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 DePuySynthes.

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 162 11 13 001
  • Event Initiated Date
    2013-12-01
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=5&rid=4855
  • 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: NCAR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Reason
    Bending iron tips broke while surgeons were attempting to bend a spinal rod. the majority of complaints involve attempts to bend the warm-worked cobalt chrome (cocr) rods that are part of the matrix system. the failure mode of the tips on the returned field products consisted of a brittle fracture of the proximal tip (i.E. the tip closest to the surgeon). the root cause was determined to be material strength and geometry of the initial design.

Device

Surgical instruments , Bending Iron
  • Model / Serial
    Part No : 03.632.040 , Bending Iron for Rods I2J 5.5 mm, left, for Coronal Plane & 03.632.041 Bending Iron for Rods 0 5.5 mm, right, for Coronal Plane. Lot No : T939750 , T939100 , T939750 , T939100 , T952744 , T939755 T939105 , T953987 …………………………………… FDA update code : Part number : ( 03.632.040 ) Lot Numbers : ( 03.632.040 T935338, T945062, T953982, T956310, T959990, T959995 ) Part number : ( 03.632.041 ) Lot Numbers : ( T935343, T939105, T945067, T952750, T956315, T960000, T960005 )
  • Product Description
    Surgical instruments
  • Manufacturer
    DePuySynthes

Manufacturer

DePuySynthes
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Manufacturers representative
    Johnson & Johnson Medical Meddile East
  • Source
    SFDA