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

Catalog Number 7510800

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

Patient Problems Swelling (2091); Weakness (2145); Burning Sensation (2146); Tingling (2171); Numbness (2415); Ambulation Difficulties (2544)

Event Type  Injury  

Event Description

It was reported that the patient underwent a transforaminal lumbar interbody fusion (tlif) l5-s1 using a peek cage; as well as a pos terolateral fusion (plf).The cage was packed with rhbmp-2/acs.The bmp-2 was also placed in the posterolateral gutters spanning the transverse processes.Reportedly, sometime following her surgery, the patient developed additional, new and/or worse pain.The patient developed progressive, disabling pain in her lower back, radiating to her legs, numbness in her feet and her activity is extremely limited.

Manufacturer Narrative

(b)(4): neither the device nor applicable imaging study films or patient medical records 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/used 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

On (b)(6) 2011 patient fell while walking and injured her back.On (b)(6) 2011: patient presented for follow-up for right ankle and right leg pain.She fell on (b)(6) 2011 while walking and injured her back.On (b)(6) 2011: patient presented with complaint of difficulty to work.Symptoms were right ankle pain, right leg pain, and severe low back pain.Diagnosis: right ankle spasm.On (b)(6) 2011: patient underwent epidural steroid injection at l4-l5.On (b)(6) 2011 patient presented for follow-up for severe low back pain radiating down her right leg.On (b)(6) 2011: patient was given epidural steroid injection.On (b)(6) 2011: patient underwent epidural steroid injection at l4-l5.On (b)(6) 2011 patient complained about back pain.She was prescribed medications.On (b)(6) 2013: patient underwent laminectomy l5-s1 surgery.On (b)(6) 2015: patient presented for cold symptoms.Patient describes cough as hacking and productive (of yellow sputum).Assessment: bronchitis.On (b)(6) 2015: patient presented with musculoskeletal pain.Associated symptoms were joint instability, joint tenderness and limping.Assessment: right foot pain; post laminectomy syndrome; sciatica; fall at home; chronic pain syndrome.Patient underwent x-ray of right foot due to right foot pain which revealed that no acute fracture or dislocation.There was no abnormal periosteal evaluation.There was small calcaneal bony spurs at the insertions of the achilles tendon and plantar aponeurosis.

Manufacturer Narrative

Updated information: "(b)(6) 2011: the patient underwent nerve conduction/electromyography test.Interpretation: 1.Normal bilateral leg examination.2.Technically difficult nerve conduction study due to large muscle mass.3.Clinical correlation was recommended.".

Event Description

(b)(6) 2011: the patient underwent nerve conduction/electromyography test.Interpretation: 1.Normal bilateral leg examination.2.Te chnically difficult nerve conduction study due to large muscle mass.3.Clinical correlation was recommended.

Manufacturer Narrative

Review of radiographic images found as follows: (b)(6) 2014 post operative l spine x ray l5 s1 fusion construct is present, ap lateral and oblique projections are obtained.Bony foraminal stenosis is present on one of the oblique images, difficult to assess which side.Scolios is present in the lumbar spine above the level of the fusion.Solid bony fusion at the interspace does not appear to be present.Impression : post operative imaging provided in form of lumbar xrays at ~ 3 year post op point.No evidence of hardware failure present.There is a paucity of bone in the interbody space for this time point.Difficult to assess an anatomic basis for patient complaint based on the lack of preop, and detailed post op imaging.

Manufacturer Narrative

(b)(4).

Event Description

It was reported that on (b)(6) 2011 the patient was presented for office visit with right foot pain and right leg pain.She also reported chronic right leg pain consistent with sciatica.Assessments: right ankle sprain.Old evulsion fracture of the right lateral malleolus; chronic c onstipation.She also underwent xrays of the right foot.No complication was reported.On (b)(6) 2011: patient presented for follow-up for right ankle and right leg pain.She fell on (b)(6) 2011 while walking and injured her back.Assessments: right ankle sprain improved; right leg pain consistent with sciatica.Symptoms still limiting the patient.On (b)(6) 2011: the patient presented with constant sharp right buttock pain, radiating down the right leg with burning sensation.Assessments: bad degenerative lumbar disease with spinal stenosis and right sciatica.On (b)(6) 2011 the patient was presented for office visit with low back pain.Assessments: low back pain; right lower extremity ra diculitis with paresthesia; bilateral sacroiliac dysfunction; mri of the lumbar spine showed l3-4 level with mild degenerative disc disease with facet joints at l4-5 level with diffuse annular bulge with facet changes at l5-s1 level and mild bilateral neural foraminal stenosis.On (b)(6) 2011: patient underwent epidural steroid injection at l4-l5.Preoperative diagnosis: refractory low back pain; lower extremity radiculitis; lumbar degenerative disc disease at l3-4 level with bulge at l4-5 level and bilateral neural foraminal stenosis; refractory pains to conservative treatment.On (b)(6) 2011 patient presented for follow-up for severe low back pain radiating down her right leg.Assessments: mri documented spinal ste nosis with no significant improvement to maximum conservative medical management.On (b)(6) 2011: patient was given epidural steroid injection.The patient was also presented for office visit with low back pain.Assessments; intractable low back pain; lower extremity radiculitis; bilateral scarolitis; lumbar degenerative disc disease at l3-4 level with facet changes at l4-5 level with diffuse annular bulge and bilateral foraminal neural foraminal stenosis.On (b)(6) 2011: patient underwent epidural steroid injection at l4-l5.Preoperative diagnosis: refractory low back pain; lower extremity radiculitis; lumbar degenerative disc disease at l3-4 level with bulge at l4-5 level and bilateral neural foraminal stenosis; refractory pains to conservative treatment.On (b)(6) 2011 the patient was presented for office visit with back pain and right leg pain.Assessments: symptomatic dld with spinal stenosis and symptoms and exam that preclude safe return to work.She is failing conservative management.On (b)(6) 2011 patient complained about back pain.She was prescribed medications.Assessments: still have impaired mobility, severe back pain despite recent surgery.On (b)(6) 2011 the patient was presented for office visit with back pain.

Manufacturer Narrative

(b)(4).

Event Description

It was reported that on, (b)(6) 2011.Patient underwent x-rays of the right ankle due to soft tissue swelling.Impression: no evidence of acute fracture; spurring of the calcaneum noted; nonunion and non-fused fracture of the tip of the lateral malleolus.X-rays of the right foot were also performed due to history of pain.Impression: no acute fracture.On (b)(6) 2015 patient presented for an office visit due to "sciatica, iim".Patient underwent bilateral mammography.Findings: there was no moderate/marked amount of fibroglandular tissue present bilaterally.There was no dominant mass.There was no clustered microcalcifications.There was no skin thickening.There were bilateral axillary soft tissue opacities consistent with lymph nodes.Conclusion: no mammographic evidence of malignancy.Continued routine clinical and mammographic surveillance was recommended.On (b)(6) 2015 patient presented for an office visit due to chronic conditions: cholesterol, chest pain, ddd lumbar, hypertension.

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patient presented with history of severe lumbar pain, right greater than left lower extremity pain.Mri indicated severe degenerative disk disease with evidence of instability at l5-s1.The patient was diagnosed with lumbar degenerative disk disease at l5-s1 with instability and radiculopathy.The patient underwent 1) bilateral nonsegmental pedicle screw instrumentation at l5-s1, 2) posterior interbody arthrodesis using peek cage, bmp, and locally harvested bone graft at l5-s1, 3) lumbar decompression at l5-s1 to decompress the l5 and s1 nerve roots, 4) posterior lateral arthrodesis using compression resistant matrix, bmp and locally harvested bone graft, l5-s1.Peek cage was filled with bmp soaked sponge, locally harvested morselized bone graft.A construct of compression resistant matrix, locally harvested bone graft and bmp were placed into the anterior disk space and tamped forward.The peek cage was then inserted into the disk space, rotated, tapped in the proper position.Rods were placed into the screw heads.Posterior lateral arthrodesis was completed using compression resistant matrix, bmp soaked sponge and locally harvest bone graft.Patient was taken to the recovery room in good condition.It should be noted there was no abnormal discharge on monitoring throughout this case.Two days post-op, patient discharged in good condition.(b)(6) 11 patient seen for follow up.Patient history included sharp continuous pain in lower back into hips.(b)(6) 2011 patient presented for follow up visit.The patient was doing well.She complained of some right leg pain.(b)(6) 2011 patient presented for follow-up with moderate to severe low back pain, left leg pain and depression.The back pain radiated to the left thigh and was described as burning, deep and shooting.Aggravating symptoms included bending, changing positions, daily activities, lifting, rolling over in bed, sitting and twisting.The leg pain was described as burning and sharp.Associated symptoms included limping, nocturnal pain and tingling in the legs.The depression was associated with chronic pain.The patient had difficulty in sleeping due to pain.Neurological examination revealed tingling in legs.Musculoskeletal examination revealed tenderness and severe pain with motion in lumbar spine.Assessment: lumbar degenerative disc disease; sciatica; depression; unspecified hypertension; gastroesophageal reflux disease (b)(6) 2011 patient underwent ct spine lumbar with and without contrast for back pain.Ct interpretation: beam hardening artifact from surgical hardware limits the radiographic assessment at the operative site, particularly of the soft tissues and spinal canal.No obvious disk protrusion is evident.Scoliotic curvature of the mid lumbar spine with convexity directed toward the patient's left side.Mild disk bulges are noted at the l2-l3, l3-l4 and l4-l5 disk levels.(b)(6) 2011 patient presented with sore throat and back pain.Musculoskeletal examination revealed tenderness and severe pain with motion in lumbar spine.Assessment: acute sinusitis; lumbar degenerative disc disease.(b)(6) 2012 patient was seen for follow up.Patient history included sharp continuous pain in lower back radiating down right leg.No changes to history noted since (b)(6) 2011.(b)(6) 2012 patient presented with low back pain.The pain was described as intolerable.The patient also complained of sciatic right leg pain.Neurological and psychiatric examination revealed anxiety, depression, extremity weakness, gait disturbance, insomnia and numbness in extremities.Musculoskeletal examination revealed back pain, muscle weakness and tenderness and severe pain with motion in lumbar spine.Assessment: scoliosis; spinal stenosis of lumbar region; lumbar disc disorder with myelopathy; chronic pain syndrome; spinal fusion.(b)(6) 2012 patient presented with severe back pain, leg pain and hypertension.Psychiatric examination revealed anxiety and depression.Musculoskeletal examination revealed back pain, joint pain, joint swelling, muscle weakness, tenderness and severe pain with motion in lumbar spine.Assessment: unspecified hypertension; depression; gastroesophageal reflux disease; symptomatic spinal fusion; lumbar degenerative disk disease.(b)(6) 2012 patient presented with cat bite and back pain.Neurological examination revealed numbness in extremities.Musculoskeletal examination revealed back pain and tenderness and moderate pain with motion in lumbar spine.Assessment: bite of other animal except arthropod cat dorsum right hand; low back pain; sciatica; carpal tunnel syndrome.(b)(6) 2012 patient presented for office visit with back pain.Patient history included onset gradual without injury.Severity level is 8.Duration 1 year.Problem is worsening.Location of pain was lower back.Pain has radiated to right buttock.Patient describes pain as an ache.Symptoms are aggravated by sitting and standing.Symptoms are relieved by rest and lying down.No evidence of recurrence.Assessment: degenerative disc disease, lumbar.Refer for scs.(b)(6) 2012 patient presented with severe back pain.Neurological and psychological examination revealed anxiety, extremity weakness, gait disturbance, depression and numbness in extremities.Musculoskeletal examination revealed back pain, joint pain, muscle weakness, tenderness and severe pain with motion in lumbar spine.Assessment: lumbar postlaminectomy syndrome; sciatica.(b)(6) 2012 patient presented with hypertension, back pain and gastroesophageal reflux disease.Neurological and psychological examinat ion revealed extremity weakness and numbness in extremities.Musculoskeletal examination revealed back pain, muscle weakness and tenderness and moderate pain with motion in lumbar spine.Assessment: lumbar disc disorder with myelopathy; lumbar postlaminectomy syndrome; benign hypertension; gastroesophageal reflux disease.(b)(6) 2013 patient presented with right heel pain, left hip pain, knot in right hand and back pain.The patient had constant pain in back and had difficulty in sitting and standing for longer periods.Neurologic and psychological examination revealed extremity weakness, gait disturbance, depression and numbness in extremities.Musculoskeletal examination revealed back pain, joint pain, tenderness and moderate pain with motion in lumbar spine, right hip tenderness and moderate pain with motion.Assessment: lumbar disc disorder with myelopathy; lumbar postlaminectomy syndrome; calcium deposit tendon; plantar fasclitis; abnormal weight gain.(b)(6) 2013 patient presented with back pain and right leg pain.Neurologic and psychological examination revealed extremity weakness, gait disturbance and numbness in extremities.Musculoskeletal examination revealed back pain, joint pain, muscle weakness and tenderness and moderate pain with motion in lumbar spine.Assessment: lumbago; lumbar postlaminectomy syndrome; fall.The patient underwent x-rays of lumbar spine.Impression: status post fusion of l5-s1 with intrapedicular screws; marked levoscoliosis noted.(b)(6) 2013 patient presented with sciatica, back pain, gastroesophageal reflux disease, hypertension and depression.Neurologic and ps ychological examination revealed anxiety, extremity weakness, gait disturbance and numbness in extremities.Musculoskeletal examination revealed back pain, joint pain, muscle weakness, tenderness and moderate pain with motion in lumbar spine.Assessment: lumbar disc disorder with myelopathy; lumbar postlaminectomy syndrome; chronic pain syndrome; sciatica; unspecified hypertension; depression; gastroesophageal reflux disease.(b)(6) 2014 patient presented with depression, low back pain and hypertension.The patient also complained of continued leg pain and nu mbness.Neurologic and psychological examination revealed anxiety, extremity weakness, gait disturbance, headache and numbness in extremities.Musculoskeletal examination revealed joint pain, back pain, tenderness and severe pain with motion in lumbar spine.Assessment: lumbar disc disorder with myelopathy; postlaminectomy syndrome, lumbar; unspecified hypertension; depression; gastroesophageal reflux disease.(b)(6) 2014 patient presented with back pain and neck pain, after a fall.Neurologic and psychological examination revealed anxiety, extremity weakness, gait disturbance, headache and numbness in extremities.Musculoskeletal examination revealed tenderness and moderate pain with motion in left hip, cervical spine and lumbar spine.Assessment: leg pain; neck pain; back pain; cervical spondylosis with myelopathy; lumbar degenerative disc disease; fall at home.The patient underwent x-rays of the lumbar spine.Impression: lumbar spondylosis with postoperative changes at l5-s1.The patient also underwent x-rays of the left hip.Impression: no fracture or dislocation revealed; mild degenerative changes.X-rays of the left femur were also done.Impression: no fracture or knee dislocation.The patient underwent x-rays of the cervical spine as well.Conclusion: cervical spondylosis with degenerative disc disease.(b)(6) 2014 patient underwent ct scan of lumbar spine due to chronic low back pain and bilateral leg pain, right worse then left, status post lumbar fusion (2012).Impression: 1.Hardware components from lumbar fusion and laminectomy as above without evidence for hardware complication.2.Degenerative changes within the lumbar spine.(b)(6) 2014 patient presented with the history of depression, hypertension, intervertebral disc disorder with myelopathy, st and gerd.Musculoskeletal examination revealed moderate pain with motion in lumbar spine.The premalignant lesion on the foot was also destroyed utilizing liquid nitrogen in the same office visit.Assessments: other specified viral warts; liquid nitrogen was used for removal; degeneration of lumbar or lumbosacral intervertebral disc; chronic pain syndrome; plantar wart, right foot; carpal tunnel syndrome; obesity.

• 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 swinnea 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: 4292036
• MDR Text Key: 21339795
• Report Number: 1030489-2014-04616
• 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,Followup,Followup
• Report Date: 12/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2013
• Device Catalogue Number: 7510800
• Device Lot Number: M111052AAO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/18/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/04/2011
• 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; Required Intervention; Disability
• Patient Weight: 93