Current information is insufficient to permit conclusions as to the cause of the events.Event details and product identification were not provided for the patients mentioned in the journal article.The following could not be completed with the limited information provided.Date of event - ni, device code - ni, expiration date - ni, date implanted - ni, date explanted - ni, (b)(6), manufacture date ¿ ni.
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Information was received based on review of a journal article titled, "ball-joint versus single monolateral external fixators for definitive treatment of tibial shaft fractures" which aimed to compare a single, rigid, monolateral external fixator without ball-joints with a modular, less rigid monolateral external fixator with ball-joints for the treatment of open and complex tibial shaft fractures.In the article, one patient was identified as having undergone a debridement and pin removal procedure due to osteomyelitis.The patient was revised to a circular external fixator.There has been no further information provided and the patient outcome is unknown.
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