• 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 7510400
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Ossification (1428); Inflammation (1932); Neuropathy (1983); Pain (1994); Weakness (2145); Stenosis (2263); Disc Impingement (2655); No Code Available (3191)
Event Type  Injury  
Event Description
It was reported that on (b)(6) 1999: the patient presented with preoperative diagnoses of herniated disc at l3-4 centrally and extending to the right and left with free fragment migrating inferiorly on the left down below the l4 pedicle on the left.The patient underwent the following procedures: hemi-laminectomy at l3-4, discectomy at l3-4, removal of free fragment from the l4 disc herniation and bilateral lateral fusion from l3-4 with internal fixation using isola internal fixation system.No patient complications were noted.(b)(6) 1999: the patient presented with preoperative diagnoses of cervical spondylosis, disc protrusion and herniated disc at c5-6, c6-7.The patient underwent the following procedures: anterior cervical discectomy c5-6, c6-7 with fusion at c5-6, c6-7 using bone from left iliac crest with internal fixation using synthes plate and screw system.No patient complications were noted.(b)(6) 2002: the patient presented with pain in his back radiating into the left hip and left leg.He also complains of increased urinary urgency.(b)(6) 2002: the patient underwent a lumbar myelogram due to low back pain radiating to both legs.Impression: disc protrusions likely representing bulges at l4-5 and l5-s1; solid lumbar fusion at l3-4.Ct following myelogram found: broad disc protrusions at l2-3 and l4-5, both probably producing neuro foraminal narrowing; fusion at l3-4.(b)(6) 2003: the patient presented with preoperative diagnoses of disc protrusion centrally into the left extending to the left neural foramen and previous fusion l3-4.The patient underwent the following procedure: removal of isola internal fixation with posterior interbody lumbar fusion l2-3, bone from left iliac crest using tangent bone plug with 3d internal fixation and crosslink l2-3.No patient complications were noted.(b)(6) 2003: the patient presented with preoperative diagnoses of biliary dyskinesia and chronic cholecystitis.The patient underwent a laparoscopic cholecystectomy.(b)(6) 2004: the patient presented with pain in his lower back and both legs.The patient has weakness of the left quadriceps.(b)(6) 2004: the patient presented with increasing pain in his back, both hips and both legs.The patient presented films that were reviewed.The internal fixation is in good position.The fusion appears solid.However, the patient has two other levels that will need evaluation.(b)(6) 2004: the patient underwent a lumbar discography l4-5 and l5-s1 due to low back pain.Findings: both discs are degenerated with posterior extravasation at l5-s1 and anterior/posterior extravasation at l4-5.(b)(6) 2004: the patient presented with a discogram that shows an annular tear at l4-5.Symptoms were reproduced at the l5-s1 level which also showed degeneration.(b)(6) -2004: the patient presented with discomfort in his back with radiating pain down into both hips greater on the left.(b)(6) 2004: the patient presented with discomfort in his back, left hip and left leg.(b)(6) 2004: the patient presented with pain in his back, left hip and left leg.The patient¿s legs tend to give out and he must use a cane.Exam found the patient to have weakness of the left quadriceps.(b)(6) 2005 : the patient presented with severe degenerative disc disease, dural scarring, l4-5, l5-s1, and radiculopathy l5-s1 as well as disc protrusion l4-5 and l5-s1.The patient underwent the following procedures: decompressive hemilaminectomy l4-5; partial facetectomy; foraminotomies l4-5 with discectomy l4-5, left sided hemilaminectomy l5-s1 left with foraminotomy and discectomy l5-s1 on the left; bilateral lateral fusion l4-s1 using rhbmp-2/acs bone bank bone and local bone.Per the op notes, large rhbmp-2/acs sponges were placed along the gutters and the team packed bone fragments and rhbmp-2/acs into the gutters appropriately.This was done after properly denuding the transverse processes l3-4 fusion mass, l5 and s1.No patient complications were noted.(b)(6) 2005: the patient presented with pain in his back, let hip and down his thighs as well as back spasms.The patient presented with x-rays.There is sparse bone laterally in the gutters and the interbody has not healed as well as i would like.(b)(6) 2005: the patient presented with pain in his back, left hip, and down the back of the left thigh and occasionally down the back of the left leg.His doctor stated that his fusion was not healing and that he thought he had some disc collapse at l2-3 above the l3-4 fusion.(b)(6) 2005: the patient underwent a lumbar myelogram and a ct post myelogram due to low back pain.Conclusion: soft disc bulge at l1-2, l4-5 and l5-s1.There is soft disc bulge across midline at c1-2 and is more impressive on myelography than ct.There are degenerative changes at l4-5 and l5-s1 with either a synovial cyst or fragment of disc compressing the left lateral recess at l5-s1.(b)(6) 2005 : the patient presented with the following preoperative diagnoses: pseudoarthrosis l5-s1 with foraminal encroachment; possible recurrent disc herniation l5-s1 to the left; re-exploration l5-s1 with partial laminectomy and foraminotomy with decompression of the nerve root and removal of scar tissue, left; bilateral lateral exploration of fusion, bilateral lateral fusion l4-5, l5-s1, transverse process with reinforcement of graft using matrix ii sets and large rhbmp-2/acs.Per the op notes, the gutters were decorticated from the l3-4 fusion mass to the l5 lateral gutters into the sacrum.A large rhbmp-2/acs kit with matrix was used to place laterally in the gutters and in the transverse processes from the l3-4 to the s1 level.No patient complications were noted (b)(6) 2006: the patient presented with discomfort in his hip and leg.(b)(6) 2007: the patient presented with pain down his hip and goes down his groin, down the leg and at times goes into his calf.(b)(6) 2007: the patient underwent a lumbar myelogram and a post myelogram ct.Findings: fusion appears incomplete posterolaterally from l4-s1.There is stenosis of the canal at the l4-5 level predominantly posterolaterally on the left.There is prominent unilaterally hypertrophied ligamentum flavum on the left l4-5 which is resulting in significant distortion of the thecal sac and moderate acquired spinal stenosis.Additional contribution by annular bulge form a degenerated disc as well as bilateral facet arthropathy is noted.There is moderate canal stenosis l1-2 secondary to a combination of annular bulge with ligamentum and facet hypertrophy.There is incomplete posterolateral bone fusion l3-s1.(b)(6) 2007 : the patient presented with preoperative diagnoses of pseudoarthrosis, l4-5, and synovial cyst compressing the left side of the thecal sac in the l4-5 root on the left.The patient underwent the following procedures: exploration of previous fusion l4-5; repair of pseudoarthrosis l4-5 using rhbmp-2/acs and mastergraft, some local bone; decompression of the l4-5 level, excision of synovial cyst and decompression of the l4-5 root on the left.Per the op notes, the transverse processes were decorticated, cleaned and decompressed with a good bleeding bone seen in the gutters as well as the transverse process of the l5-s1 fusion mass below.A large rhbmp-2/acs kit with 20cc of mastergraft with local bone that had been removed was taken and placed laterally in the gutters between l4 and l5 bilaterally.Mastergraft and rhbmp-2/acs were then packed into the gutters as well.No patient complications were noted.Lab results of specimen taken were obtained.Final diagnosis of specimen: tissue from l4-5, hyperplastic synovial tissue with fibrosis, consistent with synovial cyst, and fragments of cartilage and bone; lumbar disc material, fibrous scar-like tissue, fragments of ligament, reactive synovium, cartilage and bone.(b)(6) 2007: the patient was discharged home.(b)(6) 2007: the patient underwent mri.Findings: l1-2, bulges contribute to spinal canal narrowing; no interbody fusion of the vertebral bodies is seen at the surgical level of l2-3.(b)(6) 2007: the patient presented with pain in his back radiating down into the left hip and down into the left leg.He also reports pain in his flank as well.(b)(6) 2007: the patient underwent myelogram of the entire spine and then lumbar and thoracic ct scans.Findings: l2-3 interbody fusion that may not be solid.There are solid appearing transverse process fusion bone l3-4.Additional bone is present at l4-s1 along the posterior elements and transverse processes and it is difficult to tell whether the fusion is solid.There is a junctional stenosis at l4-5 which has evidence against a solid fusion.There is junctional stenosis at l1-2.The dorsal subarachnoid space shows a calcification which probably consists of ossification of posterior ligament at the t7-8 level and minor cord flattening.(b)(6) 2008 : the patient presented with preoperative diagnoses of junctional stenosis with spondylosis, central and foraminal stenosis at l1-2 with possible pseudoarthrosis l2-3.The patient underwent the following procedures: bilateral posterolateral fusion l1-2, l2-3; laminectomy l1-2; discectomy l1-2; repair of pseudoarthrosis, l2-3; removal of hardware l2-3; instrumentation l1-3; neuromonitoring throughout the entire case along with stimulation of screws.Per the op notes, following instrumentation, the fusion mass at l2-3 was decorticated.Following this the transverse processes at l1 and l2 were decorticated as well, followed by taking down the facet joints and a portion of the pars bilaterally.The laminectomized bone graft was placed out laterally in the gutters, followed by placement of rhbmp-2/acs soaked collagen sponges with mastergraft.No patient complications were noted.(b)(6) 2008: the patient was discharged home.(b)(6) 2008: the patient presented with pain in his back, radiating into the left hip and buttocks and down into his leg.(b)(6) 2008: the patient underwent x-rays of the lumbar spine due to pain.Impression: mild anterior wedging of l1 thought to be developmental vs.Old trauma.Small posterior spurs are noted at the l3-4 and l4-5 levels.(b)(6) 2008: the patient underwent x-rays of the lumbar spine.Impression: posterior fusion from l1-3; questionable superior endplate deformity along l1; grade i retrolisthesis of l3 with respect to l4; soft tissue calcifications posterior to l4 and l5 have the appearance of heterotopic calcifications.(b)(6) 2008: the patient underwent a lumbar myelography due to low back pain.Conclusion: early stenosis present at the l4-5 level.The patient also underwent ct.Findings: revealed lumbar pseudoarthrosis l1-2, l2-3, and l4-5.(b)(6) 2009 : the patient presented with a preoperative diagnosis of pseudoarthrosis l4-5 and l5-s1.The patient underwent the following procedures: anterior lumbar fusion l4-5, l5-s1; anterior lumbar discectomy with decompression; autograft from local bone; placement of interbody device, l4-5 and l5-s1, medtronic peek cage; anterior spinal instrumentation with medtronic pyramid plate l4-5, l5-s1; continuous neurophysiologic monitoring.Per the op notes, interbody devices were placed at l4-5 and l5-s1 and were filled with rhbmp-2/acs.Following this, autologous bone from the vertebral body was taken mixed in with progenix pro, and placed laterally in the disk space allowing for midline to be occupied by interbody device.A pyramid plate size 23 at the level of the l4-5 and the 25 at the level of l5-s1 was placed atop of the anterior aspect of the spine.No patient complications were noted.(b)(6) 2009 : the patient presented with a preoperative diagnoses of l1-2 and l2-3.The patient underwent the following procedures: posterolateral fusion l1-2 and l2-3; posterior lumbar interbody fusion l1-2; removal and exploration of fusion at l1-2 and l2-3; decompression of the l1-2 level with foraminotomy; insertion of peek cage at l1-2 with rhbmp-2/acs; autograft from laminectomy; internal refixation at l1-2; continuous neuroelectro physiological monitoring with monitoring of the patient during the entire case.Per the op notes, a 12x22 capstone cage filled with rhbmp-2/acs was taken and placed in the interspace between l1 and 2.After the transverse processes and lateral gutters were decorticated, local bone that had been harvested was taken and placed laterally in the gutters as well as rhbmp-2/acs with mastergraft and bone chips with progenix.No patient complications were noted.(b)(6) 2009: the patient underwent x-rays of the lumbosacral spine due to back pain.Impression: severe posterior element hypertrophic degenerative change of lower lumbar spine with spinal stenosis; no acute fracture or dislocation is otherwise apparent.(b)(6) 2009: the patient presented stating his axial back pain is significantly improved, however he has been having these continued radicular symptoms, left side s1 radiculopathy ever since his anterior lumbar fusion.(b)(6) 2009: the patient underwent a myelogram.The study shows that he could very well have some foraminal encroachment at l5-s1 to the left.The lateral fusion at l4-5 is not solid.Mild l4-5 disc bulge across midline and the focal pressure on the left side of the sac.(b)(6) 2009: the patient underwent x-rays of the lumbar spine due to pain.Impression: extensive postoperative change with fusion seen.There is minimal posterior positioning of l3 on l4 of 2-3 mm.(b)(6) 2009: the patient presented with continued left radicular symptoms.X-rays show solid interbody fusion at l4-5 and l5-s1 and good position of hardware.(b)(6) 2009: the patient presented with discomfort in his back and into the left hip.(b)(6) 2010: the patient presented with a preoperative diagnosis of failed back syndrome.The patient underwent the following procedures: laminotomy for dcs electrode replacement; placement of dorsal column stimulator pulse generator; intraoperative testing.No patient complications were noted.(b)(6) 2011: the patient presented with pain that radiates down into the left hip and goes down into the left leg.(b)(6) 2011: the patient underwent x-rays of the lumbar spine due to a history of the back pain.Findings: hypertrophic changes are seen posteriorly throughout the posterior elements.Intervertebral disc space narrowing is noted at l2-3 and l3-4.A spinal stimulator device is seen projecting over the right iliac wing with its lead extending in the caudal direction off the superior margin of the image.(b)(6) 2011 -(b)(6) 2012: the patient presented with low back pain and wanted to discuss removing the pain stimulator.The patient reports axial low back pain and multi-radicular pain.Assessment: failed back syndrome.(b)(6) 2012: the patient presented with a preoperative diagnosis of malfunctioning dorsal column stimulator.The patient underwent the following procedures: t9 laminectomy; removal of dorsal column stimulator electrode; removal of dorsal column stimulator ipg; intraoperative fluoroscopic interpretation.(b)(6) 2012: the patient presented stating the incision on his back is swollen and feels pressure.Exam found incision showed some redness like an irritation to the staples but not purulent.He has some swelling but does not appear unusual.The patient was given a script for bactrim ds prophylactically.(b)(6) 2012: the patient presented for post-op staple removal.(b)(6) 2012: the patient underwent mri of the lumbar spine with and without gadolinium.Impression: t11/12 right posterolateral disc herniation causing a small impression upon the right ventral aspect of the thecal sac; t12-l1, disc herniation causing a moderate ventral impression upon the thecal sac; moderate t11-12 and t12-l1 spinal stenosis; grade i spondylolisthesis at l4-5; degenerative disease.(b)(6) 2012: the patient presented with axial low back pain, left t12-l1 radiculopathy and claudication.(b)(6) 2012: the patient presented with low back pain and left leg weakness, axial low back pain and bilateral upper lower extremity radiculopathy.(b)(6) 2012: the patient underwent a ct of the lumbar spine without contrast due to displacement of thoracic or lumbar intervertebral disc without myelopathy.Findings: l1-2, mild posterior osteophyte formation which mildly narrows the central canal.The patient then underwent ct of the thoracic spine.Impression: small bilateral pleural effusions.(b)(6) 2012: the patient presented with low back pain.Assessment: stenosis; pseudoarthrosis.(b)(6) 2013: the patient presented with lower back pain and lower extremity radiculopathy.Assessment: pseudoarthrosis, hypertrophic bone growth, flat back syndrome.(b)(6) 2014 : the patient presented with the following preoperative diagnoses: thoracolumbar myelopathy and stenosis; radiculitis; sagittal plane deformity.The patient underwent the following procedures: exploration of spinal fusion; removal of posterior segmental hardware; bilateral l4-5 and l5-s1 smith peterson osteotomies; t10-11, t11-12, t12-l1, laminectomies; t10-s1 arthrodesis; t10-s1 posterior segmental instrumentation; stealth intraoperative navigation; correction of sagittal plane deformity; auto graft; allograft.Per the op notes, once all the screws were in, the transverse processes of t10 down and across the fusion mass on to the sacrum were decorticated down to bleeding bone.Across the thoracolumbar segment, rhbmp-2/acs wrapped around autograft and mastergraft were placed.From t10-s1, there was a very large fusion mass in this area.It was tedious to work because there was no normal anatomy and there was a huge fusion mass across this particular segment.
 
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.
 
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
1800 pyramid place
memphis TN 38132
Manufacturer Contact
huzefa mamoola
1800 pyramid place
memphis, TN 38132
9013963133
MDR Report Key4237756
MDR Text Key15913765
Report Number1030489-2014-04281
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
Report Date 10/09/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/07/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/01/2010
Device Catalogue Number7510400
Device Lot NumberM110706AAA
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received10/09/2014
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) Required Intervention;
-
-