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 median nerve paresthesias.The report states: ¿subject eight was treated for an intra-articular fracture from a fall from standing developed median nerve paresthesias 86 days postoperatively.At the time of data collection, the subject was scheduled to undergo median nerve neurolysis and the ae remained ongoing at 423 days after the initial surgery.This was determined to not be a device-related ae.¿.
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