PHOTODYNAMIC BONE STABILIZATION SYSTEM
Received May 22, 2024
Report 3006845464-2024-00009 · MDR key 19369088
Device
Generic name
Intremedullary Fixation Rod
Manufacturer
Illuminoss Medical Inc.Product problems
- Insufficient Device Problem Information
- Insufficient Device Problem Information
Patient
50 YR · Male
- Insufficient Information
- Insufficient Information
Narrative
Additional Manufacturer Narrative
ILLUMINOSS REACHED OUT TO THE AUTHOR OF THE PUBLICATION AND HAS OBTAINED CONTACT FOR INFORMATION FOR THE USER. THE INVESTIGATION IS PENDING A RESPONSE FROM THE USER.
Description of Event or Problem
A PUBLICATION REPORTED ON A 50 YEAR OLD MALE WITH METASTATIC LUNG CANCER THAT WAS IMPLANTED WITH AN ILLUMINOSS DEVICE HAD A RETAINED CATHETER FRAGMENT THAT EXTENDED FROM THE PROXIMAL END OF THE ILLUMINOSS IMPLANT THROUGH THE EXTRAOSSEOUS SOFT TISSUE. POST-OPERATIVE DAY 1 AXIAL CT WITH SEGMENT OF THE RETAINED CATHETER SEEN THROUGH THE GLUTEUS MUSCLE. AT 6 MONTH FOLLOW-UP CT THERE WAS A PROGRESSION OF A DESTRUCTIVE, ENHANCING LESION CENTERED IN THE RIGHT ILIAC BONE WITH CENTRAL NECROSIS, WHICH ALSO EXTENDS PERIPHERALLY ALONG THE TRACT OF THE RETAINED CATHETER.
Additional Manufacturer Narrative
ILLUMINOSS REACHED OUT TO THE AUTHOR OF THE PUBLICATION AND OBTAINED CONTACT FOR INFORMATION FOR THE USER. DESPITE NUMEROUS ATTEMPTS TO CONTACT THE SURGEON, NO FURTHER INFORMATION WAS OBTAINED. THE CAUSE OF THIS COMPLAINT IS DUE TO A PORTION OF THE CATHETER BEING RETAINED IN THE PATIENT'S SOFT TISSUE, WHICH CREATED A PATH OF LEAST RESISTANCE FOR THE LESION TO TRAVEL DOWN. HOWEVER, IT IS UNKNOWN IF THE RETAINED PIECE OF CATHETER IS DUE TO THE USER NOT ATTEMPTING TO SEPARATE THE CATHETER FROM THE IMPLANT, OR THE USER BEING UNABLE TO PERFORM THIS SEPARATION DUE TO AN INSTRUMENT FAILURE, OR DUE TO THE IMPLANT LOCATION AND THE USER NOT ENSURING THE SEPARATION INSTRUMENT COULD REACH THE BALLOON. THEREFORE, THE ROOT CAUSE OF THIS COMPLAINT IS UNKNOWN.
Description of Event or Problem
A PUBLICATION REPORTED ON A 50 YEAR OLD MALE WITH METASTATIC LUNG CANCER THAT WAS IMPLANTED WITH AN ILLUMINOSS DEVICE HAD A RETAINED CATHETER FRAGMENT THAT EXTENDED FROM THE PROXIMAL END OF THE ILLUMINOSS IMPLANT THROUGH THE EXTRAOSSEOUS SOFT TISSUE. POST-OPERATIVE DAY 1 AXIAL CT WITH SEGMENT OF THE RETAINED CATHETER SEEN THROUGH THE GLUTEUS MUSCLE. AT 6 MONTH FOLLOW-UP CT THERE WAS A PROGRESSION OF A DESTRUCTIVE, ENHANCING LESION CENTERED IN THE RIGHT ILIAC BONE WITH CENTRAL NECROSIS, WHICH ALSO EXTENDS PERIPHERALLY ALONG THE TRACT OF THE RETAINED CATHETER.