Events

Alerte De Sécurité sur Brainlab Disposable Self-Tapping Screw 1.5 X 6MM (Art. No. 52128) / KLS Martin Cross-Drive Screw 1.5x6mm (Art. No. 25-678-06)

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

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
    2011-08-04
  • 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_20110804b.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
    Field safety notice: use of brainlab skull reference base in combination with kls martin cross-drive screws brainlab ag has issued a product notification regarding the use of the brainlab disposable self-tapping screw 1.5 x 6mm (art. no. 52128) / kls martin cross-drive screw 1.5x6mm (art. no. 25-678-06) in combination with the brainlab skull reference base (art. no. 52121b, 52129, 52129a). applying too much torque or tensile force to the head of the screw during insertion and fixation of the skull reference base may cause the screw head to deform or to shear off. in such case, the screw can no longer be removed using the specified screwdriver or parts of the screw may remain inside the patient’s skull bone. depending on the used skull reference base version, brainlab ag will provide customers with updated instructions for use regarding safe use of the skull reference array kit. according to the local supplier, hong kong is affected. if you are in possession of the affected product, please contact your supplier for necessary actions.

Device

Brainlab Disposable Self-Tapping Screw 1.5 X 6MM (Art. No. 52128) / KLS Martin Cross-Drive Screw ...
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: [4 Aug 2011] Use of Brainlab Skull Reference Base in combination with KLS Martin Cross-Drive screws
  • Manufacturer
    Brainlab AG

Manufacturer

Brainlab AG