Events

Retiro De Equipo (Recall) de Device Recall SpheRx Posted Pedicle Screw System

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 NuVasive 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
    52634
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0374-2013
  • Fecha de inicio del evento
    2009-01-05
  • Fecha de publicación del evento
    2012-11-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-11-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=83525
  • 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 NKB
  • Causa
    The tulip portion of the screw assembly can disengage from the shank after implantation.
  • Acción
    Telephone communications to the sales representatives of surgeons actively using the Posted Pedicle Screw System were made on 01/05/2009. The calls were unscripted and requested that all inventory be forwarded to NuVasive's San Diego office for quarantine. Surgeons who were actively using the system were also contacted and notified of the situation. Follow-up communications were sent via mail on 01/19/2009 to all surgeons who participated in the Alpha release. The letter informed the customers of the problems identified. Customers were instructed that the recalling firm does not believe any further action is required and they were instructed to monitor the progress of their patients and notify NuVasive if any issues are detected. Customers with questions or concerns are instructed to contact the firm at (858) 909-1964.

Device

Device Recall SpheRx Posted Pedicle Screw System
  • Modelo / Serial
    Batch: JK2045, JK2038, JK2140, JK2361, JK2362, JK2365, JK2368, JK2370, JK2369, JK2377, JK2379
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC.
  • Descripción del producto
    6.5mm x 45mm Noncannulated Screw Shank || Subsequent Codes: KWP, KWQ, MNH, MNI
  • Manufacturer
    NuVasive Inc

Manufacturer

NuVasive Inc
  • Dirección del fabricante
    NuVasive Inc, 7475 Lusk Blvd, San Diego CA 92121-5707
  • Empresa matriz del fabricante (2017)
    NuVasive, Inc.
  • Source
    USFDA