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.Vice disposition is unknown if any further information is provided, the investigation report will be updated.
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The manufacturer became aware of a pmcf from inova fairfax medical campus (ifmc), usa.The title of this report is ¿a retrospective data collection of the internal fixation of fractures of the pelvis with the stryker plating system (sps)¿ which is associated with the stryker ¿plating¿ system.Within that publication, post-operative complications/ adverse events were reported, which occurred from january 2016 to january 2019.It was not possible to ascertain specific device details from the report, 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 14 complaints were initiated retrospectively for adverse events mentioned in the report.This product inquiry addresses deep infection followed by revision.The report states: ¿approximately 1 month later, patient had an infection to the right hip and pelvis and underwent three serial irrigation and debridements.Operative findings were positive for purulence and deep pelvic abscess.The infection was treated with iv antibiotics.¿.
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