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 BrainLAB.

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 029 08 11 000
  • Event Initiated Date
    2011-08-14
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=738
  • 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
    Applying too much torque or tensile force to the head of the screw during the use of brainlab skull reference base in combination with kls martin cross-drive screws may cause the screw head to deform or to shear off. in such case, the screw can no longer be removed using the specified screwdriver or parts of the screw may remain inside the patient’s skull bone.

Device

Brainlab Skull
  • Model / Serial
    Brainlab Skull Reference Base (Art. No. 52121B) Brainlab Skull Reference Base (Art. No. 52129 & 52129A) Brainlab Disposable Self-Tapping Screw 1.5 X 6MM (Art. No. 52128) KLS Martin Cross-Drive Screw 1.5x6mm (Art. No. 25-678-06)
  • Product Description
    Brainlab Disposable Self-Tapping Screw
  • Manufacturer
    BrainLAB

Manufacturer

BrainLAB
  • Manufacturer Parent Company (2017)
    Brainlab AG
  • Manufacturers representative
    Al-Faisaliah Medical System, Riyadh, (01)2119948
  • Source
    SFDA