Solera Screwdriver

Fabricante

  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    SATP

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Más información acerca de la data acá

  • Modelo / Serial
  • Descripción del producto
    Medical instruments for use in humans - bone surgery
  • Manufacturer
  • Modelo / Serial
    For this action, device lot numbers are not applicable. The action covers all lots of products distributed between September 2010 and July 2015
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (nationwide) and Internationally to Canada; United Arab Emirates; Australia; Belgium; Switzerland; China; Germany; Denmark; Spain; Finland; France; Great Britain; Greece; India; Israel; Italy; Japan; Netherlands; New Zealand; Poland; Portugal; Sweden; Singapore; Thailand; Slovakia; Turkey; and South Africa.
  • Descripción del producto
    P/N: 9735023, DRIVER 9735023 SOLERA 5.5/6.0 MAS; P/N: 9735024, DRIVER 9735024 SOLERA 5.5/6.0 MAS CAN; || P/N: 9735025, DRIVER 9735025 SOLERA 5.5/6.0 RMAS; P/N: 9735026, DRIVER 9735026 SOLERA 5.5/6.0 RMAS CAN; P/N: 9735027,DRIVER 9735027 SOLERA 5.5/6.0 FAS/SAS. || The Medtronic Navigated Solera Screwdrivers are reusable devices that are designed for use in spine surgery to assist in the placement of screws during the surgery, using a Medtronic computer-assisted surgery system.
  • Manufacturer
  • Modelo / Serial
    For this action, device lot numbers are not applicable. The action covers all lots of products distributed between September 2010 and July 2015
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (nationwide) and Internationally to Canada; United Arab Emirates; Australia; Belgium; Switzerland; China; Germany; Denmark; Spain; Finland; France; Great Britain; Greece; India; Israel; Italy; Japan; Netherlands; New Zealand; Poland; Portugal; Sweden; Singapore; Thailand; Slovakia; Turkey; and South Africa.
  • Descripción del producto
    P/N: 9734856, SCREWDRIVER, 9734856, SOLERA STD MAST; P/N: 9734857, SCREWDRIVER, 9734857, SOLERA RDN MAST; P/N: 9734279, SCREWDRIVER 9734279 SOLERA STANDARD; and P/N: 9734373, SCREWDRIVER 9734373 SOLERA REDUCTION. || The Medtronic Navigated Solera Screwdrivers are reusable devices that are designed for use in spine surgery to assist in the placement of screws during the surgery, using a Medtronic computer-assisted surgery system.
  • Manufacturer