ILLUMINOSS PHOTODYNAMIC BONE STABILIZATION SYSTEM

Additional Manufacturer Narrative

BECAUSE IT WAS FELT THAT THE LIGHT FIBER MAY HAVE BEEN COMPROMISED DUE TO THE ADDITIONAL FORCE APPLIED TO PLACE IT ACROSS THE FRACTURE, IT WAS RECOMMENDED THAT THE IMPLANT BE REMOVED AND REPLACED WITH A SMALLER DIAMETER IMPLANT THAT WOULD NOT REQUIRE THE SAME AMOUNT OF FORCE TO PLACE IT INTO POSITION. THIS ENSURED THAT THE LIGHT FIBER WAS NOT STRESSED AND WOULD TRANSMIT THE EXPECTED LIGHT INTENSITY NECESSARY TO CURE THE MONOMER MATERIAL IN THE IMPLANT. THIS IS THE SECOND ATTEMPT TO SUBMIT THIS REPORT. THE INITIAL SUBMISSION MADE 01/03/2020, FAILED DUE TO AN UNACCEPTABLE DEVICE PROBLEM CODE..

Description of Event or Problem

DURING INITIAL IMPLANT OF A 17X260MM ILLUMINOSS IMPLANT IN A (B)(6) FEMALE WITH A EWING'S SARCOMA TUMOR AND TOUGH IRRADIATED BONE, A 2ND YEAR RESIDENT BENT THE CATHETER OF THE ILLUMINOSS IMPLANT WHILE REMOVING THE SHEATH AND ATTEMPTING TO GET THE IMPLANT IN AS FAR AS POSSIBLE. THE IMPLANT WAS THEN EVALUATED THROUGH USE OF THE ILLUMINOSS LIGHTBOX TO DETERMINE WHETHER THE IMPLANT FIBER WAS COMPROMISED. IT WAS DETERMINED THAT THE FIBER WAS INDEED COMPROMISED. THE IMPLANT WAS THEN REMOVED AND REPLACED WITH A 17X220MM IMPLANT. THE NEW IMPLANT WAS THEN INFLATED WITH MONOMER AND CURED. THE PATIENT WAS NOT AFFECTED.