Events

Safety Alert for SCIENT'X Cervical Cages, Spinal Stabilizer, Record 10306840058, Model> 11CC2AC17-5 and 11CC2AC17-6. Lots code 11CC2AC17-5: 22TT, 23TZ; 23UT and 23W7. Lots code 11CC2AC17-6: 23M2; 23SS; 23SW; 23TE; 23U4; 23W1; 2464; 246R and 247O.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Promedon do Brasil Produtos Médicos Hospitalares.; Scient’x.

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
    1778
  • Date
    2015-12-22
  • 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 company, the absence of the gold wire may cause positioning error during insertion of the cage in the threaded site, which can result in neurological damage. Incorrectly positioned gold wires may cause local inflammation of adjacent fabrics that are in contact with the wire, however the consequences are limited given the biocompatibility of the gold material and the small size (0.55mm in diameter, maximum length of 2.70mm). No adverse events have been reported so far. Update of the field action: UPDATED ON 10/26/2017, the company presented the report of completion of the field action, with sending of evidences and necessary corrective actions.
  • Reason
    The device may have missing, improperly affixed and / or improperly positioned gold wire markers, which may create a 1-2mm protrusion inside or outside the cage.
  • Action
    Pick up and return to the manufacturer. Action code: 201515554. The company guides: i. inventory inventory, and identify affected devices. Segregate them and do not use; ii. notify everyone involved in the use of the product; iii. Fill out the action evaluation document and send it to the distributor; iv. Report any adverse events occurring after implanting the product and to await the company's return with the steps to be taken regarding collection.

Device

SCIENT'X Cervical Cages, Spinal Stabilizer, Record 10306840058, Model> 11CC2AC17-5 and 11CC2AC...

Manufacturer

Promedon do Brasil Produtos Médicos Hospitalares.; Scient’x
  • Source
    ANVSANVISA