniated.On (b)(6) 2015 the patient underwent ct of lumbar spine without contrast.Impression: status lower lumbar operative intervention, without mechanical or osseous failure.Left l3 and s1 screw tip placements.No significant osseous stenosis of the operative levels.Smudging of l4-5 recess fat.Mild spondylosis above the fusion, most evident at l3-4, no severe stenosis suggested.Accounting for intermodality difference, no significant changed since prior exam.The 18 mm left retroperitoneal cyst adjacent to psoas muscle, significance uncertain.On (b)(6) 2015, patient presented for follow-up on hypertension, hyperlipidemia, lumbar disc disease with radiculopathy and copd.Patient reported pain from radiculopathy and neuropathy.On (b)(6) 2015, patient presented for office visit due to bronchitis.On (b)(6) 2015: the patient presented for chief complaint of constant pain in lower back and left leg due to injury on job.Patient had no relief.On (b)(6) 2015: patient presented with left ear-pressure/ unable to hear out of that ear.Assessment: middle ear effusion; lumbar disc disease.On (b)(6) 2015 the patient presented with chief complaint of pain in lumbar spine, chronic pain syndrome.On (b)(6) 2015 the patient presented with chief complaint of chronic pain syndrome.X-rays of thoracic spine showed no fracture, no dislocation, and joint spaces well preserved.On (b)(6) 2015 the patient presented with preoperative diagnosis of chronic pain syndrome, lumbar radiculopathy, lumbar degenerative disc disease, lumbar spondylosis, spine laminectomy.The patient underwent following operation: percutaneous spinal stimulator/ lead placement under fluoroscopy.On (b)(6) 2015 the patient presented with chief complaint of pain in lumbar spine, lumbosacral radiculitis, chronic pain syndrome.On (b)(6) 2015 the patient presented with chief complaint of lower back problem.On (b)(6) 2015: patient presented for a follow up visit and complained of having chronic pain down left leg from lumbar disc.Assessment: essential hypertension; other hyperlipidemia; chronic lumbar radiculopathy; chronic obstructive pulmonary disease (copd); lumbar disc disease, influenza vaccine needed.On (b)(6) 2015: patient presented for an eval and follow-up face to face for power wheelchair.Assessment: essential hypertension; other hyperlipidemia; chronic lumbar radiculopathy; chronic obstructive pulmonary disease (copd); lumbar disc disease.On (b)(6) 2016: patient presented for a follow up of hypertension, chronic lumbar radiculopathy, lumbar disc disease, hyperlipidemia, copd, lower extremity edema.Assessment: essential hypertension; other hyperlipidemia; chronic lumbar radiculopathy; chronic obstructive pulmonary disease (copd).On (b)(6) 2016: patient presented with complaint of nosebleed and recent headache.Assessment: gerd; epistaxis; acute headache; encounter for screening mammogram for malignant neoplasm of breast.On (b)(6) 2016: patient underwent ct of head without contrast.Impression: no mass or hemorrhage.
 
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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 Key7044365
MDR Text Key92474632
Report Number1030489-2017-02365
Device Sequence Number1
Product Code NEK
UDI-Device Identifier00613994239518
UDI-Public00613994239518
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 11/20/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/20/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date12/01/2008
Device Catalogue Number7510050
Device Lot NumberM110715AAB
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received10/30/2017
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/08/2008
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 Age57 YR
Patient Weight91
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