Photodynamic Bone Stabilization Procedure Pack USSL-2213240Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI M986USSL22132400), received between Dec 21, 2022 and Oct 29, 2025 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 29, 2025Gel Leak; Material Too Soft/Flexible; Gel Leak; Material Too Soft/Flexible

  AN EVENT WAS REPORTED IN WHICH THE MONOMER DID NOT FULLY CURE. THE LED LIGHT BOX COMPLETED A FULL CYCLE; HOWEVER, UPON REMOVAL OF THE LIGHT FIBER, UNCURED MONOMER LEAKED FROM THE PROXIMAL END WHERE THE CATHETER WAS CUT. THE CENTRAL PORTION OF THE BALLOON HAD CURED, AND THE PARTIALLY INFLATED BALLOON WAS LEFT IN PLACE. ADDITIONAL FIXATION WAS ACHIEVED USING A PLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23417108 ↗
• InjuryMay 25, 2023Fracture; Fracture

  AN 84 YEAR-OLD FEMALE PATIENT EXPERIENCED A BREAK THROUGH THE MYELOMA IN HER HUMERUS IN LATE DECEMBER THAT WENT ON TO HYPERTROPHIC NONUNION. ON (B)(6) 2023, HER HUMERUS WAS TREATED WITH AN ILLUMINOSS IMPLANT (SIZE 22/13X240MM) WITH 4 SCREWS. IN LATE APRIL, THE PATIENT PRESENTED WITH LOSS OF FIXATION IN THE ARM, AND THE IMPLANT WAS FOUND TO BE BROKEN AT THE SITE OF THE ORIGINAL BONE BREAK. THE PATIENT WAS NOT EXPRESSING BEING IN PAIN. THE USER TREATED THE PATIENT WITH REVISION SURGERY WITH A PLATE STABILIZED BY THE ILLUMINOSS IMPLANT WHICH REMAINED IN THE BONE. THE PATIENT CONDITION POST-REVISION SURGERY HAS BEEN REPORTED AS GOOD.

  Patient problems: Bone Fracture(s)

  MAUDE report 17002426 ↗
• InjuryApr 26, 2023Adverse 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) 2023 FOR AN EVENT WHICH OCCURRED ON (B)(6) 2022. ON (B)(6) 2022 , A PATIENT WAS TREATED FOR A PERIPROSETHETIC FEMUR FRACTURE WITH TWO ILLUMINOSS IMPLANTS AND A PLATE AND SCREWS. THE PATIENT WAS DIAGNOSED WITH A NON-UNION OF THE PERIPROSTHETIC FEMUR FRACTURE ON (B)(6) 2022 , AND RECEIVED REVISION SURGERY - ORIF WITH BONE GRAFTING AND MEDIAL PLATING- ON (B)(6) 2022.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 16820829 ↗
• MalfunctionDec 21, 2022Fracture; Fracture

  ON (B)(6) 2022, A 77 YEAR OLD MALE WAS TREATED FOR AN IMPENDING PATHOLOGIC FRACTURE AND LESIONS IN THE HUMERUS WITH AN ILLUMINOSS IMPLANT [SIZE USSL-2213240]. ON (B)(6) 2022, THE BONE AND IMPLANT FRACTURED AT THE DISTAL THIRD. ALTHOUGH THE INVESTIGATION IS STILL ONGOING INTO THE CAUSE OF THE IMPLANT BREAK, AND WHETHER OR NOT THE PATIENT SUFFERED A SERIOUS INJURY, THIS INCIDENT MAY QUALIFY AS A DEVICE MALFUNCTION, AND THEREFORE THIS INITIAL MDR IS BEING SUBMITTED.

  Patient problems: Bone Fracture(s)

  MAUDE report 16029039 ↗
• MalfunctionDec 21, 2022Fracture; Fracture

  A 52 YEAR OLD MALE WAS TREATED FOR A TRAUMATIC FRACTURE OF THE PROXIMAL HUMERUS WAS WITH AN ILLUMINOSS IMPLANT [SIZE USSL-2213240] AND PLATE AND SCREWS. ON (B)(6) 2022 THE PATIENT WAS SEEN BY THE SURGEON, AND THE SURGEON BELIEVES THE IMPLANT HAD FRACTURED. THE PATIENT HAS STARTED THE HEALING PROCESS, HOWEVER, AND THE TREATING PHYSICIAN DETERMINED NO ADDITIONAL TREATMENT WAS WARRANTED AT THIS TIME, AND THE SURGEON WOULD MONITOR PATIENT'S PROGRESS. ALTHOUGH THE INVESTIGATION IS STILL ONGOING INTO THE CAUSE OF USER'S REPORT THAT THE IMPLANT MAY BE BROKEN, THIS INCIDENT MAY QUALIFY AS A DEVICE MALFUNCTION, AND THEREFORE THIS INITIAL MDR IS BEING SUBMITTED.

  Patient problems: Insufficient Information; Nonunion/Delayed-union Bone Fracture

  MAUDE report 16023075 ↗