Photodynamic Bone Stabilization Procedure PackRecalls & reported problems across all models
Illuminoss Medical, Inc. · 11 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 37
- Deaths reported
- 7
- Injuries reported
- 14
- Recalls
- 0
We found 11 models of Photodynamic Bone Stabilization Procedure Pack by Illuminoss Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 37 adverse event reports in the FDA's MAUDE database, received between Mar 15, 2022 and Oct 29, 2025 — classified as 7 deaths, 14 injuries, 16 malfunctions.
The most frequently reported specific device problem is “Fracture” (8 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Photodynamic Bone Stabilization Procedure Pack problems
Device problems
- Adverse Event Without Identified Device or Use Problem11
- Fracture8
- Gel Leak8
- Material Too Soft/Flexible6
- Break2
- Insufficient Device Problem Information2
- Fluid/Blood Leak1
- Gas/Air Leak1
Patient problems
- No Clinical Signs, Symptoms or Conditions11
- Bone Fracture(s)6
- Cardiac Arrest4
- Insufficient Information4
- Nonunion/Delayed-union Bone Fracture4
- Implant Pain2
- Pain2
- Swelling/ Edema2
Photodynamic Bone Stabilization Procedure Pack models
11 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Photodynamic Bone Stabilization Procedure Pack USSL-1700260Rod, Fixation, Intramedullary And Accessories, In-Vivo Cured, Light-Activated2 deaths8 reports
- Photodynamic Bone Stabilization Procedure Pack USSL-2213260Rod, Fixation, Intramedullary And Accessories, In-Vivo Cured, Light-Activated1 death6 reports
- Photodynamic Bone Stabilization Procedure Pack USSL-2213220Rod, Fixation, Intramedullary And Accessories, In-Vivo Cured, Light-Activated4 deaths5 reports
- Photodynamic Bone Stabilization Procedure Pack USSL-2213240Rod, Fixation, Intramedullary And Accessories, In-Vivo Cured, Light-Activated5 reports
- Photodynamic Bone Stabilization Procedure Pack USSL-1700220Rod, Fixation, Intramedullary And Accessories, In-Vivo Cured, Light-Activated3 reports
- Photodynamic Bone Stabilization Procedure Pack USSL-1700280Rod, Fixation, Intramedullary And Accessories, In-Vivo Cured, Light-Activated3 reports
- Photodynamic Bone Stabilization Procedure Pack USSL-2213160Rod, Fixation, Intramedullary And Accessories, In-Vivo Cured, Light-Activated3 reports
- Photodynamic Bone Stabilization Procedure Pack USML-1310090Rod, Fixation, Intramedullary And Accessories, In-Vivo Cured, Light-Activated1 report
- Photodynamic Bone Stabilization Procedure Pack USSL-0700200Rod, Fixation, Intramedullary And Accessories, In-Vivo Cured, Light-Activated1 report
- Photodynamic Bone Stabilization Procedure Pack USSL-1100220Rod, Fixation, Intramedullary And Accessories, In-Vivo Cured, Light-Activated1 report
- Photodynamic Bone Stabilization Procedure Pack USSL-1500260Rod, Fixation, Intramedullary And Accessories, In-Vivo Cured, Light-Activated1 report
Recent Photodynamic Bone Stabilization Procedure Pack adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionOct 29, 2025Gel Leak; Material Too Soft/Flexible; Gel Leak; Material Too Soft/Flexible
AN EVENT WAS REPORTED IN WHICH THE MONOMER DID NOT FULLY CURE. THE LED LIGHT BOX COMPLETED A FULL CYCLE; HOWEVER, UPON REMOVAL OF THE LIGHT FIBER, UNCURED MONOMER LEAKED FROM THE PROXIMAL END WHERE THE CATHETER WAS CUT. THE CENTRAL PORTION OF THE BALLOON HAD CURED, AND THE PARTIALLY INFLATED BALLOON WAS LEFT IN PLACE. ADDITIONAL FIXATION WAS ACHIEVED USING A PLATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23417108 ↗MalfunctionOct 17, 2025Gel Leak; Material Too Soft/Flexible; Gel Leak; Material Too Soft/Flexible
AN EVENT WAS REPORTED IN WHICH THE IMPLANT DID NOT FULLY CURE. THE PROXIMAL PORTION OF THE BALLOON CURED, WHILE THE DISTAL PORTION REMAINED UNCURED. THE PHYSICIAN PLACED A SECOND BALLOON RETROGRADE TO COMPLETE FILLING OF THE LESION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23324676 ↗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 ↗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 ↗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 ↗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 ↗InjuryFeb 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A SERIOUS ADVERSE EVENT OF INADEQUATE FIXATION AND DEVICE EXPLANT WAS ENTERED INTO THE ILLUMINOSS CLINICAL REGISTRY ON (B)(6) 2024 WITH AN EVENT DATE OF (B)(6) 2023. THE USER REPORTED LOSS OF OR INADEQUATE FIXATION IN BONE, NOT ILLUMINOSS DEVICE RELATED. THE DEVICES WERE EXPLANTED AND THE ADVERSE EVENT WAS RESOLVED ON (B)(6) 2023.
Patient problems: Nonunion/Delayed-union Bone Fracture
MAUDE report 18770077 ↗InjuryDec 14, 2023Gel Leak; Insufficient Device Problem Information; Gel Leak; Insufficient Device Problem Information
AN ADVERSE EVENT WAS ENTERED INTO THE ILLUMINOSS CLINICAL STUDY REGISTRY ON NOVEMBER 14, 2023 FOR AN EVENT WHICH OCCURRED ON (B)(6) 2022. A PATIENT UNDERWENT A PERCUTANEOUS STABILIZATION DUE TO EXTENSIVE PATHOLOGIC FRACTURES AND EXTENSIVE OSTEOLYSIS THROUGHOUT HER LEFT ACETABULUM AND HEMIPELVIS SECONDARY TO BREAST CANCER. THIS WAS FOLLOWED BY A STAGED TOTAL HIP ARTHROPLASTY. POST OPERATIVELY THE PATIENT WAS ADMITTED FOR SURGICAL DEBRIDEMENT OF THE HIP AND EXCISIONAL DEBRIDEMENT OF CHRONIC DRAINING SINUS TRACT FROM THE LEFT ILIUM, AND SEPARATE SURGICAL SITE WITH DEBRIDEMENT OF ILIOPSOAS MUSCLE IN EXCISIONAL MANNER.
Patient problems: Fever; Purulent Discharge; Swelling/ Edema
MAUDE report 18332046 ↗DeathOct 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A 65-YEAR OLD MALE WAS TREATED FOR A PATHOLOGIC FRACTURE OF THE LEFT HUMERUS USING ILLUMINOSS IMPLANTS. AFTER THE CURING PROCESS WAS BEGUN, THE PATIENT EXPERIENCED HEIGHTENED BLOOD PRESSURE AND OXYGEN ISSUES, AND REQUIRED RESUSCITATION IN THE OR. THE PATIENT WAS MOVED TO THE ICU, WHERE HE PASSED LATER THAT EVENING.
Patient problems: High Blood Pressure/ Hypertension; Insufficient Information
MAUDE report 17981309 ↗DeathAug 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DURING A PROCEDURE TO TREAT A 78-YEAR OLD FEMALE FOR A TRAUMATIC DISTAL FEMUR FRACTURE WITH AN ILLUMINOSS IMPLANT, THE PATIENT DECLINED WHILE CURING OF THE BALLOON IN SURGERY. THE PATIENT PASSED IN ICU 1.5 HOURS LATER.
Patient problems: Cardiac Arrest
MAUDE report 17574028 ↗InjuryMay 25, 2023Fracture; Fracture
AN 84 YEAR-OLD FEMALE PATIENT EXPERIENCED A BREAK THROUGH THE MYELOMA IN HER HUMERUS IN LATE DECEMBER THAT WENT ON TO HYPERTROPHIC NONUNION. ON (B)(6) 2023, HER HUMERUS WAS TREATED WITH AN ILLUMINOSS IMPLANT (SIZE 22/13X240MM) WITH 4 SCREWS. IN LATE APRIL, THE PATIENT PRESENTED WITH LOSS OF FIXATION IN THE ARM, AND THE IMPLANT WAS FOUND TO BE BROKEN AT THE SITE OF THE ORIGINAL BONE BREAK. THE PATIENT WAS NOT EXPRESSING BEING IN PAIN. THE USER TREATED THE PATIENT WITH REVISION SURGERY WITH A PLATE STABILIZED BY THE ILLUMINOSS IMPLANT WHICH REMAINED IN THE BONE. THE PATIENT CONDITION POST-REVISION SURGERY HAS BEEN REPORTED AS GOOD.
Patient problems: Bone Fracture(s)
MAUDE report 17002426 ↗InjuryMay 24, 2023Fracture; Fracture
A VERY SICK PATIENT FELL AND EXPERIENCED A PERIPROSTHETIC PROXIMAL HUMERUS FRACTURE. THE PATIENT HAD EXPERIENCED A FRACTURE OF THE SAME HUMERUS 10 YEARS PREVIOUSLY WHICH HAD BEEN TREATED WITH A PLATE. 2 MONTHS AFTER THE PERIPROSTHETIC FRACTURE, THE PATIENT WAS TREATED WITH AN ILLUMINOSS IMPLANT [SIZE 22/13X160MM]. TWO WEEKS POST IMPLANTATION, THE ILLUMINOSS IMPLANT BROKE THROUGH THE FRACTURE SITE AT THE EDGE OF THE HUMERUS PLATE.
Patient problems: Bone Fracture(s)
MAUDE report 16997022 ↗MalfunctionMay 5, 2023Gel Leak; Gel Leak
A 71 YEAR-OLD MALE WAS BEING TREATED FOR AN IMPENDING PATHOLOGIC FRACTURE OF THE HUMERUS, USING AN ILLUMINOSS IMPLANT. THE USER WAS INFUSING THE ILLUMINOSS IMPLANT BALLOON FOR THIS PROCEDURE [SIZE 22/13X260] WITH MONOMER, WHEN THEY EXPERIENCED A LEAK. THE LEAK WAS EXPERIENCED UPON INFUSION OF THE 4TH SYRINGE OF MONOMER. THE BALLOON WAS REMOVED, AND A HOLE WAS FOUND IN THE BALLOON. ANOTHER ILLUMINOSS IMPLANT WAS USED SUCCESSFULLY TO COMPLETE THE PROCEDURE, AND THE PATIENT OUTCOME WAS GOOD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16877171 ↗
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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