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

Model Number	USSL-2213220
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Respiratory Arrest (4461)
Date of Event	07/21/2022
Type of Reportable Event	Death
Additional Manufacturer Narrative
Root cause investigation: dhr review: a review of manufacturing records for the product involved in this complaint was performed, and found the product met specifications at the time of manufacture and release.Returned product evaluation the devices remained implanted, and were not returned for evaluation.Interviews: follow-up interviews with the illuminoss rep were performed regarding the procedure.The rep reported the steps performed by the treating physician and team to prepare the implant, place the implant, infuse the implant, and start the curing process were per the manufacturer's instructions for use, without product failure or malfunction.The rep's report indicates that the illuminoss products performed as intended.Illuminoss qa called the treating physician dr.(b)(6) with follow up questions.In this interview, dr.(b)(6) provided detailed descriptions of the implantation procedure, as well as his institution's conclusions about the most likely cause of the cardiac event that resulted in the patient's death.Dr.(b)(6) described the steps of the distal femur fracture and proximal tibia illuminoss implant and plate procedures.He used two illuminoss implants, one in the distal femur, and one in the proximal tibia.Both illuminoss implants had been placed, infused, and successfully cured.There was no reported device malfunction or deviation from the manufacturer's instructions for use.The doctor was plating the distal femur when the patient experienced the cardiac event that led to the patient death.Dr.(b)(6) reported that while there was no autopsy performed, the intensivist who assisted in the management of the patient concluded that the cause of the cardiac event was secondary to a large embolism (clot) thrown from the contralateral, nonoperative leg.In the opinion of the treating physician, the patient's cardiac event and death was most likely the result of a thromboembolic event from a blood clot that developed in the non-instrumented, contralateral lower extremity.Presence of these clots represented a pre-existing medical condition.Thromboembolic events that could result in organ damage or organ failure is a known risk of im fixation procedures, which is included in the product labeling.The treating physician communicated that there was no device failure, or deviation from the manufacturer's instructions for use.There is no indication that this event was a result of malfunction, failure, or change in the characteristics or performance of the device.A review of us implant ifu 900356 rev.W was performed.The ifu contains the risk that "as with any im fixation system, the following can occur: thromboembolic event or fat embolism (blood clot, fat, or other material that could result in organ damage or failure)".Conclusion: in the opinion of the treating physician, the patient's cardiac event and death was most likely the result of a thromboembolic event from a blood clot, contributed to by the patient's pre-existing medical condition (contralateral leg deep venous thrombosis).Thromboembolic events that could result in organ damage or failure is a known risk of im fixation procedures, which is included in the product labeling.The treating physician communicated that there was no device failure.There is no indication that this event was a result of malfunction, failure, misuse, or change in the characteristics or performance of the device.The event was procedure related but not device related.
Event or Problem Description
During a tibia and femur procedure performed by dr.(b)(6) for an 88 year old female trauma patient, 2 illuminoss balloons (intramedullary implants) were placed, infused, and cured successfully.While the treating physican was beginning the process to plate the distal femur, the patient experienced a cardiac event and expired.There was no observed product malfunction.

• 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: 15242712
• Report Number: 3006845464-2022-00006
• Device Sequence Number: 6293044
• Product Code: QAD
• UDI-Device Identifier: M986USSL22132200
• UDI-Public: M986USSL22132200
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/17/2022

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 Model Number: USSL-2213220
• Device Catalogue Number: USSL-2213220
• Device Lot Number: 400765
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2022
• Initial Report FDA Received Date: 08/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/02/2020
• 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: Death
• Patient Age: 88 YR
• Patient Sex: Female
• Patient Ethnicity: Hispanic
• Patient Race: Asian