Photodynamic Bone Stabilization Procedure Pack USSL-2213220Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI M986USSL22132200), received between Aug 17, 2022 and Oct 20, 2023 — classified as 4 deaths, 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood 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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• DeathOct 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 65-YEAR OLD MALE WAS TREATED FOR A PATHOLOGIC FRACTURE OF THE LEFT HUMERUS USING ILLUMINOSS IMPLANTS. AFTER THE CURING PROCESS WAS BEGUN, THE PATIENT EXPERIENCED HEIGHTENED BLOOD PRESSURE AND OXYGEN ISSUES, AND REQUIRED RESUSCITATION IN THE OR. THE PATIENT WAS MOVED TO THE ICU, WHERE HE PASSED LATER THAT EVENING.

  Patient problems: High Blood Pressure/ Hypertension; Insufficient Information

  MAUDE report 17981309 ↗
• DeathAug 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PROCEDURE TO TREAT A 78-YEAR OLD FEMALE FOR A TRAUMATIC DISTAL FEMUR FRACTURE WITH AN ILLUMINOSS IMPLANT, THE PATIENT DECLINED WHILE CURING OF THE BALLOON IN SURGERY. THE PATIENT PASSED IN ICU 1.5 HOURS LATER.

  Patient problems: Cardiac Arrest

  MAUDE report 17574028 ↗
• MalfunctionApr 25, 2023Gel Leak; Gel Leak

  THIS MDR REPORT IS BASED ON THE RECLASSIFICATION OF A PREVIOUSLY REVIEWED COMPLAINT. DURING TREATMENT OF A TRAUMATIC DISTAL FEMUR FRACTURE NON-UNION FOR A 60 YEAR OLD FEMALE WHO HAD BEEN PREVIOUSLY TREATED WITH A BLADE PLATE AND SCREWS, AN ILLUMINOSS IMPLANT [SIZE 22/13X220] WAS PLACED. FOLLOWING INSERTION OF IMPLANT, A HOLE WAS IDENTIFIED MID-BALLOON UPON INJECTION OF MONOMER. THE DAMAGED BALOON WAS REMOVED, AND A NEW BALLOON WAS USED WITHOUT ISSUES. THE SURGICAL OUTCOME WAS AS PLANNED, AND THERE WERE NO PATIENT ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16811693 ↗
• DeathSep 7, 2022Fluid/Blood Leak; Fluid/Blood Leak

  DURING AN DISTAL FEMORAL PROCEDURE PERFORMED ON AN 80 YEAR OLD FEMALE TRAUMA PATIENT, A BALLOON LEAK OCCURRED WHILE IT WAS BEING INFUSED WITH MONOMER. THE BALLOON WAS REMOVED. WHILE A REPLACEMENT BALLOON WAS BEING PREPARED, THE PATIENT EXPERIENCED A CARDIAC EVENT, AND EXPIRED.

  Patient problems: Cardiac Arrest

  MAUDE report 15375227 ↗
• DeathAug 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A TIBIA AND FEMUR PROCEDURE PERFORMED BY DR. (B)(6) FOR AN 88 YEAR OLD FEMALE TRAUMA PATIENT, 2 ILLUMINOSS BALLOONS (INTRAMEDULLARY IMPLANTS) WERE PLACED, INFUSED, AND CURED SUCCESSFULLY. WHILE THE TREATING PHYSICAN WAS BEGINNING THE PROCESS TO PLATE THE DISTAL FEMUR, THE PATIENT EXPERIENCED A CARDIAC EVENT AND EXPIRED. THERE WAS NO OBSERVED PRODUCT MALFUNCTION.

  Patient problems: Cardiac Arrest; Respiratory Arrest

  MAUDE report 15242712 ↗