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.
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The manufacturer became aware of a literature published by orthoarizona, usa.The title of this report is ¿stryker sonicanchorstm: case series of distal fibula stress reactions¿ which is associated with the stryker ¿sonicanchors¿ system.This report includes research done on 135 patients between 2017 and 2020.It was not possible to ascertain specific device details or patient information from the report, or to match the events reported with previously reported complaints.Therefore, new complaints were initiated in the system for the post-operative complications mentioned in the report.This product inquiry addresses 9 cases of swelling and pain around the anchor site which required implant removal and debridement.The report states: ¿patients returned to clinic for clinical reevaluation of swelling and pain around the anchor site itself.Patients were initially treated with a walking boot for immobilization, anti-inflammatories and activity modification for 2-4 weeks.If this did not improve their symptoms, mri was ordered.Mri confirmed bone marrow edema around the sonicanchortm.9 patients (6.67%) returned to the operating room for excision of implant(s) with debridement.¿.
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