• Decrease font size
  • Return font size to normal
  • Increase font size
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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET Back to Search Results
Catalog Number 7510800
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cyst(s) (1800); Dyspnea (1816); Pain (1994); Scarring (2061); Tingling (2171); Stenosis (2263); Neck Pain (2433)
Event Type  Injury  
Manufacturer Narrative
(b)(4) disc herniation.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 on: (b)(6) 2007: patient presented for a neurosurgical consultation regarding her back and leg pain.Patient complained of bilateral leg weakness as well as cramping in back of her calf and tingling to the back of her thighs.On (b)(6) 2007: patient underwent mri of lumbar spine without contrast due to low back and leg pain with suspected spondylosis.Conclusion: mildly bulging l4-5 disc demonstrates some asymmetry and slight lateralization towards the left.Facet and ligamentum flavum hypertrophic changes at this level are somewhat worse on the left.Facet degenerative changes are noted at l5-s1.Labelling of the lumbar level is problematic but the labelling system used is as described.Patient also underwent ct of lumbar spine without contrast.Conclusion: some facet degenerative changes, particularly at l5-s1 and to a somewhat lesser extent at l4-5.On (b)(6) 2007: patient underwent mri of lumbar spine due to low back pain and leg weakness.Conclusion: specification of lumbar level is ambiguous due to the presence of a transitional segment which is sacralized on the left and lumbarized on the right.For the purposes of this report, this segment shall be denoted s1.Using this system, there are five additional fully-segmented, nonsacralized, nonrib bearing, lumbar-type vertebral bodies.Apex left mid lumbar scoliosis with a rotatory component.No significant plain film evidence of degenerative disk disease.Facet arthropathy at l4-5 and to a greater extent l5-s1.On (b)(6) 2007: patient for a follow-up visit for review of ct, mri and x-rays of lumbar spine.On (b)(6) 2007: patient presented for a follow up visit with complaint of low back and bilateral leg pain.On (b)(6) 2007: patient presented for scheduling of upcoming appointments and surgical information.On (b)(6) 2007: patient underwent x-ray of chest.Impression: slight hypertension, otherwise negative chest.On (b)(6) 2007: patient presented with pre-op diagnoses as: lumbar spondylosis.For which, patient underwent following procedures: decompressive laminectomy l4, l5, s1.Bilateral mesial facetectomy and bilateral foraminotomy for persistent neural stenosis and compression after decompressive laminectomy l4-l5 and l5-s1.Harvesting of autologous nonstructural bone.Bone screw placement bilateral pedicles l4 using spinal element system.Bone screw placement bilaterally using spinal element system l5.Bone screw placement using spinal element system bilaterally s1.Posterolateral fusion with autologous bone l4-l5 and l5-s1.Intraoperative fluoroscopy time 12 hours.Spontaneous nerve root monitoring using nuvasive system time four hours.Accurate nerve root monitoring times six using nuvasive system.Bone growth stimulator placement.Per op notes, surgeon decorticated the transverse process of the lateral facet joints from l4 to the sacrum.The autologous bone was placed over this after a bone growth stimulator was placed over this area.In addition, bone morphogenic protein was also added.The bone growth stimulator was placed in the subcutaneous pocket.The rod was connected to the screws and appropriately torqued down with compression at each level through a normal lumbar lordosis.Sterile dressings were applied.Patient tolerated the procedure well with no complications reported.On (b)(6) 2007: patient got discharged.On (b)(6) 2007: patient presented for an office visit for postoperative suture removal.On (b)(6) 2007: patient underwent x-ray of lumbar spine.Findings: no complications were identified.Atherosclerotic vascular disease was noted.On (b)(6) 2007: patient presented for a follow up visit with complaint of postsurgical back soreness.Patient also underwent x-ray of lumbar spine which showed hardware in good placement with good alignment of the lumbar spine.On (b)(6) 2007: patient underwent x-ray of lumbar spine status post lumbar spinal fusion in (b)(6) 2007.Impressions: no significant interval changes since (b)(6) 2007.On (b)(6) 2007: patient presented for a follow up visit with complaint of experiencing some pressure in the bilateral si joint region which she attributed to her back space.On (b)(6) 2007: patient underwent x-ray of lumbar spine due to sacroiliac joint pain.Impression: status post l4-s1 posterior spinal fusion with paired pedicle screws and posterior rods.The hardware is intact and unchanged.A bone simulator unit remains in place.Morcellated bone graft material posterolaterally exits bilaterally.Unchanged.Overall alignment is unchanged.Preserved vertebral body and intervertebral disk height and alignment.No other significant change.On (b)(6) 2007: patient presented for a post-op follow up visit status post lumbar fusion with complaint of low back pain.On (b)(6) 2008: patient presented for a post-op follow up visit status post lumbar fusion.Patient underwent x-ray of lumbar spine, ap and lateral views.Conclusion: surgical deformities of the lower lumbar region.Very minimal retrolisthesis is noted.No definite fracture of the prosthesis fixation is seen.On (b)(6) 2008: patient presented for a follow up visit with complaint of low back pain.Patient underwent x-ray of lumbar spine.Impression: re-demonstrated posterior l4-s1 fusion with paired pedicular screws and posterior tension rods.Hardware is intact.Fusion alignment is anatomic.Maturing posterolateral bone graft identified bilaterally.Laminectomy defect re-demonstrated at l5.A bone stimulator remains in place, stable position.Remainder of the lumbosacral spine is unremarkable and unchanged.Vascular calcifications are present.No other significant change from prior study.On (b)(6) 2009: patient was admitted to hospital for acute exacerbation of chronic obstructive lung disease and was found to have renal mass.Impression: severe chronic obstructive lung disease.Interstitial changes on the cat scan of chest raising possibility of atypical microbacterial disease.Chronic smoking.Patient also underwent pulmonary function test.Impression: severe obstructive lung disease as seen on spirometry and flow volume loop.On (b)(6) 2010: patient underwent lab test due to left kidney tumor.Pathologic diagnosis: left kidney, highly cellular renal neoplasm with necrosis.On (b)(6) 2010: patient underwent ct of chest, abdomen, and pelvis with contrast.Impression: interval left nephrectomy.Ill-defined, low attenuation, nonenhancing oblong soft tissue is seen adjacent to the metallic surgical clips and left adrenal gland, which probably represent postsurgical changes.Previously seen left retroperitoneal lymph node is not visualized, probably resected.No other interval focal lesion in the chest, abdomen and pelvis to suggest metastasis.Previously seen groundglass and branching opacities in lung base have resolved.Stable centrilobular emphysema.Marked atherocalcific changes in the abdominal aorta and its branches, advanced for patient's age.On (b)(6) 2010: patient underwent right 25cm ct injectable chest port placement.Impression: uneventful placement of an implanted 25 cm single lumen ct injectable right sided chest port.On (b)(6) 2010: patient underwent mri of brain with and without contrast.Impression: several small, nonspecific, nonenhancing signal abnormalities were noted in deep white matter.Otherwise, an unremarkable mri of brain without evidence of metastasis.On (b)(6) 2010: patient underwent nuclear medicine bone scan due to history of wilm's tumor with left renal resection, now with low back pain.Impression: no evidence of metastatic disease.On (b)(6) 2010: patient presented for a follow up visit.Impression: kidney cancer currently going chemo; poor energy level.On (b)(6) 2010: patient underwent regadenoson pharmacologic stress as a part of myocardial perfusion scan.Impression: procedural monitor regadenoson.Patient also underwent evaluation for coronary artery disease.Impression: normal study.No evidence of a regadenoson induced reversible perfusion abnormality.On (b)(6) 2010: patient underwent examination of abdomen.Impressions: no free air or obstruction.Moderate fecal content of colon.Instrumentation of the lumbar spine.On (b)(6) 2010: patient underwent bilateral digital diagnostic mammogram due to new palpable mass and new masses seen on recent mammogram.Impression: probably benign.On (b)(6) 2010: patient underwent cyst aspiration procedure for right breast.Impression: atypical.Atypical epithelial cells in a background of hemorrhagic cyst contents.On (b)(6) 2010: patient underwent x-ray of right hand.Impression: negative study.On (b)(6) 2010: patient underwent ct of chest, abdomen and pelvis.Impression: prior left nephrectomy with decreasing nonenhancing soft tissue in the nephrectomy bed.Adjacent subcentimeter lymph nodes are unchanged.Findings of emphysema with central airway wall thickening.Advanced atherosclerotic change.No findings on the current examination to suggest recurrent or metastatic disease.On (b)(6) 2010: patient underwent mri of brain with and without contrast.Impression: no evidence of metastatic disease to the brain or skull.Several small, stable, scattered nonspecific long-tr hyperintensities within the supratentorial white matter are stable.On (b)(6) 2010: patient underwent chest port removal.Patient tolerated the procedure well with no complications reported.Impression: right-sided internal jugular vein single-lumen chest port removal.On (b)(6) 2010: patient underwent x-ray of chest.Impressions: no acute cardiopulmonary disease.On (b)(6) 2010: patient underwent x-ray of left ribs.Impression: normal left rib examination.On (b)(6) 2010: patient underwent ct of face and sinuses without contrast.Impression: mild bilateral maxillary sinus inflammatory disease, no fluid level.On (b)(6) 2010: patient underwent ct of chest, liver/ spleen and pelvis.Impression: status post left nephrectomy fro wilm's tumor.No findings suspicious for metastatic disease or lymphadenopathy.There were no significant interval changes since last examination.A 3.2 cm right ovarian cyst.Ultrasound suggested for further characterization.On (b)(6) 2010: patient underwent ct of abdomen and pelvis.Impression: normal pelvic sonography.Right ovarian cyst identified on the ct examination has resolved and likely represent a functional cyst.On (b)(6) 2010: patient underwent x-ray of left foot and great toe.Impression: hypertrophic nails were noted.The terminal tuft of the first digit appears mildly irregular.No fracture was noted.On (b)(6) 2011: patient underwent x-ray of cervical spine due to right-sided neck pain, tingling.Impression: limited degenerative chan ges of the cervical spine.No fracture, subluxation or neoplasm.No foraminal narrowing identified.Patient also underwent x-ray of chest due to shortness of breath, cough, right-sided neck pain and tingling.Impression: no acute abnormality seen.Relatively large lung volumes, consistent with copd.On (b)(6) 2011: patient underwent ct of abdomen and pelvis with contrast.Impression: left nephrectomy with no findings suspicious for metastatic disease or local recurrence.Mild stable centrilobular emphysematous change.Stable postsurgical change compatible with lumbosacral fusion.On (b)(6) 2011: patient underwent bilateral digital diagnostic mammogram.Impression: benign.The 1.5 cm mass in the right breast at 11 o'clock anterior depth appears benign.The 1 cm mass in the right breast sub-areolar depth inferior region seen on the mediolateral oblique view only on a prior examination is no longer seen.There is no mammographic evidence of malignancy.On (b)(6) 2011: patient underwent mri of cervical spine.Impression: mild multilevel degenerative disk disease, most prominent at c5-c6.Right paracentral disc herniation at c5-c6 contacts and mildly deforms the ventral cord surface.This was associated with mild/moderate spinal canal narrowing and mild/moderate bilateral foraminal narrowing; abnormal signal and enhancement within the endplates about the anterior aspect of the c5-c6 disc, likely degenerative in nature.No endplate in nature.No endplate erosion or disc enhancement to suggest discitis/ osteomyelitis.On (b)(6) 2011: patient underwent x-ray of lumbar spine.Impression: lower lumbar and lumbosacral fusion with laminectomy, unchanged when compared to studies dating back to (b)(6) 2010.No new complications identified.On (b)(6) 2011: patient underwent mri of lumbar spine with and without contrast.Impression: status post l4-s1 lumbar fusion without evidence of new focal disc herniation or recurrent canal stenosis.Degenerative disc disease at the l4 over 5 and l5-s1 level small posterior disc bulges and mild neural foraminal narrowing with preservation of perineural fat.A small amount of scar tissue in the dorsal epidural space at the l5 level.Patient underwent x-ray of left ankle.Impression: normal left ankle radiographs.On (b)(6) 2011: patient underwent mri of brain without contrast.Impression: unremarkable mri of brain.On (b)(6) 2011: patient underwent ct of chest abdomen and pelvis with contrast.Impression: no evidence of metastatic or recurrent disease in a patient status post left nephrectomy for adult wilm's tumor.Mild emphysematous changes seen predominantly in the upper lobes.On (b)(6) 2011: patient presented for an office visit with complaint of back pain and low back pain.Assessment: lumbar degenerative disk disease multilevel.Failed back syndrome s/p l4-5, l5-s1 fusion.B-sacroiliac joint arthroplasty.On (b)(6) 2011: patient underwent ct of abdomen and pelvis with contrast.Impression: no evidence of metastatic or recurrent disease in this patient post left nephrectomy.A 6.9 cm x 2.5 cm presumed septated ovarian cystic lesion within the left lower pelvis.An ultrasound of the pelvis could more definitely characterize this lesion.Mild emphysema.Hepatic steatosis.On (b)(6) 2011: patient underwent pelvic and transvaginal ultrasound.Impression: complex appearance of the left ovary may represent a combination of hemorrhagic cyst and cyst within left ovary.Endometrium measuring 8 mm in thickness which is within normal limits for a premenopausal woman.Right ovary not well seen and probably identified on the transabdominal examination which appears grossly unremarkable.On (b)(6) 2011: patient underwent x-ray of chest.Impression: no active pulmonary disease.On (b)(6) 2011: patient underwent x-ray of chest.Impression: no change in hyperinflation due to underlying "copd".No new abnormality.On (b)(6) 2011: patient underwent pelvic and transvaginal ultrasound.Impression: unremarkable pelvic ultrasound.Interval resolution of previously seen functional ovarian cyst.On (b)(6) 2011: patient underwent ct of abdomen and pelvis with contrast.Impression: status post left nephrectomy with no evidence of local recurrence, lymphadenopathy, or distant metastatic disease.Changes of emphysema and likely chronic bronchitis.Stable thrombosis of the splenic vein with mesenteric collaterals.Stable moderate atheromatous disease abdominal aorta and iliac arteries.Moderate calcific plaque at the origin of the left subclavian artery.On (b)(6) 2011: patient underwent x-ray of each foot.Impression: hammertoe deformities seen in the third through fifth digits bilaterally.Primus metatarsus varus and hallux valgus with prominent median eminence of the right foot.Hallux valgus with prominent median eminence of the left foot.On (b)(6) 2011, (b)(6) 2012: patient presented for a follow up visit with complaint of low back pain and spondylosis without myelopathy.On (b)(6) 2012: patient underwent x-ray of chest.Impression: no change and no active disease.On (b)(6) 2012: patient underwent ct of abdomen and pelvis with contrast.Impression: patient with history of metastatic wilms tumor status post left nephrectomy.No evidence of local recurrence or distant metastasis."copd".Stable moderate atherosclerotic calcifications of the thoracoabdominal aorta and left subclavian artery origin.Stable thrombosis of the splenic vein with mesenteric collaterals.On (b)(6) 2012: patient underwent x-ray of right hip and of left knee.Impression: unremarkable examination of the right hip and left knee.No fracture, dislocation, or definite evidence of avascular necrosis is noted.On (b)(6) 2012: patient underwent bilateral digital diagnostic mammogram.Impression: benign.There is no mammographic evidence of malignancy.Scattered densities and multiple benign appearing calcifications are present in both breasts.On (b)(6) 2012: patient underwent x-ray of chest due to chest pain, "copd", concern for pneumothorax.Impression: no acute cardiopulmonary disease; no definite pneumothorax.On (b)(6) 2015: patient underwent evaluation of incontinence and x-ray of chest.Impression: normal chest x-ray.On (b)(6) 2012: patient underwent ct of abdomen and pelvis with contrast.Impression: no evidence of local recurrence or adenopathy to suggest metastatic disease.Centrilobular emphysema, unchanged.Healed transverse fracture of the left 12th rib, posteriorly, which is new from the prior examination.On (b)(6) 2012: patient underwent nuclear medicine bone density scan.Impression: no evidence of metastatic disease.Impression: patient is post menopausal; the "who" classification of normal is based on the lowest t-score of the femoral neck relative to a young normal population; based on the lowest z-score of the total hip, the "bmd" is within the expected range for age.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
greg anglin
1800 pyramid place
memphis, TN 38132
9013963133
MDR Report Key5596940
MDR Text Key43274967
Report Number1030489-2016-01147
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
Report Date 03/29/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/22/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date10/31/2009
Device Catalogue Number7510800
Device Lot NumberM110608AAC
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received03/29/2016
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) Required Intervention;
Patient Age42 YR
Patient Weight76
-
-