Events

Rappel de SerenoCem Granules BCG050 (Orthopaedic bone cement)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Endotherapeutics 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-2016-RN-00439-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-07-12
  • 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-2016-RN-00439-1
  • 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
    The manufacturer, corinthian surgical ltd has been made aware of a cluster of cases in the united kingdom where it has been observed that there has been some bone re- absorption in the area adjacent to the granules in the middle ear. this can lead to exposure of the dura and facial nerve, potentially resulting in infection and/or brain herniation. as a precautionary measure corinthian surgical ltd is temporally suspending the supply of serenocem granules and there should be no further use of the granules at this time. the cause of the reported cases of bone resorption is currently under investigation.
  • Action
    Endotherapeutics is recommending that if a patient presents for a routine checkup or at the 2 yearly follow up, to perform a CT scan. Outside of these circumstances, patients should undergo a CT scan at the clinical discretion of the treating surgeon. Any remaining unused stock should be quarantined and returned to Endotherapeutics. The investigation is currently ongoing, and further communications may be required following completion of the investigation and in consultation with the Therapeutic Goods Administration (TGA).

Device

SerenoCem Granules BCG050 (Orthopaedic bone cement)
  • Modèle / numéro de série
    SerenoCem Granules BCG050 (Orthopaedic bone cement)All lots affectedARTG Number: 152441
  • Manufacturer
    Endotherapeutics Pty Ltd

Manufacturer

Endotherapeutics Pty Ltd