Photodynamic Bone Stabilization system
Received Jun 26, 2026 · Event occurred Jun 1, 2026
Report 3006845464-2026-00002 · MDR key 25635556
Device
Generic name
Intramedullary Fixation Rod, Product Code Qad
Manufacturer
Illuminoss Medical, Inc.Catalog number
SY-2100-01
Product problems
- Optical Problem
Patient
60 YR · Female
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE INVESTIGATION IS ONGOING AND RESULT WILL BE SUBMITTED UPON COMPLETION.
Description of Event or Problem
TWO ATTEMPTS TO CURE AN ILLUMINOSS IMPLANT RESULTED IN INCOMPLETE POLYMERIZATION WHEN USING THE SAME LED LIGHT BOX, WITH THE FIRST IMPLANT REQUIRING REMOVAL DUE TO FAILURE TO POLYMERIZE. A SECOND IMPLANT ALSO DID NOT FULLY POLYMERIZE AFTER THE INITIAL CURE CYCLE AND REQUIRED EXTENDED CURE TIME (APPROXIMATELY 1800 SECONDS). A REPLACEMENT LED LIGHT BOX WAS SUBSEQUENTLY USED, DEMONSTRATING VISIBLY BRIGHTER LIGHT OUTPUT, AFTER WHICH THE PROCEDURE WAS SUCCESSFULLY COMPLETED.