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 post market clinical follow-up report received from (b)(6) orthopedic consultants, in usa.The title of this report is ¿a retrospective data collection of small bone reconstruction limited to inter-digital fusion of fingers and toes and small bone fusion with x fuse® superelastic implant.¿ which is associated with the stryker ¿x fuse® superelastic¿ system.The treatment period of patients included in this report was between april 1, 2020 and may 17, 2020.It was not possible to ascertain specific device details from the report, or to match the events reported with previously reported complaints.Therefore 10 complaints were initiated retrospectively for the post-operative complications mentioned in the report.This product inquiry addresses breakage of proximal implant tines, (3) out of (5) cases.The report states: ¿in 6 cases, follow-up x-rays showed a one or more of the x-fuse tines had broken.In 5 of 6 of these cases, the arthrodesis site went on to achieve radiographic consolidation.¿.
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