Topic: NuVasive Stryde stopped shipping (Read 13636 times)

Siegfried · « **Reply #155 on:** February 20, 2021, 02:16:10 AM »

Jesus, can we please get some clarity on this matter. I really Hope it won’t take a full year and they’ll get done by the end of the year at least. my surgery also got cancelled 1 week beforehand because of this mess.

L8GrowthSpurt · « **Reply #156 on:** February 20, 2021, 02:32:38 AM »

Well said, Siegfried. What a mess! I was hoping to pull the trigger in March but hadn’t actually scheduled anything yet. Sorry about your cancellation and all the other LLers who had their surgeries actually cancelled. That sucks!

smalltaller · « **Reply #157 on:** February 20, 2021, 05:31:42 AM »

Are there any official statements? I can't find any...

Montreal172 · « **Reply #158 on:** February 20, 2021, 06:22:05 AM »

FDA is jammed baked with new covid tech, its the only reason why the review assessment is taking so long.

Siegfried · « **Reply #159 on:** February 20, 2021, 07:12:55 AM »

I don’t think the fda has any role to play here. This seems to be an internal testing study, which they failed to deliver in the past and which got uncovered by the nhs. As far as I understand there is no external agency involved here. The fda does also not play a role in Europe. But this is all speculation, since nuvasive has failed to deliver an official press statement to this day.

osiris · « **Reply #160 on:** February 20, 2021, 09:23:58 AM »

Quote from: smalltaller on February 20, 2021, 05:31:42 AM

Are there any official statements? I can't find any...

Here’s the official documentation regarding the recall.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?start_search=1&event_id=86150

permanentlybanned · « **Reply #161 on:** February 20, 2021, 10:08:40 AM »

Quote from: osiris on February 20, 2021, 09:23:58 AM

Here’s the official documentation regarding the recall.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?start_search=1&event_id=86150

That is not the correct recall documentation or link. That is not the stryde or precice stature lengthening nail. That is a recall for a limb Salvage nail called a bone transport nail. (Which was actually also recalled along with stryde this month as well) Different and was months ago in October . Unrelated am sorry

permanentlybanned · « **Reply #162 on:** February 20, 2021, 10:19:35 AM »

Toxicity assessments is expected to be completed in Q2 2021. Stryde may be put on market after this tests . s . Really sorry to everyone who want suregery

permanentlybanned · « **Reply #163 on:** February 20, 2021, 10:22:38 AM »

Stryde is product pulled because of report of bony abnormality on side of extending (telescoping) part of the nail . Perhaps risk no good need further test t.

permanentlybanned · « **Reply #164 on:** February 20, 2021, 10:25:17 AM »

Nuvasive personal recall document 200+ pages only first few are relevant

https://mhra-gov.filecamp.com/s/pz82Q5uAZowsRb7s/d

V21 · « **Reply #165 on:** February 20, 2021, 10:36:32 AM »

Quote from: ghkid2021 on February 20, 2021, 10:19:35 AM

Toxicity assessments is expected to be completed in Q2 2021. Stryde may be put on market after this tests . s . Really sorry to everyone who want suregery

Even Nuvasive is saying now July at the earliest, so definitely no quarter 2

Tartar · « **Reply #166 on:** February 20, 2021, 12:08:43 PM »

Quote from: Siegfried on February 20, 2021, 07:12:55 AM

I don’t think the fda has any role to play here. This seems to be an internal testing study, which they failed to deliver in the past and which got uncovered by the nhs. As far as I understand there is no external agency involved here. The fda does also not play a role in Europe. But this is all speculation, since nuvasive has failed to deliver an official press statement to this day.

You are true. That's just negligence by the company.

las vegas baby · « **Reply #167 on:** February 20, 2021, 02:11:38 PM »

worst part is no communication even now!!

there needs to be a PRESS RELEASE with a public apology at this point!!

permanentlybanned · « **Reply #168 on:** February 20, 2021, 08:33:41 PM »

Quote from: V21 on February 20, 2021, 10:36:32 AM

Even Nuvasive is saying now July at the earliest, so definitely no quarter 2

End of June is considered q2

permanentlybanned · « **Reply #169 on:** February 20, 2021, 08:34:54 PM »

Yah FDA did not issue a recall this is nuvasive themself

bgreeneee · « **Reply #170 on:** February 21, 2021, 05:38:28 PM »

Hi all-I had the Stryde nail implanted in Sept 2019 and removed in October 2020. I heard about the pause recently so came on here to see what news I could find. Like a lot of you on here, I’m not 100% clear on the issue. I will say, I remember some of my early xrays looking like the one on this thread...my doctor never said anything about it not being normal...like everyone else here, I’ve looked at my fair share of xrays but am by no means an expert...that’s why we have doctors! With my lengthening (not CLL, was an LLD)...I literally had 0 complications with it. So, I certainly hope they work out the issues quickly for all of your waiting for your surgery.

The other thing I will add...not sure if it’s psychological or physiological but I felt an immediate improvement after the rod was removed...it’s very heavy (I actually got to keep my rod after removal) so not sure if that’s it or if it’s just in my head lol...but I strongly recommend getting it out. The recovery is longer than 1-2 weeks...it’s more like 4 weeks but worth it. You can look at my patient experience story on this forum for more info or I have a youtube channel “Pulling my leg” that should be easy to find.

Going-For-Three · « **Reply #171 on:** February 22, 2021, 12:07:25 AM »

Is anyone considering moving forward with Precice 2 in the second half of March?

permanentlybanned · « **Reply #172 on:** February 22, 2021, 02:33:22 AM »

Quote from: bgreeneee on February 21, 2021, 05:38:28 PM

Hi all-I had the Stryde nail implanted in Sept 2019 and removed in October 2020. I heard about the pause recently so came on here to see what news I could find. Like a lot of you on here, I’m not 100% clear on the issue. I will say, I remember some of my early xrays looking like the one on this thread...my doctor never said anything about it not being normal...like everyone else here, I’ve looked at my fair share of xrays but am by no means an expert...that’s why we have doctors! With my lengthening (not CLL, was an LLD)...I literally had 0 complications with it. So, I certainly hope they work out the issues quickly for all of your waiting for your surgery.

The other thing I will add...not sure if it’s psychological or physiological but I felt an immediate improvement after the rod was removed...it’s very heavy (I actually got to keep my rod after removal) so not sure if that’s it or if it’s just in my head lol...but I strongly recommend getting it out. The recovery is longer than 1-2 weeks...it’s more like 4 weeks but worth it. You can look at my patient experience story on this forum for more info or I have a youtube channel “Pulling my leg” that should be easy to find.

Thanks man for your anecdote. Helps relieve some fear. Glad you're doing good man

_gulliver_ · « **Reply #173 on:** February 22, 2021, 07:41:45 AM »

There is probably a good reasoning to call back the nails and re-test it. However, there is also a need to check the functionality of the electromagnetic controllers as well. I have seen or heard it fail and give unexpected errors on a few patients, which required replacement or intervention from the company

kpa · « **Reply #174 on:** February 22, 2021, 08:09:50 PM »

what is surgery date

pownzorgeek · « **Reply #175 on:** February 23, 2021, 11:38:48 AM »

Quote from: bgreeneee on February 21, 2021, 05:38:28 PM

Hi all-I had the Stryde nail implanted in Sept 2019 and removed in October 2020. I heard about the pause recently so came on here to see what news I could find. Like a lot of you on here, I’m not 100% clear on the issue. I will say, I remember some of my early xrays looking like the one on this thread...my doctor never said anything about it not being normal...like everyone else here, I’ve looked at my fair share of xrays but am by no means an expert...that’s why we have doctors! With my lengthening (not CLL, was an LLD)...I literally had 0 complications with it. So, I certainly hope they work out the issues quickly for all of your waiting for your surgery.

The other thing I will add...not sure if it’s psychological or physiological but I felt an immediate improvement after the rod was removed...it’s very heavy (I actually got to keep my rod after removal) so not sure if that’s it or if it’s just in my head lol...but I strongly recommend getting it out. The recovery is longer than 1-2 weeks...it’s more like 4 weeks but worth it. You can look at my patient experience story on this forum for more info or I have a youtube channel “Pulling my leg” that should be easy to find.

Hi, how did you feel when you still had the rod inside? Were there more pains? And how was the sleep while you had the rod?

Shhh · « **Reply #176 on:** February 23, 2021, 05:10:18 PM »

Hello, first post. I am a 51 y/o male who did the stryde and gained the full 8cm on both femurs; consolidation began 1 month ago. What has precipitated this post is the "recall" and my doctor asking me to get a cobalt and chrome blood test. Any insight on these two elements in relation to the recall? thanks!

PANDA:BEAR.. · « **Reply #177 on:** February 23, 2021, 07:22:07 PM »

How come the FDA.. did not pick up.. on this matter? But the UK ... NHS did..
It's just shows poor patient care ... The UK.. NHS has a stricter policy.. It will put the UK Patients 1st.. the Stryde will have to pass a very tough test.. with the UK.. before it can go out on the Market for patients!!!!!

PANDA:BEAR.. · « **Reply #178 on:** February 23, 2021, 07:34:34 PM »

... I may go with the precise 2.. I'm not sure if I can wait for another year.. I feel sorry for the patients who were have recently booked with the Stryde.. I hope this matter is sorted out quickly

PANDA:BEAR.. · « **Reply #179 on:** February 23, 2021, 07:37:46 PM »

Quote from: Shhhzaammm on February 23, 2021, 05:10:18 PM

Hello, first post. I am a 51 y/o male who did the stryde and gained the full 8cm on both femurs; consolidation began 1 month ago. What has precipitated this post is the "recall" and my doctor asking me to get a cobalt and chrome blood test. Any insight on these two elements in relation to the recall? thanks!

Who is your Doctor... and where did you get your surgery done.. and how do you feel.. with the new height? Was it worth it ?

Jcorleone · « **Reply #180 on:** February 23, 2021, 07:57:40 PM »

Avoid precice method surgery till Nuvasive makes a second official statement.

PANDA:BEAR.. · « **Reply #181 on:** February 23, 2021, 08:02:01 PM »

Quote from: Jcorleone on February 23, 2021, 07:57:40 PM

Avoid precice method surgery till Nuvasive makes a second official statement.

Can you please ... tell me. why I should Avoid the Precice ?

Jcorleone · « **Reply #182 on:** February 23, 2021, 08:25:16 PM »

Most of the people on this forum know very well that in the last 1 year, many cases of breakage from Precice nails have been reported. The production of the nails was therefore stopped several times by the FDA and the nails were recalled. Some doctors use previously purchased nails, although they are life-threatening.

Here’s the official documentation regarding the recall.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?start_search=1&event_id=86150

Here's the another threat about some precice user doctors (b*tchers)
http://www.limblengtheningforum.com/index.php?topic=66254.0

permanentlybanned · « **Reply #183 on:** February 23, 2021, 08:32:39 PM »

I cannot believe the amount of misinformation you're spreading Jcoreleone. If you don't know about something then just shut up. It's honestly stunning when people post links that they haven't even read at all and make up random bullshït to sound credible.

V21 · « **Reply #184 on:** February 23, 2021, 08:37:35 PM »

Precice use has been aproved by the FDA. The document linked is not even related to this matter lol

Stryde2021 · « **Reply #185 on:** February 23, 2021, 09:13:40 PM »

Quote from: Shhhzaammm on February 23, 2021, 05:10:18 PM

Hello, first post. I am a 51 y/o male who did the stryde and gained the full 8cm on both femurs; consolidation began 1 month ago. What has precipitated this post is the "recall" and my doctor asking me to get a cobalt and chrome blood test. Any insight on these two elements in relation to the recall? thanks!

Semi-informed speculation here: Stryde uses metals that are more corrosive than Precice. Those metals can in theory enter your bloodstream. Also I think we have the same doc; feel free to PM

Limb Lengthening Forum

Author Topic: NuVasive Stryde stopped shipping (Read 13636 times)