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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 7510400
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Contusion (1787); Muscle Spasm(s) (1966); Neuropathy (1983); Weakness (2145); Burning Sensation (2146); Injury (2348); Numbness (2415); Ambulation Difficulties (2544)
Event Type  Injury  
Manufacturer Narrative
(b)(4).Neither device nor applicable imaging studies returned to manufacturer for evaluation.
 
Event Description
It was reported that (b)(6) 2004: patient underwent preoperative examination (pa and lateral chest x-ray) which revealed that lungs are clear and there is no evidence for pleural effusion.The heart size and pulmonary vascularity are within normal limits.No osseous abnormality.(b)(6) 2004: patient presented for preoperative medical clearance.The patient injured his head on a worker's injury back on (b)(6) 2003, while doing patient lifting and transferring at aurora sinai hospital.He has failed conservative management with anti-inflammatories, physical therapy, and epidural steroid therapy.He is currently on vicoprofen , neurontin, and flexeril for managing his pain symptoms.He has left sciatica symptoms.The patient has had previous low back trouble with l5-s1 laminectomy in (b)(6) 1988.He apparently had an mi at an earlier age but had no symptoms.Physical examination: musculoskeletal: reveals a positive modified straight leg raise on the left.Range of motion of the ls spine is diminished in terms of flexion and extension.Impression: herniated l5-s1 disk (b)(6) 2004: patient presented for an office visit.Patient slipped and fell on the floor on some water onto his elbow and left side and has had a marked exacerbation his left lumbosacral and radiating leg pain.Physical examination: patient have a slr that is positive in a seated position on the left at 60 degrees (b)(6) 2004: patient underwent mri of the lumbar spine without and with contrast.Clinical information: new onset bladder incontinence, radiculopathy.There is disk space narrowing at l5-s1.There is disk signal loss at l2-l3 through l5-s1.There is no appreciable change on mri of the lumbar spine.(b)(6) 2004: patient was admitted to hospital.Patient presented with lumbar spondylosis, l5-s1 and underwent left retroperitoneal dissection for anterior exposure of l5-s1 for discectomy and placement of cages (large anterior osteophytes was found) and anterior lumbar inter-body fusion of l5-s1 with intervertebral body cages and rh-bmp2/acs.Per op notes ".The disk space was reamed and cages placed according to manufacturer's specification, 16 x 23 mm to be flush with the anterior edge of the vertebral bodies of l5 and s1.The wound was copiously irrigated.Final removal of any disk material was performed and the rh-bmp2/acs soaked sponges were then placed into the cages.The wound was then closed in the layered fashion and subcuticular sutures were used to close the skin." intraoperative fluoroscopic views showed radiopaque markers identified in the disk space of l5-s1.No complications were noted.On postoperative day one physical therapy began and pain management with intravenous pca which progressed nicely.(b)(6): patient is discharged with restrictions of avoiding lifting more than approximately 10 pounds.Discharge instructions include: the wound is to be dressed daily as long as drainage is present from the wound.When the wound is dry, it may be left open to the air.He is to monitor for signs of erythema, discharge, induration or increased pain of the area.He is to use walking as his primary form of reconditioning.Resume pre-surgical diet as tolerated.(b)(6) 2004: patient called stating he is having left leg cramps.(b)(6) 2004: patient called to enquire about left lower extremity pain.He started developing cramp-like symptoms that are worsened with walking.(b)(6) 2004: patient presented for office visit.Patient is status post anterior lumbar inter-body fusion, whose complaints are some left leg numbness and burning, as well as some mild back pain.(b)(6) 2004, (b)(6) 2004, (b)(6) 2004, (b)(6) 2005: radiology scheduling: patient diagnosed with anterior lumbar inter-body fusion :x-rays lumbar ap/lat (b)(6) 2004: patient presented for office visit.Patient has some left-sided lumbosacral back pain and left buttock and posterior thigh pain.He feels his leg pain is different than it was preoperatively.His physical exam today shows his gait is antalgic, especially on the left.He still has a left-sided list, and his flexion of the lumbar spine is limited to 30 degrees and extension 10 degree.Patient is making slow but steady progress after an anterior lumbar inter-body fusion.From (b)(6) 2004 to (b)(6) 2004, 8 visits for physical therapy was made (b)(6) 2004: patient underwent x-rays of lumbar spine due to lumbar radiculopathy which revealed stable lumbar spine.(b)(6) 2004:patient was recommended for physical therapy with following treatment: mobilization, hep, lumbar stabilization and strengthening with frequency of 2-3 times per week for 4-6 weeks.(b)(6) 2004: patient presented for an office visit.An ap and lateral view of his lumbar spine shows his cages to be in adequate position, and there actually appears to be early bone formation in between the cages.From (b)(6) 2004 to (b)(6) 2004, 19 visits for physical therapy was made for following treatments: soft tissue mobilization, stabilization exercise, body mechanics training, work stimulation/functional activity training, postural training (b)(6) 2004: patient underwent x-rays of lumbar spine due to lumbar radiculopathy which revealed stable lumbar spine.Degenerative changes of the lumbar spine identified with anterior osteophyte formation within the l4, l5 and si vertebral bodies.Degenerative changes of the facets with narrowing of neural foramina also identified at l5-s1.(b)(6) 2004: patient with symptoms of muscle weakness and decreased functional activities was recommended for pt for core stability, functional work and task conditioning.(b)(6) 2004: patient called and complained of bad spasms and not able to walk straight.(b)(6) 2004: patient called and stated that he is having same sensation that he was having before surgery.He feels as if he is walking bare foot on gravel.(b)(6) 2004: patient presented for an office visit.Patient complained that he began to have some dysesthesia in the sole of his left foot again, similarly to what he had preoperatively.He began to use his tens unit, which he previously had, and it significantly improved his symptoms.(b)(6) 2004: patient underwent x-rays of lumbar spine which revealed anterior lumbar inter-body fusion at l5-s1.(b)(6) 2004: work conditioning program was recommended with frequency of 5 times per week.From (b)(6) 2004 to (b)(6) 2004,29 visits for physical therapy with following treatment: therapeutic exercise and work stimulati on/functional activity training were made.(b)(6) 2005, (b)(6) 2005, (b)(6) 2005, (b)(6) 2005, (b)(6) 2005: patient presented for an office visit for psychotherapy.(b)(6) 2004, (b)(6) 2005, (b)(6) 2005,: patient presented for an office visit.(b)(6) 2005: patient presented for an office visit.He notes significant dysesthesias in both lower extremities.His legs feel tight and he gets a little bit crampy in his legs.Patient is symptomatically stable after anterior lumbar inter-body fusion.His flexion is limited to 40 degrees, extension 10 degrees.He is mildly tender over the l4-5 level.He does have some pain with extension.(b)(6) 2005: patient called and stated having mood swings due to avinza and doesn't want to take it (b)(6) 2005: patient presented for an office visit due to onset of significant back pain, and his legs being unsteady.He is back to using a cane.(b)(6) 2005: radiology scheduling, patient diagnosed with lumbar spondylosis and radiculopathy.Mri: lumbar spine with gad.(b)(6) 2005: patient presented for an office visit due to lumbosacral back pain, leg pain and left toes burning sensation.He is using a cane.He has had unexplained erections x 3 over the last several weeks, and the sensation of urinating when he is not, complains of band-like pain throughout his lumbosacral spine.(b)(6) 2005: patient underwent mri of lumbar spine due to low back pain.Conclusion: interval placement of cage spacers at the lumbosacral level since (b)(6) 2004.Prominent bulging of the annulus at the l3-4 level, this has increased in prominence on the right since the earlier examination of (b)(6) 2004 and now encroaches upon the lateral recess in the anterior inferior aspect of the neural foramen.Mild bulging of the l4-5 annulus with a small annular tear present.Persistent left paracentral disk herniation at the lumbosacral level, not significantly changed in appearance in the interim.(b)(6) 2005, (b)(6) 2005: patient diagnosed with radiculopathy and given selective root injection at left l5.(b)(6) 2005: patient presented for a follow -up of his mri which shows he does have the known l3-4 and l4-s spondylosis.Ls-s1 appears to be well decompressed with no significant changes.He is known to have a solid fusion at that level.He feels like he has a grabbing calf, with squeezing pain.He fell again.His mri shows no obvious or significant neuro-compressive lesions.(b)(6) 2005: patient presented for an office visit due to increase in pain and has significant psychological stressors in terms of his pain, his job and his home life.(b)(6) 2005: patient presented for an office visit.While doing some work on his computer, he felt several pops in his back and had the subjective sensation of something slipping.He developed significant bilateral buttock and anterior thigh pain, and for approximately 2-3 hours after that time, had significant difficulties walking.Slowly, over the last several days, he has felt that he is moving back toward his baseline.There is some difficulty with starting his urinary stream.(b)(6) 2005 : radiology scheduling, patient diagnosed with anterior lumbar interbody fusion mri: lumbar spine with gad.(b)(6) 2005:patient diagnosed with failed back and given treatment(spinal cord stimulator) (b)(6) 2005: patient presented for follow-up of his lumbar spine, with continued and persistent complaints of muscle spasms, especially down his left lower extremity, a spiky feeling in to his heels, as well as buttock pain.His mri today really shows no significant changes from that back in march.There is still spondylosis at l3-4 and l4-5, however, there is no significant disc herniation, central or lateral recess stenosis.He still has some mild residual narrowing at l5-s1.(b)(6) 2005: as per patient messages patient has taken a higher dosage of neurontin and his wife noticed that the patient is having seizure type behavior during sleep.Patient is doing well with less dosage of medicine.(b)(6) 2005: patient underwent mri of lumbar spine pre- and post gadolinium.Clinical history: this is a (b)(6) male with low back pain, the patient is status post lumbar spine surgery.Impression: status post-surgery at l5-s1: there is a prominent broad-based disk protrusion which is left paracentral in location and which does cause encroachment on the left l5-si neural foramen and may be causing left si nerve root impingement.This is associated with facet arthropathy and a small spondylitic bar.Disk degeneration at l3-4 and l4-5 with disk protrusions which cause mild spinal stenosis.There also is facet arth ropathy at these two levels and the combination of the facet arthropathy and disk protrusion does cause mild encroachment on the neural foramen bilaterally.Anterior disk protrusions are also seen at l3-4 and l4-5.Disk degeneration at l3-4 and l4-5 with disk protrusions which cause mild spinal stenosis.There also is facet arthropathy at these two levels and the combination of the facet arthropathy and disk protrusion does cause mild encroachment on the neural foramen bilaterally.Anterior disk protrusions are also seen at l3-4 and l4-5.(b)(6) 2005: patient diagnosed with ddd and given chronic pain management treatment.(b)(6) 2005: patient presented after an evaluation for a potential spinal cord stimulator but thinks that it is not his best option.(b)(6) 2006: patient presented for office visit due to increase in complaints of bilateral lumbosacral back pain and increasing left, greater than right, pain through the buttock, posterior thigh, all the way to his heels.He actually has had significant difficulties in trying to maintain work-related activities.Review of an mri of his lumbar spine from (b)(6) 2006, shows some mild t2 signal changes and spondylosis at the l3-4 and l4-5 levels, with age expected facet changes at l3-4 and l4-5.He does have some mild central and lateral recess stenosis at the l3-4 levels.His l5-s1 level appears to be solid and without any difficulties.(b)(6) 2006: patient was diagnosed with ddd and given epidural steroids at l4-5.As per patient complaint/history form: right shoulder injury using basketball game on (b)(6) 2007: (b)(6) 2007: patient presented for follow up for his right shoulder injury.He does have a lot of discomfort to the right shoulder.On physical examination today of the right shoulder reveals limitation in range of motion secondary to pain.X-rays obtained of the right shoulder show no fractures.He has notable three anchors to the superior and anterior aspect of the glenoid consistent with a slap repair.Impression: right shoulder dislocation.(b)(6) 2007:patient underwent mri of right shoulder due to shoulder pain and weakness status post fall during a basketball game.Con clusion: full thickness tearing of the anterior fibers of the supraspinatus component of the rotator cuff.There is tendinosis and partial tearing of the residual intact posterior fibers.Tendinosis of the distal subscapularis tendon.Type i-ii acromion.Acromioclavicular joint degenerative changes with mild undersurface hypertrophy.Moderate glenohumeral joint effusion contiguous with the subacromial/subdeltoid bursa.Post surgical changes of prior labral repair with susceptibility artifact suggestive of bone anchors related to the anterior superior labrum.There is subtle undermining of the labrum and a small paralabral cyst at the 11 o'clock position and degeneration and fraying of the remainder of the posterior superior labrum.7) intact biceps tendon without tear or tendinosis.(b)(6) 2007: patient presented for follow-up of his right shoulder.On physical examination of the right buttock he had severe ecchymosis with some tenderness over the ischial tuberosity.It is also present over the inferior gluteus musculature.Impression: right rotator cuff tear.Right thigh/ hip contusion and hematoma.(b)(6) 2007: patient presented for follow-up of this right shoulder.As per physical examination patient had pain and weakness with external rotation against resistance consistent with his rotator cuff tear.
 
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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 Key5041634
MDR Text Key24525703
Report Number1030489-2015-02120
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 Other
Report Date 08/03/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/31/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number7510400
Device Lot NumberM111008AA
Was Device Available for Evaluation? No
Date Manufacturer Received08/03/2015
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) Other;
Patient Weight98
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