The manufacturer became aware of a post market clinical follow-up (pmcf) from (b)(6).The title of this report is ¿a post-market clinical follow-up (pmcf) of the fixation of sutures and soft tissue with the sonicanchor¿ which was published in november 2018 and is associated with the stryker sonicanchor.Within that publication, post-operative complications/ adverse events were reported, which occurred between 26-may-2016 to 1-aug-2018.It was not possible to ascertain specific device and/or patient information from the report, a review of the complaint handling database, however, revealed that the events have not been reported previously by the hospital or by the author of the publication, therefore 13 complaints were initiated retrospectively for the different adverse events mentioned in the report.This product inquiry addresses superficial wound infections; 2 out of 4 cases.
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