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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC INFUSE BONE GRAFT; HUMAN BONE FILLER

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MEDTRONIC INFUSE BONE GRAFT; HUMAN BONE FILLER Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Chest Pain (1776); Cyst(s) (1800); Neuropathy (1983); Respiratory Distress (2045); Stenosis (2263); Regurgitation, Valvular (2335); Complete Heart Block (2627); No Code Available (3191); Cancer (3262); Pericardial Effusion (3271)
Event Date 03/05/2009
Event Type  Injury  
Event Description
In 2009 i was (b)(6), was asked to join a study trial at (b)(6) for infuse bone graft by: medtronic.Dr.(b)(6) surgeon in charge and the one on my consent form to do the surgery and my doctor as well.It was to be for degenerative disc disease at a single level only.I knew nothing about this product except what i was told.It was a safe product and thousands of people were extremely happy with the results.Being that it was said to be so safe i agreed.It was to be a minimal of two years upward to four, he said.(b)(4).(b)(6) didn't do the surgery (b)(6) did it without a license.I don't even know this person (promoting off-label usage).And did c5-c7, which was not authorized by me (or the stud contract).Three months after surgery i started coughing up scabs.Told (b)(6) who replied, "aint nothing we did, i'd see a doctor if i was you" and left the room.Wow.Called to change my last study date day and was told that the study had been canceled 8 months ago.I said must be mistaken.She said i said it was canceled and hung up on me.I promptly called back and was told the same again and again and hung up on.I called the grievance number on my contract and talked for 40 minutes.About 2 1/2 hours later i get a call from (b)(6) himself asking me if there's something he could do for me.I was mortified.And this is 2013 now.He said what you been diagnosed with cancer or something (i didn't know it yet that the pathology report i requested and picked up said myeloma on it.I had not read it).He said well what could you do about it anyway, you going to take us all on, by yourself.So i hung up.On (b)(6) 2012 i had a total hip replacement that was from onset of pain to a total hip was 4 months total, with no trauma.So i asked dr.(b)(6) if my hips had anything to do with the infuse trial i was in that's causing cancer and all kinds of medical problems in people.He told me no, twice pre-op.Then when it took forever for him to give me the pathology results i became suspicious and got my report myself.When i asked (b)(6) about the myeloma he said he was sorry and i have not talked to him since.I tried several times and then got a letter in the mail said i'm not a myeloma specialist leave me alone (i have everything i said in writing).So attempted to contact my pcp and was told she left and won't be back and that i had been moved to (b)(6) and dr.(b)(6) was my new dr.Called him and gave him my report, and asked for a spep, which he did have (b)(6) do, that he said reads normal without a chance of having myeloma.Sent to (b)(6), oncologist who said the same thing ((b)(6) also showed me my hip x-rays and said the other hip is just as bad and will need replaced also.Called supercoders to find out what the codes on my pathology report say, because absolutely nobody would tell me what they meant and still to this day won't tell me.But was told that the m97303 was plasma cell myeloma stage 3 m50230 was radical nephrectomy.The others are t11711 (which may mean your granted immunity for anything you do or say to me) ( see nuclear incident in (b)(6)) tyx000, t12000 lung cancer and olig/brain caner.My op report states i'm morbid obese, severe copd, sleep apnea of which i am none, i've been (b)(6) my whole adult life.And that i had a dvt during surgery i was not told of.Got another pcp (b)(6) who assured me he was going to help me.Ran tests told me in front of my kids that i was fine, no myeloma but should maybe seek a shrink about my ocd with myeloma.Then later i get a copy of his dr's order for my blood work for him that states all the way down 2 pages.Multiple myeloma with no sign of remission, then disappears too.My heart hurts (rhgmp2 that was used by (b)(6)) and he said i was fine nothing wrong (showed him pathology) 3 valves regurgitating, av block, pericardial effusion, atrial stenosis, broad p waves (a lot more too) help me please! (b)(6).
 
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Brand Name
INFUSE BONE GRAFT
Type of Device
HUMAN BONE FILLER
Manufacturer (Section D)
MEDTRONIC
MDR Report Key6292846
MDR Text Key66390656
Report NumberMW5067564
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 01/29/2017
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? Yes
Device Operator Lay User/Patient
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/29/2017
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Life Threatening; Other; Disability;
Patient Weight63
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