PHOTODYNAMIC BONE STABILIZATION SYSTEM
Received Jul 7, 2025 · Event occurred Jun 9, 2025
Report 3006845464-2025-00009 · MDR key 22413746
Device
Generic name
In Vivo Intramedullary Fixation Rod
Manufacturer
Illuminoss Medical IncProduct problems
- No Apparent Adverse Event
- Insufficient Device Problem Information
- No Apparent Adverse Event
- Insufficient Device Problem Information
Patient
65 YR · Unknown
- Thrombosis/Thrombus
- Thrombosis/Thrombus
Narrative
Additional Manufacturer Narrative
THIS INVESTIGATION IS CURRENTLY ONGOING. A FOLLOW UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem
AN ARTICLE BY CLUNK ET AL., 2025 TITLED "EARLY EXPERIENCE WITH PERCUTANEOUS PHOTODYNAMIC NAILS FOR SACRAL METASTATIC DISEASE AND INSUFFICIENCY FRACTURES: A RETROSPECTIVE COHORT ANALYSIS OF FUNCTIONALITY AND PAIN RELIEF" WAS PUBLISHED IN BMC MUSCULOSKELETAL DISORDERS AND SUMMARIZED THE RESULTS OF 14 PATIENTS TREATED WITH AN ILLUMINOSS IMPLANT. THERE WAS ONE COMPLICATION IDENTIFIED IN THIS JOURNAL ARTICLE WITH ONE PATIENT DEVELOPING A DEEP VEIN THROMBOSIS DURING THE POST-OPERATIVE COURSE.
Additional Manufacturer Narrative
AT THE TIME THIS MDR WAS SUBMITTED, IT WAS NOT KNOWN IF THE ADVERSE EVENT WAS RELATED TO THE DEVICE AS SUCH THE MDR EVENT WAS REPORTED OUT OF AN ABUNDANCE OF CAUTION. THIS FOLLOW UP MDR CLARIFIES THAT THE ADVERSE EVENT WAS NOT RELATED TO THE ILLUMINOSS DEVICE AS CONFIRMED BY THE PHYSICIAN.
Description of Event or Problem
AN ARTICLE BY CLUNK ET AL., 2025 TITLED "EARLY EXPERIENCE WITH PERCUTANEOUS PHOTODYNAMIC NAILS FOR SACRAL METASTATIC DISEASE AND INSUFFICIENCY FRACTURES: A RETROSPECTIVE COHORT ANALYSIS OF FUNCTIONALITY AND PAIN RELIEF" WAS PUBLISHED IN BMC MUSCULOSKELETAL DISORDERS AND SUMMARIZED THE RESULTS OF 14 PATIENTS TREATED WITH AN ILLUMINOSS IMPLANT. THERE WAS ONE COMPLICATION IDENTIFIED IN THIS JOURNAL ARTICLE WITH ONE PATIENT DEVELOPING A DEEP VEIN THROMBOSIS DURING THE POST-OPERATIVE COURSE.