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 unknown.
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The manufacturer became aware of a post market clinical follow-up report received from geisinger community medical center, united states.The title of this report is ¿a presentation of the last 20 consecutive cases using the hoffman lrf hexapod for limb salvage and deformity correction.¿ which is associated with the stryker ¿hoffmann lrf¿ system.The treatment period of patients included in this report was between 2018 and 2020.It was not possible to ascertain specific device details from the report, or to match the events reported with previously reported complaints.Therefore 9 complaints were initiated retrospectively for the post-operative complications mentioned in the report.This product inquiry addresses superficial infection with pain treated with local wound care and oral antibiotics.The report states: ¿the goal was a 2 stage correction (lab technique) which was interrupted 2/3 of the way through due to pain from a superficially infected thin wire in the forefoot.The infection responded to local wound care and oral antibiotics.¿.
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