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 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 revision due to implant loosening.2 out of 2 cases."the study states, ¿in two other cases, an operative revision was required due to a secondary implant loosening during the hospital stay.[¿] in the second patient, suffering of a left nephrectomy with normal serological and endocrine parameters, the operative fixation technique was changed.An anterior plate fixation of the sacroiliac joint was preferred in re-operation via an anterolateral approach.Nevertheless, a fracture re-dislocation was observed 5 days after revision surgery.A second operative revision was refused by the patient.".
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