Events

Avis De Sécurité sur Delta Positioner-Leveler

Selon Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Slovenia qui a été fabriqué par Limacorporate spa.

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
    Field Safety Notice
  • Date
    2017-09-15
  • Pays de l'événement
    Slovenia
  • Source de l'événement
    AMPMDRS
  • Notes / Alertes
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Notes supplémentaires dans les données
  • Cause
    An internal analysis of complaints received (on the breakage of some percussion-positioners-setters during the intervention) found that the 12 batches, whose numbers are listed in table 1 (provided by the same supplier), did not perform the welding process optimally, which resulted in reduced mechanical strength of the device and the possibility of fracture during impact when the instrument is subjected to repeated multiaxial forces. figure 1 below shows in more detail the two possible types of instrument failure that have been notified.

Device

Delta Positioner-Leveler

Manufacturer

Limacorporate spa