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 Neuropathy (1983); Pain (1994); Burning Sensation (2146); Tingling (2171); Inadequate Pain Relief (2388); Sleep Dysfunction (2517)

Event Type  Injury  

Event Description

It was reported that the patient presented with persistent low back and bilateral lower extremity pain.She had now broken down at l4-5 with resultant stenosis.Diagnostic medial branch blocks secondary to her discomfort.She stated it was very painful.She underwent the ct spectroscopy.Patient had not fused despite good screw placement and no evidence of hardware loosening or failure.Mesh appeared the same as when it was installed on (b)(6) 2011.The patient was diagnosed with pseudoarthrosis at l5-s1 and lumbar stenosis at l4-5.The patient underwent 1) removal of previous interbody spacer at l5-s1 and explant of previous rods; 2) revision of posterolateral fusion at l5-s1 and fusion at l4-l5 using pedicle instrumentation at l4 extending to l5-s1, and 3) anterior lumbar interbody fusion at l4/5 and l5/s1 using a cage, bmp and anterior lumbar locking plate at l4-5 and l5-s1.It was noted that there was some inflammation over the l5-s1 disk space.The previous graft that had been placed posteriorly was easily removed.It was loose within the disk space.The surgeon performed a full diskectomy and placed a new interbody spacer with screws.A lordotic peek spacer filled with bmp was placed at l5-s1, followed by a locking plate with 2 screws into the sacrum.The same procedure was performed at l4-5 only without removal of a previous graft.The anterior portion of the surgery was complete.The patient then underwent the posterior portion of the surgery.The previous rods were removed and longer rods spanning from l4 to sacrum were placed bilaterally.The remainder of the local bone was packed in and around the fusion mass and transverse processes and joints of l4-5 bilaterally.On (b)(6) 2013, patient was seen for follow up status post fusion in her lower back done ten days prior.She stated that she had increased pain in her back currently.The fusion was done using two approaches, the abdomen and posterior lower back.There were no stitches present on exam today as the incision was closed with glue.She had not gotten any relief of her pain and continued to have pain in her legs and back.She continued to take methadone and oxycodone for pain.She was also given tylenol, valium, and robaxin.She was taking potassium because she had been having leg pain and cramps and she was told that this could be related to low potassium levels.Patient assessment: spondylolisthesis, lumbar facet arthropathy, thoracic myofascial pain syndrome, lumbar myofascial pain syndrome, thoracic arthropathy, lumbar discogenic pain syndrome, lumbar radiculopathy, lumbar failed back syndrome, lumbar epidural fibrosis, edema, thoracic degenerative disc disease, depressive disorder, cervical radiculopathy, insomnia, cervical spinal stenosis, occipital neuralgia, cervical facet arthropathy, anxiety.On (b)(6) 2013 patient was seen for follow up regarding medications and lower back pain.She was taking high doses of narcotic medication and this had been ongoing.She agreed to reducing her medications.She had been having side effects from her medications for the past week, such as shortness of breath, as well as grogginess.She had been also having aggressive thoughts and anxiety.She was discontinued from klonopin and she felt that this could be related to this as she was also taking valium.She reported severe lower back pain with radiation to the bilateral lower extremities.Pain was at 7/10.She also had neck pain and paraesthesia to the left upper extremity.Past injections for her neck were done in (b)(6) 2012.Patient assessment: spondylolisthesis, lumbar facet arthropathy, thoracic myofascial pain syndrome, lumbar myofascial pain syndrome, thoracic arthropathy, lumbar discogenic pain syndrome, lumbar radiculopathy, lumbar failed back syndrome, lumbar epidural fibrosis, edema, thoracic degenerative disc disease, depressive disorder, cervical radiculopathy, insomnia, cervical spinal stenosis, occipital neuralgia, cervical facet arthropathy, anxiety.On (b)(6) 2013 patient was seen for follow up.Her methadone had been decreased to 5 mg tid and she stated that her pain was worse.She stated that she has had no withdrawals from this decrease.Her oxycodone remained the same klonopin 0.5 mg bid was added.She stated that she continued to get a lot of anxiety attacks.She wondered if the medications could be adjusted again to tid as the medication had always been that way in the past.She asked if she could take something for pain control besides opioids now that she had decreased her dosages.Patient assessment: spondylolisthesis, lumbar facet arthropathy, thoracic myofascial pain syndrome, lumbar myofascial pain syndrome, thoracic arthropathy, lumbar discogenic pain syndrome, lumbar radiculopathy, lumbar failed back syndrome, lumbar epidural fibrosis, edema, thoracic degenerative disc disease, depressive disorder, cervical radiculopathy, insomnia, cervical spinal stenosis, occipital neuralgia, cervical facet arthropathy, on (b)(6) 2013 patient was seen for follow up.She had been started on skelaxin, celebrex and the klonopin was increased to tid.She stated that she continued to have pain and she felt desperate due to the pain level.She was weaned off the methadone and this had been decreased by 50%.So far she had been doing okay with this and she continued to take the same amount of oxycodone.Patient assessment: spondylolisthesis, lumbar facet arthropathy, thoracic myofascial pain syndrome, lumbar myofascial pain syndrome, thoracic arthropathy, lumbar discogenic pain syndrome, lumbar radiculopathy, lumbar failed back syndrome, lumbar epidural fibrosis, edema, thoracic degenerative disc disease, depressive disorder, cervical radiculopathy, insomnia, cervical spinal stenosis, occipital neuralgia, cervical facet arthropathy, anxiety.On (b)(6) 2013, patient was seen for follow up.She had been seen at this point weekly for follow up as she was weaned off methadone.She was without the methadone for a week and by (b)(6) day she had severe pain and had severe paraesthesia and burning pain.She ended up at the er the next day and it was decided to provide her with narcotic medication.She gave her methadone and ordered that she re-start methadone 5 mg tid.She was taking oxycodone for break through pain but this was not enough for her pain level.She stated that since she had taken the methadone her pain level was better.She had stopped the celebrex because she started naproxen.She stopped the lyrica because this was not working at 50 mg tid.She continued to take skelaxin.Her second surgery was done as the first fusion did not take, however she was not getting any better currently.She stated that her pain was rated at 9/10.She stated that her average pain was rated at 7-8/10.On (b)(6) her pain was rated at 10/10.Patient assessment: spondylolisthesis, lumbar facet arthropathy, thoracic myofascial pain syndrome, lumbar myofascial pain syndrome, thoracic arthropathy, lumbar discogenic pain syndrome, lumbar radiculopathy, lumbar failed back syndrome, lumbar epidural fibrosis, edema, thoracic degenerative disc disease, depressive disorder, cervical radiculopathy, insomnia, cervical spinal stenosis, occipital neuralgia, cervical facet arthropathy, anxiety.On (b)(6) 2013 patient underwent caudal epidural steroid injection for lumbar radiculopathy and sacral pain.On (b)(6) 2014 patient underwent cervical epidural steroid injection at c7-t1 for cervical discogenic pain and cervical radiculopathy.On (b)(6) 2014 patient was seen for rigger point injections.She rated her pain at 10/10 in her low back, bilateral lower extremities and her head.Her noted pain level was after medicating with methadone and oxycodone.She noted that she had had a headache since the past tuesday and she cannot get relief from this.She noted that recently her activity level had been little to none due to increased pain.Her last drug screen was consistent and she had a pain contract on file.Patient assessment: spondylolisthesis, lumbar facet arthropathy, thoracic myofascial pain syndrome, lumbar myofascial pain syndrome, thoracic arthropathy, lumbar discogenic pain syndrome, lumbar radiculopathy, lumbar failed back syndrome, lumbar epidural fibrosis, edema, thoracic degenerative disc disease, depressive disorder, cervical radiculopathy, insomnia, cervical spinal stenosis, occipital neuralgia, cervical facet arthropathy, anxiety, cervical myofascial pain syndrome, sacroilitis.On (b)(6) 2014 patient underwent left and right sacroiliac joint injections for bilateral sacroiliac arthropathy.On (b)(6) 2014, patient was seen for follow up s/p bilateral sacroiliac joint injections done on (b)(6)2014.The patient stated that she did get a couple of weeks of relief but was now getting sharp pains that radiated up her back and stated that her left side of her mid back was swollen.She rated her current pain level at a 6/10 located in her lower back and stated that she had been having a hard time sleeping.She stated that she was still taking oxycodone and methadone which did not seem to be helping much anymore.Her last uds was on (b)(6) 2014 and this was consistent.She reported that she feels depressed because she has constant pain and the medication was not helping.She was taking methadone and oxycodone first thing in the morning when getting up and then she takes another oxycodone about six hours later and then about 9 hours later.She stated that her worst time was with getting up in the morning.She had neck pain and pain that radiated to her arm.She had some trigger point injections for headache done in march of 2014 and the epidural injection worked better.She also reported that she did something to her back but she was not sure if there is a specific injury , but she reported that for the past couple weeks she had pain in the left side of her back and this had been getting worse.She reported that she was also very exhausted just with driving to the office and then home.She stated that she will have to take a nap after this trip.She had a fusion done in 2011 and this did not take and then she had to do this again on 2013.She did get a lot of relief from the si joint injection and for two to three weeks her low back pain was very much improved.Patient assessment: spondylolisthesis, lumbar facet arthropathy, thoracic myofascial pain syndrome, lumbar myofascial pain syndrome, thoracic arthropathy, lumbar discogenic pain syndrome, lumbar radiculopathy, lumbar failed back syndrome, lumbar epidural fibrosis, edema, thoracic degenerative disc disease, depressive disorder, cervical radiculopathy, insomnia, cervical spinal stenosis, occipital neuralgia, cervical facet arthropathy, anxiety, cervical myofascial pain syndrome, sacroilitis.On (b)(6) 2014, patient underwent bone scan.Abnormal asymmetric update is associated with left l3-4 facet arthrosis and is in close proximity with the left l4 pedicle screw.There is some increased single intensity at the interbody space at l4-5 and l5-s1 which may be physiological.Bone scan impression: intense uptake associated with left l3-4 facet arthrosis.

Manufacturer Narrative

(b)(6).(b)(4).Neither the device nor applicable imaging study films 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.

• 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: huzefa mamoola ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 4725152
• MDR Text Key: 5742945
• Report Number: 1030489-2015-00857
• 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,Health Professional
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 04/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2015
• Device Catalogue Number: 7510800
• Device Lot Number: M111113AAM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/14/2015
• Initial Date FDA Received: 04/23/2015
• 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 Number: 1
• Treatment: CAGE, LOCAL BONE, PLATE, PEDICLE SCREWS, RODS
• Patient Outcome(s): Required Intervention