Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.Date explanted - remains implanted there are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 3 states, ¿loosening or migration of the implant.¿.
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It was reported that patient underwent an open reduction to correct acromioclavicular joint luxation on (b)(6), 2015.Subsequently, the suture loosened resulting in luxation on (b)(6), 2015.The second luxation was treated conservatively, and patient did not undergo surgery.
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