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) medical center, in united states.The title of this report is ¿reuse of external fixation components: a randomized trial¿ which is associated with the stryker ¿hoffmann external fixation¿ system.The pubmed id for the article is 18349781.Within that publication, post-operative complications were reported, which allegedly occurred from 16 november 2001 to 16 may 2004.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 (4) cases of pin loosening, out of (333) pins.
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