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 Ossification (1428); Death (1802); Erythema (1840); Headache (1880); Nausea (1970); Nerve Damage (1979); Neuropathy (1983); Pain (1994); Seroma (2069); Urinary Tract Infection (2120); Vomiting (2144); Stenosis (2263); Numbness (2415); Confusion/ Disorientation (2553)

Event Type  Death  

Event Description

It was reported that the patient underwent a posterolateral spinal fusion from l4 to s1, during which rhbmp-2/acs was used.The patient reportedly began to experience pain sometime postop and nerve injury.The patient also has a persistent seroma at the implant site that compresses the exiting nerve roots.

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.

Manufacturer Narrative

(b)(4).

Event Description

It was reported that on (b)(6) 2005 the patient presented for an office visit.Patient complained of pain in the back and in the leg.On (b)(6) 2005 the patient admitted to hospital.Patient underwent ct scan of spine.Impression: mild degenerative changes at c3-4.Mild degenerative changes in the lumbar spine most pronounced involving the l4-5 disc.Cervical and lumbar myclogram obtained prior to ct.(b)(6) 2005 the patient underwent the surgery.Pre-op diagnosis: cervical and lumbosacral radiculopathy with degenerative cervical and lumbar disc disease.The patient underwent the following procedure: lumbar epidurogram with lumbar epidural blood patch all under fluoroscopy.On (b)(6) 2005: the patient underwent lumbar epidurogram.On (b)(6) 2005 the patient presented for an office visit due to persistent back and radicular leg pain.On (b)(6) 2005 the patient underwent the surgery.Pre-op diagnosis: lumbar stenosis, recurrent l4/5 disk herniation, incapacitating back and radicular leg pain.The following procedure was performed: decompressive lumbar laminectomy at l4 and l5, removal of the recurrent l4,5,s1 disk, exploration at l5/s1 with foraminotomies with a lateral mass fusion at the l4/5, s1 level bilaterally using a right autogenous iliac bone graft and bone morphogenenic protein(bmp).On (b)(6) 2005 the patient presented for an office visit for staple removal from his lumbar fusion.On (b)(6) 2005 the patient presented for an office visit due to trouble with the back.On (b)(6) 2005 the patient presented for an office visit.On (b)(6) 2005 the patient underwent mri of lumbar spine with intravenous contrast.Impression: post operative changes without confirmation of recurrent and/or residual disc herniation.Seroma versus abscess as above.Degenerative changes.On (b)(6) 2005 the patient presented for an office visit due to back pain.On (b)(6) 2005 the patient presented for an office visit due to pain.Patient had a little bit of fluid seroma in his back.On (b)(6) 2005 the patient presented for an office visit.On (b)(6) 2011 the patient underwent lumbar spine, x-ray.Impression: degenerative disc disease at l4 l5 and l5-s1 status post laminectomy fusion at these levels with heterotopic bone showing satisfactory fusion.The symptoms that the patient experienced before the rhbmp-2/acs surgery included: cervical and lumbar disc disease with pain in back and numbness in upper and lower extremities.Since the rhbmp-2/acs surgery, the patient had suffered from the following injuries: difficulty swallowing, extreme pain, more pain after rhbmp-2/acs surgery, difficulty speaking, nerve injury, radiating pain to the legs, significant pain, fluid seroma in back; bony overgrowth and staph infection for two months.The list of symptoms included: pain, particularly in lower back and both lower extremities; would sometimes walk hunched over.

Event Description

It was reported that on (b)(6) 2011: patient underwent x-ray of sacroiliac joint due to pain.Impression: symmetric si joints without evidence of fusion.On (b)(6) 2010, (b)(6) 2011, (b)(6) 2012, (b)(6) 2013, (b)(6) 2014, patient presented for office visit due to back pain and getting testosterone injections.(b)(6) 2013, (b)(6) 2014, as per medical billing record the patient was presented for office visit.

Manufacturer Narrative

(b)(4).

Event Description

It was reported that on (b)(6) 2005 the patient presented with pre-op diagnosis: post lumbar puncture headache, status post myelogram, status post laminectomy x2.The patient underwent: lumbar epidurogram with lumbar epidural blood patch all under fluoroscopy.(b)(6) 2005 the patient presented with complaining of extensive headache, nausea and vomiting 24 hours after he had undergone myelogram studies.On clinical examination, the patient looked lethargic, very uncomfortable and restless with his blood pressure around 90/60.The diagnosis of post-myelogram lumbar puncture headache has been entertained.(b)(6) 2005: the patient postoperatively started developing erythema of the back and then that started spreading with increase in white count of 21,000 and also some confusion and restlessness.Impression: postoperative wound infection in a patient.Urinary tract infection.(b)(6) 2005 the patient underwent ct of abdomen with contrast due to abdominal pain.Impression: 1.Negative study for abscess or mass lesion in the abdomen.2.Postsurgical changes in the lower lumbar spine.3.A defect in the right ischial tuberosity filled with air collection.This area is partially included in the study and may be secondary to a bedsore or may represent postsurgical change.Ros: the patient is a little nauseous.The patient's heart rate is running a little fast, up to 110 and 120.The patient is a little anxious and restless.He denies any chest pain, shortness of breath, or coughing.(b)(6) 2005 the patient underwent x-ray of chest 2 views.Impression: no active pulmonary disease.

Event Description

It was reported that on: (b)(6) 2008, (b)(6) 2008, (b)(6) 2008, (b)(6) 2008, (b)(6) 2008, (b)(6) 2008, (b)(6) 2009, (b)(6) 2009, (b)(6) 2009, (b)(6) 2010, (b)(6) 2010, (b)(6) 2010, (b)(6) 2010, (b)(6) 2010, (b)(6) 2010, (b)(6) 2010, (b)(6) 2010, (b)(6) 2010, (b)(6) 2010: patient went for an office visit due to back pain.(b)(6) 2002, patient underwent mri of lumbar spine.Impression: small right paramedical residual/recurrent disc herniation at l4 and l5 with significant amount of epidural scarification as well as total encasement of the right s1 nerve root.(b)(6) 2005, patient underwent ct of lumbar spine.Impression: mild degenerative changes in the lumbar spine most pronounced involving the l4-5 disc.(b)(6) 2005, patient underwent procedure for spinal cord stimulator placement for pre-op diagnosis of: post laminectomy syndrome.(b)(6) 2006, patient underwent mri of lumbar spine w w/o contrast due to radiculopathy.Impression: 1.Bilateral laminectomies at the fourth and fifth lumbar intervertebral discs with osteotomy of the spinous processes at the respective l4 and l5 segments.2.Discectomy of the fourth and fifth lumbar intervertebral discs with secondary degenerative changes.3.Modic's type ii bone marrow reactive changes at the vertebral endplates at l4/l5.4.Spinal cord stenosis (mild) at the level of third lumbar intervertebral disc due to combination of osteoarthiritis and slight disk protrusion and epidural fibrosis (scar).5.Ostearthiritis at the level of l3-4 and l4-5 bilaterally.(b)(6) 2006, patient underwent caudal epidural injections with fluoroscopic guidance for pre-op diagnosis of lumbar post laminectomy syndrome.

• 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: 3598035
• MDR Text Key: 4169084
• Report Number: 1030489-2014-00280
• 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
• Report Date: 01/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 7510800
• Device Lot Number: M114007AAC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/08/2016
• 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
• Patient Outcome(s): Death; Other
• Patient Weight: 108