Photodynamic Bone Stabilization Procedure Pack USML-1310090Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M986USML13100900), received between May 19, 2022 and May 19, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Material Too Soft/Flexible” (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 16, 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.

• InjuryMay 19, 2022Material Too Soft/Flexible; Material Too Soft/Flexible

  THIS EVENT IS BEING REPORTED AS A SERIOUS INJURY REPORT, FOR A MEDICAL INTERVENTION PERFORMED FOR A PATIENT CONDITION THAT PRESENTED AFTER AN IMPLANTATION PROCEDURE WITH THE MANUFACTURER'S DEVICE. ALTHOUGH THE MANUFACTURER'S INVESTIGATION (STILL ONGOING) HAS NOT YET CONCLUDED THAT THE NEED FOR MEDICAL INTERVENTION WAS DUE TO THE USE OF THE MANUFACTURER'S DEVICE, THIS EVENT IS BEING REPORTED OUT OF AN ABUNDANCE OF CAUTION. ON (B)(6) 2022, DR. (B)(6) OF MEDICAL CENTER (B)(6) TREATED A (B)(6) FEMALE FOR PATHOLOGIC FRACTURE OF THE PELVIS, AND PLANNED TO USE THREE ILLUMINOSS PHOTODYNAMIC BONE STABILIZATION SYSTEM IMPLANTS [SIZED 1. 22X100MM 2. 13/10X90MM 3. 13/10X90MM]. AFTER PERFORMING THE IMPLANT CURING PROCESS, ONE OF THESE IMPLANTS [THE 13/10X90MM SIZED IMPLANT IN THE ANTERIOR COLUMN] WAS FOUND UNDER-CURED. IT WAS REPLACED WITH ANOTHER IMPLANT [SIZED 13/10X120MM]. THE NEW IMPLANT WAS PLACED IN THE SAME LOCATION AND WAS CURED SUCCESSFULLY, ADDING 20 MINUTES TO THE OVERALL PROCEDURE TIME, AND THE PATIENT OUTCOME AFTER THIS PROCEDURE WAS REPORTED AS GOOD. ON (B)(6) 2022, ILLUMINOSS WAS NOTIFIED BY THE TREATING PHYSICIAN THAT THERE WAS A CHANGE IN THE PATIENT CONDITION. ON (B)(6) 2022,

  Patient problems: Inflammation; Pain; Swelling/ Edema

  MAUDE report 14438699 ↗