N
Patient 1
AN UNKNOWN PATIENT RECEIVED A PRODISC C IMPLANT AT AN UNKNOWN DATE. THE COMPLAINT REPORTER REQUESTED A RETRIEVAL KIT IN PREPARATION FOR A REMOVAL PROCEDURE SCHEDULED FOR (B)(6) 2020. THE RETRIEVAL KIT WAS SHIPPED DIRECT TO THE HOSPITAL HOSTING THE REMOVAL AS REQUESTED. NO FURTHER INFORMATION INDICATING WHY THE DEVICE WAS BEING REMOVED WAS PROVIDED BY THE REPORTER. ATTEMPTS TO GATHER ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL. THERE HAS BEEN NO CONFIRMATION THAT THE CASE WENT AHEAD AS SCHEDULED. THERE HAS BEEN NO INDICATION OF PATIENT SYMPTOMS, COMPLICATIONS, OR HARM RELATED TO THE PRODISC C DEVICE. THERE HAS BEEN NO INDICATION OF A MALFUNCTION OF THE PRODISC C DEVICE. REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE AS NO PART OR LOT NUMBERS FOR THE DEVICE INVOLVED WERE PROVIDED. REVIEW OF THE RISK DOCUMENTATION INDICATES THAT NO NEW OR UNKNOWN RISKS HAVE BEEN IDENTIFIED. THE RISKS IDENTIFIED HAVE BEEN MITIGATED AND DETERMINED TO BE ACCEPTABLE. THERE HAS BEEN NO TREND OR INFORMATION TO SUGGEST A DEVICE RELATED PROBLEM. THE INVESTIGATION COULD NOT DETERMINE A CAUSE FOR THIS ADVERSE EVENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE AT A LATER DATE, A FOLLOW UP SUBMISSION WILL BE COMPLETED AS APPROPRIATE.