Photodynamic Bone Stabilization System US1500180Recalls & reported problems

Illuminoss Medical, Inc. · 15mmx180mm Photodynamic Bone Stabilization LED Light System · Implant

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 2
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI M986US15001800), received between Sep 9, 2025 and Sep 12, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

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

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Insufficient Device Problem Information2
Optical Problem2
Power Problem1

Patient problems

No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

MalfunctionSep 12, 2025Optical Problem; Insufficient Device Problem Information; Optical Problem; Insufficient Device Problem Information
A USSL-2213240 ILLUMINOSS IMPLANT WAS NOT FULLY CURED DURING A CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23042709 ↗
MalfunctionSep 9, 2025Optical Problem; Power Problem; Insufficient Device Problem Information; Optical Problem; Power Problem; Insufficient Device Problem Information
A 15X180MM IMPLANT WAS INSERTED, INFLATED AND CURED. DURING THE CATHETER SEPARATION STEPS, THE BALLOON SLID OUT OF THE REAMED BONE ENTRY HOLE. THE IMPLANT WAS COMPLETELY REMOVED BY HAND BY THE USER AND THE BALLOON WAS NOT FULLY CURED. IT IS NOT BELIEVED THAT THE BALLOON LEAKED AND NO LIQUID MONOMER ESCAPED THE BALLOON. THE REP PRESENT OBSERVED THAT THE LIGHT FIBER DID NOT APPEAR BRIGHT BLUE AS IT TYPICALLY DOES DURING THE CURING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23005903 ↗

Device details

UDI-DI	`M986US15001800`
Brand	Photodynamic Bone Stabilization System
Model	US1500180
Catalog no.	US-1500180
Company	Illuminoss Medical, Inc.
Product code	—
Class	—
FDA submission	None listed
Implant	Yes
Rx / OTC	—
Single use	Yes
Sterile	Yes
MRI safety	MR Conditional
Status	In Commercial Distribution
Record updated	Jul 14, 2025

Device type (GMDN): Orthopaedic bone pin, non-bioabsorbable

A thin, implantable rod intended to be used for the stabilization of a bone fracture or bone grafts, or for an osteotomy or arthrodesis (internal and/or external fixation). It is typically drilled into bone and may be smooth or threaded, solid or cannulated, and/or semi-flexible. Also known as a Kirschner-wire (K-wire), it may in addition be intended to assist with the introduction of a surgical instrument and/or implant; it is not intended for implantation into the intramedullary canal (i.e., not a nail). It is made of a non-bioabsorbable material (e.g., stainless steel). Some designs may have a break-off shank and/or be coated to improve long-term fixation. This is a single-use device.

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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