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

Model Number	USSL-2213240
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	08/09/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Returned product evaluation: no device was returned for evaluation because the implant remains implanted in the patient.Dhr review: a review of the manufacturing records for this device found that it was in specification at the time of manufacture and release.Medical oversight review the firm conducted a medical oversight review of the radiographs and complaint information from the registry.It was observed that: · at 4 monhts when the non-union was diagnosed, the plate, screws and both illuminoss implants were intact and did not appear to have any movement.The reduction was still relatively anatomic, and that there was no illuminoss implant failure or break, and no ancillary hardware failure or break.· the patient has significant knee arthritis which may have caused them pain, and there was incomplete healing of the medial cortex · the fracture was rigidly fixed due to the plate, multiple screws and two illuminoss implants.· the illuminoss implants appear to have sufficient intermedullary wall contact and span the entire length of the fracture.The plate and screws appear to be capturing the illuminoss implants to provide a stable fixation.· in this case, the illuminoss implants successfully provided supplemental mechanical stability to the plate and screws, as there was no hardware movement observed, and the screws remained in place as they had purchase in the illuminoss implant.Follow up information provided by the user: the patient presented with pain at the 4 month follow up visit so the user performed a ct.Based on the ct a nonunion was diagnosed, for which the revision surgery was performed.The user speculated that a contributor to the nonunion may have been that he used two illuminoss implants with a large plate and the construct may have been too stiff.Literature review: · fracture non-unions can be caused or contributed to by multiple factors including: insufficient blood supply to the fracture site which both decreases osteogenic cells and decreases biologic growth factors to the bone, damage to the osteoconductive scaffold causing the distance needed to heal bone to be significant, and poor mechanical stability at the fracture site.Risk factors for fracture nonunions include: nutritional status, diabetes, smoking, vascular disease, renal sufficiency and use of nsaids or steroids.There is no indication that poor mechanical stability at the fracture site contributed to the nonunion, as the initial fixation appeared sound and the implants used to stabilize the fracture were in the same position at 4 months post op and the reduction remained relatively anatomic.· the user posited that the construct they used to stabilize the fracture may have been too stiff, which may have resulted in the nonunion.Stress shielding can occur when rigid implants are used to repair fractures in which the higher stiffness of the implant results in a decreased physiological loading on the bone and can result in bone loss or poorer bone healing.Conclusion the illuminoss devices were intact, in place, and securely providing supplemental fixation to the plate via the secure screw placement into the illuminoss implants.The possible causes of the nonunion in this case include an insufficient blood supply, damage to the osteoconductive construct causing the distance to heal the bone to be significant, or stress shielding due to the higher stiffness of the implant construct than the bone.The specific cause of the nonunion and resulting revision surgery in this case cannot be determined.
Event or Problem Description
An adverse event was entered into the illuminoss clinical study registry on (b)(6) 2023 for an event which occurred on (b)(6) 2022.On (b)(6) 2022 , a patient was treated for a periprosethetic femur fracture with two illuminoss implants and a plate and screws.The patient was diagnosed with a non-union of the periprosthetic femur fracture on (b)(6) 2022 , and received revision surgery - orif with bone grafting and medial plating- on (b)(6) 2022.

• Brand Name: PHOTODYNAMIC BONE STABILIZATION SYSTEM
• Common Device Name: IN VIVO INTRAMEDUILLARY 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: 16820829
• Report Number: 3006845464-2023-00030
• Device Sequence Number: 6850141
• Product Code: QAD
• UDI-Device Identifier: M986USSL22132400
• UDI-Public: M986USSL22132400
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/26/2023

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: 02/28/2025
• Device Model Number: USSL-2213240
• Device Catalogue Number: USSL-2213240
• Device Lot Number: 410632
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2023
• Initial Report FDA Received Date: 04/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2021
• 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: Other
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 107 KG