Photodynamic Bone Stabilization Procedure Pack USSL-0700200Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M986USSL07002000), received between Mar 15, 2022 and Mar 15, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Fracture” (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.

• InjuryMar 15, 2022Fracture; Fracture

  ILLUMINOSS PHOTODYNAMIC BONE STABILIZATION SYSTEM IMPLANTS WERE IMPLANTED IN THE RADIUS AND ULNA ON THE SAME SIDE FOR A PATIENT WHO HAD A MIDSHAFT BREAK OF BOTH. 11-12 DAYS POST OP BOTH IMPLANTS BROKE AND REVISION SURGERY WAS PERFORMED (B)(6) 2022 ADDING PLATE AND SCREWS. FURTHER DETAILS: THE PATIENT BROKE BOTH THEIR RADIUS AND ULNA ON THE SAME SIDE, AT THE SAME POINT MIDSHAFT. ON (B)(6) 2022 TWO ILLUMINOSS IMPLANTS WERE USED TO TREAT BOTH FRACTURES (7X200MM DIAMETER IMPLANTS). THE INITIAL SURGERY WENT WELL AND THE IMPLANTS HAD GOOD CORTICAL WALL CONTACT. THE PATIENT WAS DOING WELL FOR 10-11 DAYS POST-OP WITH NO PAIN AND NO ISSUE. ON DAY 11 OR 12, BOTH IMPLANTS BROKE AT THE LOCATION OF THE ORIGINAL BONE FRACTURES. REVISION SURGERY WAS PERFORMED FOR THE BONE FRACTURES OF BOTH RADIUS AND ULNA ON (B)(6) 2022 TO ADD PLATES AND SCREWS. THE ILLUMINOSS IMPLANTS WERE LEFT IN THE BONE, AND USED TO SECURE THE ADDITIONAL PLATES AND SCREWS. THE PATIENT CONDITION WAS REPORTED AS GOOD, AFTER THE REVISION SURGERY. THE PATIENT WAS NOT GIVEN ANY POST-OPERATIVE IMMOBOBILIZATION, RESTRICTION OF MOVEMENT OR OTHER STABILIZATION INSTRUCTIONS UPON INITIAL IMPLANTATION WITH THE ILLUMINOSS IMPLANTS IN THE

  Patient problems: Pain

  MAUDE report 13775228 ↗