Device Problem
Insufficient Information (3190)
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Patient Problem
Bone Fracture(s) (1870)
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Event Type
Injury
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Manufacturer Narrative
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Information was received via published literature.Please reference literature at the following location: http://www.Ncbi.Nlm.Nih.Gov/pubmed/20056455
(b)(4).This report will be amended when our investigation is complete.
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Event Description
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It has been reported that 1 patient experienced an epicondylar fracture.
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Manufacturer Narrative
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No device or photos were received; therefore the condition of the component is unknown.Device history records cannot be reviewed since the part and lot number is unknown.This device is used for treatment.Surgical notes were not provided; it is unknown whether the components were implanted with the correct fit and orientation as per the surgical technique.It was noted from the journal article that the patient had ¿intraoperative notching of humerus with epicondylar fracture¿.Product history search cannot be completed since the part and lot number is unknown.A definite root cause cannot be determined with the information provided.
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Search Alerts/Recalls
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