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

Catalog Number 7510200

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

Patient Problems Chest Pain (1776); Muscle Spasm(s) (1966); Muscle Weakness (1967); Tingling (2171); Joint Swelling (2356); Numbness (2415)

Event Type  Injury  

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.

Event Description

Patient demographics: height- (b)(6).It was reported that on an unspecified date in (b)(6) 2008, patient underwent spinal fusion.On (b)(6) 2008: patient underwent ap lateral of lumbar spine.Impression: degenerative disc disease of l5-s1.On (b)(6) 2008: patient underwent ap lateral of lumbar spine.Impression: mixed spondylotic disk protrusion at l5-s1 with mild to moderate narrowing of the neural foramine.On (b)(6) 2009: patient presented with back, left leg, left buttock pain.Patient has weakness in his shoulders and lower back.Patient underwent mri of the lumbar spine.Findings: lumbar degenerative disc disease, facet arthrosis, left l5-s1 radiculitis.Patient has severe pain in his lower back and down his left leg going on since about 2005.On (b)(6) 2009: patient presented with the following pre-op diagnosis l5-s1 disk protrusion, left l5-s1 radiculitis, facet arthrosis, lumbar degenerative disk disease, lumbago.Procedure: transforaminal epidural injection left l5-s1.Caudal epidural injection.Bilateral facet joint injections, l3-l4, l4-l5, l5-s1, fluoroscopy.Per op notes: the ap view was aligned with the proper tilt so that the end plates tightened to an excellent bite, at which time the guidewire was then removed, and the working portal was then removed.In this fashion, the l5-s1 facet fusion and facet instrumentation was performed.In the same manner bilateral facet fusion was performed with bilateral facet instrumentation was placed on the contralateral side.Image of the lumbar spine confirmed all the hardware to be in good position.No complications were reported.On (b)(6) 2009: patient presented with low back pain.Patient underwent mri of the lumbar spine.Findings: lumbar disc protrusion, lumbar degenerative disc disease, lumbar radiculitis, mild foraminal stenosis l5-s1 bilaterally.On (b)(6) 2009: patient presented with low back pain, left leg pain.Procedure: the patient underwent mri of the pelvis region w/o contrast.Impression: gluteus medius tendinopathy, more prominent on the left.Greater trochanteric bursitis.On (b)(6) 2009: patient presented with the following pre-op diagnosis, lumbar degenerative disk disease.Bilateral l5 radiculitis, lumbago.Procedure: anterior lumbar spinal effusion, l5-s1.Anterior lumbar spinal instrumentation, l5-s1 (trans screw).Posterior lumbar spinal fusion, l5-s1 (facet fusion), posterior lumbar spinal instrumentation, l5-s1 (trans s1 facet screws).Use of allograft bone (grafton demineralized bone matrix and rhbmp2).Use of autograft (sacral bone graft).Per op notes- biplane fluoroscopy was then used to visualize the lumbar spine.The blunt probe was found to be in appropriate position under biplane fluoroscopy.Once the working portal was dilated and embedded into the sacrum in appropriate position, a hand drill was then used to drill out the sacrum into l5-s1 disk space to create a channel for the interbody fusion.An inserter for the bone graft was placed into the l5-s1 disk space, and a bmp sponge was placed anteriorly in the disk space, followed by placement of grafton demineralized bone matrix.The patient's own bone graft that was removed from the s1 sacrum was also inserted into the l5-s1 disk space for a fusion.Once the bone graft was placed into the l5-s1 space, an adequate inter body fusion was performed.An appropriate length trans s1 screw was selected, and it was placed over the guide wire into the s1 sacrum, across the l5-s1 disk space into the l5 vertebral body.Appropriate position was confirmed under fluoroscopic imaging.Ap and lateral fluoroscopic imaging confirmed good distraction and good positioning of the hardware and a good fusion of l5-s1.Bone graft was placed into the working portal and a small plunger was utilized to plunge the bone graft into the l5-s1 facet joint for a facet fusion.An identical procedure was performed on the contralateral side and in this fashion bilateral facet fusion was performed with bilateral facet instrumentation placed.No complications were reported.Patient underwent x-ray of the lumbar spine region.Findings: metallic spacer extends from the s1 vertebral body through the l5-s1 intervertebral disk space into the l5 vertebral body.Bilateral l5-s1 facet screws.Narrowing of l5-s1 intervertebral disk space persists.Remaining lumbar intervertebral disk space as well as lumbar vertebral body heights are maintained.One trans1 3d axial rod, 45mm 10x12 and one 5mmx30mm facet screw was used during the surgery.No complications were reported.On (b)(6) 2009: patient presented for follow-up.Patient underwent x-rays which suggests post fusion syndrome, lumbar degenerative disc disease.Impression: s/p anterior and posterior fusion at l5-s1 in good position.On (b)(6) 2009: patient presented for follow-up through telephonic conversation.Patient presented with significant amount of pain.On (b)(6) 2009: patient presented for follow-up.Patient presented with low back pain and left leg pain.Patient underwent x-rays which suggests no sign of loosening.Fusion is in good position.Assessment: post laminectomy syndrome.Lumbar degenerative disc disease.On (b)(6) 2009: patient presented for follow-up.Patient presented with low back pain and left leg pain.Assessment: post fusion syndrome, lumbar degenerative disc disease.Rom ls spine: flex 60 with pain, ext 10 with pain, lat r 30 with pain, rot r 20 with pain, lat l 30 with pain, rot l 20 with pain.Patient underwent x rays which reveal a fusion at l5-s1 with no signs of hardware loosening.On (b)(6) 2010: patient presented for follow-up.Patient presented with low back pain and left leg pain.Assessment: post fusion syndrome, lumbar degenerative disc disease, and l4-5 degenerative disc disease.Rom ls spine: flex 45 with pain, ext 0 with pain, lat r 30 with pain, rot r 20 with pain, lat l 30 with pain, rot l 20 with pain.Patient underwent x rays which reveal a fusion at l5-s1 with no signs of hardware loosening.Patient underwent x- ray of the lumbar spine region.Impression: s/p anterior and posterior fusion at l5-s1 in good position.On (b)(6) 2010: patient presented for follow-up.Patient presented with low back pain and left leg pain and also his neck.Assessment: post fusion syndrome, lumbar degenerative disc disease, and cervical degenerative disc disease.Rom ls spine: flex 50 with pain, ext 10 with pain, lat r 30 with pain, rot r 20 with pain, lat l 30 with pain, rot l 20 with pain.On (b)(6) 2010: patient presented for follow-up.Patient presented with low back pain.Assessment: post fusion syndrome, lumbar degenerative disc disease, and possible adjacent level disease versus pseudoarthrosis.Patient underwent x-rays which suggests mild sclerosis and narrowing of l5-s1.Rom ls spine: flex 40 with pain, ext 10 with pain, lat r 30 with pain, rot r 20 with pain, lat l 30 with pain, rot l 20 with pain.Patient underwent x rays which reveal a fusion at l5-s1 with no signs of hardware loosening.On (b)(6) 2012: patient presented for initial induction therapy on suboxone.On (b)(6) 2012: patient presented for initial induction therapy on suboxone.Patient presented with leg pain.On (b)(6) 2012: patient presented for initial induction therapy on suboxone.Patient presented with joint pain.Back: spine normal without deformity or tenderness, normal rom.Extremities: no deformities, clubbing, cyanosis, or edema.Musculoskeletal: normal symmetry, tone, strength and rom.No effusions, instability or tenderness to palpation.On (b)(6) 2012: patient presented for initial induction therapy on suboxone.Patient presented with joint pain.Extremities: no deformities, clubbing, cyanosis, or edema, musculoskeletal: strength adequate for self ambulation, normal gait.Patient was diagnosed with hormone deficiency- low testosterone level and has been getting hormone replacement injections.Patient states that since his suboxone has been decreased to 4 mg, he is experiencing more pain in his lower back, legs, and knee and ankle joints.On (b)(6) 2012: patient presented for initial induction therapy on suboxone.Patient presented with joint pain.Musculoskeletal: both knee(s) swollen moderately tender.On (b)(6) 2012: patient presented for initial induction therapy on suboxone.Patient presented with joint pain.Current suboxone dose: 4 mg.Musculoskeletal: no arthralgias, myalgias or joint swelling.On (b)(6) 2012: patient presented for initial induction therapy on suboxone.Patient presented with joint pain.Current suboxone dose: 3 mg.Musculoskeletal: no arthralgias, myalgias or joint swelling.On (b)(6) 2012: patient presented for initial induction therapy on suboxone.Patient presented with chronic pain: lumbago.Suboxone dose 8 mg.On (b)(6) 2012: patient presented with chest pain.Examination revealed anxiety and joint pain.On (b)(6) 2013: patient presented for initial induction therapy on suboxone.Suboxone dose 8 mg.On (b)(6) 2013: as per the letter from love family practice group, dr.Patel, fusion surgeon was advised to do rhbmp2 from an anterior approach.On (b)(6) 2013: patient presented for follow-up.Patient presented with lumbar spine pain, neck pain radiating to shoulder blades.Patient presented with the following chronic problems cervical root lesion, herniated disc w/o myelopathy, neuralgia- cervical , spasm of muscle, stenosis, cervical pain, therapeutic drug monitor, degenerative disc degeneration, herniated, degenerative disc displacement, bulging lumbar w/o.As per examination, patient presented with leg numbness, numbness in extremities, spasms, leg pain, tightening in legs.Patient underwent ct cervical spine without contrast.Impression: no acute osseous abnormality.Mild to moderate degenerative disc disease with uncovertebral osteophytes in particular causing mild to moderate narrowing of the lateral recesses at c3-4 with potential compromise of exiting right and left c4 nerve roots.Minimal canal narrowing also seen at c4-5 and to a lesser extent at other levels.Abnormal mastoid air cells bilaterally suggestive of chronic mastoid air cell disease for which correlation advised.Prominence of soft tissues in the region of the lingual tonsils left greater than right may be related to some asymmetric reactive changes from underlying inflammation and lymphoid hypertrophy.There is also nonspecific prominence of vocal cords as described above above.Ent consultation advised and direct visualization recommended to exclude a discrete mass.Nonspecific soft tissue nodules projecting off the akin surface of the posterolateral right neck and likely a sebaceous cysts and mild inflammatory changes as well for which correlation advised.On (b)(6) 2013: patient presented for follow-up.Patient presented with cervical spine pain.As per examination, patient presented with paresthesia, muscle weakness, numbness and tingling in the upper extremity.Impression: the above electrodiagnostic study reveals evidence of an ulnar neuropathy at the wrist, a median neuropathy, and a radial neuropathy of bilateral upper extremities.There were features of axon loss and demyelination.On (b)(6) 2014: patient presented for follow-up.Patient presented with cervical spine pain.Procedure: epidural injection.The injection was performed under fluoroscopic guidance.No complications were reported.On (b)(6) 2014: patient presented for follow up.Patient presented with cervical spine pain radiating to the left heart and left interscapular.Patient presented for fu from cesi.States 90% improvement with pain level.On (b)(6) 2014: patient presented for the follow up.Patient presented with cervical spine pain and lumbar spine pain.Lumbar spine: the problem is fluctuating.It occurs persistently.Location of pain is lower back, gluteal area and legs.Pain is radiated to the back, left ankle, right ankle, left calf, right calf, left foot and right foot.The patient describes the pain as an ache, deep and stabbing.Context: bending forward.Symptoms are aggravated by ascending stairs, bending, coughing, daily activities and flexion.Symptoms are relieved by rest.Cervical spine pain: the severity of the problem is moderate.The frequency of pain is intermittent location of pain is left head, left posterior neck, left shoulder, left upper back, left scapula and left interscapular.There is radiation of pain to the left head and left interscapular.Aggravating factors include hyperextension, rotation and turning head.Pertinent negatives include bladder incontinence, bowel incontinence, and decreased mobility, loss of balance, numbness and rash.Additional information: patient presents today for fu for cervical pain.States pain level at a 2.Patient underwent x ray of the lumbar region.Evidence of lumbar fusion with advanced ddd at l5-s1.As per review, patient is having difficulty in walking.On (b)(6) 2014: patient underwent mr- lumbar spine with and without contrast.Impression: postsurgical changes at l5-s1.Disc osteophyte laterally at this level minimally narrows the foramina and contacts the exiting l5 nerve root on the tight as it exits the foramina.There is also some mild prominence of the epidural fat narrowing the thecal sac at this level.Minimal lateral recess narrowing at this level.No tight canal or foraminal stenosis appreciated.Minimal enhancement and increased signal at the disc posteriorly at l4-5 may be related to annular tear and small broad-based protrusion versus postsurgical changes with only minimal narrowing of the bilateral lateral recesses at this level.Please see full report above for findings at each level.Impression without contrast: minimal disc desiccation in the thoracic spine with trace right paracentral protrusion at t2-3.No significant canal or foraminal narrowing noted throughout.

• 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 Key: 5044338
• MDR Text Key: 24761963
• Report Number: 1030489-2015-02138
• 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
• Reporter Occupation: Attorney
• Report Date: 08/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2011
• Device Catalogue Number: 7510200
• Device Lot Number: M110706AAC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/03/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/23/2008
• 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
• Patient Outcome(s): Other
• Patient Weight: 117