Photodynamic Bone Stabilization Procedure Pack USSL-1700260Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI M986USSL17002600), received between May 18, 2022 and Aug 25, 2025 — classified as 2 deaths, 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• DeathAug 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ARTICLE BY MINA ET AL., 2025 "FATAL COMPLICATIONS DURING PHOTODYNAMIC BONE STABILIZATION: A CASE REPORT" DETAILS COMPLICATIONS EXPERIENCED DURING A HUMERUS IMPLANTATION PROCEDURE. A 68-YEAR-OLD FEMALE WITH A HISTORY OF METASTATIC SARCOMA UNDERWENT PROPHYLACTIC STABILIZATION OF THE RIGHT HUMERUS WITH AN ILLUMINOSS IMPLANT ON (B)(6) 2023. THE PATIENT'S COMORBIDITIES INCLUDE METASTATIC INVOLVEMENT OF THE LUNG AND REMOTE HISTORY OF DEEP VEIN THROMBOSIS AND PULMONARY EMBOLISM AND USED SUPPLEMENT OXYGEN. DURING THE BONE REAMING AND SUBSEQUENT BALLOON INFLATION STEPS, THE PATIENT EXPERIENCED A SUDDEN CARDIOPULMONARY COLLAPSE CHARACTERIZED BY PULSELESS ELECTRICAL ACTIVITY, HYPOXIA AND HYPOTENSION. ADVANCED CARDIAC LIFE SUPPORT WAS PROVIDED, AND A TRANSESOPHAGEAL ECHOCARDIOGRAPHY WAS PERFORMED SHOWING A SEVERELY DILATED RA AND RV WITH AN UNDERFILLED, HYPERDYNAMIC LV, SUGGESTIVE OF A MASSIVE PE. DESPITE RESUSCITATION EFFORTS, THE PATIENT'S CONDITION CONTINUED TO DETERIORATE, AND SEVERAL DAYS POST OPERATIVELY THE PATIENT PASSED AWAY. THE AUTHORS SPECULATE THE CAUSE OF THIS COMPLICATION WAS LIKELY DUE TO THE BALLOON INSUFFLATION-INDUCED DISLODGEMENT OF MARROW AND SUBSEQUENT EMBOLIZATION. TH

  Patient problems: Pulmonary Embolism

  MAUDE report 22884066 ↗
• MalfunctionJul 25, 2024Break; Break

  A PATHOLOGIC FEMUR FRACTURE WAS TREATED WITH AN ILLUMINOSS IMPLANT AND PLATE AND SCREWS. FOUR WEEKS OUT THERE WAS A DISTAL FEMUR FAILURE IN WHICH THE PLATE AND ILLUMINOSS BROKE. THE HARDWARE WAS REMOVED AND THE FRACTURE WAS REVISED WITH THE SAME ILLUMINOSS IMPLANT.

  Patient problems: Bone Fracture(s)

  MAUDE report 19826438 ↗
• InjuryJul 24, 2024Fracture; Fracture

  A 17X260MM IMPLANT WAS IMPLANTED IN A TRAUMATIC HUMERUS FRACTURE WITH FOUR SCREWS ON (B)(6) 2024. ABOUT A MONTH POST OP THE IMPLANT BROKE AND THE FRACTURE LOST STABILIZATION. THE PATIENT HAD A REVISION SURGERY PERFORMED WITH ANOTHER SURGEON SO THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Bone Fracture(s)

  MAUDE report 19822079 ↗
• MalfunctionJul 22, 2024Break; Break

  A 17X260MM IMPLANT WAS IMPLANTED ON (B)(4) 2024 IN A IMPENDING PATHOLOGIC FRACTURE OF THE HUMERUS. FIVE DAYS LATER ON (B)(6) 2024 THE IMPLANT BROKE WITH NO REPORTED TRAUMA BY THE USER. A REVISION SURGERY WAS PERFORMED TO PLATE THE FRACTURE.

  Patient problems: Insufficient Information

  MAUDE report 19790854 ↗
• MalfunctionApr 27, 2023Material Separation; Material Separation

  THIS MDR REPORT IS BASED ON THE RECLASSIFICATION OF A PREVIOUSLY REVIEWED COMPLAINT. DURING PREPARATION FOR A CASE IN GERMANY, A USER FOUND THE LIGHT FIBER OF THE ILLUMINOSS IMPLANT BROKEN AFTER TAKING IT OUT OF THE PACKAGE. THE DEVICE WAS NOT USED. ANOTHER ILLUMINOSS IMPLANT WAS USED. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16826289 ↗
• DeathJan 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 93 YEAR OLD FEMALE WAS BEING TREATED FOR A TRAUMATIC FEMUR FRACTURE WITH AN ILLUMINOSS IMPLANT, TO BE FOLLOWED BY PLATE AND SCREWS AFTER IMPLANT PLACEMENT. DURING THE CURING CYCLE, THE PATIENT BLOOD PRESSURE DROPPED, AND THE PATIENT PASSED.

  Patient problems: Cardiac Arrest

  MAUDE report 16221517 ↗
• InjuryJan 8, 2023Gel Leak; Gel Leak

  ON (B)(6) 2022 A 69 YEAR OLD FEMALE PATIENT WAS BEING TREATED FOR A LEFT PATHOLOGIC HUMERUS FRACTURE. THIS PATIENT HAS A LONG HISTORY OF MYELOMA, AND HER STATUS WAS POST BONE MARROW TRANSPLANT. SHE IS CURRENTLY IN PALLIATIVE CARE ONLY, ON HOSPICE. A 17X260MM ILLUMINOSS IMPLANT WAS INSERTED AND INFUSED WITH MONOMER. AFTER THE IMPLANT WAS INFLATED, THE USER WANTED TO PERFORM A MINOR RE-REDUCTION, SO HE ASPIRATED SOME OF THE LIQUID MONOMER OUT, PERFORMED THE MINOR RE-REDUCTION OF THE FRACTURE USING THE C-ARM IMAGING, AND ATTEMPTED TO RE-INFLATE THE IMPLANT. THE USER NOTICED A TEAR IN THE IMPLANT AND MONOMER LEAKED OUT OF THE BALLOON. THE USER REMOVED THE TORN IMPLANT AND PERFORMED RIGOROUS IRRIGATION AND FLUSHING OF THE CANAL WITH 2L NORMAL SALINE AND CANAL IRRIGATOR WITH SUCTION. THE USER THEN INSERTED A NEW IMPLANT AND SUCCESSFULLY INFUSED AND CURED IT. ABOUT 2 WEEKS POST OPERATIVELY THE PATIENT WAS DRAINING LIQUID FROM HER ELBOW AND HAD MULTIFOCAL COLLECTIONS IN UPPER ARM AT AREA OF FRACTURE. CULTURES WERE TAKEN OF THE FLUID, AND ALL WERE NEGATIVE. THE PATIENT RECEIVED DEDICATED WOUND CARE AND PACKING TO THE AREA OF DRAINAGE FOR 2 WEEKS, AND HER ELBOW WOUND HEALED. THE PATIENT DID

  Patient problems: Fluid Discharge

  MAUDE report 16119298 ↗
• MalfunctionMay 18, 2022Material Too Soft/Flexible; Material Too Soft/Flexible

  ON (B)(6) 2022, DR. (B)(6) OF (B)(6) IN THE US INTENDED TO TREAT A 66-YEAR OLD MALE TRAUMA PATIENT WITH A DISTAL FEMUR FRACTURE WITH TRADITIONAL PLATE AND SCREW FIXATION, AUGMENTED WITH AN ILLUMINOSS PHOTODYNAMIC BONES STABILIZATION SYSTEM IMPLANT (17X260MM) AS AN AUGMENTATION TO PROVIDE ADDITIONAL SUPPORT WITHIN THE AFFECTED BONE. THE FRACTURE WAS REDUCED AND ILLUMINOSS IMPLANT PLACED. DURING THE CURING PROCESS FOR THE ILLUMINOSS IMPLANT, THE REP NOTICED THE LIGHT FIBER COMING FROM THE LIGHT BOX TO THE BALLOON WAS NOT AS BRIGHT AS IT USUALLY IS AND THE LIGHT ON THE BACK RIGHT OF THE BOX WAS NOT AS BRIGHT WAS IT NORMALLY WAS. WHEN THE USER WENT TO DRILL THROUGH THE BALLOON FOR THE NEXT PART OF THE PLANNED PROCEDURE, THE MONOMER CAME OUT, INDICATING THAT THE IMPLANT HAD NOT CURED. THE USER SUCKED OUT ALL THE MONOMER, AND DECIDED TO LEAVE THE BALLOON IN PLACE AS THE MONOMER HAD ALL BEEN REMOVED AND THE CATHETER ALREADY CUT OFF. THE USER THEN DECIDED TO DO A DOUBLE BALLOON TECHNIQUE IN THE FEMUR USING A NEW IMPLANT SIZED 17X260MM AND ANOTHER NEW IMPLANT SIZED 22/13X240MM. THE 22X13X240MM IMPLANT WAS CURED WITH A SECOND LIGHT BOX AND CURED SUCCESSFULLY. THE NEW 17X260MM IMPLANT WAS CUR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14432105 ↗