MAUDE Adverse Event Report: MEDTRONICS INFUSE BMP; BONE GRAFT

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Debris, Bone Shedding (1803); Undesired Nerve Stimulation (1980)

Event Date 10/01/2013

Event Type  Injury  

Event Description

In (b)(6) 2010 i had a lower back infusion and the surgeon used without my knowledge or consent the product called - infuse bmp.I am having complications of uncontrolled bone growth that is impinging my nerves.The surgeon already removed excessive bone growth over hardware and bone removed every few years or so as needed.The whole use of infuse was hidden from me until dr.Retired abruptly and i received my medical records from his office.After seeing lawyer commericals about infuse bmp i noticed that it was used 2 times in surgeries in 2010.Only initially went in to remove hardware which was supposedly the pain generator.The surgeon said layers of one just to get at the hardware.Then he had to free up nerves from bone to help with pain and to save the nerves from extensive damage.Surgeon stated that it would have to be removed from nerves every few years! that shouldn't be the case with a fusion.The costs of this is going to be through the roof over my lifetime.Dr.(b)(6) was the surgeon and he abruptly retired in (b)(6) 2014 when all this infuse and telling me i am lucky to be able to grow all that new bone.He said most people can't grow that much new bone.Because most people don't have infuse in their body.This dr.(b)(6) used infuse in an unapproved fashion on my body without any consent or explantation.Very upset with infuse and dr.(b)(6).He ruined by body with that infuse bmp product that should be banned seeing the side effects stated.Product should be removed from circulation and the company should be held liable for all the lives they have ruined because of medtronic's hiding known side effects.

• Brand Name: INFUSE BMP
• Type of Device: BONE GRAFT
• Manufacturer (Section D): MEDTRONICS
• MDR Report Key: 4728004
• MDR Text Key: 5581102
• Report Number: MW5042236
• Device Sequence Number: 1
• Product Code: NEK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/08/2015

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: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/08/2015
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Disability
• Patient Age: 37 YR
• Patient Weight: 82