Events

Field Safety Notices about Transpedicular Schanz Screw

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 Synthes Gmbh.

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
    2013-06-12
  • 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
    Synthes received several complaints that the clamps could not be connected with the transpedicular schanz screw, because in some cases, the shaft of the screw is too thick.

Device

Transpedicular Schanz Screw
  • Model / Serial
    296.630 Transped‘ ular Schanz Screw a 5.0 mm. shaft 2 5.0 mm, see separate list length 180/35 mm. Stainless Steel 296.690 Transpedlcular Schanz Screw 0 6.0 mm, shaft 9 5.0 mm, see separate list length 180/35 mm, Stainless Steel 296.780 Transped ular Schanz Screw 2/ 7.0 mm, shah 2 5.0 mm. see separate list length 180/35 mm. Stainless Steel 496.630 Transpedlcular Schanz Screw a 5.0 mm, shaft 6 5.0 mm, see separate list length ISO/35 mm, Titanium Alloy (TAN). gold 496.690 Transpedlcular Schanz Screw ¢ 6.0 mm, shaft 9 5.0 mm, see separate list length 180/35 mm. Titanium Alloy (TAM, gold 496.711 Transped ular Schanz Screw E 5.0 mm with dual core, length see separate list 180/35 mm. Titanium Alloy (TAN). violet 496.712 Transpedlcular Schanz Screw Bi 5.0 mm with dual core. length see separate list 185/40 mm. Titanium Alloy (TAN), violet 496.713 Transpedicular Schanz Screw a 5.0 mm with dual core, length see separate list 190/45 mm, Titanium Alloy (TAN), violet 496.714 Transpedicular Schanz Screw 2 5.0 mm with dual core, length see separate list 195/50 mm Titanium Alloy (TAN), violet 496.715 Transpedicuiar Schanz Screw 2/ 5.0 mm with dual core, length see separate list 200/55 mm, Titanium Alloy (TAN), violet 496.721 Transpedicular Schan: Screw 2 6.2 mm with dual core, length see separate list 180/35 mm Titanium Alloy (TAN), dark blue 496.722 Transpedloular Schanz Screw 0 6.2 mm with dual core. length see separate list 185/40 mm Titanium Alloy (T AN), dark blue . 777 496.723 Transpedicular Schanz Screw 9 6.2 mm with dual core. length see separate list 190/45 mm, Titanium Alloy (TAN), dark blue 495.724 Transpedicular Schanz Screw Z 62 mm with dual core, length see separate list 195/50 mm Titanium Alloy (TAN), dark blue 496.725 Transpedicular Schanz Screw z 6.2 mm with dual core. length see separate list 200/55 mm, Titanium Alloy (TAN), dark blue 496.780 Transpedicular Schanz Screw a 7.0 mm. shah a 5.0 mm, see separate list length 180/35 mm, Titanium Alloy (TAN)
  • Manufacturer
    Synthes Gmbh

Manufacturer

Synthes Gmbh