The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.This complaint has been reported during a literature review performed by the post market surveillance group.No product identification is possible and no additional information will be requested to the customer as this serves for trending purpose.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.Based on the rmf the probable root cause would be: (e.G.Insufficient post-operative mobilization and large volume intramedullary implants are inserted.A review of the labeling did not indicate any abnormalities.The ifu states: in many instances, adverse results may be clinically related rather than device related.The following are the most frequent adverse effects involving the use of internal fracture fixation devices: deep venous thrombosis.Based on the above observations the event is not linked to a deficiency of a device.If the device is returned or if any additional information is provided, the investigation will be reassessed.Device disposition is unknown.
|
The manufacturer became aware of a study from (b)(6) which was published on 27-november-2018.The title of this report is ¿percutaneous screws ct guided to fix sacroiliac joint in tile c pelvic injury.Outcomes at 5 years of follow-up¿ which is associated with the stryker asnis screw system.Within that publication, postoperative complications/ adverse events were reported.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 26 complaints were initiated retrospectively for different adverse events mentioned in the report.This product inquiry addresses deep vein thrombosis within the first 3 months post-op.6 out of 11 cases.The study states, ¿about 11.3% of the patients developed non-clinically significant deep vein thrombosis within the first 3 months post-op, despite anti-thromboembolic prophylaxis.These were diagnosed by performing lower limb echo-doppler scans following onset of symptoms and clinical evaluation.¿.
|