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

Catalog Number	USSL-1700220
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Date of Event	05/31/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
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.
Additional Manufacturer Narrative
Returned product evaluation was not possible in this case, as the device remains implanted.Dhr review: a review of manufacturing records for the device used in this complaint found that the device met specifications at the time of manufacture and release.Information from the doctor: the patient was treated with excisional wound debridement, irrigation, wound vacuum assisted closure, doxycycline, and cefazolin (antibiotics).Two months after the procedure the patient was treated with simple irrigation and debridement at bedside as the wound was not healing on (b)(6) 2022).Four months post-op the previous medial wound was found to be healing.A wound more distal than the previous was present with necrotic fat at the base and mild surrounding erythema with no purulence on (b)(6) 2022).At the 6 month post op follow up the user notes that the patient is immunocompromised, on remicade for crohn's, and has had some wound healing difficulty, which is not related to the device.Three days after the 6 month follow up, excisional debridement and irrigation was performed on the wound, and the previous dehiscence wound is now with visible purulence.It does appear there is a sinus track, mild erythematous, no abscesses or tenderness, and mild swelling.Per the user information from the registry, the cause of the patient would healing difficulty is due to her immunocompromised condition and is nothing directly related to the device.Medical oversight review: an internal medical oversight review was held in which the information and x-rays in this case were reviewed, and made the following conclusions: at the index procedure reduction looks good, and the device looks appropriately placed.The fracture has eventually healed and the device was intact.The surgery was done well, but was significant: there were several incisions, from the percutaneous screws, the lateral plate and in order to place the medial plate, the user has to make a large incision.The patient is immunocompromised and on remicade for crohn's, has a history of cancer, and this is a significant surgery for an immunocompromised patient.Medical oversight concurred with the report from the treating physician, that the cause of the wound infection was due to the patient being immunocompromised and undergoing a significant surgery, and was not device related.Review of ifu: a review of the device labeling and indications for use found that the device was used to treat an anatomy (femur) that is within its intended indications.Instructions for use 900365 was reviewed.The risk of infection, including wound complications, is included in the labeling.Conclusion: in the opinion of the treating physician and internal medical oversight, the wound infection is most likely due to the patient being immunocompromised and undergoing a significant surgical procedure.

• Brand Name: PHOTODYNAMIC BONE STABILIZATION SYSTEM
• Common Device Name: 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: 19176939
• Report Number: 3006845464-2024-00006
• Device Sequence Number: 11704712
• Product Code: QAD
• UDI-Device Identifier: M986USSL17002200
• UDI-Public: M986USSL17002200
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K181228
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/24/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2024
• Device Catalogue Number: USSL-1700220
• Device Lot Number: 400897
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2024
• Initial Report FDA Received Date: 04/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/10/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 84 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White