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 from (b)(6) 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 loss of reduction and implant breakage.The report states: ¿at the 12 week follow-up visit, patient was noted to radiographically have a slight loss of reduction anteriorly and a broken symphyseal plate and broken screws.On examination clinically, patient did not appear to have an unstable pelvis and was advanced to weightbearing as tolerated while on crutches.¿.
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