Should I avoid using precice in India?

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I am choosing between precice or fully external tibias in India. Based on my research Dr. Parihar has done the most precice cases in India but even he has only done half a dozen or so. Dr. Suhas Shah also has some experience but then again very few in number.

But they have done plenty of externals. Externals means no chance of deep bone infection and fat embolism. I can also weight bear and not be confined to whellchair.
I don't know if Precice will get support from Nuvasive in India if there are problems with the nail or ERC machine. Also from what I heard we have to get a license from the Indian FDA for Precice which is  another extra step.

In the US Precice would be the right choice but in India would it be different?

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He is good but my question is more about whether the surgeon not using preecice nails enough can be  a problem.

Another thing is He wants you to bring a family member with you so you can't do it with full privacy. This is true even if you are an adult.

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My question is more like if the surgeon is not much experienced with Precise nails but is experienced with externals will he have difficulties with Precice?

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Quote from: overandover on March 06, 2022, 09:03:41 AMPrecice surgery is just putting a nail into the femur which any surgeon can do. Also, Dr Parihar doesn't require you to bring someone with you. He just needs you to inform someone close to you like a wife or a parent so that they know you are doing this. I think his 6-7 cases experience is enough. He has a lot of experience with externals and even with treating bone infections and complex fractures. Fully externals is the best method for tibia in my opinion but if you want to do femurs then precice is better.

Yeah he can handle any complications that's for sure.

My concern is more about the working of the precice nails. Like if doesn't work or the ERC machine stops working. I checked that Nuvasive does not have an office in India and to use the nails I have apply for a special license. So if there any problems with the devices then I don't know if I can swiftly get a replacement.

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One more thing I am worried about is I do not think he gives anticoagulants, not even for 2 to 3 weeks after surgery. With precice we are completely in wheelchair. He is quite strict about not walking. Is it not very high risk to not take anticoagulants? Some people have died after this surgery due to this.

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That is very good to know. It reassured me as that was the biggest worry. Do you know if they will send the new ERC machines or old ones? It does not matter much if they send multiple but I was just curious.

Can I DM you please?

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To get a license for precice in India you have to fill a form called 12A with the Indian FDA called : CDSCO. In that form they ask for details about the employer and what occupation the applicant is doing. Is that really necessary?? They even asked for contact details of the company. Will they talk to the applicant's employer about this license?

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Quote from: overandover on March 06, 2022, 09:03:41 AMPrecice surgery is just putting a nail into the femur which any surgeon can do. Also, Dr Parihar doesn't require you to bring someone with you. He just needs you to inform someone close to you like a wife or a parent so that they know you are doing this. I think his 6-7 cases experience is enough. He has a lot of experience with externals and even with treating bone infections and complex fractures. Fully externals is the best method for tibia in my opinion but if you want to do femurs then precice is better.

How do we prove to him that we have informed someone? Does he need some letter to be signed by a family member?

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ok that is better. That is a phone call that can be taken care of. It should be possible to convince a family member although not ideal

But the employer thing is just odd. Why should we get our employer's permission to get a license to use Precice?? This license thing really sucks.

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Quote from: overandover on March 08, 2022, 01:42:27 PMYou don't have to fill anything. Just give your id to the agent he'll take care of everything. He won't ask you employee details or anything like that. He'll write self-employed on the form and no one cares about that. They add it to make sure that you're not in business of selling these products in India and you are ordering it for personal use only.

That makes sense why they ask for this detail.

Do they write "LL" in any part of the license application? Would be nice if it is kept completely discreet.