Photodynamic Bone Stabilization Procedure Pack USSL-1100220Recalls & reported problems
Illuminoss Medical, Inc. · Photodynamic Bone Stabilization Procedure Pack · Class 2 · Implant
All models of Photodynamic Bone Stabilization Procedure Pack (11)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M986USSL11002200), received between Dec 7, 2022 and Dec 7, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Too Soft/Flexible” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Material Too Soft/Flexible1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 7, 2022Material Too Soft/Flexible; Material Too Soft/Flexible
ON (B)(6)2022, AN (B)(6) YEAR OLD FEMALE WAS TREATED FOR A RIGHT HUMERUS PATHOLOGIC MID SHAFT FRACTURE. THE PLANNED PROCEDURE WAS TO USE AN ILLUMINOSS IMPLANT, AND THEN PLATE AND SCREWS. AFTER THE CURING CYCLE HAD BEEN COMPLETED FOR THE ILLUMINOSS IMPLANT [SIZE USSL-1100220], THE DOCTOR FOUND THAT THE MONOMER HAD NOT FULLY CURED. THE IMPLANT WAS REMOVED AND REPLACED WITH ANOTHER SUCCESSFULLY, THEN THE ADDITIONAL PLATE AND SCREWS WERE ADDED. THE PATIENT OUTCOME WAS GOOD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15934089 ↗
Other Rod, Fixation, Intramedullary And Accessories, In-Vivo Cured, Light-Activated devices
- Photodynamic Bone Stabilization Procedure Pack USSL-1700260Illuminoss Medical, Inc. · Rod, Fixation, Intramedullary And Accessories, In-Vivo Cured, Light-Activated2 deaths8 reports
- Photodynamic Bone Stabilization Procedure Pack USSL-2213260Illuminoss Medical, Inc. · Rod, Fixation, Intramedullary And Accessories, In-Vivo Cured, Light-Activated1 death6 reports
- Photodynamic Bone Stabilization Procedure Pack USSL-2213220Illuminoss Medical, Inc. · Rod, Fixation, Intramedullary And Accessories, In-Vivo Cured, Light-Activated4 deaths5 reports
- Photodynamic Bone Stabilization Procedure Pack USSL-2213240Illuminoss Medical, Inc. · Rod, Fixation, Intramedullary And Accessories, In-Vivo Cured, Light-Activated5 reports
- Photodynamic Bone Stabilization Procedure Pack USSL-2213160Illuminoss Medical, Inc. · Rod, Fixation, Intramedullary And Accessories, In-Vivo Cured, Light-Activated3 reports
- Photodynamic Bone Stabilization Procedure Pack USSL-1700220Illuminoss Medical, Inc. · Rod, Fixation, Intramedullary And Accessories, In-Vivo Cured, Light-Activated3 reports
- Photodynamic Bone Stabilization Procedure Pack USSL-1700280Illuminoss Medical, Inc. · Rod, Fixation, Intramedullary And Accessories, In-Vivo Cured, Light-Activated3 reports
- Photodynamic Bone Stabilization Procedure Pack USML-1310090Illuminoss Medical, Inc. · Rod, Fixation, Intramedullary And Accessories, In-Vivo Cured, Light-Activated1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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