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

Catalog Number	USSL-2213260
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	05/27/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
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.
Additional Manufacturer Narrative
At the time of this initial mdr report, the investigation into the cause of the event is complete.·information provided by the user: information about this complaint including the baseline injury information, the index procedure, follow up appointments, as well as x-rays from the adverse event were provided by the user.This 81 year old female patient was treated for a traumatic distal fracture of the left femur after a fall.The user treated her with an illuminoss implant, and plate with screws on (b)(6) 2023.The adverse event onset date was (b)(6) 2023, when loss of fixation was documented.It was resolved on (b)(6) 2023 with a revision surgery, in which the illuminoss implant and other fixation devices were explanted, reported as hardware removal; revision of periprosthetic distal femur fracture to distal femur replacement.The user noted in the that the adverse event is not illuminoss device related.·review of manufacturing records: the firm reviewed the manufacturing records for this device, and found that it was in specification at the time of manufacture and release.·returned product evaluation: no evaluation of the device was possible as it was discarded by the user upon device explanation revision surgery.· medical oversight review: an internal medical oversight review was performed of the information about the case, medical records, and x-rays, to supplement the complaint investigation.Illuminoss clinical and medical affairs met with independent medical oversight and made the following observations: · on the index procedure x-rays, although the plate placement looks good, a gap is present at the fracture site between the piece of bone and femur, resulting in an inadequate fixation.· on a followup visit x-ray, it is observable that there has been some motion that has taken place due to the callous formation and the distal screw has started to back out.The motion at the fracture site was likely due to the fact that the fracture had not been fully reduced, evident by the gap at the fracture site.· in the followup x-rays, the illuminoss implant does not look compromised, however the distal screw may not be fully embedded in the illuminoss implant, which could have contributed to the motion in the distal femur.· overall this was a challenging case to achieve fixation, and inadequate initial reduction (gap remained between bones at the fracture site) led to a nonunion and a stabilization failure.· the loss of fixation was determined by internal medical oversight to not be a result of the illuminoss implant or its use (which is in alignment with the evaluation by the user).·ifu review: instructions for use 900356 rev w was reviewed and found that it captures the risk of loss of or inadequate fixation in bone due to insufficient initial fixation experienced in this complaint."risks: as with any im fixation system or rod the following can occur: loosening, bending, cracking, fracture, or mechanical failure of the components or loss of or inadequate fixation in bone attributable to delayed union, nonunion, insufficient quantity or quality of bone, markedly unstable comminuted fractures, or insufficient initial fixation." the ifu also states that the illuminoss system may be used in the femur and tibia to provide supplemental fixation to an anatomically appropriate fda-cleared fracture fixation system.In this case, the illuminoss was providing supplemental fixation to the plate and screws used.Conclusion: the adverse event of loss of fixation in the bone was due to insufficient initial fixation (poor fracture reduction with a gap at the fracture site) which allowed motion at the fracture site and caused a persistent nonunion.The medical oversight review and the user information provided both note that this adverse event was not attributable to the illuminoss device, and there was no observed or alleged damage to the illuminoss device.Further, when the illuminoss is used in the femur, it is used as a supplemental fixation to an fda-cleared fracture fixation system, in this case the plate and screws.

• 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: 18770077
• Report Number: 3006845464-2024-00001
• Device Sequence Number: 7739503
• Product Code: QAD
• UDI-Device Identifier: M986USSL22132600
• UDI-Public: M986USSL22132600
• 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: 2023
• Device Explanted Year: 2023
• 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): 02/23/2024

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: 01/31/2024
• Device Catalogue Number: USSL-2213260
• Device Lot Number: 390674
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2024
• Initial Report FDA Received Date: 02/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/22/2019
• 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: 81 YR
• Patient Sex: Female
• Patient Weight: 75 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: American Indian Or Alaskan Native