MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Muscle Spasm(s) (1966); Weakness (2145); Stenosis (2263); Discomfort (2330); Ambulation Difficulties (2544)

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2005, the patient underwent spine fusion surgery on the lumbar region of the spine from vertebrae l4 to s1.The patient was implanted with rhbmp-2/acs which was placed outside the cage (in the disk space).Post-operatively, patient complained of chronic pain in lower back and radiculopathy, muscle spasms and weakness in lower extremities.The patient continued to experience severe and unrelenting low back pain and radiculopathy into left leg.The patient had difficulty in standing and walking and required a cane or scooter to assist in ambulation for any extended distance.The serious injuries prevented patient from practicing and enjoying the activities of daily life.The patient allegedly suffered serious and permanent injuries.

Manufacturer Narrative

(b)(6).(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) 2003 the patient was presented for office visit with low back and left leg pain.Diagnosis: degenerative disc disease l4-5 and l5-s1; grade 1 spondylolisthesis l5-s1 with bilateral foraminal stenosis, left greater than right l5-s1; possible foraminal disc herniation left l5-s1; tarlov¿s cyst right s1; left ilium cystic lesion.On (b)(6) 2003 the patient was presented for office visit with more bilateral leg symptoms.She does have severe foraminal stenosis at left l5-s1 and moderate at right l5-s1.There are foraminal disc herniation bilaterally, more so on the left.There is moderate disc degeneration at l4-5.There is a small posterior disc bulging.There is increased joint fluid at l4-5.On (b)(6) 2004 the patient underwent: bilateral decompressive laminectomy, l5-s1; bilateral foraminotomies, l5-s1; left l5-s1 lateral and foraminal discectomy; posterior interbody fusion, left l5-s1; insertion of nuvasive interbody prosthesis, l5-s1 with local bone graft from the decompression that was meticulously cleaned; posterolateral fusion, right l5-s1 with local bone graft; insertion of spinal instrumentation, l5-s1.Preoperative diagnosis: grade 1 lytic spondylolisthesis l5-s1; severe bilateral foraminal stenosis, l5-s1, left greater than right; left foraminal disc herniation, l5-s1; and degenerative disc disease, l4-5 and l5-s1.The patient also underwent x rays of the lumbar spine: demonstrated irregular lucent lesion left iliac bone with peripheral marginal sclerosis.On (b)(6) 2004 the patient was presented for office visit with leg symptoms, left grater than right.Examination: she does have mild tenderness in the low back and over both iliac crests.On (b)(6) 2004 the patient underwent x rays of the lumbar spine.Findings: there are degenerative changes in the mid and lower facet joints.The irregular mineralization involving the left innominate bone is unchanged.On (b)(6) 2004 the patient was presented for follow up.She did have ab lytic spondylolisthesis at l5-s1.She also had a severe left l5-s1 foraminal nerve compression in part due to a lateral disc herniation.On (b)(6) 2004 the patient underwent ct scan of the lumbar spine.Impressions: the interbody fusion at l5-s1 is not solid.There has been wide dorsal decompression surgery without solid dorsolateral fusion and there is a grade 1 subluxation of l5 on s1 without significant foraminal stenosis; loosening along the right l5 pedicle screw.The remaining pedicle screws are intact without loosening; there are no fractures identified.Mild left posterolateral l4-5 annular bulging is evident without central or lateral neural compression.L4-5 facet joints are unremarkable.On (b)(6) 2004 the patient was presented for follow up with coughing and increased back pain.On (b)(6) 2004 the patient was presented for follow up.She did have a non union and has been in a tlso with a bone stimulator.She does have moderate back pain.Her leg discomfort is intermittent.On (b)(6) 2004 the patient underwent ct scan of the lumbosacral spine.Impressions: post-op interbody and dorsolateral spinal fusion at l5-s1 with no evidence of healing.Bilateral laminectomy and facetectomy defects are seen with a residual 4mm spondylolisthesis and mild narrowing of the neural foramen in the up-down direction; small midline disc herniation and diffuse posterior annular bulging at the supra-adjacent l4-5 level without significant narrowing of the central canal.Mild right-sided and moderate left-sided foraminal stenosis is also seen at this level without ganglionic impingement; comparison with previous ct of (b)(6) 2004 shows that the small midline disc herniation at l4-5 appears to be new in the interval.There has been some resorption of interbody graft in the interval with a slight decrease in disc space height since the previous exam.On (b)(6) 2005 the patient was presented for office visit for follow up.Review of (b)(6) 2004 dated ct scan showed a persistent non-union at l5-s1.There is some collapse and resorption of the interbody graft.¿she does have a central disc herniation at l4-5.It also does appear that she may have a new central extrusion.It does appear that the central extrusion is new.It does appear that the l4-5 disc is probably contributing to her present back pain.On (b)(6) 2005 the patient underwent : left anterior retroperitoneal approach; anterior discectomy and fusion, l4-5, 30 exploration of fusion mass, l5-s1 with anterior fusion, l5-s1; left anterior iliac crest bone graft; insertion of fibular allograft prosthesis, l4-5 and l5-s1; insertion of fibular allograft strut grafts, l4-5 and l5-s1; insertion of rhbmp-2 bone graft.Stage 2: removal of hardware; exploration of fusion; posterior spinal fusion, l4-5; insertion of spinal instrumentation.Preoperative diagnosis: non-union l5-s1; central disc herniation, l4-5; degenerative disc disease, l4 to s1.Per-op notes: ¿i also resected part of the prior interbody graft.The interspace was opened.The interspace was sized and shaved with disc space shavers.It was then packed.I then did obtain a 11mm and a 12mm fibular allograft prosthesis.These were place in saline.A small section of this was placed into the fibular allograft prosthesis.It was tapped into position at l5-s1.I then placed further bmp followed by bo ne graft.A fibular allograft strut of appropriate size was then cut from stock and fashioned.This was placed into the position anteriorly at l5-s1.Good fixation was obtained.I then exposed the l4-5 level.The interspace was sized to 12 to 13mm.The endplates have been decorticated.The fibular allograft prosthesis with bmp was placed into position anteriorly and slightly to the right.I then placed further infused bmp and bone graft from iliac crest.Fibular allograft strut was placed in position.This was followed by further autograft and bmp.On (b)(6) 2005 the patient underwent anterior approach to the lumbar spine at l4-5 and l5-s1 (2 levels).Preoperative diagnosis: degenerative disc disease, l4-5 and l5-s1(2 levels).The patient also underwent x rays of the pine.Findings: there is irregularity over the left iliac wing which may be an overlying artifact or perhaps be related to a lesion within the iliac bone.There is a surgical drain over the spine as well.On (b)(6) 2005 the patient was presented for office visit for her post-operative visit.She reported having spasms and discomfort into her right leg, nausea and ambulation difficulty.On (b)(6) 2005 the patient was presented for office visit with increased lower back pain if she walks more than 25 steps.On (b)(6) 2005 the patient underwent ct scan of the lumbar spine.Impressions: status post interbody and posterior fusion with instrumentation as described above; no definitive bridging bone at l5-s1 (pseudoarthrosis) interbody fusion.There is grade 1 anterior lytic spondylolisthesis; moderate up-down foraminal stenosis on the right at l5-s1 with mild ganglion compression; limited surface area of bridging bone at l4-5 (interbody fusion) is demonstrated as noted above; no demonstrable instrumentation failure or complication.On (b)(6) 2006 the patient underwent mri of the lumbar spine.Impressions: extensive postoperative changes following anterior and posterior spinal fusion and decompressive laminectomy at l4-5 and l5-s1; 6-7mm anterolisthesis of l5 in relationship to s1.Neural foramina at this level are elongated in the ap dimension, but there is moderate loss of foramina at this level are elongated in the ap dimension, but there is moderate loss of foraminal height bilaterally possibly contacting the exiting l5 nerve roots, especially on the left side.The patient was presented for office visit for follow up.On (b)(6) 2006 the patient underwent ct scan of the lumbar spine.Conclusion: the l4-5 and l5-s1 interbody fusions are now solid with no distal screw loosening nor other instrumentation complications; no evidence of any solid dorsolateral fusion at l4-5 nor l5-s1.There has been attempted l4-5 facet joint fusion without solid ankyloses; subtotal l5-s1 facetectomies with a chronic grade 1 spondylolisthesis of l5 on s1; no acute fractures are identified.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• 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: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 4893735
• MDR Text Key: 15573604
• Report Number: 1030489-2015-01369
• Device Sequence Number: 1
• Product Code: NEK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,consumer
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup
• Report Date: 09/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/11/2017
• 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 Number: 1