Events

Alerte Ou Avis De Sécurité sur Orthopaedic bone plates and cortical screws

Selon Medicines and Healthcare products Regulatory Agency, ce/cet/cette alerte ou avis de sécurité concerne un dispositif en/au/aux/à United Kingdom qui a été fabriqué par Newdeal SAS.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert / Field Safety Notice
  • Date
    2018-08-01
  • Date de publication de l'événement
    2018-08-01
  • Pays de l'événement
    United Kingdom
  • Source de l'événement
    MHRA
  • URL de la source de l'événement
    https://www.gov.uk//drug-device-alerts/orthopaedic-bone-plates-and-cortical-screws-advansys-mlp-dlp-advansys-ttc-large-qwix-tibiaxys-and-uni-cp-sterile-risk-of-infection-mda-2018-028
  • Notes / Alertes
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • Notes supplémentaires dans les données
    In May 2018, Newdeal SAS, a company within Integra LifeSciences Group, issued a Field Safety Notice informing distributors and clinicians of devices possibly affected with defective packaging. This defect may result in insufficient sealing, a potential consequence of which is an increased risk of infection.This Medical Device Alert is being issued to ensure that all hospitals are aware of the issue and that adequate action is taken to mitigate potential risk to patients.
  • Cause
    Manufactured by newdeal sas – risk of infection from compromised packaging.
  • Action
    1.Identify and quarantine all affected devices. 2. Locate and return affected devices to Smith & Nephew as detailed in the Field Safety Notice. 3 Complete the certificate of acknowledgement attached to the Field Safety Notice and return it to the manufacturer. 4. Report adverse events involving these devices to your local incident reporting system, the manufacturer, and your national incident reporting authority: England, Scotland, Northern Ireland, Wales.

Device

Orthopaedic bone plates and cortical screws
  • Modèle / numéro de série
  • Description du dispositif
    The affected devices are used in various bone and joint reconstruction procedures.In addition to the Field Safety Notice which details affected product, please refer to the spreadsheet below which accompanies this MDA for additional unique device identification information.
  • Manufacturer
    Newdeal SAS

Manufacturer

Newdeal SAS
  • Adresse du fabricant
    Newdeal SAS Tel: +33 (0)4 37 47 51 51 Fax/telecopy: +33 (0)4 37 47 59 30emea-fsca-recon@integralife.com or marilyse.latour@integralife.com
  • Société-mère du fabricant (2017)
    Integra LifeSciences Holdings Corporation
  • Source
    MHRA