MalfunctionQAD

PHOTODYNAMIC BONE STABILIZATION SYSTEM

Received Apr 8, 2026 · Event occurred Mar 11, 2026

Report 3006845464-2026-00001 · MDR key 24817626

Device

Generic name

Intramedullary Fixation Rod, Product Code Qad

Manufacturer

Illuminoss Medical, Inc.

Catalog number

SY-2100-01

Product problems

Optical Problem
Insufficient Device Problem Information

Patient

84 YR · Female

No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

THE INVESTIGATION INTO THE EVENT IS CURRENTLY ONGOING. A FOLLOW-UP MDR WIL BE SUBMITTED WHEN MORE INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

DURING A PROCEDURE ON (B)(6) 2026 TWO BALLOON IMPLANTS WERE INSERTED INTO THE RIGHT PROXIMAL TIBIA. WHEN THE LIGHTBOX WAS USED TO CURE THE IMPANTS BOTH IMPLANTS FAILED TO CURE. THE USER REPORTED THAT THE LIGHTBOX DID NOT DIPLAY ERROR CODES.