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 Abdominal Pain (1685); Anemia (1706); Diarrhea (1811); Headache (1880); Neuropathy (1983); Pain (1994); Tingling (2171); Cramp(s) (2193); HIV, Human Immunodeficiency Virus (2197); Stenosis (2263); Depression (2361); Numbness (2415); Neck Pain (2433); Post Operative Wound Infection (2446); Sleep Dysfunction (2517); Ambulation Difficulties (2544); Hematuria (2558); Weight Changes (2607)

Event Type  Injury  

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.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: (b)(6) caucasian permedical records, it was reported that on (b)(6) 2008 the patient presented with a complaint of painful large multiple varicose veins of the right leg.He underwent endovenous laser ablation treatment of greater saphenous vein and litigation and excision of multiple varicosities and ligation of venous perforators.No complications were reported.On (b)(6) 2009 the patient presented for lumbar ct myelogram which showed severe stenosis at l2-3 and l3-4.On (b)(6) 2009 the patient was admitted following lumbosacral spondylosis without myelopathy.On (b)(6) 2009 the patient underwent following procedures: posterior l2 and l3 and partial l4 decompressive laminectomy with l2-3 and l4 pedical screw fixation , bilateral transverse process fusion,l2-l3 and l4.Bone, which had been saved during the compression, was ground up and mixed with the stryker bone additive and also with rhbmp-2.This was all mixed together, and, after roughing up the transverse processes with the drill to have a bleeding contact surface.The rhbmp-2 and the patient's own bone and the dbm from stryker was then all placed in the lateral gutters over the transverse processes bilaterally to form a lateral fusion.The patient was discharged on (b)(6) 2009 with severe stenosis l2-l3, l3-l4, spondylosis, spinal stenosis, lumbar radiculopathy, pseudoclaudication, transient ischemic attack, esophageal reflux, postnasal drip , epilepsy, constipation and anemia.On (b)(6) 2009 the patient was discharged.The discharge diagnosis was back pain, hiv, venous thrombosis, hyperlipidemia, esophageal reflux, mononeuritis, gout, herpes simplex, spinal stenosis of the lumbar region, anemia, hematuria, diarrhea.On (b)(6) 2009 the patient underwent an ultrasound test which reported extensive bilateral lower extremity deep vein thrombosis.On (b)(6) 2010 the patient presented for an office visit and got ct of brain done.On (b)(6) 2010 the patient presented with chronic diarrhea and underwent colonoscopy with biopsy.Postoperative diagnosis was internal hemorrhoids only.On (b)(6) 2010 the patient was admitted for caudal epidural steroid injection and diagnostic epidurogram following post-laminectomy and fusion pain syndrome, chronic back and bilateral lumbar radiculopathy and peripheral neuropathy.No complications were reported.On (b)(6) 2010 the patient presented with cervicalgia.Neck pain.Pain and numbness in both upper extremities from forearms to hands and fingers.Symptoms for 7 years, getting worse over the last 10 months.The patient underwent multiplanar, multisequence mri examination of the cervical spine without intravenous contrast.Impression: multilevel degenerative cervical spondylosis with neural foraminal stenosis at multiple levels.On (b)(6) 2010 the patient presented for an office visit to get his cspine and mri results reviewed.On (b)(6) 2010 the patient presented for an office visit due to pain and weakness.The patient was diagnosed with cervical stenosis and radiculopathy.On (b)(6) 2010 the patient was admitted to undergo the following procedures, c7-t1 translaminar epidural steroid injection and diagnostic epidurogram.The patient was diagnosed with bilateral cervical radiculopathy, multilevel cervical foraminal stenosis , (b)(6) and hypercoagulable on coumadin with an inr of 1.1 this morning.No complications were reported.On (b)(6) 2011 the patient presented with the following indications: hydrocephalus.Vp shunt followup.The patient underwent ct scan of the brain without contrast.Impression: ventriculoperitoneal shunt in place.There are mild hydrocephalus and periventricular white matter changes, no significant interval change.The patient also underwent ultrasound examination of the thyroid gland.Impression: no significant change in tiny bilateral nodules.On (b)(6) 2012, (b)(6) 2013, the patient presented with complaints of low back and bilateral leg pain.Review of systems : constitutional: feeling tired (fatigue) and having headaches, but not good general health lately, no recent weight change and no fever.On (b)(6) 2012 the patient presented for multiplanar, multisequence mri examination of the lumbar spine with and without intravenous contrast.Impression: no significant interval change in degenerative lumbar spondylosis with decompression and fusion.Mild spinal canal stenosis is noted at l1-2.Neural foraminal stenosis is noted at multiple levels.On (b)(6) 2012 the patient presented with low back pain.Per op notes the patient underwent ct scan of the lumbar spine without intravenous contrast.Impression: degenerative lumbar spondylosis status post decompression and fusion.Mild spinal canal stenosis is noted at l 1-2.Multilevel neural foraminal stenosis is noted, worst at li-2 and l2-3.Mild t12 vertebra body compression fracture.Clinical correlation is suggested for left-sided l2 pedicle findings.Consider loosening.On (b)(6) 2012 the patient reported with low back pain and worsening compression fractures.On (b)(6) 2013 the patient was diagnosed with intractable back pain, status post lumbar instrumentation.The patient underwent ct ls spine post myelogram.Impression: status post multilevel laminectomies and instrumentation.There is loosening of the left l2 transpedicular screw.There is spinal stenosis above the fusion at ll-l2.On (b)(6) 2013 the patient presented with low back pain.On (b)(6) 2013 the patient presented for an office visit with the following results, there is appearance of a vp shunt with suspected shearing of the peroneal component of the catheter.Status post recent lumbar instrumentation.On (b)(6) 2013 the patient was admitted.He was diagnosed with intractable left low back and left leg pain.Status post multilevel lumbar instrumentation and fusion with spinal instrumentation.Malposition of left l2 pedicle screw.Per op notes the following procedure were performed, reexploration of left lumbar posterior spinal instrumentation.Removal of malpositioned left l2 pedicle screw and refusion.A small gouge was then used to gouge into the bone and then grafton was packed into the screw hole.Some grafton was also then used to supplement the bony growth that was present.There did not appear to be any instability on the left side at this point in time either.This was felt to be all that was necessary to be done.Fluoroscopy was then used to obtain ap and lateral views.It showed the other screws to be in good position.On (b)(6) 2013 the patient presented for sip re-exploration of left lumbar posterior spinal instrumentation; removal of malpositioned left l2 pedicle screw and refusion.Patient reported back pain.Review of systems: constitutional: recent loss of 5 pounds weight change, feeling tired (fatigue) and having headaches, but not good general health lately and no fever.Neurological: frequent or recurring headaches, dizziness and numbness or tingling sensation, but no convulsions, no tremors, no paralysis, no stroke and no head injury.Psychiatric: memory loss of confusion, nervousness, depression and insomnia.No suicidal tendencies no hallucinations.Musculoskeletal: joint pain, joint stiffness or swelling, weakness of muscles or joints, muscle pain or cramps, back pain, cold extremities and difficulty in walking, but no sports injury.On (b)(6) 2013 the patient presented for sip re-exploration of left lumbar posterior spinal instrumentation; removal of malpositioned left l2 pedicle screw and refusion.The patient also complained of excruciating low back pain radiating into legs, headache, fever.Patient reported having a little pain in the legs all the way to his feet.Patient reported numbness/tingling in bilateral feet.Patient denies bowel/bladder problems.Patient reported having dry heaves.Incision to lower back has no drainage but noted some redness to top of incision with noticeable puffiness to middle of incision.Patient reported tenderness with palpation to puffy area.Review of systems : constitutional: recent gain of (b)(6) weight change, feeling tired (fatigue) and having headaches, but not good general health lately and no fever.On (b)(6) 2013 the patient was admitted to undergo debridment and drainage of wound abscess with high pressure pulsating waterjet, sharp selective debridment with scissors and wound revision.The patient was diagnosed with infected posterior lumbar laminectomy wound.On (b)(6) 2013 the patient presented for sip debridement and drainage of wound abscess with high pressure pulsating waterjet, sharp selective debridement with scissors and wound revision and with a complaint of back pain.On (b)(6) 2013 the patient presented for an office visit with a complaint of hydrocephalus and severe headaches.He underwent ct brain without contrast.Impression: mild hydrocephalus noted with a ventriculostomy in place.Underlying periventricular white matter leukoencephalomalacia noted.A component of transependymal seepage of csf cannot be excluded with certainty.On (b)(6) 2013 the patient presented with a complaint of headache and for ct head results.Patient reported headaches usually come and go but have been persistent.Patient reported back pain when turning certain positions or getting up out of a chair.On (b)(6) 2013 the patient went to er due to extreme abdominal pain.Per the medical records the patient underwent ct scan which showed enlarged lymph nodes.On (b)(6) 2013 the patient presented for an office visit as a follow up on headaches, dizziness and back pain.Patient reports headaches, dizziness, low back pain radiating into legs at times.Patient reported neuropathy in feet worsening.Patient reported using cane at times.

• 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: 5044146
• MDR Text Key: 24655614
• Report Number: 1030489-2015-02133
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/03/2015
• 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: 75