Events

INTRAMEDULAR STEMS WITH ISKD - ORTHOFIX KINETIC DISTRACTION. Registro Anvisa n ° 10392060017 .. Products Affected :. . Femoral stems. Catalog Description. F12-255-305 12.5 diameter, range 255 mm - 305 mm ;. F12-255-335 12.5 diameter, range 255 mm - 335 mm ;. F12-300-350 12.5 diameter, range 300 mm - 350 mm ;. F12-300-380 12.5 diameter, range 300 mm - 380 mm ;. F12-345-395 12.5 diameter, range 345 mm - 395 mm ;. F12-345-425 12.5 diameter, range 345 mm - 425 mm. Tibial stems. Catalog Description. T10-215-265 10.7 diameter, range 215 mm - 265 mm ;. T10-255-305 10.7 diameter, range 255 mm - 305 mm ;. T10-255-335 10.7 diameter, range 255 mm - 235 mm ;. T10-300-350 10.7 diameter, range 300 mm - 350 mm ;. T12-215-265 12.5 diameter, range 215 mm - 265 mm ;. T12-245-295 12.5 diameter, strip 245 min - 295 mm ;. T12-255-305 12.5 diameter, range 255 mm - 305 mm ;. T12-255-335 12.5 diameter, range 255 mm - 335 mm ;. T12-300-350 12.5 diameter, range 300 mm - 350 mm ;. T12-300-380 12.5 diameter, range 300 mm - 380 mm. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Orthofix Brasil Ltda. 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 사례 ID
    1168
  • 날짜
    2012-08-27
  • 사례 국가
    Brazil
  • 사례 출처
    ANVISA
  • 사례 출처 URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 비고 / 경고
    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.
  • 데이터 추가 비고
    The ISKD Rod is formed of a body embedded in the other, containing a magnet inside it that functions as a reference sensor for reading, done externally through the Manual Monitor accessory (FTM code 222) that the doctor and patient use periodically to monitor progress of the extension. The extension is produced by small movements in the form of small rotational oscillations of the limb under treatment - with these movements, the mechanism within the shaft gradually produces distraction of the limb. The extent index can vary by changing the level of activity of the patient or by manipulating the extremity. Through measurements, both the physician and the patient can regularly monitor the level of extent achieved. With the problem mentioned in this alert, the product may stop distracting in the postoperative period during treatment, resulting in premature bone healing (limb does not reach the desired length) - which can lead to revision surgery to remove or replace the device.
  • 원인
    The rod extender mechanism may be defective and not distract the expected length, or even distract.
  • 조치
    The company has already started collecting the product. If you have affected products in your stock, segregate them to avoid inadvertent use, and contact the company to verify the procedures for returning the products.

Device

INTRAMEDULAR STEMS WITH ISKD - ORTHOFIX KINETIC DISTRACTION. Registro Anvisa n ° 10392060017 .. P...

Manufacturer

Orthofix Brasil Ltda.