MAUDE Adverse Event Report: MEDTRONIC INFUSE BMP BONE GRAFT 12 MG

Catalog Number 7510600

Device Problems Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017)

Patient Problems Emotional Changes (1831); Unspecified Infection (1930); Necrosis (1971); Pain (1994); Cramp(s) (2193); Stenosis (2263); Disability (2371); Meningitis (2389)

Event Date 12/15/2009

Event Type  No Answer Provided  

Event Description

My surgeon used infuse bone morphogenetic protein (2 large packages) off label for bone grafting in a rather large spinal revision.He never told me of this product.Fda has not approved this product for my procedure.It was a spinal revision for scoliosis, t-11 to s-1, with rods, screws and a wedge resection at l-4, he also did bilateral foraminotomies and laminectomies l-1 through l-5.Post op day 6 i got an infection in my incision.The doctors denied this! the doctors failed to recognize the infection and sent me home day 9.On day 12 my husband took me to the emergency room for the necrotic spot on my incision and uncontrolled pain.The necrotic area had been shown to the surgeons by my nurse in (b)(6) on post op day 6, but they were not concerned.I was taken to the operating room in (b)(6), the same post op day 12 and had a debridement and ended up with a skin graft and wound vac later.I was in icu for about 9 days and almost died.The infection was in all the fluid caused by the infuse along the rods.The ct scan showed fluid all along the rods where the 12 cellulose sponges were placed with infuse in them.In the initial surgery the ortho doc also tore my dura which most likely explains the meningitis i ended up with! i was declared stable 1 year later.My cat scans in 2010, 2011, 2012 and 2013 have all shown severe foraminal narrowing/stenosis l-1 to l-5 bilaterally most likely due to the overzealous use of infuse.I am in constant pain and take pain meds daily and wear a pain patch.I have never felt this bad.I have chronic leg pain and pelvic and tailbone pain.I cannot have normal sexual relations because of the pelvic pain.On a level of 1 to 10 on the pain scale even with meds on board, it gets no lower than a 7.I may have to go on disability because i can't continue to work feeling this way! my left leg cramps at night and i can't sleep.After being in icu for about 9 days and almost dying i have been diagnosed with ptsd.I am the director of research at my hospital and i can't get myself to go into the icu.This surgery with the infuse product has left me decimated.Medtronic needs to answer for this unsafe product.I found out after my surgery that the research was a sham and the surgeons were on the payroll for medtronic.How could fda let these unethical doctors get away with this.I guess it's the millions of dollars they received! these guys and medtronic's executives need to serve jail time.The fda needs to have more power to police these unethical companies and send them packing! dates of use: (b)(6) 2009 - (b)(6) 2010.Reason for use: bone graft spinal fusion t-11 to l-5 with rods and screws.Pt was not using any biologics at this time.Pt is diabetic and wears a pump for insulin administration.

• Brand Name: INFUSE BMP BONE GRAFT 12 MG
• Type of Device: INFUSE BMP BONE GRAFT
• Manufacturer (Section D): MEDTRONIC; phoenix AZ
• MDR Report Key: 3603241
• MDR Text Key: 4094269
• Report Number: MW5034119
• Device Sequence Number: 1
• Product Code: NEK
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/28/2014
• 2 Devices were Involved in the Event: 1 2

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?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 7510600
• Device Lot Number: M110810AAH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ADVAIR; LEVOTHYROXIN 50 MCG; CARVEDILOL 25 MGS; INSULIN PUMP; PRN; CRESTOR 10 MG; ASTHMA INHALER; PROGESTERONE 100 MGS
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention; Disability
• Patient Age: 52 YR
• Patient Weight: 73