Balt usa reference #(b)(4).Note: this complaint file is being reported late as part of a corrective action following an fda inspection.After a review of historical complaint files, it was determined that for this complaint the claimed malfunction did not lead to a death or serious injury.However, based on post market surveillance data and the intial information that was reported to balt, the same malfunction has led to a serious injury or death in a separate incident which was already mdr reported (remains as an unlikely probability according to risk analysis document).Further analysis pending final investigation results from legal manufacture.The submission of this report or related information to the fda, and its release by fda, does not reflect a conclusion by the party submitting this report of the fda that the report or related information is an admission that the manufacturer, their employees, or the device caused or contributed to the reportable event.
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