• 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 7510200
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Failure of Implant (1924); Pain (1994)
Event Date 03/21/2014
Event Type  Injury  
Manufacturer Narrative
X-ray image review results: ap <(>&<)> lateral post operative image from thoraco pelvic fixation provided no hardware failure is evident on these images.Product was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.Although it is unknown if the device caused or contributed to the reported event or not, we are filing this report for notification purposes.If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that on: (b)(6) 2014: the patient was preoperatively diagnosed with: scoliosis correction.The patient underwent the following procedure: stage 2: t10 to ilium decompression and fusion.L5 to s1 transforaminal lumbar interbody fusion.As per operative notes, ¿the patient was brought to the operating theatre on (b)(6) 2014.And a #10 scalpel blade was then used to cut through the dermis.We started at the t10 level.Under fluoroscopy guidance, we then used the high-speed midas rex drill and placed our pedicle screw entry points at t10.After that placed the pedicle screw under fluoroscopic imaging.This was done all the way down to the s1 level.On the left side at the l1 level, we were not able to place a pedicle screw because of a bridge medially.In addition, we were not able to place one at l5 because of a bridge as well.After placing screw then focused our attention on undertaking the transforaminal lumbar interbody at the l5-s1.We found that the l5 nerve root was quite large and exited quite low below the pedicle of l5.Then decided to place the spacer on the left side.Using the nerve root retractor, we then retracted the nerve root.After that we used different shaver sizes starting from 7mm all the way up to 13mm.We then decided to place bmp as well as grafton anteriorly at the disc space.Once this was done, we then decided to focus on the iliac bone screw.Using the high speed drill, we then placed the elct bolt entry point under imaging.We then placed a 8x100 mm iliac bolt screw on the right, and a 8x90 mm iliac bolt screw on the left.We then used a connector to connect the iliac bolt screw to the rest of the rod.Once this was done, we then proceeded to remove the facets at the l3-4, l2-3 using the high-speed drill.Once we were satisfied that pedicle tract was satisfactory, we then placed the pedicle screw under fluoroscopic imaging.This was done all the way down to the s1 level.On the left side at the l1 level, we were not able to place a pedicle screw because of a bridge medially.In addition, we were not able to place one at l5 because of a bridge as well.Once all our lumbar, thoracic, and s1 screws were placed, we then focused our attention on undertaking the transforaminal lumbar interbody fusion at the l5-s1.As such, we also used the pituitary rongeur to remove any disc fragments.We decided on a 13 mm spacer.We then decided to place bmp as well as graft on anteriorly at the disc space.This was followed by the 13 mm spacer that was placed under direct fluoroscopic imaging.We then proceeded to place the rod on the both sides.As such, we used a 300x6 mm rod.It was contoured to sit in the screw heads.We then secured the rods to the pedicle screw using the collar and nut.Once this was done, we then decided to focus on the iliac bone screw.We then continued our dissection lateral to expose the ilium.We then placed a 8 x 100 mm iliac bolt screw on the right, and a 8x 90 mm iliac bolt screw on the left.Its trajectory placement was confirmed om imaging.We then used a connector to connect the iliac screw to the rest of the rod.Once this was done, we then decorticated the facet joints at the levels above.Once this was done, we placed some bone chips and some bmt along the gutter.The bone chips were then o verlaid over the bmp.¿ on (b)(6) 2014: the patient underwent post-op for t-10 ilium instrumentation and fusion.Findings: unchanged vertebral body discs spacers from l2 down to l4.There has been interval placement of a disc spacer at l5-s1.Interval placement of pedicular screws with bilateral fixation rods and bony cement from t-10 down to the sacrum and iliac bones bilaterally.There is a cross at the t12 -l1 disc level.The pedicle screw on the left at t11 impinges approximately 4 mm into the left aspect of the spinal canal.There is more significant impingement of the spinal canal at t12 with the left sided pedicular screw impinging into the left aspect of the spinal canal approximately 7 mm.There is a single pedicular screw at the l1 vertebral level on the right.The pedicular screws minimally impinge the lateral aspects of the spinal canal at l2.Impression: interval improvement of the degenerative lumbar scoliosis with posterior fusion from t10 down to the sacrum and iliac bones.There was partial impingement of the spinal canal at several levels as described.Hardware appeared intact.Expected post surgical changes are noted in the posterior soft tissues from the thorax to the pelvis.On (b)(6) 2014: findings: posterior spinal instrumentation from the level of the 10 to the sacrum.Intervertebral disc spacers at the levels l2-l3, l3-4, l4-5 and l5-s1.No evidence of instrumentation failure or complication.Bone graft material seen at the levels t11-l2.General alignment on the lateral and ap projections are near anatomical.Double j stent seen overlying the mild abdomen likely with in bowel.Density seen in relation to the hilus of the left kidney was not seen on recent ct lumbar spine.Cholecystectomy y clips in the right upper quadrant.Stable cardio mediastinal silhouette.Area of linear atelectasis in the right lung base and suggest follow up in the subsequent.Imaging: no evidence for pleural effusion or pneumothorax.Visualized pelvis and proximal femurs show no gross abnormalities.On (b)(6) 2014: clinical history: post-op 2-stage dlif l1-l5.Complaining of severe collection of fluid lower to the incisional site and lower abdomen.Findings: posterior rods and transpedicular screws from t10 through upper sacrum.Although screws through the iliac crests.L2-3 through l5-s1 intervertebral disc spacers.Extensive beam hardening artifact related to the metallic hardware limits assessment of the spinal canal.Impression: spinal hardware is unchanged compare to prior ct from (b)(6) 2014.New elongated loculated fluid collection in the posterior midline at the site of prior surgery.On (b)(6) 2014: findings: posterior spinal fixation instrumentation again demonstrated from the t 10 to sacral levels with intervertebral disc spacers at the l3-4, l4-5 and l5-s1 levels.Stable position of the double -j catheter overlying the central abdomen.On (b)(6) 2014: the patient underwent a 2 stage anterior and posterior t10 to ilium correction of scoliosis.On (b)(6) 2014: the patient underwent co2 laser ablation of actinic keratosis.On (b)(6) 2014: the patient was admitted due to abdominal pain.On (b)(6) 2014: the patient was admitted due to incisional hernia repair.On (b)(6) 2014: the patient went for follow up visit.Severe degenerative disc disease with complete loss of the intervertebral disc space at c5/c6 and c6/c7.Mild degenerative changes in the thoracic and lumbar spine.On (b)(6) 2014: the patient underwent examination because of recent surgery for scoliosis with more recent injury.The observations were: the cervical spine shows degenerative disc disease extending from c5-c7 with marginal osteophytes and there is partial fusion of the disc endplate of c6-7.Facets show normal alignment.The neural foramen are unremarkable.No cervical ribs were seen.The thoracic and lumbar spine shows extensive fusion of the lower thoracic and lumbar spine extending from t10-s1 with as well as a trans stent in place.No complications to the fixation.Alignment is maintained.Intervertebral disc spacers are seen extending from l2-l5.Screws are rods are intact.On (b)(6) 2014: the patient underwent examination due to intermittent c6 radicular symptoms.The results were: there has been fusion of c6-7 with moderate degenerative change seen at the c5-6 disc interspace.On flexion extension there is limitation of cervical motion but no abnormal subluxation is seen.There is no soft tissue swelling.Neural foramen are unremarkable.There are no cervical ribs.Since the previous of (b)(6) 2013, there has been posterior spinal fixation from t11 to the pelvis.The thoracolumbar scoliosis convex the left in this area has resolved.There is a minimal thoracic scoliosis convex to the right from t7-t10 measuring 5 degrees which is likely insignificant.No vertebral body abnormality is noted.The double pigtail pancreatic duct stent is again noted in the upper abdomen.On (b)(6) 2015: the patient underwent rad/c spine w flex/exten due to intermittent c6 radicular symptoms.There has been fusion of c6-7 with moderate degenerative change seen a the c5-6 disc interspace.On flexion extension there is limitation of cervical motion but no abnormal subluxation is seen.There is no soft tissue swelling.Neural foramen are unremarkable.There are no cervical ribs.On (b)(6) 2015: the patient underwent rad/scoliosis ap examination.The results were: there has been posterior spinal fixation from t11 to the pelvis.The thoracolumbar scoliosis convex the left in this area has resolved.There is a minimal thoracic scoliosis convex to the right from t7-t10 measuring 5 degrees which is likely insignificant.No vertebral body abnormality is noted.The double pigtail pancreatic duct stent is again noted in the upper abdomen.Upon examination, the impressions were: the patient has had previous cervical spine surgery and complains of intermittent c6 distribution radicular symptoms and neck pain.Furthermore she has had previous thoracolumbar fusion for a deformity.At this stage, her cervical spine needs to be imaged further with an mri which i will order to be done at (b)(6) hospital and i will also order flexion and extension view x rays.On (b)(6) 2015: the patient went for follow up visit to the clinic.There is extensive pedicular fixation extending from t10 to the sacrum in the neutral position.There is radio-opaque intervertebral spacer at l5-s1.On (b)(6) 2015: the patient underwent rad/scoliosis ap lat due to chronic back pain.The results were: intact pedicular screws and rods are seen transfixing the lumbar spine extending from t11-s2 with as well fixation to the pelvis.There is minimal upper thoracic scoliosis of less than 5 degrees.A drainage stent is seen in the epigastrium.The cervical spine shows severe spondylosis especially at c5-6 and c6-7 with disc narrowing an anterior osteophytes.On (b)(6) 2016: the patient went for follow up visit.Findings: posterior fixation with posterior rods, screws and intervertebral disc spacers from t10 to the ileum again noted.No evidence of hardware complication or failure.No scoliosis of the thoracic or lumbar spine.No obvious discrepancy i level of the hips.On (b)(6) 2016: the patient underwent mri/c/spine examination.The findings were:c1-2, c2-3 and c3-4 levels are unremarkable.C4-5 demonstrates mild degenerative disc disease with mild concentric disc bulging and endplate osteophyte formation.Findings combine to produce borderline spinal stenosis.There is no disc herniation and there is no significant foraminal narrowing.C5-6 demonstrates moderate degenerative disc disease with mild spinal stenosis and left-sided bony foraminal narrowing secondary to unconvertebral osteophytes.There is no discrete disc herniation.C6-7 level is fused.There is no spinal or foraminal stenosis.C7-t1 demonstrates mild degenerative disc disease and minor degenerative anterolisthesis.There is no spinal or foraminal stenosis and no disc herniation and signal intensity.The impressions were: previous c6-7 fusion.C4-5, c5-6 and c7-t1 degenerative disease most marked at c5-6.Borderline spinal stenosis c4-5 with mild spinal stenosis c5-6.No cord edema or myelopathic signal change.No disc herniation.Left 5-6 bony foraminal narrowing.No other significant abnormality.On (b)(6) 2017: the patient was admitted and underwent revision anterior and posterior lumbar fusion l5-s1.On (b)(6) 2017: the patient went for follow up visit with leg pain and admitted due to pelvis bone graft done on (b)(6) and hardware removed from lower back on same day.Pain radiating from thigh to calf.Difficult to stand due to increase pain, swelling and tenderness.On (b)(6) 2017: the patient went for follow up visit.The diagnosis were: status 2 weeks post anterior lumbar fusion l5-s1 and revision for pseudoarthrosis.Lumbar x-ray from (b)(6) 2017.Findings were: two views of the vertebral column were performed while the patient was upright for scoliosis survey.Vertical rods from t10-s1 posterior instrumented fusion.There are also bilateral iliac screws present.The hardware has been revised since (b)(6) 2016.Disc spacers are again seen at l2-3, l3-4 and l4-5 disc spaces, unchanged in position and orientation since (b)(6).Anterolisthesis at the c4-5 level is also unchanged since that study.Lumbar lordosis measures approximately 57 degrees.T1 spinopelvic inclination measures -5 degrees.There is new minimal right basilar atelectasis since (b)(6) 2016.Scoliosis view radiograph.Findings were : upright standing ap and lateral spine view scoliosis series were provided.On (b)(6) 2017: the patient went for follow up visit and the diagnosed with post anterior lumbar fusion l5-s1 and revision for pseudoarthrosis.Her leg pain was resolved.Numbness over the anterolateral aspect of the thigh and left side is still lingering.She had developed some left side trochanteric bursitis that is tender to palpitation.X-ray demonstrates that patient has intact interbody at l5-s1, no signs of loosening.Overall, hardware is intact.On (b)(6) 2018: the patient underwent scoliosis/2 view examination.The findings were: two views of the vertebral column were performed while the patient was upright for a scoliosis survey.There are bilateral pedicle screws joined by vertical rods from t10-s1 posterior instrumented fusion with bilateral iliac screws.Note was made of disc spacers within the l2-3 through l5-s1 disc spaces.There is a grade 1-2 anterolisthesis at the c4-5 level.This is unchanged dating back to (b)(6) 2016.A grade 1 anterolisthesis is seen at l3-4 level, stable since (b)(6) 2017.No new spinal malalignments are identified.No new fracture is seen in the vertebral column.The patient has got some pain towards the left upper area of her thoracic spine at the location of top-most screw.She has 5/5 strength in bilateral lower extremities.She has exquisite tenderness to the greater trochanter bilaterally, left worse than right.Upright scoliosis x-ray the hardware is intact.The l5-s1 cage is well aligned.On (b)(6) 2018: the patient underwent rad/abd multi 3 views due to abd pain.The findings were: cholecystectomy clips right upper quadrant.Thoraco lumbar internal fixation multilevel intervertebral disc spacers at l2-s1 unchanged.On (b)(6) 2018: the patient went for follow up visit.Findings were: the diagnosed to add fixation right l5.Issue with the notching or contouring of the rod, then may be changing out the screw to multiaxial screws would allow positioning of the rod with less contouring.It would be highly unusual for an anterior lumbar interbody device with allograft and bmp not to fuse.Ct scan and gallium scan to exclude infection as soon as these imaging are done.
 
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
stacie ziemba
1800 pyramid place
memphis, TN 38132
9013963133
MDR Report Key8933784
MDR Text Key159613769
Report Number1030489-2019-00944
Device Sequence Number1
Product Code NEK
UDI-Device Identifier00681490843782
UDI-Public00681490843782
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
P000058
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign,health profe
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 11/27/2019
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 Date10/01/2015
Device Catalogue Number7510200
Device Lot NumberM111302AAS
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 07/23/2019
Initial Date FDA Received08/27/2019
Supplement Dates Manufacturer Received10/28/2019
Supplement Dates FDA Received11/27/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/09/2013
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
-
-