| Dokumendiregister | Terviseamet |
| Viit | 11.2-4/24/7728-1 |
| Registreeritud | 29.07.2024 |
| Sünkroonitud | 30.07.2024 |
| Liik | Sissetulev dokument |
| Funktsioon | 11.2 Turustamise eelne järelevalve (pre-marketing surveillance) |
| Sari | 11.2-4 Erandid vastavushindamismenetlusest, taotlused ja kirjavahetus |
| Toimik | 11.2-4/2024 |
| Juurdepääsupiirang | Avalik |
| Juurdepääsupiirang | |
| Adressaat | PERH |
| Saabumis/saatmisviis | PERH |
| Vastutaja | Maarika Ojala (TA, Peadirektori asetäitja (1) vastutusvaldkond, Meditsiiniseadmete osakond) |
| Originaal | Ava uues aknas |
From: Paul-Sander Vahi - PERH <[email protected]>
Sent: Wed, 24 Jul 2024 05:46:45 +0000
To: "[email protected]" <[email protected]>
Cc: Berit Silvet - PERH <[email protected]>
Subject: Terviseameti nõusoleks CE-sertifikaadita proteesikomponentide tellimiseks
|
Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu saatja korral palume linke ja faile mitte avada. |
Tere!
Olen Paul-Sander Vahi, Põhja-Eesti Regionaalhaigla III ortopeedia osakonna juhataja ja pöördun Teie poole väikese murega. Nimelt meil on üks patsient, kel tehti ligikaudu 20 aasta eest põlveliigese proteesimine tuumorproteesiga. Nüüd on patsiendil proteesi lukustusmehhanism purunenud ning ta vajaks selle vahetust. Proteesi tarnija on Eesti turult lahkunud, kuid õnnestus endise edasimüüja kaudu saada kontakt tootjaga. Selgus, et proteesikomponente veel toodetakse, kuid kuna tegemist on väga vähe kasutatava tuumorproteesi komplektiga, millest on ka uus mudel väljas, siis sel puudub CE sertifikaat. Tootja on siiski nõus meile neid lukustusmehhanismi komponente tarnima, kuid nõuab selleks Terviseameti nõusolekut, kus oleks kirjas konkreetsed implantaadi komponendid ning konkreetne patsient, kellele need implanteeritakse ja ka haigla, kes operatsiooni teostab. Patsiendile on selgitatud, et sertifikaati komponentidel pole ning patsient on nõus ilma sertifikaadita komponentide implanteerimisega (samad komponendid on tal juba üle 20 aasta sees). Patsiendil teisi alternatiivseid variante pole – vastasel korral tuleks eemaldada kõik juba luu sisse fikseerunud komponendid, mis võib ka lõppeda reiest jala amputatsiooniga.
Kui saaksime teiepoolse nõusoleku, saaksime saata edasi ka täpsema info patsiendi kohta, mis peaks siis kirjas sisalduma. Seejärel on Stryker nõus meile komponente müüma. Komponentide tarneaeg on ligikaudu 2 kuud, seega oleks patsiendi huvides võimalikult kiiresti protsessiga algust teha.
Abile lootes ja ette tänades,
Paul Vahi
From: Strezikozin, Valeriy <[email protected]>
Sent: teisipäev, 23. juuli 2024 16:14
To: Paul-Sander Vahi - PERH <[email protected]>; Vahur Metsna <[email protected]>; Berit Silvet - PERH <[email protected]>
Cc: Anghel, Daniela <[email protected]>
Subject: RE: HMRS revision case
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|
Tähelepanu: E-kiri saadeti väljastpoolt Regionaalhaigla gruppi. Kui sa ei tunne saatjat või kahtled sisu ohutuses, siis ära ava linke ega manuseid! |
Hello Dr.Vahi, All,
Following today call and discussion with Dr Vahi, during which I shared approach we need to follow with regard your request, please see below couple very important points:
With regards starting this process and following your questions, please see below expected quotation.
Delivery cost will be added in the final offer.
Please keep in mind: if items will be not used or you will require additional items for surgery, you will be obliged to purchase all needed items or q-ty and we will not be able to accept any return!
Below you can see expected quotation:
|
CATALOG NUMBER |
GIM_ID |
ITEM_DESCRIPTION |
PACK_CONTENT |
2024 Price per Pack, EUR |
|
6466-9-230 |
544731 |
HMRS/G I-II. CIRCLIPS |
1 |
173.07 EUR |
|
6366-9-220 |
435518 |
HMRS AXIS PIN |
1 |
1,500.60 EUR |
|
6465-6-007 |
436235 |
HMRS WEDGE - 7 X 18 |
1 |
285.60 EUR |
|
6465-6-018 |
436237 |
HMRS BEARING - 18 X 24 |
1 |
236.80 EUR |
In the case of any questions, comments, please feel free to communicate or call me directly.
Best regards, Valeriy.
Valeriy Strezikozin
Sr Business Development Manager, CEE
Stryker
+40(725)565 638
TOGETHER WITH OUR CUSTOMERS, WE ARE DRIVEN TO MAKE HEALTHCARE BETTER
From: Paul-Sander Vahi - PERH <[email protected]>
Sent: Tuesday, July 23, 2024 9:52 AM
To: Strezikozin, Valeriy <[email protected]>
Subject: RE: HMRS revision case
Hi, Valery!
Thank you for getting in touch! You can reach me at +372 617 1866 or +372 53 40 9727
Best wishes,
Paul
From: Strezikozin, Valeriy <[email protected]>
Sent: kolmapäev, 10. juuli 2024 09:05
To: Paul-Sander Vahi - PERH <[email protected]>; Vahur Metsna <[email protected]>; Berit Silvet - PERH <[email protected]>
Cc: Ingrid Suuder <[email protected]>
Subject: RE: HMRS revision case
|
Some people who received this message don't often get email from [email protected]. Learn why this is important |
|
Tähelepanu: E-kiri saadeti väljastpoolt Regionaalhaigla gruppi. Kui sa ei tunne saatjat või kahtled sisu ohutuses, siis ära ava linke ega manuseid! |
Dear Ingrid,
Appreciated for sharing contacts.
Hello Dr Vahi, Dr Metsna and Ms Silvet,
I will be appreciated if you can share phone details with me, so I will be able contact you directly with regards providing details we can follow.
Required items for revision surgery communicated by Ingrid, below, do not have CE Mark and we will have to follow with some specific
and special steps, which will required require some effort from your side as well.
|
CATALOG NUMBER |
GIM_ID |
ITEM_DESCRIPTION |
|
6466-9-230 |
544731 |
HMRS/G I-II. CIRCLIPS |
|
6366-9-220 |
435518 |
HMRS AXIS PIN |
|
6465-6-007 |
436235 |
HMRS WEDGE - 7 X 18 |
|
6465-6-018 |
436237 |
HMRS BEARING - 18 X 24 |
Following that I would like to provide you details.
Thank you, Valeriy.
Valeriy Strezikozin
Sr Business Development Manager, CEE
Stryker
+40(725)565 638
TOGETHER WITH OUR CUSTOMERS, WE ARE DRIVEN TO MAKE HEALTHCARE BETTER
From: Ingrid Suuder <[email protected]>
Sent: Monday, July 8, 2024 12:18 PM
To: Strezikozin, Valeriy <[email protected]>; Paul-Sander Vahi - PERH <[email protected]>; Vahur Metsna <[email protected]>;
[email protected]
Subject: HMRS revision case
EXTERNAL EMAIL
Hello,
This is to share the contacts for the revision HMRS Case.
Valeriy from Stryker has been working with this case; Dr Vahi has the patient and he is head of the department; dr Metsna is head of the clinic and Ms Silvet is from purchasing department.
Dear Valeriy, please feel free to communicate directly with the hospital regarding all the paperwork, logistics etc.
I hope it will work out!
Best Regards,
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