Events

T8 Removal Driver for the CD Horizon Spire and Spire Z Spinal System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Medtronic Sofamor Danek USA Inc 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    66010
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2200-2013
  • 사례 시작날짜
    2013-08-12
  • 사례 출판 날짜
    2013-09-14
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-12-27
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121220
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Screwdriver - Product Code HXX
  • 원인
    One lot of the t8 removal head had incorrect hardness specification, which could result in the t8 removal head failing during removal of the cd horizon spire and spire z spinal system implant. there is a potential for tissue damage to occur and/or minor surgical delay to remove the remaining fragments of the tip.
  • 조치
    Medtronic sent an Urgent Voluntary Market Removal Recall letter dated August 9, 2013 with Recall Questionnaires and Confirmation forms included to Risk Managers and Sales Representatives. The letter identified the affected product, problem and action to be taken. Customers were instructed to remove the affected product, discontinue use and contact your Medtronic Sales Representative to coordinate the return and replenishment of affected product. For questions call your Medtronic Sales Representative or Global Quality Department at 800-876-3133.

Device

T8 Removal Driver for the CD Horizon Spire and Spire Z Spinal System
  • 모델명 / 제조번호(시리얼번호)
    RS12K008
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    USA Nationwide Distribution in the state of GA, AK, WA, and CA.
  • 제품 설명
    T8 REMOVAL HEAD, REF 8910641, QTY: 1 EA, || Product Usage: || The non-sterile T8 Removal Diriver is used with the Spire and Spire Z Spinal System in conjunction with the set screwdriver to remove the implant during removal surgery. The set screw driver is attached to the end of the removal head and used to disengage the remaining portion of the set screw within the device.
  • Manufacturer
    Medtronic Sofamor Danek USA Inc

Manufacturer

Medtronic Sofamor Danek USA Inc
  • 제조사 주소
    Medtronic Sofamor Danek USA Inc, 1800 Pyramid Place, Memphis TN 38132
  • 제조사 모회사 (2017)
    Medtronic plc
  • 제조사 의견
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA