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[V21]

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

[V21]

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

[limbcllnea]

Yeah 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?

[V21]

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

[Arcon]

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

I agree.

[Vibes]

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?

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

[AllAboutPerspective]

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.

[Body Builder]

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.

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.

[permanentlybanned]

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.

WOW dude. I am so sorry that happened to you man. That f**king sucks. Words cannot describe how angry I am at what happened to you.

I'm sorry dude.

[V21]

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.

Giotikas told me that he has stock for like 3 months, and that all doctors (Paley, etc) were going on with their surgeries too. However, it seems that Nuvasive recalled all devices today... That sucks, you can't cancel somebody's surgery like that, lots of money and planning involved. He does say that the issue will be solved before summer, and that his sources in Nuvasive say that around May, but of course, how could you not be worried after a cancelation like this?

[AllAboutPerspective]

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.

He does have stock, and we even had a call on Saturday discussing the problems and if I wanted to go ahead anyway. He said the problems with the nail aren't serious at all and agreed that I should go ahead with it. But today Nuvasive has officially recalled the nails, so he can't even use the ones he has in stock

[AllAboutPerspective]

WOW dude. I am so sorry that happened to you man. That f**king sucks. Words cannot describe how angry I am at what happened to you.

I'm sorry dude.

Thanks man. I'm devastated. I planned so much and now I have to fly back to my country. I just can't believe it

[AllAboutPerspective]

Giotikas told me that he has stock for like 3 months, and that all doctors (Paley, etc) were going on with their surgeries too. However, it seems that Nuvasive recalled all devices today... That sucks, you can't cancel somebody's surgery like that, lots of money and planning involved. He does say that the issue will be solved before summer, and that his sources in Nuvasive say that around May, but of course, how could you not be worried after a cancelation like this?

I wasn't too worried about the problems because they aren't serious. Dr. Giotikas said the company cares about their image, and their stock price, so they decided to take no chances and just recall all the nails

[pownzorgeek]

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.

Hi, thanks a lot for the update, and I think it really sucks what happened. I honestly hope the whole thing is solved quickly, but let's see. This has also changed my plans, but better safe and do it a bit later than sorry.

[V21]

I contacted Debiparshad and his office said this:  There are no confirmed biological safety issues with these products.

Release was issued in UK and Ireland for a. Gaps in material testing b. Lack of testing in pediatric use. Their MRA like our  FDA - requested more testing.  The company is trying to resolve that issue.   We have not had a recall here in the States. We have continued to do the leg lengthening procedure.
I can check on the precice 2 nail.  You would have to stay here the whole duration of the distraction using that nail.

[Siegfried]

This is madness. I have My Surgery scheduled for next week with Köhne. Gonna find out tmr if we can go through with it I guess.

[V21]

This is madness. I have My Surgery scheduled for next week with Köhne. Gonna find out tmr if we can go through with it I guess.

It seems like we Europeans will have to wait until summer..

[RB]

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.

That's horrible man. Really fked up, especially since you had already flown into Greece. I had a call with Giotikas yesterday and we decided to go ahead but now that Nuvasive has recalled all nails, I assume I will get notice that my surgery in March has been cancelled too.

Does anyone know if the US doctors will continue to be able to use stryde? I assume Nuvasive will recall nails globally.

Are there any other alternatives to stryde at the moment that are good options? I had planned my entire life/job around doing surgery in March and now I'm screwed.

[Siegfried]

I have just gotten a reply from Koehne regarding My Surgery next week. Its cancleed and according to him nuvasive will widraw the nails globally. I’ll be honest here, this is absolutely crushing. As a person of short stature your used to experiencing a lot of speedbumbs and things being out of your line of control, but this takes it to a another level. I’m very disappointed to say the least. Nuvasive did say the nail might be ready by may/ June, but I’ll take that with a grain of salt as of right now.

[RB]

I have just gotten a reply from Koehne regarding My Surgery next week. Its cancleed and according to him nuvasive will widraw the nails globally. I’ll be honest here, this is absolutely crushing. As a person of short stature your used to experiencing a lot of speedbumbs and things being out of your line of control, but this takes it to a another level. I’m very disappointed to say the least. Nuvasive did say the nail might be ready by may/ June, but I’ll take that with a grain of salt as of right now.

Damn sorry to hear man.

I contacted Dr Mahboubian and they said they are waiting to hear an update from Nuvasive's internal audit and will hear from them next week but I am unsure of what this means for future use of the nail over the next few weeks.

This is devastating, it just seems like its setback after setback. I am really unsure of what to do.

The May / June timeline is probably best case scenario. It could even be July / August till stryde is available again.

[V21]

It seems Nuvasive is telling all doctors the issue will be solved by May/June, but it seems hard to trust them after this. My surgery is for July 7. I think I will try to move it to late July, also changing the dates for my Airbnb, I think that way I will have more margin... The thing is, worst case scenario, does anyone know if Precice 2 is available?

[V21]

To the guys who want to do it with Giotikas this summer... If you want to you can PM and I will give my Whatsapp number so we can share information. This is such a mess

[AllAboutPerspective]

It seems Nuvasive is telling all doctors the issue will be solved by May/June, but it seems hard to trust them after this. My surgery is for July 7. I think I will try to move it to late July, also changing the dates for my Airbnb, I think that way I will have more margin... The thing is, worst case scenario, does anyone know if Precice 2 is available?

Precise-2 isn't available either. The whole Precise family has been recalled. Dr. Giotikas offered me to do external tibias but I just don't want to do that

[V21]

Precise-2 isn't available either. The whole Precise family has been recalled. Dr. Giotikas offered me to do external tibias but I just don't want to do that

Oh f**k. Then I really do expect their timelines are true and this doesn't take longer than summer. I can wait until september at worst...

[azman]

This is good and bad, but above all safety is the number #1 priority. 
I’ll text Chris Yunker tomorrow afternoon and see if he has any updates or possible timeline.
For the meantime, let’s pray it’s just as simple as Dr. G informed.

[V21]

I wrote to him and he said that they can't guarantee anything. but they are expecting it to be solved during quarter 2

[Nestor]

This is terrifying. I haven't had any of the bony issues mentioned but the idea of microscopic pieces of the nails breaking off and potentially causing cancer scares the sh*t out of me! I have no idea when I'll be able to get the nails removed yet due to covid. How can a company that big be allowed to sell medical devices that haven't been fully tested? I'm really stressing out after reading all of this, I hope me and others dont end up as some horror report of cases gone wrong

[las vegas baby]

This is terrifying. I haven't had any of the bony issues mentioned but the idea of microscopic pieces of the nails breaking off and potentially causing cancer scares the sh*t out of me! I have no idea when I'll be able to get the nails removed yet due to covid. How can a company that big be allowed to sell medical devices that haven't been fully tested? I'm really stressing out after reading all of this, I hope me and others dont end up as some horror report of cases gone wrong

I hear ya bro. even though the contents of that NHS letter are grim sounding nuvasive is like "ok dont worry, be good in 3 months". How the hell are they gonna prove in 3 months that it does NOT cause cancer or that weird bone thing is no big deal?

we gotta wait for the NHS to approve this nail again. UK has got one thing right  the NHS, God bless it. they really care for their country citizens and I hope they will thouroughly scrutinize nuvasive before unbannin the nail.

nuvasive is the best nail company so far, but I wouldnt take a corporate's word as the truth. big pharma will do anything to make big bucks.

[V21]

Another doctor has just told me that Nuvasive will meet with the FDA next week, and that will determine if Stryde is allowed to be used during this months in the States. He also states that is realistic to expect this to be solved by summer and, in the worst case, to have at least Precice 2. I think that this meeting with the FDA will be really telling.

[Nestor]

I thought Stryde was already FDA approved?

This is all just really confusing at the moment. Like las vegas said how are they going to prove or disprove anything in the space of just a few months, especially in terms of device toxicity. Really hope this was something that was blown out of proportion but its worrying that these questions are even being raised at all. This isn't like some consumer product with a flaw that gets taken off the shelves, peoples lives could be at risk.

[permanentlybanned]

You can be FDA approved and then have that approval revoked. Happens all the time. ISKD was an FDA approved nail that kept lengthening and was not accurate in distraction.