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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC INFUSE BMP-2

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MEDTRONIC INFUSE BMP-2 Back to Search Results
Device Problem Nonstandard Device (1420)
Patient Problems Stroke/CVA (1770); Pain (1994); Depression (2361); Disability (2371); No Code Available (3191)
Event Date 04/03/2006
Event Type  Injury  
Event Description
After a previous spinal stenosis issue involving 4 herniated discs, i had an anterior plate and a posterior fusion using metal rods and screws and my own hip bone in 2003.No problems.In 2006 pain returned.Spinal surgeon informed me that i had broken a screw and suggested surgery.He told me there was a better way to do this surgery using bmp-2 and explained that it grew bone and promised my wife and i that i would be a brand new man.I was never told of the off label use or of any complications.I trusted him.He did a revision of the c3-c7, extended down to t5, an 8 level cervical and thoracic fusion using medtronic infuse bmp-2.I never worked again.I am told that it may never be possible to fix because of the extreme bone growth and facet damage.I had a hard time controlling pain and blood pressure, developed ptsd, depression, and at (b)(6) recently had a stroke caused by possibly by blocked carotid artery.The pain only gets worse with time as the pressure and stress from such a large solid fusion in degenerating discs, facets above and below the fusion area.I did not know about the trouble and controversy over medtronic practices and false marketing until recently.It was 2006 when i had this procedure that ruined mine and my family's life.I have tried everything.I was told that instead of being that brand new man.I should plan on finding another career and be on pain medicine for the rest of my life.Pain medicine became utterly useless and i no longer take it unless i am in so much pain that i have to go to the hospital, they admit me and have learned the only way to get my pain level to a tolerable level, they have to treat the pain first.I've read the initial studies and the later ones done, senate reports, (b)(6) complaints and the recent rulings.Innovation is vital, but since infuse bmp-2 spinal fusion surgeries performed in the us have quadrupled on average from 20 years ago, unlike the rest of the world, while knee surgeries or any other comparative bone related procedures have not risen.(b)(6) is collecting my extensive medical records.No spinal surgeon would even see me, or even give me a consult once they seen or heard i had a multi-level cervical fusion with bmp-2 (b)(6) took on my case and i just had 2 mris and a cat scan.My lower back now is just as bad and i can't even take ibuprofen anymore because of the meds i have to take from the stroke and taking nsaids for years.I know i am one of thousands that have reported in about this product and i still see my old surgeon, who i couldn't afford to pay anymore, who still has never told me about all the risks he took with my health either knowingly or not.Shareholders got a settlement because they lost money.Why is it pts like me have to lose everything, including my health and ability to live a functional life before my government will put a stop to this profiteering and dishonesty about a product, but rather protect them instead."is the product compounded (your health professional may be able to help you identify whether the drug was compounded: yes.".
 
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Brand Name
INFUSE BMP-2
Type of Device
INFUSE
Manufacturer (Section D)
MEDTRONIC
MDR Report Key6633123
MDR Text Key77451755
Report NumberMW5070288
Device Sequence Number1
Product Code NEK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 06/08/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/08/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Life Threatening; Other; Disability;
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