Events

Retiro De Equipo (Recall) de Arsenal Set-Screw, a sub-component of the Arsenal Spinal Fixation System

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Scientx Australia.

¿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
    RC-2016-RN-01639-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-12-22
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01639-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    For certain lots of set screw, the manufacturer has become aware of a trend specific to set screw postoperative disengagement from the screw body (set screw back-out). 16 complaints were received from october 2015 through august 2016. in the short term, there is a risk that set screw post-operative disengagement from the screw body at the end of a construct may lead to hardware failure and/or pedicle screw pull-out on adjacent levels, and may also lead to revision surgery. the long term risk is that set screw post-operative disengagement from the screw body may lead to loss of correction, as well as the non-union/non-fusion of bone (pseudoarthrosis). there is also an unrelated issue for other lots of set screws where a small proportion of lots were manufactured in an oversized condition. for this issue, testing conducted by alphatec indicates that if the set screw is successfully inserted and locked to the required tightening torque, the construct will perform appropriately.
  • Acción
    For the screw back-out issue, implanting surgeons are being informed to consider more frequent follow-up visits during the initial postoperative phase(s) after surgery. For the oversized condition issue, surgeons are advised that tightening the set screws to the prescribed tightening torque (80in-lbs) should fully mitigate the possibility of an adverse screw body splay event.

Device

Arsenal Set-Screw, a sub-component of the Arsenal Spinal Fixation System
  • Modelo / Serial
    Arsenal Set-Screw, a sub-component of the Arsenal Spinal Fixation SystemPart Number: 47127Lot Numbers affectedFor screw back-out issue:700942For oversized condition: 7689802, 7689803, 7766301ARTG Number: 178654
  • Manufacturer
    Scientx Australia

Manufacturer

Scientx Australia
  • Source
    DHTGA