Events

Safety Alert for Eurospine instruments, HRCID09 models - 3x9 thin lumbar distractor - Lot 883; HRCID10 - Fine lumbar distractor 3.5x10 - Lot 856; HRCID11 - Fine lumbar distractor 3.5x11 - Lot 883, record 10355870048, risk class I.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Biomedica Equipamentos e Suprimentos Hospitalares Ltda.; Eurospine.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    1813
  • Date
    2016-02-01
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the data
    According to the registry holder, there are no negative impacts related to the patient, because the breaks occurred in the rod near the cable, externally to the patient, without the production of debris. There are also no risks related to lack of surgery, as the manufacturer also offers a series of "monobloc" lumbar distractors (HRCIDx / x references) that can be used instead of the instruments used for this recall.
  • Reason
    According to the record holder there may be breakage of the cable of two surgical instruments that may have been caused by the soldering point or deviations in its form of use.
  • Action
    Pick up and return to the manufacturer. Action code: 00003. It is recommended to stop immediately the use of the affected products and their segregation, with subsequent return to the importer; the importer will be responsible for returning the instruments affected to the manufacturer, as well as the replacement of the items collected to the customers. It is also recommended that any adverse events noted should be reported to the importer and to the competent health authority.

Device

Eurospine instruments, HRCID09 models - 3x9 thin lumbar distractor - Lot 883; HRCID10 - Fine lumb...

Manufacturer

Biomedica Equipamentos e Suprimentos Hospitalares Ltda.; Eurospine
  • Source
    ANVSANVISA