MAUDE Adverse Event Report: MEDTRONIC BMP7; NONE

Device Problems Patient-Device Incompatibility (2682); Device Operates Differently Than Expected (2913)

Patient Problems Foreign Body Reaction (1868); Impaired Healing (2378)

Event Date 03/08/2013

Event Type  Injury  

Event Description

I was told i had 2 failed fusions (1 lumbar sacral and one of the sacroiliac joint) because my body developed antigen from the bmp7 that was used.Ct scan and mri's show i have a vacuum in my lumbar sacral facet joints as well as my sacroiliac joints.Surgeries were on (b)(6) 2007 (anterior l-2) and 05/09/2013 (bilateral si joints).I had a failed fusion in 1995, lumbar - sacral.I do not know if bmp was used.I was told the surgeon put in "a glue" type of product.I failed that fusion also.Three failed fusions.I have 12 screws holding my lumbar sacral and sacroiliac joints together.

• Brand Name: BMP7
• Type of Device: NONE
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 4649552
• MDR Text Key: 5599211
• Report Number: MW5041758
• 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: 01/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 53 YR
• Patient Weight: 68