BIOGENNIX OSTEOSPAN

Description of Event or Problem

RECURRENT FLUID COLLECTION IN THE PT AFTER USE OF PRODUCT/DEVICE AND SPINAL FIXATION HARDWARE. THE FLUID COLLECTION IMPROVED AFTER EXAM AND REMOVAL OF THE PRODUCT/DEVICE AND SPINAL FIXATION HARDWARE.

Additional Manufacturer Narrative

BIOGENNIX MEDICAL ASSESSMENT: OSTEOSPAN HAS BEEN USED FOR AN INSTRUMENTED SPINAL FUSION WITH SUBSEQUENT FLUID COLLECTION IN THE PT AND SUSPECTED INFECTION. THIS COMPLICATION REQUIRED RE-INTERVENTION WITH FIXATION HARDWARE AND MATERIAL (BONE GRAFT) REMOVAL. OSTEOSPAN IS PROVIDED STERILE AND IS UNLIKELY TO CAUSE A CONTAMINATION OR INFECTION. ALTERNATIVE ROOT CAUSES OF INFECTION SUCH AS PT-, PATHOLOGY-, INSTRUMENTATION AND OTHER SURGERY-RELATED CAUSES ARE TO BE CONSIDERED. HOWEVER, SINCE THE PRODUCT WAS NOT RETURNED AND ADDITIONAL PRODUCT SAMPLES FROM THIS LOT ARE NO LONGER AVAILABLE, WE CANNOT CONDUCT ANY FURTHER INVESTIGATION OR RULE OUT THAT THE SERIOUS ADVERSE EVENT WAS RELATED TO THE USE OF OSTEOSPAN. IT SHOULD BE NOTED, HOWEVER, THAT THE BALANCE OF THE LOT WAS USED (IMPLANTED) AND NO OTHER ADVERSE REPORTS HAVE BEEN RECEIVED. UPON F/U WITH THE PHYSICIAN TO RETRIEVE ADDITIONAL CASE INFO, THE PHYSICIAN TO RETRIEVE ADDITIONAL CASE INFO, THE PHYSICIAN STATED THAT HE DID NOT HAVE A COMPLAINT WITH THE PRODUCT AND CONTINUES TO USE IT IN HIS PRACTICE. SINCE THE PHYSICIAN WAS NOT COMPLAINING ABOUT THE PRODUCT, HE DID NOT WISH TO PROVIDE ANY FURTHER CASE INFO. SINCE CURRENT INFO IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT, NO FURTHER INVESTIGATION IS PLANNED. HOWEVER, IF ADDITIONAL INFO IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A F/U REPORT WILL BE SUBMITTED. THIS CASE WILL BE KEPT ON FILE FOR TRENDING PURPOSES.