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) medical center.The title of this report is ¿a retrospective data collection of the treatment of pelvis and acetabulum fractures with the pro system.¿ which is associated with the ¿pro pelvis and acetabulum system ¿.Within that report, post-operative complications/ adverse events were reported which occurred between 2011 - april 2019.It was not possible to ascertain specific device catalog or patient information 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 4 complaints were initiated retrospectively for different adverse events mentioned in the report.This product inquiry addresses purulent material draining from the pelvic wound requiring irrigation and debridement.3 out of 4 cases.The pmcf report states, ¿a third patient was noted at her 2-week postoperative visit to have purulent material draining from her pelvic wound, requiring irrigation and debridement.The infection resolved without incident and the patient¿s fracture consolidated by 3 months.¿.
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