ILLUMINOSS PHOTODYNAMIC BONE STABILIZATION SYSTEM

Additional Manufacturer Narrative

IMPLANT DATE: (B)(6) 2018. IT WAS REPORTED THAT THE CASE WENT WELL. AFTER THE MONOMER WAS CURED, THE OPERATOR DRILLED FOR AND THEN INSERTED A ZIMMER 4.0MM CANNULATED SCREW. IT WAS LATER LEARNED THAT THE SCREW WAS PLACED THROUGH THE IMPLANT AT THE FRACTURE SITE. ILLUMINOSS TRAINERS INSTRUCT USERS TO PLACE SCREWS THROUGH THE IMPLANT AT LEAST 3CMS OR MORE, AWAY FROM THE FRACTURE LINE.

Description of Event or Problem

SURGEON REPORTED THAT A PATIENT'S IMPLANT HAD FRACTURED. THE PATIENT HAD A FRACTURE OF THE HUMERUS WITH ILLUMINOSS IMPLANT AND SCREW FIXATION. THE SURGEON ALSO INDICATED THAT THE FRACTURE MAY HAVE OCCURRED WITHIN 6 WEEKS OF THE INCIDENT REPORT DATE OF (B)(4) 2018. IT WAS NOTED BY THE SURGEON THAT THEY HAD PLACED A 4.0MM CANNULATED SCREW THROUGH THE IMPLANT DIRECTLY AT THE FRACTURE LINE. THEY BELIEVE THE IMPLANT DID NOT EXPAND TO ITS FULLEST DIAMETER WHERE THE SCREW WAS PLACED WHICH MAY HAVE WEAKENED THE IMPLANT. HOWEVER, A REVIEW OF THE X-RAY SHOWED THE IMPLANT NEARLY FULLY EXPANDED. THE IMPLANT FRACTURE OCCURRED WHERE THE SCREW WENT THROUGH IT. IT WAS NOTED THAT THE SCREW WAS NOT CENTERED IN THE IMPLANT. THE SURGEON REPORTED THAT THE PATIENT WAS DOING FINE AND THE FRACTURE WAS HEALING AS EXPECTED WITH THE ILLUMINOSS PRODUCT STILL IN PLACE.