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 university of kentucky, usa.The title of this report is ¿a retrospective data collection of the treatment of wrist fractures with the variax distal radius locking plate system¿ which is associated with the stryker ¿variax distal radius locking plate system¿ system.The research period of patients included in this report was between 9/2019 and 2/2020.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, 20 complaints were initiated retrospectively for adverse events mentioned in the report.This product inquiry addresses rupture of extensor digitorum communis (edc) of the middle and ring fingers followed by hardware removal and tendon transfer.The report states: ¿subject five was treated for an intra-articular fracture from a fall from height had rupture of the edc of the middle and ring fingers noted 215 days postoperatively.A procedure was performed to remove hardware and transfer an extensor tendon to the dorsal aspect of the left hand and wrist and the ae resolved 228 days after the initial surgery.This was determined to not be a device-related ae.¿.
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