Topic: NuVasive Stryde stopped shipping (Read 14837 times)

Erkan · « **on:** January 27, 2021, 07:49:21 AM »

Hey,

just got an information, that NuVasive doesnt ship any new Stryde Nails, because they do new internal quality control checks.
This is very bad news for anyone, who wants to do the surgery this year because nobody knows how long it will take.
Anyone heard about it yet?

Highest · « **Reply #1 on:** January 27, 2021, 08:43:16 AM »

Who told you they are not shipping any new Stryde nails? Regarding the quality checks are you saying that previously nuvasive did not do internal quality checks?

Erkan · « **Reply #2 on:** January 27, 2021, 09:30:40 AM »

Quote from: Highest on January 27, 2021, 08:43:16 AM

Who told you they are not shipping any new Stryde nails? Regarding the quality checks are you saying that previously nuvasive did not do internal quality checks?

Of course I assume that there were quality controls in the first place, but apparently after 10,000 operations a few cases have now emerged that are being investigated

Ascending · « **Reply #3 on:** January 27, 2021, 10:24:18 AM »

Quote from: Erkan on January 27, 2021, 09:30:40 AM

Of course I assume that there were quality controls in the first place, but apparently after 10,000 operations a few cases have now emerged that are being investigated

I heard the same in November last year. Stryde was put on hold by the NHS in the UK pending some investigations - but the older non-weight bearing precise nail is still available.

2020hope · « **Reply #4 on:** January 27, 2021, 10:50:35 AM »

It's probably same reason in India - Dr. Parihar had mentioned some "company audit" for Stryde.

Siegfried · « **Reply #5 on:** January 27, 2021, 11:01:18 AM »

Does this mean the production of stryde will be put on hold for several months? That is very hard to imagine.

more · « **Reply #6 on:** January 27, 2021, 11:55:13 AM »

This is true NuVasive put Stryde nail on hold for quality check .I knew it in October 2020.

more · « **Reply #7 on:** January 27, 2021, 12:22:32 PM »

Quote from: Ascending on January 27, 2021, 10:24:18 AM

I heard the same in November last year. Stryde was put on hold by the NHS in the UK pending some investigations - but the older non-weight bearing precise nail is still available.

Precice was also on hold. they released precice in November 2020. lets see when they will release Stryde again .

V21 · « **Reply #8 on:** January 27, 2021, 12:56:34 PM »

How long should that take?

Siegfried · « **Reply #9 on:** January 27, 2021, 01:08:25 PM »

how long was precise 2 on hold?

10cmOnTibiaOrGTFO · « **Reply #10 on:** January 27, 2021, 01:14:51 PM »

well thats fked up. i hope people did not die.

Ascending · « **Reply #11 on:** January 27, 2021, 01:52:20 PM »

Details can be found here - note it's a PDF file: https://www.boa.ac.uk/uploads/assets/552dea10-c795-4c9f-b1a08177bf9151c1/NuVasive-MHRA-notice.pdf

V21 · « **Reply #12 on:** January 27, 2021, 02:33:14 PM »

Is it worldwide or just the UK? Sorry if it's a dumb question after reading the document, I have bad English

Ascending · « **Reply #13 on:** January 27, 2021, 03:24:04 PM »

Quote from: Giotikas2021 on January 27, 2021, 02:33:14 PM

Is it worldwide or just the UK? Sorry if it's a dumb question after reading the document, I have bad English

Well that document only talks about the UK so I don't know. But assuming the exact same product is being marketed everywhere then surely we can expect the same issue to be present regardless of where it is used.

limbcllnea · « **Reply #14 on:** January 27, 2021, 03:52:58 PM »

Why is it that only Styde has been suspended and not precise 2?

Did Stryde have negative effects that Precise 2 did not have?

Medium Drink Of Water · « **Reply #15 on:** January 27, 2021, 04:40:00 PM »

Quote from: questpeanut on January 27, 2021, 03:52:58 PM

Why is it that only Styde has been suspended and not precise 2?

Did Stryde have negative effects that Precise 2 did not have?

They have all been suspended.

It specifically says Stryde patients have had issues of "pain and bony abnormalities" at the site of the telescoping mechanism, but the Brits have other, more general concerns about the whole family of products.

more · « **Reply #16 on:** January 27, 2021, 04:43:39 PM »

Quote from: Medium Drink Of Water on January 27, 2021, 04:40:00 PM

They have all been suspended.

It specifically says Stryde patients have had issues of "pain and bony abnormalities" at the site of the telescoping mechanism, but the Brits have other, more general concerns about the whole family of products.

its not telescopic only , many cases of screws breaking too.

permanentlybanned · « **Reply #17 on:** January 27, 2021, 04:49:28 PM »

I have read many diaries regarding that bony thing regarding stryde. It's like a bone outgrowth or something and Dr. M tells patients to press on it consistently and eventually it subsides. No one knows what it is. Didn't really do anything negative as far as I'm aware of.

more · « **Reply #18 on:** January 27, 2021, 05:28:43 PM »

How can they say it is full weight bearing , what does it meaning full weight bearing??

V21 · « **Reply #19 on:** January 27, 2021, 05:45:22 PM »

Giotikas did told me about that bony thing, but said it was nothing to really worry about

Vibes · « **Reply #20 on:** January 27, 2021, 06:39:11 PM »

I hope it turns out that Nuvasive is simply doing its due diligence to keep people safe. It would be not nearly as "fun" to learn that there are serious concerns with these intramedullary nails still.

azaghul · « **Reply #21 on:** January 27, 2021, 06:40:43 PM »

Quote from: ghkid2021 on January 27, 2021, 04:49:28 PM

I have read many diaries regarding that bony thing regarding stryde. It's like a bone outgrowth or something and Dr. M tells patients to press on it consistently and eventually it subsides. No one knows what it is. Didn't really do anything negative as far as I'm aware of.

What diaries had this? And how much do u press

Polvorón · « **Reply #22 on:** January 27, 2021, 08:17:42 PM »

There are still other nails (or even externals for tibia), but I hope that this problem is solved soon, because there are a lot of people who need this surgery, for cosmetic or medical reasons. Stryde was a great improvement to the procedure.

V21 · « **Reply #23 on:** January 27, 2021, 08:37:43 PM »

Let's hope it gets solved soon

las vegas baby · « **Reply #24 on:** January 28, 2021, 07:10:12 AM »

this is worrying. if the NHS bans stryde nail that is breaking news. was stryde hurried ? is good old external frames the king after all this? how did FDA approve this if there were such major concerns?

can any Paley or dr. Debiparshad patients ask them about this? They have a great relationship with Nuvasive (first and second to implant stryde respectively). They have both been vocal about stryde being the best, so we should know what they have to say.

I like how dr. Rozburch was a little cautious from the beginning to his patients. He said stryde is still new, lets wait awhile before implanting it.

V21 · « **Reply #25 on:** January 28, 2021, 08:37:24 AM »

Before all of this happened Giotikas told me about that bony thing, but said that it has no bad effects: it just happens and they don't know why, so they have to look into it. I'm hopeful it gets solved soon

V21 · « **Reply #26 on:** January 28, 2021, 08:43:19 AM »

Here it is from Nuvasive: https://www.boa.ac.uk/uploads/assets/1b8d2c68-b020-4c0c-bdf4cbb66b23d583/NuVasive-Field-Safety-Notice.pdf

My English is bad, but I think it says Q2 2021 (Quarter two I guess?).

pownzorgeek · « **Reply #27 on:** January 28, 2021, 08:57:40 AM »

This is really bad news. So now if someone wants to do an LL surgery and was counting on Stryde, what other options/surgeons are there for a weight bearing nail?

V21 · « **Reply #28 on:** January 28, 2021, 09:03:53 AM »

If it's solved in quarter 2 2021, I think it's better to just wait a few months

Siegfried · « **Reply #29 on:** January 28, 2021, 09:08:40 AM »

i have enquired with dr. koehne, who is in direct contact with nuvasive. they say it will take till quarter 3, which basically means it could take till quarter 4. so everybody who was planning on doing stryde this year, better put your plans on hold or check alternatives surgery method. this could be the covid-19 of ll.

pownzorgeek · « **Reply #30 on:** January 28, 2021, 09:11:18 AM »

Quote from: Giotikas2021 on January 28, 2021, 09:03:53 AM

If it's solved in quarter 2 2021, I think it's better to just wait a few months

Yes, this is probably a good idea. It just sucks that I was really planning to have the surgery during the pandemic (so before June, July). After the pandemic it will be harder since I will be working.

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Author Topic: NuVasive Stryde stopped shipping (Read 14837 times)