Photodynamic Bone Stabilization System US2213240Recalls & reported problems

Illuminoss Medical, Inc. · 22/13mmx240mm Photodynamic Bone Stabilization LED Light System · Implant

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 1
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M986US22132400), received between Nov 18, 2025 and Nov 18, 2025 — classified as 1 death.

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 16, 2026.

Reports received per month

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

Most reported problems

Device problems

Adverse Event Without Identified Device or Use Problem1

Patient problems

Embolism/Embolus1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

DeathNov 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ILLUMINOSS IMPLANTED IN LEFT HUMERUS, CURED. RIGHT FEMUR RETROGRADE IM NAIL DURING THE CURING PROCESS OF ILLUMINOSS. ILLUMINOSS IMPLANT FULLY CURED AND FEMORAL NAIL WAS INSERTED AND DISTAL CROSS LOCKING SCREWS FOR THE FEMUR NAIL WERE PLACED BY RESIDENT WHILE SURGEON SCORED AND REMOVED THE CATHETER. AFTER SCORING AND REMOVAL OF CATHETER, WHILE RESIDENT WAS PLACING DISTAL CROSS LOCKING SCREWS IN FEMORAL IM NAIL, ANESTHESIA NOTIFIED SURGEON THAT PATIENTS PRESSURES WERE LOW. PT CODED AND WAS REVIVED AND CODED AGAIN AND PASSED. NOTE THAT THE REP NOTIFIED ANESTHESIA PRIOR TO ILLUMINOSS INSERTION THAT SURGEON WAS GOING TO IMPLANT AND TO BE AWARE OF PRESSURIZATION OF CANAL SAYING IT OUT LOUD TO THE OR ROOM, INCLUDING ANESTHESIA AND WAS THANKED FOR THE COMMENT AND ALERT. PATIENT WAS NORMAL DURING IMPLANTATION AND TOTAL CURING OF ILLUMINOSS.
Patient problems: Embolism/Embolus
MAUDE report 23584170 ↗

Device details

UDI-DI	`M986US22132400`
Brand	Photodynamic Bone Stabilization System
Model	US2213240
Catalog no.	US-2213240
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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