Photodynamic Bone Stabilization System SY210001Recalls & reported problems
Illuminoss Medical, Inc. · Photodynamic Bone Stabilization LED Light Box
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 M986SY2100010), received between Jun 26, 2026 and Jun 26, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Optical Problem” (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.
Reports received per month
Most reported problems
Device problems
- Optical Problem1
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.
MalfunctionJun 26, 2026Optical 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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25635556 ↗
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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