The manufacturer became aware of a study from (b)(6).The title of this report is ¿ten years stable internal fixation of metacarpal and phalangeal hand fractures- risk factor and outcome analysis show no increase of complications in the treatment of open compared with closed fractures¿, which was published in 2010 and is associated with ¿profyle modular titanium implant system¿.Within that publication, post-operative complications/ adverse events were reported, which occurred between 1994 to 2003.It was not possible to ascertain specific device or patient information from the article, 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 60 complaints were initiated retrospectively for different adverse events mentioned in the journal.This product inquiry addresses other unknown complications.Two out of 8 cases.
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