Events

Retiro De Equipo (Recall) de IPS CASEDESIGNER

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por NOBEL BIOCARE CANADA INC.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    96899
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2017-12-11
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Notas adicionales en la data
  • Causa
    A bug has been discovered via a support case for the ips casedesigner software on november 24 2017 which might lead to designing an incorrect intermediate splint and the user to place the maxilla (and as a result of the occlusion matching also the mandibula) incorrectly during surgery in a very specific scenario: 1.A surgery is planned in the version 1.2 of ips casedesigner using the maxilla rotation point function - moving it from its default position. 2. the user updates the software to the version 1.3. 3. the user opens the planning previously made in the version 1.2 with the version 1.3: the maxilla rotation point will move back to its default position changing the plan originally made by the user. 4. the user saves the planning in the version 1.3. 5. the user orders the splints (intermediate and final) according to the revised planning without noticing the change. the modification of the surgery planning by the sfotware due to the buy can only be detected if the change to the original planning is obvious. the user should always carefully check the surgery planning before proceeding to creating the surgical splint file. a total 37 articles were deployed to 20 customers. only one article 300011_v1.3_win64 was sold in canada.

Device

IPS CASEDESIGNER
  • Modelo / Serial
    Model Catalog: 300011_V1.3_MAC (Lot serial: K0000022); Model Catalog: 300011_V1.3_WIN64 (Lot serial: K0000022)
  • Descripción del producto
    IPS CaseDesigner
  • Manufacturer
    NOBEL BIOCARE CANADA INC

Manufacturer

NOBEL BIOCARE CANADA INC
  • Dirección del fabricante
    RICHMOND HILL
  • Empresa matriz del fabricante (2017)
    Danaher Corporation
  • Source
    HC