ILLUMINOSS PHOTODYNAMIC BONE STABILIZATION SYSTEM

Additional Manufacturer Narrative

SURGEON REPORTED THAT THE LIGHT FIBER WAS PLUGGED INTO MACHINE AT TOO ACUTE OF AN ANGLE AND MAY HAVE LED TO THE FAILURE. THE LIGHT BOX WAS REPOSITIONED IN A DIFFERENT LOCATION IN OPERATING ROOM (OR) IN THE SECOND IMPLANT CURED COMPLETELY AT 1200 SECONDS. STATUS OF THE PATIENT IS IN GOOD CONDITION, WENT HOME POST OP (DAY OF SURGERY). PLEASE NOTE THIS REPORT IS BEING RESUBMITTED BASED UPON CORRESPONDENCE WITH EMDR STAFF.

Description of Event or Problem

CASE INVOLVING A (B)(6) MALE WITH LEFT HUMERUS, MID SHAFT FRACTURE. THE PRODUCT WAS A 17 X 220 MM IMPLANT. THE IMPLANT WAS PLACE BUT THEN DRAINED AND REMOVED IN ORDER TO SECURE A BIOPSY. THE IMPLANT WAS REINSERTED RE-INFLATED AND THEN CURED. APPROXIMATELY 2 MINUTES INTO CURING SOME ACTION BY THE MEDICAL STAFF CAUSED THE LIGHT FIBER TO BREAK. AN ATTEMPT TO REMOVE THE ORIGINAL LIGHT FIBER WAS MADE, TOWARDS INSERTING ANOTHER FIBER AND CONTINUING THE CURING CYCLE. ONLY A PORTION OF THE LIGHT FIBER WAS ABLE TO BE REMOVED, WHICH PRECLUDED THE CONTINUATION OF THE CURING CYCLE. AN ATTEMPT TO REMOVE THE MONOMER FROM THE PARTIALLY CURED IMPLANT WAS MADE, BY PIERCING THE IMPLANT AND ASPIRATING SOME OF THE MONOMER. SOME OF THE MONOMER WAS REMOVED IN THIS FASHION, ALTHOUGH NOT A SIGNIFICANT AMOUNT. THE ORIGINAL IMPLANT WAS ATTEMPTED TO BE REMOVED FROM THE CANAL BY PULLING ON THE CATHETER, BUT WAS NOT ABLE TO BE DISLODGED. A SECOND IMPLANT 22/13 X 160 WAS DELIVERED ALONGSIDE THE ORIGINAL IMPLANT. THE SECOND IMPLANT WAS INFUSED WITH MONOMER. THE EXPANSION OF THE SECOND IMPLANT CAUSED THE RESIDUAL MONOMER IN THE FIRST NOW PIERCED IMPLANT TO BE EXPELLED THROUGH THE PATHWAY IN THE HUMERAL HEAD AND REMOVED. THE SECOND IMPLANT WAS CURED FOR 1200 SECONDS. THIS REPRESENTED AN ADDITIONAL 400 SECONDS REQUIRED FOR THE SECOND IMPLANT. THE REASON WAS TO ENSURE CURING OF ANY RESIDUAL MONOMER RETAINED FROM THE INITIAL IMPLANT. THERE WAS NO ADVERSE EVENT TO THE PATIENT. HOWEVER, THE PROCEDURE WAS EXTENDED IN TIME.