MAUDE Adverse Event Report: ILLUMINOSS MEDICAL, INC PHOTODYNAMIC BONE STABILIZATION SYSTEM; IN VIVO INTRAMEDULLARY FIXATION ROD

Catalog Number USSL-2213160

Device Problems Gel Leak (1267); Insufficient Information (3190)

Patient Problems Purulent Discharge (1812); Fever (1858); Swelling/ Edema (4577)

Event Date 10/31/2022

Event Type  Injury  

Manufacturer Narrative

At the time of this initial mdr report, the investigation into the cause of the event is still ongoing.Returned product evaluation: no returned product evaluation is possible as the devices remain in the patient.Dhr review: a review oft the manufacturing records found the devices to be in specification at the time of manufacture and release.Review of ifu: instructions for use 900356_w states "risks: as with any im fixation system can occur: adverse tissue reaction, infection, including wound complications." the risk of adverse tissue reaction, infection and would complications is captured in the device labeling.X-rays: x-rays have been provided by the user and are included in the ongoing complaint investigation.Medical oversight review.An internal medical oversight review of this case is ongoing at this time.An initial medical oversight review meeting has been held, and identified additional information requests for the user.Follow up with user: upon request, the user has provided some additional follow up information pertaining to the patient's medical records related to the implant surgery and following events.A follow-up mdr will be submitted when further information is known about this case.

Event Description

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.

Manufacturer Narrative

At the time of this followup 1 mdr report, the investigation into the cause of the event is still ongoing.This followup mdr is submitted to submit new information.Medical oversight review: internal medical oversight review is ongoing for this complaint investigation.Upon review of the case information known, further requests for information from the user were identified.The firm reached out to the user, and received additional information from the user on 21 dec 2023.At the time of this mdr report, the firm is performing an internal medical oversight review of the additional information provided by the user to complete the complaint investigation.A follow up mdr will be submitted when these ongoing activities are complete.

Manufacturer Narrative

At the time of this followup 2 mdr report, the investigation into the cause of the event is complete.This followup mdr is to submit new information, as well as updated codes for medical device problem code, investigation findings code, and investigation conclusion code.The following additional information was provided via followup from the user: the adverse event was described as 2 weeks after illuminoss implantation surgery the patient developed swelling about the hip and drainage from the illuminoss balloon entry site of the left ilium.The ct scan showed extensive abscess from the proximal thigh up through the hip into the iliopsoas and pelvis.Neutrophil count was consistent with inflammatory reaction potentially from monomer that had leaked out from a photodynamic balloon during its implantation, that was removed and replaced during the procedure.The user confirmed that during the initial implantation, the illuminoss balloon being placed in the posterior column ruptured by contact with sharp bone, and that he washed it out and put in a new balloon which was infused and cured.On (b)(6) 2022, the patient was admitted for surgical debridement.An arthrotomy of the left hip with debridement and femoral head exchange was performed with excisional debridement of chronic draining sinus tract from the left ilium and separate surgical site with debridement of iliopsoas muscle in an excisional manner.The user reported that during the debridement procedure, it looked to him there was monomer in the muscle.The mri looked very inflamed and there was a yellow gooey exudate that was sent to pathology.The exudate was found to have fat necrosis and proteinaceous debris with rare material on it.The adverse event was resolved on november 3, 2022 by the surgical intervention performed.Medical oversight review: the firm performed internal medical oversight review of the case and the information provided by the user, and made the following conclusions: monomer leak: from review of the x-rays, medical oversight confirmed the presence of sharp bone in the area of the posterior column which could have punctured the originally implanted posterior column balloon, further supporting the user's identification of this as the cause for the monomer leak.Adverse tissue reaction: from review of the operative reports and additional user information, medical oversight concluded that the adverse reaction appears to be a sterile abscess, probably inflammation and irritation caused by monomer in the soft tissue.Ono infection was identified in the patient, all cultures were found to be negative, and the patient was treated with multiple antibiotics, making an infection highly unlikely.All cultures and pathology were negative for the appearance of an infection.Obiological safety testing performed by the firm demonstrates that acute, subchronic, and chronic timepoints to evaluate local and systemic tissue response to liquid monomer was performed in which the test article was well tolerated and results were similar to local tissue responses reported for pmma.There is a known risk of skin sensitization by the liquid monomer due to an ingredient in the monomer which was determined to be a weak skin sensitizer in the guinea pig maximization test, and based on ambiguous human patch test results, has sensitizing properties and potential cross-reactivity with other acrylates.The margin of safety for 2-hydroxyethyle methacrylate was calculated and supports the conclusion that the risk of induced toxicity from this ingredient in the photodynamic bone stabilization system is very small, but in this case the liquid monomer composition cannot be ruled out as a cause of the adverse tissue reaction after prolonged contact.Oin addition, in the case that liquid monomer was left behind in the soft tissue, it could have led to an aseptic inflammatory response, as a foreign body in a relatively enclosed space is likely to lead to some type of inflammatory reaction.Oalthough the user reported that when the balloon leaked he washed the implantation site out, the user's observations about the exudate removed during debridement, the pathology identification of it as containing "rare material" without reported infection, and the patient's adverse tissue reaction, suggests that some of the liquid monomer was left behind.Therefore medical oversight concluded that the most likely cause of the abscess is due to an aseptic inflammatory response due to the presence of residual liquid monomer.Ifu review: the firm identified no deviations from the manufacturer's instructions for use.The procedure performed was for an on-label indication (pelvis for a skeletally mature adult, in the us).The ifu includes the risks of adverse tissue reaction, infection, including wound complications and soft tissue damage, as well as balloon leakage.In addition, the risk of skin sensitization due to contact with liquid monomer is also communicated in ifu, along with instructions to the user to wash immediately.There are more detailed instructions in surgical technique guide for the pelvis 900598_a for liquid monomer removal technique in the event of a balloon leak.Conclusion the cause of the intraoperative balloon leak was due to the balloon being punctured by a sharp piece of bone during the implantation procedure.The cause of the adverse tissue reaction necessitating debridement is an aseptic inflammatory response most likely caused by liquid monomer remaining in the soft tissue.

• Brand Name: PHOTODYNAMIC BONE STABILIZATION SYSTEM
• Type of Device: IN VIVO INTRAMEDULLARY FIXATION ROD
• Manufacturer (Section D): ILLUMINOSS MEDICAL, INC; 993 waterman ave; east providence RI 02914
• Manufacturer (Section G): ILLUMINOSS MEDICAL, INC; 993 waterman ave; east providence RI 02914
• Manufacturer Contact: robert rabiner ; 993 waterman ave; east providence, RI 02914 ; 4017140008
• MDR Report Key: 18332046
• MDR Text Key: 330546557
• Report Number: 3006845464-2023-00046
• Device Sequence Number: 1
• Product Code: QAD
• UDI-Device Identifier: M986USSL22131600
• UDI-Public: M986USSL22131600
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181228
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: USSL-2213160
• Device Lot Number: 421047
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/14/2023
• Initial Date FDA Received: 12/14/2023
• Supplement Dates Manufacturer Received: 11/14/2023; 11/14/2023
• Supplement Dates FDA Received: 01/12/2024; 02/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 38 YR
• Patient Sex: Female
• Patient Weight: 190 KG