Events

Field Safety Notices about Delta Positioner-Leveler

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by Limacorporate spa.

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
    Field Safety Notice
  • Date
    2017-09-15
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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