Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI)에 따르면, 해당 현장 안전성 서한 는
Slovenia
에서 Synthes GmbH 에 의해 제조된 제품과 관련되어 있습니다.
이것은 무엇인가요?
현장 안전성 서한은 의료기기 제조사 또는 제조사 대리인이 시중에 유통되고 있는 자사 의료기기 제품에 대하여 취할 수 있는 조치를 알리는 소통방식입니다. 주요 대상층은 보건의료업계 종사자와 의료기기 사용자들입니다. 여기에는 회수(recall) 조치와 경고도 포함될 수 있습니다.
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.
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Two lots of 4.5mm cortex screws, length 20mm, may contain a 4.5mm cortex screw that is
22mm in length. the screws are both etched and labeled with the above 20mm part
numbers.
potential hazard:
the outside package labeling and the etching on the product would indicate to the user that
the screw is 2mm shorter than its actual length of 22mm. for non—sterile products, there is
an opportunity to detect the issue if the screw is measured prior to placement into the
tray/module. once the screw enters the operating room, either sterile or unsterile, the user
should measure the screw prior to insertion. if detected at this time it may result in a surgical
delay while a replacement is obtained or if the surgeon inserts the screw, determines it was
the wrong length on radiographic imaging, and then removes and replaces it.