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.
|
The manufacturer became aware of a study from (b)(6) which was published on 7-july-2010.The title of this report is ¿2d-fluoroscopic navigated percutaneous screw fixation of pelvic ring injuries - a case series¿ which is associated with the stryker asnis iii screw system.Within that publication, post-operative complications/ adverse events were reported which occurred between august 2004 and december 2007.It was not possible to ascertain specific device catalog or patient 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 11 complaints were initiated retrospectively for different adverse events mentioned in the study.This product inquiry addresses screw malplacement, perforation of the cortical bone.4 out of 5 cases.The study states, ¿no screw misplacement was observed in intraoperative fluoroscopic control images, whereas in the postoperative ct scans 6% of the screws were malplaced, penetrating cortical bone structures.In two cases, a screw was changed, due to anterior penetration and the fear of arrosion of the main vessels.¿.
|