Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The new information states that this complaint is a duplicate of the report 3005975929-2018-00350, is the same patient, surgery and implants reported therefore, it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.
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