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 bg klinik tubingen, germany.The title of this report is ¿retrospective data collection report pmcf variax hand.¿ which is associated with the stryker ¿variax hand locking plate¿ system.The investigation for the patients included in this report was performed between 5 november 2018 and january 2019.It was not possible to ascertain specific device details from the report, or to match the events reported with previously reported complaints.Therefore 20 complaints were initiated retrospectively for the post-operative complications mentioned in the report.This product inquiry addresses infection & lymphangitis with partial necrosis & pain followed by hardware removal.The report states: ¿a (b)(6) year old female had a purulent infection of the hand and lymphangitis, a plate infection with subsequent partial necrosis of the m.Interosseus dorsalis of the metacarpal bone v.She still retained restricted mobility of the small finger and a complex-regional-pain-syndrom.Radiographic and clinical consolidation was observed eventually.However, the subject was not pain free at consolidation.Hardware removal was performed 28 days after initial surgery due to a pronounced plate infection.After the removal, the hand remained swollen and painful for at least 6 months.This case is the only adverse event considered to be device related.¿.
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