MAUDE Adverse Event Report: IlluminOss Medical, Inc. Photodynamic Bone Stabilization system; Intramedullary Fixation Rod, Product Code QAD

Catalog Number	SY-2100-01
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing and result will be submitted upon completion.
Event or Problem Description
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.

• Brand Name: Photodynamic Bone Stabilization system
• Common Device Name: Intramedullary Fixation Rod, Product Code QAD
• Manufacturer (Section D): IlluminOss Medical, Inc.; 993 waterman ave; providence RI 02914
• Manufacturer (Section G): Iluminoss Medical Inc.; 993 waterman ave; providence 02914
• Manufacturer Contact: robert rabiner ; 993 waterman ave; east providence, RI 02914 ; +1(401)714-0008
• MDR Report Key: 25635556
• Report Number: 3006845464-2026-00002
• Device Sequence Number: 15886806
• Product Code: QAD
• UDI-Device Identifier: M986SY2100010
• UDI-Public: M986SY2100010
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K233436
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: SY-2100-01
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/04/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2026
• Supplement Date Received by Manufacturer: 06/01/2026
• Initial Report FDA Received Date: 06/26/2026
• Supplement Report FDA Received Date: 07/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/17/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 60 YR
• Patient Sex: Female