Events

Retiro De Equipo (Recall) de Medtronic TSRH 3DX Splined Connector

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK.

¿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
    50185
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1016-2009
  • Fecha de inicio del evento
    2008-10-31
  • Fecha de publicación del evento
    2009-03-12
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2009-11-18
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74916
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Orthosis, spinal pedicle fixation, for degenerative disc disease - Product Code MNI
  • Causa
    The thickness of the connector may be under specification, which could cause the implant to break during surgery or after implantation.
  • Acción
    Hospital risk managers and implanting physicians were notified separately by letters dated 1/9/09. The letters advised of the recall, reported that a firm representative would visit the facility to pick up the recalled products. Physicians were instructed to closely monitor their patients during postoperative visits, to notify any other physician who may be monitoring the patient in lieu of the implanting physician, and to advise their patients to contact them immediately if they have any sudden and significant symptoms (increased discomfort, sudden change in their clinical symptoms, or new symptoms such as leg pain, back pain or irritation of local tissue). Customers were also instructed to complete and return the attached questionnaire to Medtronic SOFAMOR DANEK via mail (enclosed self-addressed stamped envelope) or fax at 901-399-2047. Direct questions to your Medtronic SOFAMOR DANEK Sales Representative or the firm's Global Quality Department at 800-876-3133, extension 6333.

Device

Medtronic TSRH 3DX Splined Connector
  • Modelo / Serial
    All lots.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide Distribution including states of Arizona, Connecticut, Georgia, Indiana, Minnesota, New Jersey, New York, South Carolina, Texas and Washington.
  • Descripción del producto
    Medtronic TSRH Spinal System, 3Dx Splined Connector, Large; Medtronic Sofamor Danek, Memphis, TN; REF 8351512. || The device is intended for orthosis, spinal pedicle fixation for degenerative disc disease. The product is used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients; posterior non-cervical, non-pedicle screw fixation or for anterior use for certain conditions.
  • Manufacturer
    Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK

Manufacturer

Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK
  • Dirección del fabricante
    Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK, 2500 Silveus Crossing, Warsaw IN 46582-8598
  • Source
    USFDA