Events

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

Selon Saudi Food & Drug Authority, ce/cet/cette translation missing: fr.activerecord.attributes.event.types.recall_field_safety_notice concerne un dispositif en/au/aux/à Saudi Arabia qui a été fabriqué par DePuySynthes.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Recall / Field Safety Notice
  • ID de l'événement
    mdprc 162 11 13 001
  • Date de mise en oeuvre de l'événement
    2013-12-01
  • Pays de l'événement
    Saudi Arabia
  • Source de l'événement
    SFDA
  • URL de la source de l'événement
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=5&rid=4855
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Report Source: NCAR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Cause
    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
  • Modèle / numéro de série
    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 )
  • Description du dispositif
    Surgical instruments
  • Manufacturer
    DePuySynthes

Manufacturer

DePuySynthes
  • Société-mère du fabricant (2017)
    Johnson & Johnson
  • Représentant du fabricant
    Johnson & Johnson Medical Meddile East
  • Source
    SFDA