Events

Alerte De Sécurité sur INTRODUCTION GUIDELINES USED IN ORTHOPEDICS AND TRAUMATOLOGY FOR THE GUIDED CANULATION OF SCREWS SYSTEMS

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par (1) B BRAUN MEDICAL LTDA.; (2) BIOMET MERCK LTDA.; (3) DE PUY INTERNATIONAL LTDA.; (4) SMITH & NEPHEW PLC; (5) STRATEC MEDICAL LTDA.; (6) STRYKER HOWMEDICA OSTEONICS DIV STRYKER CORP.; (7) ZIMMER LTDA..

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
  • ID de l'événement
    46
  • Date
    2001-06-01
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 Brazil.
  • Notes supplémentaires dans les données
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Cause
    Medical devices agency, mda / uk, laid an alert due to the report of a fatal incident, in which a canulated drill went into the introduction guide and advanced about the pelvis reaching the ilíaca veia. mda alert on the risk of advancing guidelines for underlying tissues during procedures involving insertion, scratching, inserting screws and screwing through guides with canulated instruments.
  • Action
    MEDICAL DEVICES AGENCY, MDA / UK, RECOMMENDS THAT PROFESSIONALS: (1) VERIFY THE POSITION OF THE INTRODUCTION GUIDELINES WITH IMAGE INTENSIFIER (FLUOROSCOPY) FREQUENTLY TO AVOID ADVANCEMENT AND PENETRATION IN THE ADJACENT FABRICS. (2) CLEANING THE CANULATED INSTRUMENTS DURING OPERATION TO AVOID BONE PARTICULATE ACULVULATION IN THE CELL. FOR TECHNICAL INVESTIGATIONS, MEDICAL DEVICES AGENCY, MDA / UK, HAS PLACED TWO EXPERTS IN DISPOSAL, DRS. J. COOKE OR DR. J. SHAW (FAX: 0021-44-207-972-8106, PHONE 0021-44-207-972-8267 OR 8343 OR MAIL, HANNIBAL HOUSE, ELEPHANT AND CASTLE, LONDON SE1 6TQ, ENGLAND). FOR CLINICAL RESEARCH, DR. J. HOPPER (FAX: 0021-44-207-972-8103, PHONE 0021-44-207-972-8126 OR BY MAIL, HANNIBAL HOUSE, ELEPHANT AND CASTLE, LONDON SE1 6TQ, ENGLAND). FOR ALL INVESTIGATIONS, CIT THE REFERENCE NO. 20000519011-8.

Device

INTRODUCTION GUIDELINES USED IN ORTHOPEDICS AND TRAUMATOLOGY FOR THE GUIDED CANULATION OF SCREWS ...

Manufacturer

(1) B BRAUN MEDICAL LTDA.; (2) BIOMET MERCK LTDA.; (3) DE PUY INTERNATIONAL LTDA.; (4) SMITH & NE...
  • Source
    ANVSANVISA