Events

Retiro De Equipo (Recall) de MEDTRONIC SPINOUS PROCESS CLAMP

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

¿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
    60650
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2017-07-11
  • 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
    Medtronic has become aware of instances where spine clamps have been damaged when forced open beyond their intended limits during use and will subsequently not open once attached to a patient's spinous process. when the spine clamp is forced open beyond its intended limits a component (captive washer) may break off. the washer could then be inadvertently left behind in a patient's body if the breakage occurs during the procedure. if the washer is missing from the device the spine clamp cannot be re-opened after placement on the spinous process. the unintended removal of spinous process can lead to damage of adjacent vertebra and cause premature degradation. this notification is intended to provide instructions to help healthcare practitioners identify whether a spine clamp has been damaged prior to use.

Device

MEDTRONIC SPINOUS PROCESS CLAMP
  • Modelo / Serial
    Model Catalog: 9735500 (Lot serial: >10 lot numbers contact mfg); Model Catalog: 9734716 (Lot serial: >10 lot numbers contact mfg); Model Catalog: 9734715 (Lot serial: >10 lot numbers contact mfg)
  • Descripción del producto
    MEDTRONIC SPINOUS PROCESS CLAMP
  • Manufacturer
    MEDTRONIC OF CANADA LTD.

Manufacturer

MEDTRONIC OF CANADA LTD.
  • Dirección del fabricante
    BRAMPTON
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • 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
    HC