THERE WAS NO PRODUCT RETURN FOR THIS EVENT. THE DEVICE HISTORY RECORD (DHR) FOR LOT #113270 WAS REVIEWED BY THE (B)(4), HE SAW NO ISSUES WITH THE MANUFACTURING PROCESS. THIS LOT PRODUCED (B)(4) OTOMIMIX UNITS. XRD TESTING IS PERFORMED ON THE POWDER FOR EACH LOT TO VERIFY ITS COMPOSITION. THE AMOUNT OF POWDER AND LIQUID IS MEASURED AND RECORDED FOR EACH VIAL. AN EVALUATION OF THE SET AND HARDENING TIMES ARE PERFORMED FOR THE POWDER AND LIQUID COMPONENT DURING THE MANUFACTURING PROCESS. AS PART OF THE LOT RELEASE TEST, THE SET AND HARDENING TIMES ARE ALSO VERIFIED FOR THE FINISHED GOOD PRODUCT. THE SET TIMES MET THE REQUIREMENTS. HE COMPARED THE SET TIMES WITH MULTIPLE LOTS AND HISTORY OF THE PRODUCTION PROCESS AND VERIFIED THIS LOT IS CONSISTENT WITH THE RESULTS FROM MULTIPLE LOTS. THE MANUFACTURING PROCESS IS VERY CONSISTENT; NO VARIATION WITH THIS LOT WAS IDENTIFIED. THE PACKAGE INSERT CONTAINS MIXING INSTRUCTIONS. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT.
D
Patient 1
IT WAS REPORTED IN AN OSSICULAR CHAIN RECONSTRUCTION (OCR) AND TYMPANOPLASTY PROCEDURE ON (B)(6) 2016, THIS WAS THE SURGEON'S SECOND USE OF OTOMIMIX. AT THE OPENING OF THE FIRST SAMPLE, THE SURGEON FELT THE COMPONENTS SHOWED A DIFFERENT ASPECT AND MECHANICAL PROPERTIES; SOMEWHAT HARDER COMPARED TO THE FIRST USE. WHEN SHE TRIED TO MIX THEM, THE ASPECT REMAINED UNUSUAL COMPARED TO THE PREVIOUS INTERVENTION. WHEN HANDLING THE MIXTURE, SHE FELT THAT IT WOULD STICK WELL AND HOLD AS EXPECTED ON THE OSSICULAR CHAIN. SHE THEREFORE DECIDED NOT TO USE THE FIRST SAMPLE AND OPENED THE SECOND SAMPLE. THE EXACT SAME OBSERVATIONS WHERE MADE ON THE SECOND SAMPLE AND OTOMIMIX WAS EVENTUALLY NOT USED ON THE PATIENT. THERE WAS NO CONSEQUENCE FROM THE USE OF OTOMIMIX ON THE PATIENT SINCE THE MIXTURE WAS NOT APPLIED IN THE MIDDLE EAR FROM ANY OF THE SAMPLES.