Topic: NuVasive Stryde stopped shipping (Read 16043 times)

BreaktoGrow · « **Reply #217 on:** March 03, 2021, 06:36:18 PM »

Hm, my doctor informed me that they were experiences issues with material corroding and reports were anecdotally relating the depletion of material to pain in the thigh. If we assume this is the case, wouldn't they need to address that and therefore make adjustments?

Siegfried · « **Reply #218 on:** March 03, 2021, 07:07:35 PM »

This is just speculation, but i think that might be another set of problems, which may not be directly related to the recall. Maybe they will address those problems after they complete the tests and resend the nails, since it appears to be a minor problem. But hey, i'm just trying to be optimistic here.

BreaktoGrow · « **Reply #219 on:** March 03, 2021, 09:25:20 PM »

I'm happy that you're being optimistic. Definitely helps justifying waiting as oppose to going forward with Precice. Any other information you have on hand that could shed light? By the way, if you had the choice of getting Precice tomorrow, or waiting it out for Stryde, what would you do?

V21 · « **Reply #220 on:** March 03, 2021, 10:17:48 PM »

I think it depends on your need for it. In my case, it must be done before September. I would wait for september, but it seems very unlikely it would be available there. Then, I will do Precice in June. I think it's quite worse, but doable if you have someone to help you. Besides, I will try to buy things like pedals to exercise my legs while being on the ground. Also a big walker with wheels to walk every day without weight bearing.

BreaktoGrow · « **Reply #221 on:** March 03, 2021, 10:23:28 PM »

When do you imagine it returning? Also - what's your current height and how many cm's are you trying to achieve? Congrats, by the way.

V21 · « **Reply #222 on:** March 03, 2021, 10:27:46 PM »

Maybe like november? All seems quite uncertain right now, that's the problem, no info a no communication. And I'm 172/173, I just want to do 5 cm so it's not that bad in my case to take precice.

Arctic · « **Reply #223 on:** March 03, 2021, 11:27:26 PM »

I think it's going to take a while. I would anticipate it getting modified and remanufactured. They're not going to risk future lawsuits (as evidenced by participating in a voluntary recall) just to get this out, especially when they already have alternate products on the market that do the same thing.

BreaktoGrow · « **Reply #224 on:** March 04, 2021, 01:56:13 AM »

On the opposing side, they're losing millions upon millions. They're team must be working around the clock to get this out.

Shhh · « **Reply #225 on:** March 07, 2021, 01:29:33 PM »

Had f/u appointment with Dr. conway. Company rep was at appointment too.

VERY interesting inferences I took from this. Dr. Conway is professional and cautiously guarded. She nor the rep would make any official statements; they're not stupid to stick their necks out.

But I inferred these opinions and was not corrected by either.

-Stryde is NOT coming back ANYTIME soon..... and here's the big one.... not coming back potentially EVER.

-my chromium levels were double almost triple what would be "normal". BUT I believe for poisoning you would need at least 20 times the normal amount.

-I believe she is looking in a completely different direction from anything Nuvasive.

-The rep was quiet but would neither confirm nor deny any of my polite questions. The rep recommended Precise for anybody else. I asked him if the implant is stainless steel why or how could it be leaching these other elements? He said yes it is stainless but it is still formulated with other metals. Interesting.

To reiterate I am a 51 y/o physical therapist and ex-gymnast who achieved 8 cm at 51 years old consolidating just this past January. IMHO IMHO IMHO ..... this kind of stuff has happened with hip replacement surgery. But with a partial or total hip replacement you have a constant movement or constant rubbing of the ball and socket joint so I could understand how a poorly formulated implant could leach metal over time. But after the lengthening phase of the stryde nail it's existence in your body is static. So by that analogy there should be less exposure to these metals leaching because there is simply no more movement. what is very slightly concerning to me is in a hip replacement surgery you have a titanium femoral head (ball) that is rotating in the acetabulum (socket). The acetabulum is always a plastic composite material so you really don't have Metal on metal whereas in the distraction phase of the stryde nail you do have metal rotating on metal.

Still in the long term I could see a hip implant corroding overtime due to constant movement. I'm hoping the saving grace for those that have these nails is that after consolidation there is no movement. But is it a frictional sloughing of metals or is it truly a corrosion. Because if the operative word is corrosion that can be a bit concerning.

Arctic · « **Reply #226 on:** March 07, 2021, 02:36:42 PM »

Quote from: Shhh on March 07, 2021, 01:29:33 PM

Had f/u appointment with Dr. conway. Company rep was at appointment too.

VERY interesting inferences I took from this. Dr. Conway is professional and cautiously guarded. She nor the rep would make any official statements; they're not stupid to stick their necks out.

But I inferred these opinions and was not corrected by either.

-Stryde is NOT coming back ANYTIME soon..... and here's the big one.... not coming back potentially EVER.

Very useful information and is what I feared. Looks like I will be going ahead with Precice.

Erkan · « **Reply #227 on:** March 07, 2021, 02:48:12 PM »

Quote from: Shhh on March 07, 2021, 01:29:33 PM

Had f/u appointment with Dr. conway. Company rep was at appointment too.

VERY interesting inferences I took from this. Dr. Conway is professional and cautiously guarded. She nor the rep would make any official statements; they're not stupid to stick their necks out.

But I inferred these opinions and was not corrected by either.

-Stryde is NOT coming back ANYTIME soon..... and here's the big one.... not coming back potentially EVER.

-my chromium levels were double almost triple what would be "normal". BUT I believe for poisoning you would need at least 20 times the normal amount.

-I believe she is looking in a completely different direction from anything Nuvasive.

-The rep was quiet but would neither confirm nor deny any of my polite questions. The rep recommended Precise for anybody else. I asked him if the implant is stainless steel why or how could it be leaching these other elements? He said yes it is stainless but it is still formulated with other metals. Interesting.

To reiterate I am a 51 y/o physical therapist and ex-gymnast who achieved 8 cm at 51 years old consolidating just this past January. IMHO IMHO IMHO ..... this kind of stuff has happened with hip replacement surgery. But with a partial or total hip replacement you have a constant movement or constant rubbing of the ball and socket joint so I could understand how a poorly formulated implant could leach metal over time. But after the lengthening phase of the stryde nail it's existence in your body is static. So by that analogy there should be less exposure to these metals leaching because there is simply no more movement. what is very slightly concerning to me is in a hip replacement surgery you have a titanium femoral head (ball) that is rotating in the acetabulum (socket). The acetabulum is always a plastic composite material so you really don't have Metal on metal whereas in the distraction phase of the stryde nail you do have metal rotating on metal.

Still in the long term I could see a hip implant corroding overtime due to constant movement. I'm hoping the saving grace for those that have these nails is that after consolidation there is no movement. But is it a frictional sloughing of metals or is it truly a corrosion. Because if the operative word is corrosion that can be a bit concerning.

Yeah thx for the info. Im nearly 40 days post surgery with stryde. I will try to get my chromium level checked.

RealLostSoul · « **Reply #228 on:** March 08, 2021, 03:56:17 PM »

Talked with Paley, he says maybe STRYDE returns in August or September but only if you are optimistic. Probably till the end of this year

. So I guess even when I start in summer with precice I will be done before stryde is back.

V21 · « **Reply #229 on:** March 08, 2021, 05:59:25 PM »

And I guess he meant in the US, because it will be even longer in Europe. I'm in the same boat as you, Precice it is this summer...

2020hope · « **Reply #230 on:** March 08, 2021, 06:02:32 PM »

From reading all this, even if stryde got approved this year I would be vary of using it.

RealLostSoul · « **Reply #231 on:** March 08, 2021, 06:03:33 PM »

Quote from: V21 on March 08, 2021, 05:59:25 PM

And I guess he meant in the US, because it will be even longer in Europe. I'm in the same boat as you, Precice it is this summer...

Yep... Where are you doing it? and when? I'll travel to the US in early June.

RB · « **Reply #232 on:** March 08, 2021, 06:07:13 PM »

Quote from: RealDamagedLostSoul on March 08, 2021, 03:56:17 PM

Talked with Paley, he says maybe STRYDE returns in August or September but only if you are optimistic. Probably till the end of this year . So I guess even when I start in summer with precice I will be done before stryde is back.

Did he seem concerned about the delay or did he clarify why it will take longer than expected?

PANDA:BEAR.. · « **Reply #233 on:** March 08, 2021, 06:14:40 PM »

Hi... does anyone know.. what they have changed with the Precise.... Due to the Stryde recall problems.. Panda

RealLostSoul · « **Reply #234 on:** March 08, 2021, 06:20:33 PM »

Quote from: RB on March 08, 2021, 06:07:13 PM

Did he seem concerned about the delay or did he clarify why it will take longer than expected?

No, he didn't seem concerned nor did his assistant surgeon. They told me it's just because of the extra bone growth abnormality.

Quote from: PANDA:BEAR.. on March 08, 2021, 06:14:40 PM

Hi... does anyone know.. what they have changed with the Precise.... Due to the Stryde recall problems.. Panda

not 100% sure here but I doubt there is anything different. Paley told me he will use the same precice he did for years before stryde. he said it's a good nail and does its job but the weight-bearing thing is really not to be underestimated. They said something along the lines they will have to check if they can use the strongest diameter one for me because I have a relatively tall starting height but I am not sure since I am also very thin.

V21 · « **Reply #235 on:** March 08, 2021, 11:14:45 PM »

Quote from: RealDamagedLostSoul on March 08, 2021, 06:03:33 PM

Yep... Where are you doing it? and when? I'll travel to the US in early June.

Greece on July. I think I have big bones, so I'm getting X rays to see if at least I'm lucky enough for the big nail lol

RealLostSoul · « **Reply #236 on:** March 08, 2021, 11:31:34 PM »

Quote from: V21 on March 08, 2021, 11:14:45 PM

Greece on July. I think I have big bones, so I'm getting X rays to see if at least I'm lucky enough for the big nail lol

Good idea! good luck with that. Do you think you can weight bear, or at least use crutches for the majority of the time if you can use the big diameter P2.2? I mean if you are below 146 lbs it should work, shouldn't it?

PANDA:BEAR.. · « **Reply #237 on:** March 17, 2021, 04:58:53 PM »

Update

Arctic · « **Reply #238 on:** March 17, 2021, 10:24:38 PM »

Spoke to my doctor recently, he reiterated that this would take at least a year before STRYDE is back for CLL, possibly up to two years.

Siegfried · « **Reply #239 on:** September 10, 2021, 10:29:02 AM »

Any sign of precise returning in September? My surgery for the 10. September was cancelled due to precise not having the appropriate certificate in Europe. 2021 has been quite the sihtshow for nuvasive to be honest

Limb Lengthening Forum

Author Topic: NuVasive Stryde stopped shipping (Read 16043 times)