Events

Rappel de Arsenal Set-Screw, a sub-component of the Arsenal Spinal Fixation System

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Scientx 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-01639-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-12-22
  • 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-01639-1
  • 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
    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.
  • Action
    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
  • Modèle / numéro de série
    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