NUVASIVE NSO Precice-titanium IFU Update Final logo

NUVASIVE NSO Precice-titanium IFU Update Final

NUVASIVE NSO Precice-titanium IFU Update Final product

Dzina Lazamalonda: Precice Intramedullary limb lethening (IMLL), Precice Short, Unyte, ndi mayina amalonda a Ufulu
Zochita: Chidziwitso cha Advisory
NuVasive Specialized Orthopedics, Inc. (NSO) mwaufulu ikupereka Field Safety Notice (FSN) kuti idziwitse opereka chithandizo chamankhwala zotsatirazi, potsatira kuyambira Feb 2021 Precice FSN isanachitike ndi Epulo 2021 - kulumikizana kwa NSO Statement:

  1. Chidziwitso ichi cha zosintha zamakalata athu a US Instructions for Use (IFU). Zosinthazi zikuphatikiza:
    •  Kufotokozera kuti chipangizocho chimapangidwa kuti chigwiritsidwe ntchito kwa odwala omwe ali ndi zaka 18 kapena kuposerapo.
    •  Kuti zipangizo zosaposa 2 ziyenera kuikidwa panthawi imodzi, ndi
    •  Odwala ayenera kulemera 50lbs kapena kupitirira pamene akulandira chithandizo cha zipangizo zomwe zalembedwa.
  2. Chidziwitsochi ndikudziwitsani kuti sitima ya Precice IMLL ndi Short yakwezedwa ndipo zinthuzi zikupezekanso kuyambira pa Nov 15, 2021.
  3. Chidziwitsochi ndikudziwitsa kuti sitima ya Precice Unyte ndi Freedom yakwezedwa ndipo zinthuzi zikupezekanso kuyambira pa Nov 30, 2021.

Kufotokozera kulikonse kwa Precice kumaphatikizapo Precice IMLL, Short, Unyte, and Freedom.
Zosintha zotsatirazi zapangidwa ku US IFUs yathu yomwe ili pa www.nuvasive.com/eIFU. Timalimbikitsa ogwiritsa ntchito omwe ali ndi zida zomwe zilipo kale kuti asunge FSN iyi ngati chikalata chofotokozera.

Gawo la IFU Chilankhulo Chasinthidwa cha IFU (m'mawu olimba mtima)
Ntchito Yogwiritsidwa Ntchito
(IMLL, Short, Unyte)
………. pseudoarthrosis, mal-unions, non-unions, kapena mayendedwe a mafupa a mafupa aatali kwa odwala azaka 18 ndi kupitirira.
Ntchito Yogwiritsidwa Ntchito
(Ufulu)
………. kuleza mwendo wotsalira wa chikazi mwa odwala azaka 18 ndi kupitilira apo.
machenjezo Odwala ………. sayenera kuikidwa ndi zipangizo zoposa ziwiri panthawi imodzi ndipo kulemera kwa wodwalayo kuyenera kukhala osachepera 50 lbs.

Zifukwa Zosintha za IFU:

  • Zosinthazi zikutsatiridwa ndi mauthenga am'mbuyomu:
    • Feb 2021 Precice FSN ndi Epulo 2021 - NSO Statement
  •  Zosinthazi zimamveketsa bwino malangizo okhudzana ndi chiwerengero cha odwala omwe akutsata malinga ndi umboni waposachedwa wa sayansi.

Zachipatala:
NuVasive ikupitiriza kuyang'anira deta yonse yowunika pambuyo pa msika yokhudzana ndi makina a Precice IMLL, Short, Unyte, ndi Freedom. Mpaka pano, palibe malipoti okhudza zoopsa za toxicological zomwe zadziwika. Kuwunika kowonjezera kwachilengedwe kukupitilirabe kuti muwone ngati pali zoopsa zomwe zingachitike kwa odwala osakwana 50lbs kapena kwa odwala omwe ali ndi zida zopitilira ziwiri. Mpaka kuyesako kumalizidwa, kugwiritsa ntchito Precice IMLL, Short, Unyte, ndi Freedom sikuvomerezeka kwa odwala omwe ali pansi pa 50lbs kapena okhala ndi zida zopitilira 2.

Zoyenera kuchita:
FSN iyi imapereka zambiri zokhudzana ndi zosintha za IFUs za Precice IMLL, Short, Unyte, and Freedom. Ma IFU omwe asinthidwa amamveketsa bwino momwe angagwiritsire ntchito ndipo akuyenera kufunsidwa (www.nuvasive.com/eIFU) asanasamale komanso panthawi yosamalira odwala omwe akuthandizidwa ndi zida za Precice System.

  •  IFU iyenera kufunsidwa nthawi zonse odwala asanalandire chithandizo.
  •  Woimira NSO azilumikizana ndi ofesi yanu kapena inu kuti akuthandizeni ndi mafunso kapena nkhawa zilizonse.
  •  Kuvomereza zosinthazi ndikofunikira. Chonde review, malizitsani, sainani ndi kubweza Fomu Yotsimikizira Wolandira Wotumizidwayo yolumikizidwayo motsatira malangizo omwe ali pa fomuyo (yotsagana ndi chidziwitsochi).
  • Kwa odwala omwe pano akulemera makilogalamu ochepera 50 komanso/kapena okhala ndi zida zopitilira ziwiri zobzalidwa ayenera kuonana ndi gulu lawo lachipatala kuti awone momwe chithandizo chawo chikuyendera ndikuganiziranso kuchotsedwa kwa misomali nthawi yomweyo kumapeto kwa chithandizo. Kutsatira izi zomwe zikulimbikitsidwa kutha kuchepetsa kuthekera kwa kuyika kwapang'onopang'ono komanso kuchepetsa zoopsa zomwe zimayenderana ndi maopaleshoni obwerezabwereza komanso kutembenuzira njira zochiritsira zapakati pamankhwala.

Malingaliro otsatirawa akuyenera kuganiziridwa mukamagwiritsa ntchito zida zilizonse za Precice molingana ndi IFU (IMLL, Short, Unyte, and Freedom) kuphatikiza, koma osati ku:

  •  Misomali ya Precice imakhalabe yobzalidwa mpaka kugwirizanitsa mafupa kumalizidwa. Dokotala akazindikira kuti msomali wakwaniritsa cholinga chake ndipo sukufunikanso, umachotsedwa pogwiritsa ntchito njira zopangira opaleshoni.
  •  Chipangizocho chichotsedwe pambuyo pa implantation nthawi yosapitirira chaka chimodzi.
  •  Zida za Precice ndizotsutsana ndi odwala omwe msomali umadutsa malo olowa kapena kutsegula mbale za kukula kwa epiphyseal.
  •  Zida za Precice ndizotsutsana ndi odwala omwe sakufuna kapena osatha kutsatira malangizo osamalira pambuyo pa opaleshoni.
  •  Misomali ya Precice siingathe kupirira kupsinjika kwa kulemera kwathunthu kwa tibia ndi ntchito za femur.
  •  Zida za Precice ndizoletsedwa kuti zigwiritsidwe ntchito kwa odwala omwe ali ndi ziwengo zachitsulo komanso zomverera.
  •  Ma implants achitsulo amatha kumasula, kuthyoka, kuwononga, kusuntha, kapena kuyambitsa kupweteka.
  •  Kusuta, kugwiritsa ntchito steroid / mankhwala osokoneza bongo komanso kugwiritsa ntchito mankhwala ena odana ndi kutupa kwatsimikiziridwa kuti kukhudza machiritso a mafupa ndipo kungakhale ndi zotsatira zovulaza za kusinthika kwa fupa panthawi yotalikitsa. Kuonjezera apo, odwala ayenera kuyesedwa chifukwa cha kudalira kwa narcotic komwe kumakhudzana ndi kuchepetsa ululu.

Pakachitika zovuta kapena zovuta zamtundu wogwiritsa ntchito mankhwalawa, wotumiza atha kufotokozera izi kwa NuVasive pa. complaints@nuvasive.com, ndi pulogalamu ya FDA's MedWatch Adverse Event Reporting mwina pa intaneti, kudzera mwa makalata kapena fax.

Kutumiza Chidziwitso cha Chitetezo cha Mundawu:
Chidziwitsochi chiyenera kuperekedwa kwa onse omwe akuyenera kudziwa za bungwe lanu. Chidziwitsochi chaperekedwa kwa akuluakulu onse ogwira ntchito.
_____________________________
Matthew Collins
Wachiwiri kwa Purezidenti, Global Quality Assurance
101 Makampani #100
Aliso Viejo, CA 92656
Chidziwitso Chachitetezo cha Precice Field - Novembara 30, 2021
November 30, 2021
Date
Dzina Lazamalonda: Precice Intramedullary limb lethening (IMLL), Precice Short, Unyte, ndi mayina amalonda a Ufulu
Zochita: Chidziwitso cha Advisory

Fomu Yotsimikizira Wolandira
Ndikofunika kuti bungwe lanu lichite zomwe zafotokozedwa mu FSN iyi ndikutsimikizira kuti mwalandira FSN iyi. Chonde lembani ndikubweza fomuyi ku NSO malinga ndi malangizo omwe ali pansipa. Yankho la bungwe lanu ndi umboni womwe tikufunika kuti tiwunikire kufalitsidwa kwa chidziwitsochi. NUVASIVE NSO Precice-titanium IFU Kusintha Final 01Ndikuvomereza kulandira ndikuwerenga Novembala 30, 2021 Precice IMLL, Short, Unyte, ndi Freedom FSN NUVASIVE NSO Precice-titanium IFU Kusintha Final 02Fomu iyi iyenera kubwezeredwa ku NSO - Jambulani ndikutumizirani fomuyi ku FSNprecice@nuvasive.com

Zolemba / Zothandizira

NUVASIVE NSO Precice-titanium IFU Update Final [pdf] Malangizo
NSO Precice-titanium IFU Update Final, IFU Update Final, NSO Precice-titanium, Update Final, Final

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