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  #1  
Old 08-22-2006, 08:35 AM
james gilmour james gilmour is offline
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Does anyone have any idea when the Maverick will get FDA approval, looking at the different discs , as I am planning on having the sugery very soon. The maverick seems to have the best right up as the metal on metal design did not show any wear in 31.5years of testing , and its design does not cause any extra load to the facet joints, this is far superior compared to the Charite or the prodisc which uses a polyethelene core which will wear , and the design will cause facet loading. Any information would be appreciated.
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  #2  
Old 08-22-2006, 02:33 PM
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Eddie_G Eddie_G is offline
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Do you have any links to the long term studies of the Maverick? I haven't seen the one about the 31.5 year test. The Maverick seems to be the best design on paper but the long term studies are important. I have also heard of 2 metals rubbing together "scoring" (sp?) and causing problems. I also heard the Maverick can't be used for multi-level because the keel can crack the vertebrae. Alot of us have to take what our insurance gives us. I waited a long time for this approval. I can't wait any longer for the Maverick. The combo of pain/drugs has driven me to a quicker decision. Prodisc is the industry standard right now so I am very happy to be (hopefully) getting a Prodisc in October.

So anyway, How 'bout that link buddy?

Thx & Good Luck!
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12/16/03 Work Accident
Herniation and DDD at L4-L5
4/1/05 Discectomy
Epidurals and facet injections
5/15/06 Discogram confirmed L4-L5 DDD also an asymptomatic L5-S1 tear
10/24/06 L4-L5 Prodisc surgery with Dr. Goldstein
CAT scans & X-Rays show ossification
Trigger Point Injections, Medial Branch Blocks, Acupuncture, Weekly Deep Tissue Massage
10/27/08 Discogram (positive L5-S1 tear)
11/25/08 L5-S1 fusion with Dr. Goldstein
FAILED BACK SYNDROME
Liberty Mutual WC
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  #3  
Old 08-22-2006, 05:26 PM
annapurna annapurna is online now
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The technical term for the most common type of metal-on-metal wear is galling. You can search on the web to find it's effects and tendency for various alloy and alloy combinations to gall.
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Laura - L5S1 Charitee
C5/6 and 6/7 Prodisc C
Facet problems L4-S1
Knee, Shoulder, Toe, Finger, Elbow Problems

Jim - no spine problem but lots of other fun medical challenges

"There are many Annapurnas in the lives of men" Maurice Herzog
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  #4  
Old 08-22-2006, 10:46 PM
Poncho Poncho is offline
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Hummmm....I didn't think that there were any long-term studies out there like that on any of the ADRs really.

I thought that the longest in use was the Charite which is around 15 - perhaps approaching 20 years max of actual human implantation and follow up....
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  #5  
Old 08-23-2006, 04:30 AM
annapurna annapurna is online now
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The study is an version of the following logic: An average person bends so often and so much as they live so if you take an ADR device and put it into a bend fixture and flex it to x degrees y times it simulates z period of time in a real person's back. You can see all of the assumptions that go into it, not to mention the degree to which the fixture simulates real movement greatly affects the quality of the test. As I mentioned in a different thread, these studies are great indicators but you'd be foolish to look at one device tested in one study for 25.684739372027 equivalent years and a second tested in a different study for 36.5743923173 equivalent years and decide one is really better than the other.
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Laura - L5S1 Charitee
C5/6 and 6/7 Prodisc C
Facet problems L4-S1
Knee, Shoulder, Toe, Finger, Elbow Problems

Jim - no spine problem but lots of other fun medical challenges

"There are many Annapurnas in the lives of men" Maurice Herzog
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  #6  
Old 08-23-2006, 05:12 AM
james gilmour james gilmour is offline
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Hi,

Yes Anna is correct the 35.5 years is a simulated test in some kind of test rig. The web link where I found the info was www.centerforspinecare.com , FDA approval should be arounf mid 2007 , it looks like the best from a design point of view , but that could stand for nothing , until the FDA trials are complete ...lets see!! All I am concerned about is revisions , if the charite or prodisc wears out to soon. say 10 years , I will be back under the knife. Saying that Anna mantioned that the Charite testing data was 20+ years but in real life it only lasts 10 years , so I guess that says a lot about the accuracy of the testing figures.
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DDD , Herniated disc at L5/S1 , Had Prodisc ADR at L5/S1 & L4/L5 JAN-10-2007
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  #7  
Old 08-23-2006, 08:54 AM
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Eddie_G Eddie_G is offline
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Quote:
Charite testing data was 20+ years but in real life it only lasts 10 years
Thanks for the first link.

Now...do you know anyone who has had a failed Charite after 10 years?

Link away my friend...

GALLING...THAT'S it! Thanx!

Good Stuff!
__________________
12/16/03 Work Accident
Herniation and DDD at L4-L5
4/1/05 Discectomy
Epidurals and facet injections
5/15/06 Discogram confirmed L4-L5 DDD also an asymptomatic L5-S1 tear
10/24/06 L4-L5 Prodisc surgery with Dr. Goldstein
CAT scans & X-Rays show ossification
Trigger Point Injections, Medial Branch Blocks, Acupuncture, Weekly Deep Tissue Massage
10/27/08 Discogram (positive L5-S1 tear)
11/25/08 L5-S1 fusion with Dr. Goldstein
FAILED BACK SYNDROME
Liberty Mutual WC
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  #8  
Old 08-23-2006, 09:32 AM
james gilmour james gilmour is offline
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I dont know of anyone myself , but I have read that lots have failed and there are a few law suits out there.
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DDD , Herniated disc at L5/S1 , Had Prodisc ADR at L5/S1 & L4/L5 JAN-10-2007
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  #9  
Old 08-23-2006, 11:07 AM
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Harrison Harrison is offline
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James, can you reiterate on what you mean when you say, "lots have failed?"
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Fell on my ***winter 2003, Canceled fusion April 6 2004
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  #10  
Old 08-23-2006, 11:29 AM
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Eddie_G Eddie_G is offline
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I'm no champion of the Charite but the lawsuits are a VERY small percentage of the people implanted with the Charite.

Lots more have succeeded than failed. Somewhere between 83-93% success I think.
I'll take those odds from any bookie!
__________________
12/16/03 Work Accident
Herniation and DDD at L4-L5
4/1/05 Discectomy
Epidurals and facet injections
5/15/06 Discogram confirmed L4-L5 DDD also an asymptomatic L5-S1 tear
10/24/06 L4-L5 Prodisc surgery with Dr. Goldstein
CAT scans & X-Rays show ossification
Trigger Point Injections, Medial Branch Blocks, Acupuncture, Weekly Deep Tissue Massage
10/27/08 Discogram (positive L5-S1 tear)
11/25/08 L5-S1 fusion with Dr. Goldstein
FAILED BACK SYNDROME
Liberty Mutual WC
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