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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC BMP INFUSE; PROTEIN, COLLAGEN SCAFFOLD WITH METAL PROSTHESIS OSTEOINDUCTION
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MEDTRONIC BMP INFUSE; PROTEIN, COLLAGEN SCAFFOLD WITH METAL PROSTHESIS OSTEOINDUCTION Back to Search Results
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem Pain (1994)
Event Date 12/19/2011
Event Type  Injury  
Event Description
I injured my back and was referred to an orthopedic dr by my primary care provider.He performed a discectomy, but i had no relief from pain so he ordered another mri which showed that the disc had reruptured.He said that i needed a spinal fusion to fix my problem, so i agreed to let him do it.I was not informed that he would be putting medtronic bmp in my body and the nightmare of pain that i would have to endure.He performed a posterior lumbar fusion which was not approved by fda for that surgery.I have developed epitopic bone spurs throughout my spine encroaching nerve roots.I have been told there is nothing else that can be done for me because a neurosurgeon removed one of the ectopic bones and within a month it had grown back.I live with terrible pain and have no quality of life.I believe someone should be held responsible for the pain i have to endure every day.
 
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Brand Name
BMP INFUSE
Type of Device
PROTEIN, COLLAGEN SCAFFOLD WITH METAL PROSTHESIS OSTEOINDUCTION
Manufacturer (Section D)
MEDTRONIC
MDR Report Key7388041
MDR Text Key104224652
Report NumberMW5076240
Device Sequence Number1
Product Code NEK
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 03/29/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/30/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention; Disability;
Patient Age60 YR
Patient Weight52
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