NuVasive Stryde stopped shipping

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Quote from: pownzorgeek on January 29, 2021, 05:52:09 PMYeah he might say that, but to me it seems more like "yeah, come to me so I can take your money, it's safe". But could he commit to have in written form (which would legally bind him) that he is certain that that nail doesn't cause any weird side effects on the body or even cancer? Probably not. The Field safety notice the company has produced is stating even carcinogenic, they wouldn't put that on paper lightly. Just my opinion.

I don't want to bash that doctor specifically, I would say any doctor doing stryde while the investigation is going on would seem irresponsible to me. I came in contact with Dr. Donghoon Lee few days ago, and he had retired the stryde nails, as an example. That doctor I would trust 10x more.

In fact for you it might be ok, since your surgery is in July and they might have already cleared this out by then. But how many others will have done the procedure until then?

I thing you are wrong...All top doctors in the US and Europe have kept using Stryde nails all these months even in non-cosmetic cases. I don't think that they would do that if they had serious concerns.

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What he told me during our appointment is that the "bony" thing has happened in some cases. However, regarding cancer, it's not that it has happened: it's that there have not been enough tests in order to clinically assure the nail's safety. So I think people are blowing things out of proportions. Of course it is concerning, but it's not like people have been getting cancer or anything. It's that they must pass some safety tests that they didn't pass before. Anyway, to be honest and I may seem dumb, I have been suffering from severe height dysphoria for 4 years, in which I almost have not left my house. At this point, I'm willing to take any risks so... my only true concern is getting the surgery in July and getting my life back. I'm terrified about having to postpone lol

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Regarding his honesty as a doctor... of course you never know. But he did told me about these abnormalities BEFORE all of this happened, so I think that's a good sign

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By the way, Nuvasive told me this:

In response to your email below, I will attempt to answer your questions as best as possible.  You are correct in both the following ways:

 

The document you read, titled Precice Field Safety Notice, states, “The generation of evidence, to bridge the current gaps are ongoing with expected completion in Q2 2021 for all NSO devices.”
It is not possible for NSO to 100% guarantee this timeline. 

However, completion in the second quarter of 2021 is what our internal team is anticipating.
 

Whether or not to maintain the arrangements and accommodations you have made in preparation for your July surgery, that is a question best answered by yourself and Dr. Giotikas

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Quote from: pownzorgeek on January 29, 2021, 05:52:09 PMYeah he might say that, but to me it seems more like "yeah, come to me so I can take your money, it's safe". But could he commit to have in written form (which would legally bind him) that he is certain that that nail doesn't cause any weird side effects on the body or even cancer? Probably not. The Field safety notice the company has produced is stating even carcinogenic, they wouldn't put that on paper lightly. Just my opinion.

I don't want to bash that doctor specifically, I would say any doctor doing stryde while the investigation is going on would seem irresponsible to me. I came in contact with Dr. Donghoon Lee few days ago, and he had retired the stryde nails, as an example. That doctor I would trust 10x more.

I think this is a very good take on the situation. It makes sense that they suspended it for a reason, a corporation wants to make money, and the fact that they voluntarily suspended a whole family of products must mean there is at least some type of serious risk. If it was "no big deal", I don't believe they would take such drastic actions. MHRA report said "Unknown long-term biological safety profile", so I don't believe this is just stupid empty action.

Do you know specifically why Dr. Donghoon retired the STRYDE nail? Did he find problems himself or is it because of the report?

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I don't think there are serious risks as 99% of doctors are going on with the surgeries

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Quote from: Giotikas2021 on January 30, 2021, 07:49:59 AMI don't think there are serious risks as 99% of doctors are going on with the surgeries

I agree.

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Quote from: questpeanut on January 30, 2021, 03:38:41 AMI think this is a very good take on the situation. It makes sense that they suspended it for a reason, a corporation wants to make money, and the fact that they voluntarily suspended a whole family of products must mean there is at least some type of serious risk. If it was "no big deal", I don't believe they would take such drastic actions. MHRA report said "Unknown long-term biological safety profile", so I don't believe this is just stupid empty action.

Do you know specifically why Dr. Donghoon retired the STRYDE nail? Did he find problems himself or is it because of the report?

Seconding this. Why did Dr. Lee do this? That seems very telling..

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I went to my pre-op today, my surgery was supposed to be in two days but Dr. Giotikas cancelled it because NuVasive are recalling all nails as of today.

Honestly I'm devastated. All my plans are ruined and I spent a lot of money to get to Greece and prepare everything. I even met someone on this forum and we are sharing an apartment together, he already had his surgery 3 weeks ago so it's ruined it for both of us.

I just can't believe I came this far and now I can't do it until the summer. And I'll potentially have to do it alone rather than doing it with someone. Ah I'm just so upset.

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Quote from: AllAboutPerspective on February 01, 2021, 01:56:14 PMI went to my pre-op today, my surgery was supposed to be in two days but Dr. Giotikas cancelled it because NuVasive are recalling all nails as of today.

Honestly I'm devastated. All my plans are ruined and I spent a lot of money to get to Greece and prepare everything. I even met someone on this forum and we are sharing an apartment together, he already had his surgery 3 weeks ago so it's ruined it for both of us.

I just can't believe I came this far and now I can't do it until the summer. And I'll potentially have to do it alone rather than doing it with someone. Ah I'm just so upset.

Didn't Giotikas have stock nails as he said?
I really hope there is not something really dangerous going on with that nail that led doctors to stop using it asap and in a few days things will get back to normal.