This complaint has been reported during a literature review performed by the post market surveillance group.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 pmcf report from university hospital (b)(6).The title of this report is ¿a retrospective data collection of the internal fixation, stabilization and support of fractures, and bone fixation after osteotomies with the axsos locking plate system¿ which was published in august 2019 and is associated with the stryker axsos locking plate system.Within that report, post-operative complications/ adverse events were reported which occurred between november 2010 to june 2018.It was not possible to ascertain specific device catalog or patient details from the study, a review of the complaint handling database, however, revealed that the events have not been reported by the hospital or by the author of the publication, therefore 12 complaints were initiated retrospectively for different adverse events mentioned in the study.This product inquiry addresses exchange of prominent screws in the distal femur.4 out of 7 cases.The pmcf states, "1 reoperation was to exchange some screws in the distal femur that were prominent.Not considered a device related complication.".
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