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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Non-union Bone Fracture (2369)

Event Date 10/24/2022

Event Type  Injury  

Event Description

An 84 year-old active female had a mechanical trip and fall on (b)(6) of 2021.The user treated her with a femoral pin, static interlocking screws, and placement of 2 illuminoss implants in the femur to supplement the pin/screw construction.At the 3.5 month post-op in (b)(6) 2022, the patient was in no pain, walking with a walker.The patient fell in early (b)(6) 2022 and went to the emergency room (b)(6)2022, reporting pain.The user identified at that time that the patient's initially treated femoral break had not healed (non-union), in addition to a new fracture at the proximal tibia.The user performed revision surgery (b)(6)2022 to treat the tibial fracture from the fall, as well as the observed non-union of the femoral fracture treated in (b)(6) 2021.The patient outcome was good.At the 6 month followup, the patient reported no pain, able to walk with cane or walker.

Manufacturer Narrative

Manufacturer's narrative: at the time of this initial mdr report, the investigation into the cause of the event is still ongoing.Returned product evaluation: no device was returned for evaluation as the implant was discarded at the time of the revision surgery.Dhr review: no review of manufacturing records was possible as the user was not able to provide product identification information.X-rays: radiographs of the treated anatomy were requested and received from the user.Medical oversight review.Illuminoss performed an internal medical oversight review of this case, information received from the doctor, and the radiographs provided.Illuminoss clinical and medical affairs met with independent medical oversight and identified additional information to request from the user to support the investigation.Follow up with user we have reached out to the user with followup questions and requests for additional radiographs.A follow-up mdr will be submitted when further information is known about this case.

Manufacturer Narrative

At the time of the initial mdr submission for this event, the investigation into the cause of this event was still underway.This followup mdr is submitted to submit new information, including - investigation findings codes - investigation conclusion codes - manufacturer's narrative with the firm's root cause conclusions.Returned product evaluation: no device was returned for evaluation as the implant was discarded at the time of the revision surgery.Dhr review: no review of manufacturing records was possible as the user was not able to provide product identification information.X-rays: radiographs of the treated anatomy were requested and received from the user.Follow up with user we reached out to the user with follow-up questions and requests for additional radiographs, which the user provided.The user reported that: · the nonunion was not a deficiency of the illuminoss implants · the stiffness of the original construct (pin, with static interlocking screws, supported by 2 illuminoss implants) may have contributed to the nonunion.· after receiving revision surgery, the patient outcome was good medical oversight review illuminoss performed internal medical oversight review of this case, information received from the doctor, and the radiographs provided, and made the following observations and conclusions: · from the radiographs of the patient from april 2022 at the 3.5 month post-op follow up, there is not a lot of healing callous visible at the fracture side.The distal interlocking screw appears to be intact, along with the other implanted hardware, and the construct appears very rigid.Specifically, the use of the 2 static interlocking screws with the pin rendered the fixation very rigid, and did not allow the fracture to compress and the bones to be in contact, so it went onto a nonunion.· from the radiographs of the patient from october 2022 (post patient fall), the illuminoss implants were not fractured, bent, or moved, yet there is evidence that the femoral fracture had not healed since the original treatment, and was a nonunion.A gap was seen at the fracture site.· the nonunion occurred because of the rigid construct and static fixation resulting from the static interlocking screws and pin, that prevented compression of the fracture (the bones to be in contact), and so delayed healing.· the illuminoss implant when used in the femur provides supplemental fixation to an anatomically appropriate fda-cleared fracture fixation system.In this case, the intermedullary rod and screws used were the primary sources of fixation and stabilization.The illuminoss implant appropriately provided supplemental fixation to the pin and screws and mechanical stability of the fracture, as evidence by the stability of the fracture at the 3.5 month followup, despite the nonunion.Conclusion this case appears to be an adverse event, but there does not appear to have been a problem with the illuminoss device or the way it was used.The nonunion is attributed to the use of both proximal and distal static interlocking screws which held the fracture at a set length that did not allow for compression of the fracture and contact between the fractured pieces of bone, to allow proper healing.

• Brand Name: PHOTODYNAMIC BONE STABILIZATION SYSTEM
• Type of Device: 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: 17243049
• MDR Text Key: 318270798
• Report Number: 3006845464-2023-00037
• Device Sequence Number: 1
• Product Code: QAD
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/07/2023

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/01/2023
• Initial Date FDA Received: 06/30/2023
• Supplement Dates Manufacturer Received: 06/01/2023
• Supplement Dates FDA Received: 07/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other
• Patient Age: 84 YR
• Patient Sex: Female