Events

translation missing: en.activerecord.attributes.event.titles.recall_field_safety_notice

According to Saudi Food & Drug Authority, this translation missing: en.activerecord.attributes.event.types.recall_field_safety_notice involved a device in Saudi Arabia that was produced by Stryker.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Recall / Field Safety Notice
  • Event ID
    mdprc 094 10 11 000
  • Event Initiated Date
    2011-10-31
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=973
  • Notes / Alerts
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 recall data from the U.S. and Saudi Arabia.
  • Extra notes in the data
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Reason
    There is potential for the blade to break from the arbor while the surgeon is cutting mandibular bone. the broken piece may: 1. fall into the surgical site. this may result in possible: a. delay in surgery time whilst the surgeon removes the part and obtains a replacement device the probability of occurrence is low. 2. be swallowed or aspirated into the lungs. this may result in possible: a. delay in surgery time b. tissue damage c. need for further surgery to remove the part. d. infection should the part not be removed the probability of occurrence is negligible. 3. become lodged in the mandibular bone. this may result in possible: a. delay in surgery time b. need for further surgery to remove the part c. need for x-rays and mri scans to locate the part i. mri rays may cause temporary temperature changes of the remaining implanted part. d. infection should the part not be removed the probability of occurrence is remote.

Device

Inferior Border Osteotomy (IBO) blades
  • Model / Serial
    Catalogue No: 5100-037-901; 5100-037-902; 5100-037-903; 5100-037-901S2; 5100-037-902S2 Lot No: All lots manufactured from the 31st July 31 2006 to 15th June 2011 All lots with expiry dates from 1st July 2011 to 1st July 2016
  • Product Description
    IBO, blades
  • Manufacturer
    Stryker

Manufacturer

Stryker
  • Manufacturer Parent Company (2017)
    Stryker
  • Manufacturers representative
    Al-Faisaliah Medical System
  • Source
    SFDA