Photodynamic Bone Stabilization Procedure Pack USSL-2213160Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI M986USSL22131600), received between Mar 18, 2023 and Dec 14, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Fracture” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 14, 2023Gel Leak; Insufficient Device Problem Information; Gel Leak; Insufficient Device Problem Information

  AN ADVERSE EVENT WAS ENTERED INTO THE ILLUMINOSS CLINICAL STUDY REGISTRY ON NOVEMBER 14, 2023 FOR AN EVENT WHICH OCCURRED ON (B)(6) 2022. A PATIENT UNDERWENT A PERCUTANEOUS STABILIZATION DUE TO EXTENSIVE PATHOLOGIC FRACTURES AND EXTENSIVE OSTEOLYSIS THROUGHOUT HER LEFT ACETABULUM AND HEMIPELVIS SECONDARY TO BREAST CANCER. THIS WAS FOLLOWED BY A STAGED TOTAL HIP ARTHROPLASTY. POST OPERATIVELY THE PATIENT WAS ADMITTED FOR SURGICAL DEBRIDEMENT OF THE HIP AND EXCISIONAL DEBRIDEMENT OF CHRONIC DRAINING SINUS TRACT FROM THE LEFT ILIUM, AND SEPARATE SURGICAL SITE WITH DEBRIDEMENT OF ILIOPSOAS MUSCLE IN EXCISIONAL MANNER.

  Patient problems: Fever; Purulent Discharge; Swelling/ Edema

  MAUDE report 18332046 ↗
• InjuryMay 24, 2023Fracture; Fracture

  A VERY SICK PATIENT FELL AND EXPERIENCED A PERIPROSTHETIC PROXIMAL HUMERUS FRACTURE. THE PATIENT HAD EXPERIENCED A FRACTURE OF THE SAME HUMERUS 10 YEARS PREVIOUSLY WHICH HAD BEEN TREATED WITH A PLATE. 2 MONTHS AFTER THE PERIPROSTHETIC FRACTURE, THE PATIENT WAS TREATED WITH AN ILLUMINOSS IMPLANT [SIZE 22/13X160MM]. TWO WEEKS POST IMPLANTATION, THE ILLUMINOSS IMPLANT BROKE THROUGH THE FRACTURE SITE AT THE EDGE OF THE HUMERUS PLATE.

  Patient problems: Bone Fracture(s)

  MAUDE report 16997022 ↗
• InjuryMar 18, 2023Fracture; Fracture

  AN ADVERSE EVENT WAS ENTERED INTO THE ILLUMINOSS CLINICAL STUDY REGISTRY ON (B)(6) 2023 FOR AN EVENT WHICH OCCURRED (B)(6), 2023. ON (B)(6) 2022, AN ILLUMINOSS IMPLANT (SIZE 22/13X160MM) WITH 3 SCREWS WAS USED TO TREAT A PATIENT WITH A TRAUMATIC FRACTURE OF THE RIGHT HUMERUS IN A 68 YEAR-OLD FEMALE PATIENT WITH HYPERTENSION AND A HISTORY OF HEMORRHAGIC STROKE. APPROXIMATELY 6 WEEKS AFTER HER INITIAL PROCEDURE THE PATIENT PRESENTED WITH WORSENING PAIN IN THE RIGHT SHOULDER. ON (B)(6) 2023 SHE UNDERWENT EXPLANT OF THE ILUMINOSS DEVICE AND IT WAS FOUND TO BE BROKEN. SHE WAS REFERRED FOR SURGICAL INTERVENTION TO ADDRESS THIS WITH REVERSE TOTAL SHOULDER ARTHROPLASTY.

  Patient problems: Implant Pain

  MAUDE report 16569473 ↗