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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 7510800
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Incontinence (1928); Neuropathy (1983); Pain (1994); Stenosis (2263); Injury (2348); Dysuria (2684)
Event Type  Injury  
Event Description
It was reported that the patient underwent spine fusion surgery on the thoracic and lumbar region at levels t4-s1.During the surgery, the patient was implanted with rhbmp-2 and collagen sponge.The rhbmp-2 collagen sponge was applied from posterolateral approach.The rhbmp-2 collagen sponge was used to fuse more than one level of the spine and was placed outside a cage (i.E.In the posterolateral gutters).Post-op, the patient complained of progressively worsening pain in her low back and radiculopathy into her lower extremities., due to which patient underwent revision surgery.On (b)(6) 2012, the patient underwent spine fusion surgery on the thoracic region at levels t1-t7.During the surgery, the patient was implanted with rhbmp-2 and collagen sponge.The rhbmp-2 collagen sponge was applied from posterolateral approach.The rhbmp-2 collagen sponge was used to fuse more than one level of the spine and was placed outside a cage (i.E.In the posterolateral gutters).Post-op, the patient complained of progressively worsening pain in her lower back, with radiculopathy into her lower extremities.Patient still continues to experience severe and unrelenting pain in her low back with radiculopathy into her lower extremities.Patient has difficulty standing for any length of time and walking any distance, and requires the use of a cane to assist in ambulation.Patient injuries prevented her from practicing daily life activities and reportedly the patient has suffered serious and permanent injuries.
 
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.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that on (b)(6) 2007 the patient underwent x rays of the chest.Impressions: no acute cardiopulmonary processes.On (b)(6) 2007 the patient underwent spinal cord (ssep) monitoring.Baseline ssep under anesthesia.Nerve conduction study.Trans-cranial motor evoked potentials.Diagnosis: scoliosis.Surgical procedure: ptlf t4-s1, poss pso, poss tlif with instrumentation.Impression: no significant intraoperative change in dorsal column function rostral to l5 at surgical closure.Posterior tibial nerve somatosensory pathways function under anesthesia bilaterally.All m-wave thresholds to pss below criterion at l5/ all other thresholds within normal limits.No significant interoperative change in motor pathway function at surgical closure.On (b)(6) 2007 the patient underwent transforaminal lumbar interbody fusion l3-4 with 9mm carbon fiber cage.Transforaminal with 9mm carbon fiber cage, l4-5.T4 to the sacrum, segmental spinal instrumentation.T4 to s1 bilateral posterolateral fusion.Right l5-s1 hemilaminectomy and foraminotomy of the l5 and s1 nerve root.Local autogenous graft for fusion and two large kits of bone morphogenic protein.Preoperative diagnosis: spinal stenosis l3-4, l4-5, l5-s1.Scoliosis.Per-op notes: "impression was performed on the transverse process hook on the left.Ap and lateral x rays were obtained which showed excellent correction of the spinal deformity.The image was brought into the check the shoulders which appeared to be level.The spinous processes were then removed.Local bone was generated.It was mixed with two large kits of bone morphogenic protein.A 1/4 inch osteotome was used to decorticate and a high speed #5 fluted ball bur.The bone graft was placed.Prior to the placement of the bone graft, the final torquing was preformed.The muscles were debrided of dead tissue." on (b)(6) 2007, patient presented with complaint of urinary incontinence.On (b)(6) 2007 patient underwent procedure for cystoscopy/marshall test for pre-op diagnosis of: mixed incontinence.No complications were reported.On (b)(6) 2007 the patient underwent x rays of the lumbosacral spine.Impression: bilateral thoracolumbar ileal posterior surgical fusion.The alignment of the visualized portion of the dorsal spine with some mild subluxations looks unchanged from (b)(6) 2007.No evidence for a fracture or loss of lumbar or inferior thoracic vertebral height.The patient underwent ct scan of the abdomen and pelvis.Impressions: abdomen- abdomen grossly unremarkable.Orthopedic instrumentation from a thoracolumbar posterior fusion creates stellate artifact on all scan slices.Pelvis- suboptimal scans of pelvis due to orthopedic instrumentation from posterior fusion and a right total hip replacement.The pelvis is grossly unremarkable.On (b)(6) 2007 the patient underwent x rays of the thoracic spine due to mid back pain.Impression: patient status post extensive thoracolumbar spinal fusion.No new compression fracture identified.Stable appearance to the extensive thoracolumbar sacral spinal fusion.Stable disc space cages at l3-4 and l4-5.The patient underwent ct scan of the lumbar spine.Impression: patient status post extensive thoracolumbar fusion with pedicle screws at all lumbar vertebral body levels.L5 degenerative anterolisthesis on s1 with no further spondylolisthesis.Broad disc bulging disc with spurring at multiple lumbar disc space levels accounting for broad base ventral thecal sac deformity.However, there is no large disc extrusion or high grade spinal stenosis identified.On (b)(6) 2007 the patient underwent thoracic myelogram.Impression: significantly limited examination.The patient also underwent x rays of the chest.Impression: limited exam, left basilar subsegmental atelectasis without chf or pneumonia.The patient also underwent x rays of the lumbosacral spine.Impressions: patient status post extensive thoracolumbar sacroiliac iliac fusion.No lumbar compression fracture or spondylolisthesis.The patient also underwent ct scan of the thoracic spine.Impression: t5-t6 end plate probable erosions, small subchondral fracture, mild kyphosis with posterior bone chips and secondary scarring with cord compression.Left superior pedicle screw displacement as described previously.Significant degenerative changes and mild extradural changes as described above, no other significant interval change is seen.On (b)(6) 2007 the patient underwent x rays of the chest.Impressions: picc catheter tip at the superior vena cava/right atrial junction.On (b)(6) 2007 the patient underwent x rays of the left knee.Impression: mild osteoarthritis.Two well corticated bony densities seen along the medial condyle possibly representing loose bodies within the joint.The patient also underwent x rays of the left hip due to left hip pain.Impression: mild degenerative change of the left hip.On (b)(6) 2007 the patient underwent x rays of the chest.Impression: lungs clear.Heart not enlarged.Thoracic orthopedic instrumentation intact.On (b)(6) 2007 the patient underwent x rays of the chest.Impressions: improving minor basilar atelectasis/infiltrate.On (b)(6) 2007 the patient underwent x rays of the chest.Impressions: limited portable study without change.Stable left basilar subsegmental atelectasis.Minimal atelectasis in the lung bases.Extensive posterior fusion hardware in most of the thoracic spine without obvious hardware fracture.Some of the screws do extend through the vertebral body cortex.The patient also underwent ct scan of the abdomen and pelvis.Impression: findings consistent with pancolitis.Clostridium difficile colitis and infectious colitis would be the two leading diagnosis.Although the study is mildly limited by streaky artifact there is no evidence of abscess, free fluid or bowel obstruction.On (b)(6) 2008, patient presented with complaint of urge incontinence.Patient had infection after major back surgery.On (b)(6) 2008, patient underwent procedure for cystoscopy/marshall test for pre-op diagnosis of: urgency, frequency.No complications were reported.(b)(6) 2008, patient underwent procedure for urodynamics for pre-op diagnosis of voiding dysfunction.No complications were reported.On (b)(6) 2008 the patient underwent x ray of the chest.Impressions: limited exam, new left lower lobe atelectasis.On (b)(6) 2008 the patient underwent x rays of the chest due to shortness of breath.Impression: atelectasis infiltrate in left base probably overall unchanged.Continued follow up would be recommended.Heart size is unchanged.On (b)(6) 2008, patient presented with history of mixed urinary incontinence.On (b)(6) 2009 the patient underwent x rays of the thoracolumbar spine.Impression: extensive thoracolumbar sacroiliac spinal fusion.On (b)(6) 2009 the patient underwent: removal of segmental spinal instrumentation, t3-t7.Exploration of fusion.T1-t7 segmental spinal instrumentation.T3 vertebral column resection.T1-7 posterolateral fusion using local autogenous bone.Preoperative diagnosis: non-union, scoliosis.Per-op notes: "subperiosteal dissection was performed from t1 down to the old instrumentation.It was loose.It had pulled out.It was removed.The soft tissue was stripped of the tips of the transverse process of t1 and t2, as well as removing the pseudoarthrosis.The pedicle screws were then placed.This was done in a standard fashion by first identifying the appropriate starting points, making a cortical defect in that area, placing pedicle finder down the pedicle , palpating it, tamping it, measuring it and putting in the appropriate length screw.The screw at t1 were 6.0x30, t2 6.0x30 on the left and 5.5x30 on the right.All screws had excellent purchase." on (b)(6) 2009 the patient underwent x rays of the thoracolumbar spine.Impression: extensive thoracolumbar sacroiliac spinal fusion.On (b)(6) 2009, patient presented with complaint of recurrent incontinence and urinary tract infection.On (b)(6) 2010, patient presented with history of urge incontinence.Patient underwent renal sonogram.Impression: possible small non-obstructing right lower pole stone.On (b)(6) 2010, patient presented with history of urge incontinence.On (b)(6) 2010, patient presented with complaint of recurrent urinary tract infection and overactive bladder.On (b)(6) 2011, patient presented with complain of back infection.Patient reported that wound started draining in middle of (b)(6) with blood and pus coming out which was followed by yellow fluid coming out.(b)(6) 2011, patient presented for follow-up on post-op wound infection.Patient reported pain in lower back area, below the wound.On (b)(6) 2011, patient presented with complaints of dysuria and urge incontinence.(b)(6) 2010, (b)(6) 2011, (b)(6) 2012, patient presented with history of recurrent urinary tract infection.(b)(6) 2012, patient presented for follow-up on post-op wound infection.Patient reported low back pain, below wound, occasional neck pain and upper thoracic wound opened on (b)(6) with purulent drainage and had enlarged with no surrounding erythema or induration.The left and second toe nail have orange brown discoloration underneath the nail for last two months and started from end of the nail.On (b)(6) 2012, patient underwent x-ray.Impression: contrast media was introduced into the subcutaneous tissue through a catheter with several small tributaries, however, it remained in the localized area overlying the sacroiliac joint.Under aseptic conditions the catheter was introduced in the opening in the lower cervical and upper thoracic region posteriorly.Contrast media was introduced through the catheter which remained in the subcutaneous tissue.A total of 40cc of contrast media was used.Some of the contrast media leaked out of the openings.The pedicle screws and spinal rods extending from approximately t2 through s2.(b)(6) 2012, patient presented for follow-up on post-op wound which opened up in 2010.Patient reported small pieces of metal coming out of the wound and wound size had decreased after dressing with silvadene cream.On (b)(6) 2012, patient presented for follow-up on infection.On (b)(6) 2012, patient presented for follow-up on right total hip replacement done nine years ago.Patient underwent x-ray of right hip for follow-up on right total hip replacement.Impression: stable right total hip replacement.Patient underwent x-ray of pelvis for follow-up on right total hip replacement.Impression: stable right total hip replacement.On (b)(6) 2012 the patient underwent x rays of the chest.Impressions: no acute disease.Also underwent x rays of thoracolumbar spine.Impressions: bilateral harrington rods extending from l1 to s2.A mild thoracic ureter convexed was left is present.No hardware failure is present.Multiple mild chronic compression fractures of several mid to lower thoracic vertebral bodies.On (b)(6) 2012, patient underwent following procedure: removal of t1 to s1 and pelvis instrumentation (stainless steel), exploration of fusion, re-instrumentation t1 to t12 with titanium, t1 to t7 posterolateral fusion using autogenous bone, 1 large kit bmp, 10ml of bone graft; for pre-op diagnosis of: drainage from spine secondary to possible infection, non-union, scoliosis, stenosis.Per-op notes: ".The screws were all removed in lumbar spine as well as the pelvis.Again, there was little pockets of pus associated with the pelvic wing screws.The fusion appeared solid.We replaced thoracic screws with 70 x 40 at t10, t11, t12 on the right and t11 and t12 on the left.The t9 screw did not appeared to be good so it was left out.The bone graft was performed after decortication.Patient was taken to recovery room in stable condition." on (b)(6) 2012 the patient underwent x rays of the thoracolumbar spine.Impressions: post revision of spinal fusion.Minimal midthoracic scoliosis convex to the left.On (b)(6) 2012, patient presented for follow-up after removal of stainless steel rods and placement of titanium rods.On (b)(6) 2012, patient presented for follow-up two weeks post-op removal of instrumentation from t1 to pelvis and re-instrumentation t1-t12.Scoliosis x-rays showed remaining thoracic instrumentation in good position from t1 to t12.(b)(6) 2012, patient presented for post-op follow-up.On (b)(6) 2012, patient presented with complaints of dysuria and urge incontinence.Patient reported incontinence and severe pain.On (b)(6) 2012 the patient underwent x rays of the lumbosacral spine and thoracic spine.Impression: no fracture-dislocation lumbosacral spine.No change in alignment of lumbar sacral spine.Posterior bony fusion and resection of posterior spinous processes unchanged from (b)(6) 2012 scoliosis films.Status post posterior surgical fusion od thoracic spine with alignment unchanged.Metallic cylinder in place and upper thoracic spine unchanged.The patient also underwent mri of the thoracic spine.Impressions: multi level post-operative change again noted with extensive artifact significantly limits evaluation of the thoracic spine.Scattered degenerative change.No definite spinal cord deformity.Follow up ct myelogram could be performed for further evaluation if needed.The patient also underwent x rays of the lumbar spine.Impression: extensive post operative change status post anterior lumbar discectomy bony fusion extending l2-3 through l5-s1.Prior hardware removal partial posterior decompressions posterior lateral bony fusions.Persistent hardware fusion again noted lower thoracic spine.A large septated fluid collection in posterior para spinous soft tissue as above possible minor foci of air.Although this may be secondary to post operative change hematoma, seroma infection abscess is not excluded.Multilevel spinal stenosis most marked with moderate spinal stenosis l5-s1.Multilevel foraminal narrowing most marked right l4-5 bilaterally l5-s1 greater right.Scattered degenerative change elsewhere are lower thoracic lumbar spine.Slight loss of lordosis minor multilevel anterior retrolisthesis scoliosis.On (b)(6) 2012 the patient underwent ct scan of the lumbar and thoracic spine.Impression: ct guided aspiration of lumbar paraspinal fluid.Deep midline posterior fluid collection extending along the lumbar spine.Fluid was aspirated for cultures.No complications were noted.The patient underwent mri of the lower back.Impressions: once again, exam significantly limited secondary to extensive post operative fusion changes through out the thoracic spine resulting susceptibility artifact.Allowing for these limitations, there is no obvious new compression fracture or spondylolisthesis.No obvious new cerebral body or disc space edema evident that would clearly indicate osteomyelitis.No definite new large disc extrusion or spinal stenosis although evaluation must be considered limited for these purposes.No obvious new paraspinal soft tissue inflammatory collection or fluid collection identified, although once again, evaluation limited.Somewhat smaller but still extensive rim-enhancing deep midline posterior fluid collection, consistent with hematoma, seroma, or csf pseudocyst, potentially infected.This is certainly amenable to percutaneous aspiration.No findings indicative of osteomyelitis.Post operative changes from spinal fusion.Pre-existing fusion rods on the lower thoracic and upper lumbar levels.These extend to l1 inferiorly.On (b)(6) 2012, patient presented for follow-up.Patient reported pain.Mri of thoracic and lumbar spine showed a lot of fluid collection.On (b)(6) 2012, patient presented for follow-up and reported back pain, located over lower back and hip area.Patient reported that three weeks after surgery she developed urinary incontinence.On (b)(6) 2012, patient presented for follow-up on seroma on lower back.Patient reported moderate pain in left hip region which radiates down the leg.On (b)(6) 2012, patient presented for follow-up.Patient reported low back pain.Scoliosis x-ray showed instrumentation from t1 to t12.She had good balance and correction of deformity was maintained.On (b)(6) 2012, patient presented for follow-up.Urine culture was tested positive two weeks ago.On (b)(6) 2012, patient presented with complaints of dysuria and urge incontinence.Patient also reported nocturia.On (b)(6) 2012, (b)(6) 2013, patient presented for follow-up and evaluation on post-op back infection.On (b)(6) 2012, patient presented for six month follow-up for fusion and removal of instrumentation.Patient reported occasional back pain.Scoliosis x-ray showed instrumentation from t1 to t12.On (b)(6) 2013, patient presented for office visit with chief complaint of history of urinary tract infection.On (b)(6) 2013, (b)(6) 2014, (b)(6) 2015, patient presented for follow-up on treatment and evaluation of prosthetic spinal hardware infection.Patient reported mild pain.On (b)(6) 2013, patient presented for follow-up on recurrent urinary tract infection and history of overactive bladder.On (b)(6) 2013, patient presented for follow-up on treatment and evaluation of prosthetic spinal hardware infection.Patient reported a click in hip.X-ray was done which showed no abnormalities.On (b)(6) 2014, patient presented with recurrent urinary tract infection, urgency/frequency.On (b)(6) 2014, patient presented with complaints of overactive bladder.On (b)(6) 2014, patient presented for follow-up on right total hip replacement 11 years post-op.Patient underwent x-ray of right hip for follow-up on right total hip replacement.Impression: stable right total hip replacement.Patient underwent x-ray of pelvis for follow-up on right total hip replacement.Impression: stable right total hip replacement, mild to moderate osteoarthritis left hip.On (b)(6) 2015, patient presented for office visit with complaints of overactive bladder.
 
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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 Key4893976
MDR Text Key6534659
Report Number1030489-2015-01378
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,consumer
Reporter Occupation Attorney
Type of Report Initial,Followup
Report Date 03/10/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/07/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date07/01/2009
Device Catalogue Number7510800
Device Lot NumberM110603AAI
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received03/10/2016
Was Device Evaluated by Manufacturer? No
Date Device Manufactured12/13/2006
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;
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