Photodynamic Bone Stabilization Procedure Pack USSL-2213260Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI M986USSL22132600), received between Aug 12, 2022 and Feb 23, 2024 — classified as 1 death, 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Gel Leak” (3 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.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SERIOUS ADVERSE EVENT OF INADEQUATE FIXATION AND DEVICE EXPLANT WAS ENTERED INTO THE ILLUMINOSS CLINICAL REGISTRY ON (B)(6) 2024 WITH AN EVENT DATE OF (B)(6) 2023. THE USER REPORTED LOSS OF OR INADEQUATE FIXATION IN BONE, NOT ILLUMINOSS DEVICE RELATED. THE DEVICES WERE EXPLANTED AND THE ADVERSE EVENT WAS RESOLVED ON (B)(6) 2023.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 18770077 ↗
• MalfunctionMay 5, 2023Gel Leak; Gel Leak

  A 71 YEAR-OLD MALE WAS BEING TREATED FOR AN IMPENDING PATHOLOGIC FRACTURE OF THE HUMERUS, USING AN ILLUMINOSS IMPLANT. THE USER WAS INFUSING THE ILLUMINOSS IMPLANT BALLOON FOR THIS PROCEDURE [SIZE 22/13X260] WITH MONOMER, WHEN THEY EXPERIENCED A LEAK. THE LEAK WAS EXPERIENCED UPON INFUSION OF THE 4TH SYRINGE OF MONOMER. THE BALLOON WAS REMOVED, AND A HOLE WAS FOUND IN THE BALLOON. ANOTHER ILLUMINOSS IMPLANT WAS USED SUCCESSFULLY TO COMPLETE THE PROCEDURE, AND THE PATIENT OUTCOME WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16877171 ↗
• MalfunctionApr 25, 2023Gas/Air Leak; Gas/Air Leak

  THIS MDR REPORT IS BASED ON THE RECLASSIFICATION OF A PREVIOUSLY REVIEWED COMPLAINT. ON (B)(6) 2020, A PROCEDURE INVOLVING THE FIXATION OF THE LEFT HUMERUS WITH THE ILLUMINOSS IMPLANT AND A PLATE WAS COMPLETED ON A 57-YEAR-OLD MALE PATIENT. HE WAS IN STABLE CONDITION THROUGHOUT THE PROCEDURE. WHILE PREPARING THE IMPLANT AND NEGATIVE PREPPING THE BALLOON, THE SCRUB TECH WAS REMOVING THE SYRINGE AND TURNED THE SYRINGE FURTHER CLOCKWISE OVERTIGHTENING THE SYRINGE. THE SYRINGE WAS THEN REMOVED PROPERLY. WHILE ATTEMPTING TO WET PREP THE BALLOON, IT WAS NOTED THAT THERE WAS A GREAT DEAL OF AIR IN THE SYSTEM. WHILE DRAWING A VACUUM TO REMOVE THE AIR AND MONOMER, IT WAS NOTED THAT AIR WAS CONTINUALLY ENTERING THE SYSTEM. THE IMPLANT WAS DISCARDED AND NOT USED. ANOTHER ILLUMINOSS IMPLANT WASSUCCESSFULLY PREPPED AND IMPLANTED. THE PROCEDURE WAS COMPLETED AS PLANNED AND THE PATIENT WAS NOT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16812204 ↗
• MalfunctionApr 25, 2023Gel Leak; Gel Leak

  THIS MDR REPORT IS BASED ON THE RECLASSIFICATION OF A PREVIOUSLY REVIEWED COMPLAINT. IN A CASE TO TREAT A TRAUMATIC HUMERUS FRACTURE FOR A 90 YEAR OLD FEMALE, AN ILLUMINOSS IMPLANT [SIZE 22/13X260] WAS INSERTED, AND DURING THE MONOMER INFUSION PROCESS THE SYRINGE LOST PRESSURE. THE IMPLANT WAS REMOVED AND HAD A VISIBLE TEAR IN THE BALLOON. THE MEDULLARY CANAL WAS WASHED OUT AND A SECOND IMPLANT OF THE SAME SIZE WAS INSERTED AND IMPLANTED WITH NO ISSUES. THERE WAS NO SIGNIFICANT SURGICAL DELAY DUE TO THE IMPLANT LEAKING AND BEING REPLACED. THE PATIENT OUTCOME WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16811880 ↗
• MalfunctionDec 21, 2022Gel Leak; Gel Leak

  A PATIENT WAS BEING TREATED FOR A AN IMPENDING PATHOLOGIC FRACTURE OF THE LEFT DISTAL FEMUR. TWO ILLUMINOSS IMPLANTS (SIZE 22/13 X 260MM) WERE INSERTED INTO THE DISTAL FEMUR, ONE FROM THE MEDIAL CONDYLE ONE FROM THE LATERAL CONDYLE. THERE WERE NO ISSUES THROUGHOUT THE PROCEDURE UNTIL THE SURGEON WAS INFLATING THE BALLOON. AS THE SURGEON WAS INJECTING WHAT SHOULD HAVE BEEN THE FINAL 10CC OF MONOMER THERE WAS A NOTICEABLE DECREASE IN THE PRESSURE NEEDED TO ADVANCE THE MONOMER. WHEN HE DREW BACK ON THE PLUNGER BLOOD AND MONOMER FILLED THE SYRINGE. REALIZING THERE WAS A LEAK HE REMOVED ALL THE MONOMER, IRRIGATED THE WOUND, AND SUCTIONED OUT ANY REMAINING MONOMER. A REPLACEMENT BALLOON WAS THEN INTRODUCED AND INFLATED WITH NO ISSUES, WITHOUT SIGNIFICANT DELAY. THE PATIENT OUTCOME WAS GOOD. ON THE BACK TABLE IT WAS DETERMINED AND SEEN THAT THERE WAS A SMALL HOLE ABOUT 15MM, FROM THE END OF THE BALLOON. (THE SIDE CLOSEST TO WHERE THE MONOMER WAS INTRODUCED). ALTHOUGH THE INVESTIGATION IS STILL ONGOING INTO THE CAUSE OF THE BALLOON LEAK, THIS MAY BE THE RESULT OF A DEVICE MALFUNCTION, AND THEREFORE THIS INITIAL MDR IS BEING SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16023173 ↗
• DeathAug 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2022 DR. (B)(6) WAS PERFORMING A DISTAL FEMORAL IMPLANT ON A 78 YEAR OLD FEMALE TRAUMA PATIENT. WHILE THE IMPLANT WAS CURING, THE PATIENT EXPIRED. THE PATIENT WAS VERY SICK, WITH PRE-EXISTING MEDICAL CONDITIONS, AND IT WAS NOTED THAT THE PATIENT HAD NOT BEEN MEDICALLY CLEARED FOR SURGERY THE DAY BEFORE THE PROCEDURE. THE PROCEDURE PROGRESSED WITHOUT ANY PRODUCT MALFUNCTION OR DEVIATION FROM THE MANUFACTURER'S INSTRUCTIONS FOR USE. THE ANESTHESIOLOGISTS OBSERVED THAT THE PATIENT'S DECLINE BEGAN AND PROGRESSED SO RAPIDLY THAT IT SUGGESTED A POTENTIAL FAT EMBOLISM AS THE CAUSE.

  Patient problems: Embolism/Embolus

  MAUDE report 15216168 ↗