Titanium screws-back fusion. recall?

What is the name of your state? Montana, I was wondering if anyone has had any problems with a titanium screw fracturing in a low back fusion. My husband had this surgery in 2004 and was wondering if anyone has heard of this or is there a recall on the product? He is looking at more surgery and we are not sure what direction to go. Any input would help. I have called the manufacturer about this and they told me that they have had no problems on this hardwear. Or was this put in right? Trying to find answers. Thank-you

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Originally Posted by weina

What is the name of your state? Montana, I was wondering if anyone has had any problems with a titanium screw fracturing in a low back fusion. My husband had this surgery in 2004 and was wondering if anyone has heard of this or is there a recall on the product? He is looking at more surgery and we are not sure what direction to go. Any input would help. I have called the manufacturer about this and they told me that they have had no problems on this hardwear. Or was this put in right? Trying to find answers. Thank-you

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What did his surgeon have to say about it?

surgeon has said that titanium can fracture and he did not heal properly, we had an x-ray done about 6 months after the surgery and he said things look really good. (that was in 2004) Now 2007 he is told that the titanium is fractured. Looks like from the head of the screw in as if you sawed it through the middle of the screw from the head to the tip.

There are tremendous forces at work in the human spine. Titanium is not miraculous matrial, despite the claims. A 5/8 retaining bolt on my treadmill sheared off - that was titanium.

A sheared screw is not enough to prove a defective product. If Dr. is claimimg screw is defective he needs to go to bat with you on that - otherwise he isn't playing it strait.

Hubby was very ill to require a fusion surgery.

If Dr. told him this certainly was the last surgury he would ever need, than Dr. was too optimistic.

Best of luck to you and your husband, I feel your for your spinal issues.

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Originally Posted by weina

surgeon has said that titanium can fracture and he did not heal properly, we had an x-ray done about 6 months after the surgery and he said things look really good. (that was in 2004) Now 2007 he is told that the titanium is fractured. Looks like from the head of the screw in as if you sawed it through the middle of the screw from the head to the tip.

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It is totally possible that your husband's x-rays looked good 6 months after surgery, but are changed now. As Xylene said, there is a tremendous amount of stress placed on the spine. Most likely, when the surgeon removes the screw, he will contact the manufacturer and report the problem. It would be in his best interest also, as I'm sure he does not want to perform surgeries using defective equipment.

Best of luck with your husband's surgery.

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Originally Posted by weina

What is the name of your state? Montana, I was wondering if anyone has had any problems with a titanium screw fracturing in a low back fusion. My husband had this surgery in 2004 and was wondering if anyone has heard of this or is there a recall on the product? He is looking at more surgery and we are not sure what direction to go. Any input would help. I have called the manufacturer about this and they told me that they have had no problems on this hardwear. Or was this put in right? Trying to find answers. Thank-you

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I need additional information to make sure that when I answer, my answer is appropriate.

What procedure did your husband have and what was the name/type of the orthopedic implant (plate with screws, cage, etc.)?

EC

ellencee**************......my husband had a fusion at L4-L5 with pedicle screw fixation, all titanium so we were told. thanks

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Originally Posted by weina

ellencee**************......my husband had a fusion at L4-L5 with pedicle screw fixation, all titanium so we were told. thanks

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Barring an additional accident/injury to the lumbar spine, it is not likely that this occurred after the surgery but rather occurred during the procedure when proper alignment was not achieved and the screw was inserted at such an angle that torque resulted in fracture of the screw.

Six month follow-up x-rays are not sufficient. Additional x-rays should have continued for at least for 16 months--not, that doing so would have prevented the need for a second surgery.

My suggestion is to have a totally non-related orthopedic surgeon assess your husband and perform the second surgery; that way, you will receive an objective finding or report.

Your husband has some serious choices to make. Is the pain from the broken screw real or is it pain from misalignment? Is it worth having this surgery performed again or is it something that physical therapy can treat?

Your husband may want to go ahead and consult with a medmal attorney. The statute of limitations must be protected and it seems your husband's claim could be very close to the end of the statute of limitations.

EC

Thank-you**************.. and thank-you for all who posted.

Check this link [url]http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=11927807&dopt=Abstract[/url]

It was demonstrated that AO/ASIF screws coated with osteoconductive materials achieve optimal fixation strength, even in the early phase.

Titanium is not the best choice for screwing into and holding bone.


And this one
[url]http://ajs.sagepub.com/cgi/content/abstract/29/4/420?ck=nck[/url]

Although there was no significant difference in the ultimate failure load, more bone block fractures were found in the grafts fixed with a titanium interference screw. Bioabsorbable interference screw fixation thus seems to provide a reasonable alternative to titanium screws.

Same answer.