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Author Topic: NuVasive Stryde stopped shipping  (Read 13812 times)

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badbuddy

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Re: NuVasive Stryde stopped shipping
« Reply #93 on: February 03, 2021, 03:50:23 PM »

I had a consultation with Mahoubian a few days ago. He says that he definitely does not believe that the Stryde nail could be chipping off and causing cancer. He mentioned that he is waiting to hear back from the FDA - and should in two weeks. He has halted all new Stryde patients until then.
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pownzorgeek

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Re: NuVasive Stryde stopped shipping
« Reply #94 on: February 03, 2021, 05:47:16 PM »

Just a question here: how much worse of an alternative is betzbone v2?
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permanentlybanned

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Re: NuVasive Stryde stopped shipping
« Reply #95 on: February 03, 2021, 05:56:26 PM »

Betzbone break allot
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V21

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Re: NuVasive Stryde stopped shipping
« Reply #96 on: February 03, 2021, 08:39:12 PM »

What about fitbone? Some doctors are considering it
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Activatedxx

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Re: NuVasive Stryde stopped shipping
« Reply #97 on: February 03, 2021, 08:59:58 PM »

What about fitbone? Some doctors are considering it

Eh it’s kinda stupid tbh, everyone needs to just calm down and wait. I’m sure within 3-6 months max stryde will be back. If not they will develop something else before the year ends I’m sure. I’ll be fkdd if I’m expected to pay the same price as stryde for a crappier product, betz/fit bone is trash compared to stryde, they’re not terrible but definitely not worth the same price 
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HeightGain

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Re: NuVasive Stryde stopped shipping
« Reply #98 on: February 03, 2021, 09:47:15 PM »

One of Paley's papers about the development of stryde states that they avoided a cobalt chrome based due to the potential for toxicity.

Stryde is stainless steel, precise titanium which are used in lots of implants but I don't know if the lengthening mechanism is different between the two nails and their components. If it is different then hopefully the issue won't be across both nails.

Most components should have gone through toxicity testing, I would imagine the tests will be looking at what forces release what quantities of components which should be fairly quick to perform to see if they reach potential toxic levels
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E Z

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Re: NuVasive Stryde stopped shipping
« Reply #99 on: February 04, 2021, 06:38:51 AM »

One of Paley's papers about the development of stryde states that they avoided a cobalt chrome based due to the potential for toxicity.

Stryde is stainless steel, precise titanium which are used in lots of implants but I don't know if the lengthening mechanism is different between the two nails and their components. If it is different then hopefully the issue won't be across both nails.

Most components should have gone through toxicity testing, I would imagine the tests will be looking at what forces release what quantities of components which should be fairly quick to perform to see if they reach potential toxic levels
Awesome post, really appreciate your insight.
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pownzorgeek

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Re: NuVasive Stryde stopped shipping
« Reply #100 on: February 04, 2021, 07:35:07 AM »

Eh it’s kinda stupid tbh, everyone needs to just calm down and wait. I’m sure within 3-6 months max stryde will be back. If not they will develop something else before the year ends I’m sure. I’ll be fkdd if I’m expected to pay the same price as stryde for a crappier product, betz/fit bone is trash compared to stryde, they’re not terrible but definitely not worth the same price

I'm not so sure to be honest.

They will test the toxicity of the product (which they are testing as they obviously had certain allegations, patients having adverse issues with them otherwise they wouldn't have recalled their devices), but what about the weird callus formation, which if I'm not mistaken is formed around the telescopic area of the stryde nail? I don't think that them saying "it's no biggie" would be good enough. And I don't think then that them changing their product so that it doesn't form the weird callus only takes 3-4 months. They would probably have to redesign quite some stuff.

Just my opinion/assumptions.
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V21

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Re: NuVasive Stryde stopped shipping
« Reply #101 on: February 04, 2021, 09:01:39 AM »

If everything goes well, they are not going to modify anything. They just will run test to "prove" there are not biological risks involved.
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permanentlybanned

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Re: NuVasive Stryde stopped shipping
« Reply #102 on: February 04, 2021, 12:58:17 PM »

What about fitbone? Some doctors are considering it

Fitbone has alot of problems. I don't know what problems, but it has alot
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Body Builder

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Re: NuVasive Stryde stopped shipping
« Reply #103 on: February 04, 2021, 01:57:27 PM »

Fitbone has alot of problems. I don't know what problems, but it has alot
It is very unreliable as too many stopped working and needed a new surgery to put a new one in.
Also it has almost zero weight bearing capabilities which means that even standing is almost impossible.

It ia a very bad nail, I wouldn't use it no matter what.
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V21

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Re: NuVasive Stryde stopped shipping
« Reply #104 on: February 04, 2021, 01:59:19 PM »

It is very unreliable as too many stopped working and needed a new surgery to put a new one in.
Also it has almost zero weight bearing capabilities which means that even standing is almost impossible.

It ia a very bad nail, I wouldn't use it no matter what.
Thanks for the info, I really did not know much about Fitbone. I expect Stryde to be available in summer, but I just wanted to know about other options. Worst case scenario, Precice 2 then
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AnotherShorty

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Re: NuVasive Stryde stopped shipping
« Reply #105 on: February 04, 2021, 02:18:25 PM »

In case anyone wants to know how much other nails s*cks :


Regards
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AllinStryde

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Re: NuVasive Stryde stopped shipping
« Reply #106 on: February 04, 2021, 08:04:13 PM »

Is anyone familiar with the Lot numbers, Serial numbers, or date-of-production  for the series of Stryde nails which are in question?  This is definitely not good news.  Thanks to anyone who may respond to this question, much appreciation.
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Vibes

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Re: NuVasive Stryde stopped shipping
« Reply #107 on: February 05, 2021, 12:46:07 AM »

Anyone who seriously considers anything less than Precise 2 is asking for a world of pain and complications.

Just wait. The sun will still shine tomorrow. They will become approved again in no time.
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limbcllnea

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Re: NuVasive Stryde stopped shipping
« Reply #108 on: February 05, 2021, 01:46:04 PM »

Is anyone familiar with the Lot numbers, Serial numbers, or date-of-production  for the series of Stryde nails which are in question?  This is definitely not good news.  Thanks to anyone who may respond to this question, much appreciation.

This is for everything in existence. They recalled pretty must everything in Europe thus far.
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Activatedxx

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Re: NuVasive Stryde stopped shipping
« Reply #109 on: February 05, 2021, 10:31:06 PM »

I'm not so sure to be honest.

They will test the toxicity of the product (which they are testing as they obviously had certain allegations, patients having adverse issues with them otherwise they wouldn't have recalled their devices), but what about the weird callus formation, which if I'm not mistaken is formed around the telescopic area of the stryde nail? I don't think that them saying "it's no biggie" would be good enough. And I don't think then that them changing their product so that it doesn't form the weird callus only takes 3-4 months. They would probably have to redesign quite some stuff.

Just my opinion/assumptions.


But within a year I think for sure it will be resolved worst case scenario if it is really that bad
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Brutal painful process, if considering external femurs please change your mind
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curlyfella

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Re: NuVasive Stryde stopped shipping
« Reply #110 on: February 10, 2021, 02:33:26 PM »

are you sure the precice is still available?
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curlyfella

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Re: NuVasive Stryde stopped shipping
« Reply #111 on: February 10, 2021, 02:34:19 PM »

I  contacted nuvasive and they said the precice is not available
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V21

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Re: NuVasive Stryde stopped shipping
« Reply #112 on: February 10, 2021, 02:52:25 PM »

No, all Precice products were recalled in Europe.
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RealLostSoul

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Re: NuVasive Stryde stopped shipping
« Reply #113 on: February 10, 2021, 11:31:59 PM »

I can only agree with Giotikas2021 here. This   seems absolutely terrible. I have had it all planned for July as well. I really hope this doesn‘t terminate everything. I wouldn‘t want to take it anymore longer honestly because It‘s really unpleasant to live with the neurological effects of this mental illness. I have had this   since kindergarden and life is worse than ever. I won‘t be able to leave my house anymore too, especially after lockdown.. I can only pray that quarantine goes on forever which isn‘t realistic since it‘s gonna be over in may or june when we are all vaccined here (more or less at least).

E:/ plus having to do it later would fk my university schedules so hard. It‘s close to impossible then without cancelling which I never ever want to do.

But then, imagine you do the surgery just to get cancer in the end... fk that has to be just an assumption by health services right? I can‘t imagine this actually being true, it would be terrible, just think about all the people that have already done it! fk life man makes me wondering if maybe it‘s just better to kill myself honestly, then I won‘t have to think about this crap anymore anyways...
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permanentlybanned

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Re: NuVasive Stryde stopped shipping
« Reply #114 on: February 11, 2021, 01:18:30 AM »

I can only agree with Giotikas2021 here. This   seems absolutely terrible. I have had it all planned for July as well. I really hope this doesn‘t terminate everything. I wouldn‘t want to take it anymore longer honestly because It‘s really unpleasant to live with the neurological effects of this mental illness. I have had this   since kindergarden and life is worse than ever. I won‘t be able to leave my house anymore too, especially after lockdown.. I can only pray that quarantine goes on forever which isn‘t realistic since it‘s gonna be over in may or june when we are all vaccined here (more or less at least).

E:/ plus having to do it later would fk my university schedules so hard. It‘s close to impossible then without cancelling which I never ever want to do.

But then, imagine you do the surgery just to get cancer in the end... fk that has to be just an assumption by health services right? I can‘t imagine this actually being true, it would be terrible, just think about all the people that have already done it! fk life man makes me wondering if maybe it‘s just better to kill myself honestly, then I won‘t have to think about this crap anymore anyways...

You should honestly do LL, then really get some help with a cognitive behavioral therapy. There's some trauma in here that goes beyond height that the surgery won't fix, I can tell.

And no one's getting cancer... At least Not in the way you're thinking about it.
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V21

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Re: NuVasive Stryde stopped shipping
« Reply #115 on: February 12, 2021, 08:08:54 PM »

Giotikas right now

Following the recent, temporary, global recall of all Precise/Stryde family products by the manufacturer,

We announce:

All surgeries with Stryde nail, scheduled for anytime sooner than 18th August 2021, are postponed until further notice.
 

Precise-2 nail is expected to be available for clinical use again in our Centre in the second half of March 2021. The first available date for surgery with Precise-2 nail in our centre is the 23rd March 2021. The longer track of satisfactory clinical performance of Precise-2 since 2012 allowed for this early resolution of the matter for the Precise-2.
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Arcon

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Re: NuVasive Stryde stopped shipping
« Reply #116 on: February 12, 2021, 08:15:39 PM »

Giotikas right now

Following the recent, temporary, global recall of all Precise/Stryde family products by the manufacturer,

We announce:

All surgeries with Stryde nail, scheduled for anytime sooner than 18th August 2021, are postponed until further notice.
 

Precise-2 nail is expected to be available for clinical use again in our Centre in the second half of March 2021. The first available date for surgery with Precise-2 nail in our centre is the 23rd March 2021. The longer track of satisfactory clinical performance of Precise-2 since 2012 allowed for this early resolution of the matter for the Precise-2.

Great news! I got this in my email too: https://www.athensbjr.com/announcement-about-stryde-and-precise-nails-availability/
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V21

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Re: NuVasive Stryde stopped shipping
« Reply #117 on: February 12, 2021, 08:33:42 PM »

Great news! I got this in my email too: https://www.athensbjr.com/announcement-about-stryde-and-precise-nails-availability/
Well, it depends on accuracy... it says Precice 2 will be ready in March, but nothing sure about Stryde. If it is available in late August great, but it does not confirm anything.... My surgery was booked for July 7th, changing it means losing 1000 euros. If I change it to August and Stryde is still not available what happens? More money lost? Lol. I hope he gives me more info about those timelines
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las vegas baby

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Re: NuVasive Stryde stopped shipping
« Reply #118 on: February 13, 2021, 07:14:57 AM »

Great news! I got this in my email too: https://www.athensbjr.com/announcement-about-stryde-and-precise-nails-availability/

thank you for pasting that link! It is a bit CONCERNING to read that. it says people who have nails and have aches and pains should consult Dr. Giotakis. It says people who have nails since 14 months should get it removed asap.

something is not right here. Stryde is probably not comin back anytime soon (and probably shouldnt with all these concerns).

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V21

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Re: NuVasive Stryde stopped shipping
« Reply #119 on: February 13, 2021, 02:35:16 PM »

Assayag says that the last report from Nuvasive says July, but of course, they can't guarantee it 100%
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Michael J. Assayag, MD

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Re: NuVasive Stryde stopped shipping
« Reply #120 on: February 13, 2021, 02:48:46 PM »

Alright!

So here is the news.

Further biocompatibility testing is needed for all of NuVasive's stainless steel implants, including STRYDE.

Until further notice (Nuvasive quotes July, possibly later) Stryde nail is completely unavailable and all inventory needs to be returned. IN the past few months we were still allowed to use our inventory ,however we are not allowed to implant any further STRYDE at this time.

We thankfully can continue using PRECICE titanium implants , which have a 10 year track record of success and accuracy. We are also continuing lengthening over nails (LON) Lengthening and then Nailing (LATN) and circular fixator lengthenings

On the bright side, a lot of people are still going forward with PRECICE lengthenings which represent a considerable cost saving.
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V21

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Re: NuVasive Stryde stopped shipping
« Reply #121 on: February 13, 2021, 03:15:57 PM »

Alright!

So here is the news.

Further biocompatibility testing is needed for all of NuVasive's stainless steel implants, including STRYDE.

Until further notice (Nuvasive quotes July, possibly later) Stryde nail is completely unavailable and all inventory needs to be returned. IN the past few months we were still allowed to use our inventory ,however we are not allowed to implant any further STRYDE at this time.

We thankfully can continue using PRECICE titanium implants , which have a 10 year track record of success and accuracy. We are also continuing lengthening over nails (LON) Lengthening and then Nailing (LATN) and circular fixator lengthenings

On the bright side, a lot of people are still going forward with PRECICE lengthenings which represent a considerable cost saving.
Thanks for the news, you definitely are one of doctors who are more involved with patients. Many of us just want to have some certainty and information in order to make a choice about our treatment, so thank you again for the information you provided.
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PANDA:BEAR..

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Re: NuVasive Stryde stopped shipping
« Reply #122 on: February 13, 2021, 03:27:31 PM »

The British NHS... has found problems regarding the Stryde nail.  what is puzzling that the American FDA.. did not do the correct checks..  let's see what happens.. as the NHS.. will make sure patients safety.. comes 1st

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V21

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Re: NuVasive Stryde stopped shipping
« Reply #123 on: February 13, 2021, 04:32:07 PM »

The issue is that they said may/june, now july.... It's hard to trust. I could wait for Stryde until September, but this makes me consider taking Precice 2 in July
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