Events

Alerte De Sécurité sur Dynamic Locking Screw Stardrive

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Synthes.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2013-06-14
  • Date de publication de l'événement
    2013-06-14
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130614b.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: synthes dynamic locking screw stardrive medical device manufacturer, synthes, has issued a medical device safety alert concerning certain lots of the dynamic locking screw stardrive ø 3.7mm, self-tapping, cobalt-chrome alloy (cocrmo), sterile [length 22mm to 70mm] and ø 5.0 mm, self-tapping, cobalt-chrome alloy (cocrmo),sterile [length 32mm to 90mm]. the manufacturer received several complaints and investigations showed breakage at the bottom of the pin of the dynamic locking screw (dls). the breakages are recognized during planned implant removal of the whole construct after successful healing. there is the potential that the breakage of a dls may result in a mal-union or non-union requiring additional medical intervention. in a worst case scenario there is the potential for permanent impairment to occur in the presence of a mal-union or non-union. serious injury described as soft tissue damage/irritation and prolonged surgical procedures have been reported as a result of dls breakage. however, no known events of permanent impairment have been reported due to the breakage of a dls. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 14 june 2013.

Device

Dynamic Locking Screw Stardrive
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Synthes Dynamic Locking Screw Stardrive
  • Manufacturer
    Synthes

Manufacturer

Synthes