Photodynamic Bone Stabilization Procedure Pack USSL-1500260Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M986USSL15002600), received between Nov 22, 2022 and Nov 22, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Lack of Effect” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 22, 2022Lack of Effect; Lack of Effect

  AN ADVERSE EVENT WAS ENTERED INTO THE ILLUMINOSS CLINICAL STUDY REGISTRY ON OCTOBER 25, 2022 FOR AN EVENT WHICH OCCURRED ON (B)(6) 2021. ON (B)(6) 2021, AN ILLUMINOSS IMPLANT (SIZE 15MMX260MM) AND ALSO 4 SCREWS WERE USED TO TREAT A PATIENT WITH A METASTATIC FRACTURE OF THE LEFT HUMERUS IN A 63 YEAR-OLD MALE PATIENT. SIGNIFICANT BONE LOSS WAS NOTED BY THE TREATING PHYSICIAN AT THE TIME OF FINAL REDUCTION AND IMPLANTATION. THE ADVERSE EVENT "LOOSENING, BENDING, CRACKING, FRACTURE OR MECHANICAL FAILURE OF COMPONENTS " WAS OBSERVED BY THE TREATING PHYSICIAN AT A FOLLOW UP VISIT ON (B)(6) 2021. THE USER NOTED A LARGE AMOUNT OF CALLOUS FORMATION. AT THAT TIME THE USER ALSO NOTED THAT THE SCREWS WERE STABLE, AND THAT THE FRACTURE HAD NO INSTABILITY. THE TREATING PHYSICIAN DETERMINED THAT NO FURTHER TREATMENT WAS NECESSARY, AND NONE WAS PERFORMED. ALTHOUGH THE INVESTIGATION IS STILL ONGOING INTO THE CAUSE OF REPORTED EVENT, THE "LOOSENING, BENDING, CRACKING, FRACTURE, OR MECHANICAL FAILURE" REPORTED BY THE REGISTRY PARTICIPANT MAY BE THE RESULT OF A DEVICE MALFUNCTION, AND THEREFORE THIS INITIAL MDR IS BEING SUBMITTED.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 15845382 ↗