Photodynamic Bone Stabilization Procedure Pack USSL-1700220Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI M986USSL17002200), received between Oct 12, 2022 and Oct 11, 2024 — classified as 2 injuries, 1 malfunction.

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 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.

• MalfunctionOct 11, 2024Insufficient Device Problem Information; Material Too Soft/Flexible; Insufficient Device Problem Information; Material Too Soft/Flexible

  THE REP STATED THAT WHEN THE SURGEON TRIED TO INFUSE THE IMPLANT WITH MONOMER, HE WAS UNABLE TO APPLY PRESSURE TO THE SYRINGE HANDLE AND COULD NOT GET ANY MONOMER INTO THE BALLOON. ACCORDING TO THE REP, THE PREPPED IMPLANT HAD NOT BEEN EXPOSED TO LIGHT AT ANY POINT. THEY THEN REMOVED THE IMPLANT FROM THE CANAL AND USED A NEW ONE. THE SECOND IMPLANT WAS PREPPED USING THE MONOMER SYRINGE FROM THE FIRST ATTEMPT, BUT WHEN TRYING TO APPLY THE MONOMER, THE SURGEON STATED THAT THE SYRINGE WAS CURING AND AGAIN COULD NOT INFUSE THE BALLOON. THE SECOND IMPLANT WAS REMOVED AND DISCARDED. THEY THEN TRIED A THIRD BALLOON FROM A NEW IMPLANT KIT, WHICH WAS SUCCESSFUL WITH NO ISSUES.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20428767 ↗
• InjuryApr 24, 2024Adverse 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 MARCH 26, 2024 FOR AN EVENT WHICH STARTED ON MAY 31, 2022. A 75 YEAR OLD FEMALE EXPERIENCED A TRAUMATIC FALL AND LEFT FEMUR FRACTURE WHICH WAS TREATED WITH ONE 17X280MM ILLUMINOSS IMPLANT AND A PLATE WITH 8 SCREWS. ABOUT A MONTH AND HALF AFTER THE INDEX PROCEDURE, THE PATIENT EXPERIENCED AN INFECTION AND A DEHISCENCE WOUND ON THE LEFT MEDIAL WOUND, LIKELY WITH A DRAINING SINUS TUNNEL.

  Patient problems: Post Operative Wound Infection

  MAUDE report 19176939 ↗
• InjuryOct 12, 2022Fracture; Fracture

  AN ADVERSE EVENT WAS ENTERED INTO THE ILLUMINOSS CLINICAL STUDY REGISTRY ON (B)(6) 2022 FOR AN EVENT WHICH OCCURRED ON (B)(6) 2019. A 59 Y/O FEMALE PATIENT WAS TREATED ON (B)(6) 2018 WITH ILLUMINOSS IMPLANT FOR A PATHOLOGICAL FRACTURE OF THE RIGHT HUMERUS. THE PATIENT EXPERIENCED PAIN AT THE TREATED SITE OVER THE COURSE OF FOLLOW-UP VISITS, AND 296 DAYS POST IMPLANTATION ON (B)(6) 2019 THE PATIENT RECEIVED SURGICAL INTERVENTION TO EXPLANT THE ILLUMINOSS IMPLANT, RESECT THE CENTRAL SEGMENT OF TUMOR FROM THE MID HUMERUS, AND RECONSTRUCT IT WITH A CEMENTED INTERCALARY METAL REPLACEMENT TO ACHIEVE STABILIZATION OF THE ORIGINAL BONE FRACTURE.

  Patient problems: Implant Pain

  MAUDE report 15591383 ↗