OSTEOSPAN MORPHEUS

Additional Manufacturer Narrative

THE DEVICE WAS NOT RETURNED.

Description of Event or Problem

A HOSPITAL REPRESENTATIVE VERBALLY CONTACTED A BIOGENNIX DISTRIBUTOR REQUESTING PRODUCT TESTING AND STERILIZATION INFORMATION ON THREE DIFFERENT MORPHEUS LOTS. THE HOSPITAL WAS PERFORMING A FOLLOW-UP INVESTIGATION ON THREE SEPARATE PATIENT INFECTIONS THAT OCCURRED OVER A PERIOD OF SEVERAL WEEKS FOLLOWING SURGICAL PROCEDURES IN WHICH MORPHEUS WAS USED CONCOMITANTLY WITH OTHER UNDISCLOSED DEVICES. BIOGENNIX ASSESSMENT: DHR REVIEW CONFIRMED THAT MORPHEUS WAS PROVIDED STERILE AND IS UNLIKELY TO CAUSE A CONTAMINATION OR INFECTION. SINCE THE PRODUCT WAS NOT RETURNED AND ADDITIONAL PRODUCT SAMPLES FROM THIS LOT ARE NO LONGER AVAILABLE, WE CANNOT CONDUCT ANY FURTHER INVESTIGATION. ALL UNITS FROM THIS LOT HAVE BEEN IMPLANTED AND NO OTHER ADVERSE REPORTS HAVE BEEN RECEIVED. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SUBMITTED.