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The Latest Defective Product from China: Titanium

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Washington, DCYet another defective product issue has originated in China—and while personal injury in connection with the product has yet to be identified, the alarm bells are once again ringing over the potential for yet another defective product personal injury case. This time, the battles lines are being drawn over titanium.

TitaniumThe latter is a specialized alloy used in various products, including orthopedic implants used during surgery. As reported by the GMP Letter September 3, a device maker was unsuccessful in processing titanium through a machine used to manufacture a device (the specific device was not identified). The manufacturer approached its supplier, G&S Titanium, an importer-distributer.

According to Roger Geiser, G&S CEO, the defect was identified as alloy segregation, an indication that the metals were not melded homogenously. If the alloy is not melded properly, the metals remain unmixed.

G&S said the raw material was imported from Dalian Sunny Titanium Industry, an enterprise based in China. Geiser added that his company is no longer purchasing titanium from there.

While the US Food and Drug Administration (FDA) visited the G&S facility about two months ago, no details about the inspection were released. In the interim, the Orthopedic Surgical Manufacture's Association (OSMA) is working with affected device makers to address the problem. "It's not an easy issue," OSMA's Tom Craig told GMP.

Not easy because the defective titanium from China actually met international standards set out for titanium by ASTM, a standards organization. Second, nothing short of a destructive test could possibly identify the defect—although such a test would serve to weaken the titanium. Destructive tests are not required by the ASTM under current regulations.

What's more, says Craig, the defect could be so localized that only a small piece of one device could actually be defective.

What does that mean for a patient concerned over a defective product and personal injury? Hard to say. OSMA indicated it did not know of any defective products migrating out to patients as a result of the problem. Craig also said that a few companies have initiated pre-emptive recalls, although he did not identify the manufacturers or what those products were.

G&S tested the titanium in question, which demonstrated adequate strength and chemistry specifications. "The certification we got from the supplier said this should never happen," G&S' Geiser said. But it did—and the defect occurred further down the supply chain than what the FDA generally inspects, said Craig. "This caught everybody off-guard."

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Posted by

i had back surgery when i was 15 i am 28 now it was sum 13 years ago in 2002 i had 2 metal rods and screws put in my back i have had constant pain for these past 13 years i have worked so many factory wants they find out about my back they say i am a liability risk. right now i have been able to work in this one factory for three years latley my back has gotten even more severe so i decided to go to a spine doc. witch intern found out the left rod is broken in 2 places and the right one is broken in one place they are also bent thease are titanium rods. i was wondering would thease rods be a result of this article.

Posted by

Titanium plate broke shortly after surgery in 06', I know the SOL is well past the time frame, but just last week my doctor informed me that it was the wrong plate install in the 1st place and did more damage, plate shifted and screws are starting to come loose, which he explained should not be happening, and the way the plate was installed prevented the non union fracture from healing, I'll know more once the CT scan results come in. ...

Posted by

as the person has stated above in the reader comments I have had a plate put in my leg and as soon as the doctor released me for work the plate broke that day and I had to have two put in and I will never be able to work again due to the fact that it shattered my leg and it will not heal properly. I feel that it is due to the defective plate that he had put in my leg in the beginning. it was a titanium plate. from my understanding.

Posted by

Hello, I have had two surgeries redone because the titanium plate in my leg snapped twice. Could this be caused by what was in the article? Just wondering....


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