Events

Rappel de Custom Made Implant Systems with Minimally Invasive Grower (MIG) component

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Stryker Australia Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2018-RN-00083-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-01-30
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00083-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    In march 2007 the minimum invasive grower (mig) component with locking mechanism was utilised with custom made long bone replacement implants for limb salvage procedures of skeletally immature or juvenile patients, to prevent unintended changes in the length of the device. the instructions for use (ifu) for these types of devices did not clarify the function of the locking mechanism and the warnings related to the locking screw until october 2014, resulting in potential lack of awareness of the locking mechanism and its function during that time.The omission of this information in the ifu has been identified as a potential risk in risk management files for custom made devices, with the potential effects including; prolonged surgery, instability, pain, impaired function (gait) and early revision. limb length discrepancy was also identified as a potential effect based on complaints data review.
  • Action
    Patients implanted with an affected lot number of the Custom Implants with MIG component should continue to be followed per the normal protocol established by his/her surgeon.

Device

Custom Made Implant Systems with Minimally Invasive Grower (MIG) component
  • Modèle / numéro de série
    Custom Made Implant Systems with Minimally Invasive Grower (MIG) componentComponents implanted prior to October 2014Item Numbers: 13271, 14092, 14205, 15757, 16782, 17944These items are custom made to the patients ID and exempt from ARTG Numbers
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

Stryker Australia Pty Ltd
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    DHTGA