The reported event could not be confirmed, since the device was not returned for evaluation and no other additional information is available.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.The device history record could not be reviewed because the affected lot number was not communicated.If any further information is provided, the investigation report will be updated.Device disposition is unknown.
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The manufacturer became aware of a literature published by (b)(6) hospital, in (b)(6).The title of this report is ¿use of smart toe implant for small toe arthrodesis: a smart concept?¿ which is associated with the stryker ¿smart toe¿ system.The article can be found at pubmed with id 25937410.Within that publication, post-operative complications were reported, which allegedly occurred from february 2011 to december 2012.It was not possible to ascertain specific device details or patient information from the report, or to match the events reported with previously reported complaints.Therefore, 8 complaints were initiated retrospectively for the post-operative complications mentioned in the report.This product inquiry addresses implant failure.The report states: ¿there was one incidence of implant failure.The patient was a (b)(6)-year-old female.She did not have any symptoms and thus declined to undergo a revision procedure.She remained asymptomatic at her 6-month follow up¿.
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