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.
|
The manufacturer became aware of a post market clinical follow-up report received from (b)(6), in usa.The title of this report is ¿a retrospective data collection of the treatment of femoral fractures with the femoral nail piriformis fossa (pf) of the t2 alpha femur antegrade gt/pf nailing system¿ which is associated with the stryker ¿t2 alpha femur antegrade gt/pf nailing system¿.This study includes research done on 18 patients (19 cases) requiring surgery between the period march 2019 and october 2019.It was not possible to ascertain specific device details from the report, or to match the events reported with previously reported complaints.Therefore, new complaint was initiated in the system for the post-operative complication mentioned in the report.This product inquiry addresses pain.The report states: ¿patient was (b)(6) years old male, his bmi is 31.6, he was a previous smoker, with history of diabetes and drug abuse.His injury was due to a motor vehicle accident and was classified as 32-b2, closed type.The device used in the initial surgery was 11x360 t2 alpha femoral nail pf, right, with a proximal recon locking mode.The pain is sharp 3.5 months post op, located at the fracture site.Pain medication was prescribed for him.¿.
|