Rappel de ROTAIO Cervical Disc Prosthesis

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

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-01457-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-11-23
  • Pays de l'événement
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
  • 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 the postoperative course patients reported a temporary or permanent development of noise. concerned were approx. 0.12 % of the disc prostheses. in some individual cases the doctors in charge decided to remove the implant. extensive analyses by the manufacturer, signus medizintechnik has not identified any indications as to the causes of the noise development as yet. examinations of implants removed and reference implants performed in that context showed that the prostheses were properly manufactured and fully functional with no structural defects or abnormal signs of wear and tear.
  • Action
    The manufacturer is adding the possible side effect “temporary or permanent noise development” in the Instructions For Use (IFU).

Device

Manufacturer