Photodynamic Bone Stabilization Procedure Pack USSL-1700280Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI M986USSL17002800), received between Nov 22, 2022 and Oct 17, 2025 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Gel Leak” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 17, 2025Gel Leak; Material Too Soft/Flexible; Gel Leak; Material Too Soft/Flexible

  AN EVENT WAS REPORTED IN WHICH THE IMPLANT DID NOT FULLY CURE. THE PROXIMAL PORTION OF THE BALLOON CURED, WHILE THE DISTAL PORTION REMAINED UNCURED. THE PHYSICIAN PLACED A SECOND BALLOON RETROGRADE TO COMPLETE FILLING OF THE LESION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23324676 ↗
• InjuryDec 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2022, AN 82 YEAR OLD FEMALE PATIENT WITH DEMENTIA AND MULTIPLE CO-MORBIDITIES WAS TREATED FOR A TRAUMATIC DISTAL FEMUR FRACTURE WITH AN ILLUMINOSS IMPLANT [SIZE USSL-1700280]. AFTER THE MONOMER WAS INFUSED INTO THE BALLOON AND THE IMPLANT CURING PROCESS WAS STARTED, THE PATIENT BECAME EXTREMELY HYPOTENSIVE, HYPOXIC, AND CODED. THE PATIENT WAS STABILIZED USING CHEMICAL CPR, CHEST COMPRESSIONS, AND BLOOD INFUSION. THE PROCEDURE PROGRESSED AND WAS COMPLETED. AS OF (B)(6) THE PATIENT OUTCOME WAS GOOD.

  Patient problems: Low Blood Pressure/ Hypotension; Low Oxygen Saturation

  MAUDE report 15942255 ↗
• InjuryNov 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ADVERSE EVENT WAS ENTERED INTO THE ILLUMINOSS CLINICAL STUDY REGISTRY ON (B)(6) 2022 FOR AN EVENT WHICH OCCURRED ON (B)(6) 2021. ON (B)(6) 2021, AN ILLUMINOSS IMPLANT (SIZE 17MMX280MM) WAS USED TO TREAT A PATIENT WITH A NON-TRAUMATIC IMPENDING PATHOLOGIC FRACTURE OF THE LEFT HUMERUS IN A 63 YEAR-OLD MALE PATIENT WITH MULTIPLE MYELOMA. DIAPHYSEAL, SIMPLE, TRANSVERSE, CLOSED FRACTURE. SIGNIFICANT BONE LOSS WAS NOTED BY THE TREATING PHYSICIAN AT THE TIME OF FINAL REDUCTION AND IMPLANTATION. NO DEVICES WERE USED IN CONJUNCTION WITH THE ILLUMINOSS IMPLANT. A SOFT CAST/SPLIT WAS USED POST IMPLANTATION FOR FRACTURE SUPPORT. THE ADVERSE EVENT "LOSS OF OR INADEQUATE FIXATION IN BONE" WAS OBSERVED BY THE TREATING PHYSICIAN ON (B)(6) 2022. SURGICAL INTERVENTION WAS PERFORMED ON (B)(6) 2021 TO ADDRESS THIS WITH ADDITIONAL FIXATION PROCEDURE IM NAILING. ALTHOUGH THE INVESTIGATION IS STILL ONGOING INTO THE CAUSE OF THE LOSS OF FIXATION, THIS INCIDENT NECESSITATED SURGICAL INTERVENTION TO ADD ADDITIONAL FIXATION (IM NAILING) TO ACHIEVE STABILIZATION OF THE ORIGINAL BONE FRACTURE, AND THEREFORE THIS INITIAL MDR IS BEING SUBMITTED.

  Patient problems: Bone Fracture(s)

  MAUDE report 15847264 ↗