MAUDE Adverse Event Report: ILLUMINOSS MEDICAL INC. ILLUMINOSS PHOTODYNAMIC BONE STABILIZATION SYSTEM; INVIVO INTRAMEDULLARY FIXATION ROD

Catalog Number USSL-2213240

Device Problem Material Integrity Problem (2978)

Patient Problem Failure of Implant (1924)

Event Date 09/21/2019

Event Type  malfunction  

Manufacturer Narrative

Based on the investigation into the event it was apparent that the user had inadvertently bent the light fiber into such a tight bend that it prevented the necessary light intensity to reach the monomer material inside the balloon which resulted in the failure of the curing cycle.

Event Description

On (b)(6) 2019, a procedure involving the fixation of the left humerus with the illuminoss implant and a small fragment plate was completed on an (b)(6) female patient with metastatic thyroid cancer.She was in stable condition at the beginning of the procedure but had significant risk factors.The humerus was significantly involved by tumor cells and there was little cortical bone remaining in many spots.During patient preparation, the impending fracture fully fractured.Used to pin the fracture was illuminoss implant (b)(4).After preparing the canal, the implant was inserted across the fracture without incident.The surgeon reduced the fracture prior to injecting the monomer into the implant.The implant was inflated satisfactorily, and the curing cycle was completed.Removal of the light fiber by the fellow was met with resistance.With additional force applied the light fiber was partially removed before it eventually fractured and only the majority of the fiber was removed from the catheter.It was noted at this time that there were several kinks in the catheter (and hence, the light fiber).The y hub was cut off as per procedure however, due to the multiple kinks in the catheter, the fellow was unable to pass the stabilizer over the catheter.A rongeur was utilized to cut the catheter at the origin of the pathway to the humeral canal.At this time, it was confirmed using live fluoroscopy that the fracture site was not stabilized.It was determined that, due to the kinks in the catheter, considerable light leakage occurred during the curing process and the implant was only partially cured.It was determined that we should attempt to complete the curing process by drilling into the implant and placing additional light fibers through the channel(s).The initial attempt at accessing the distal aspect of the implant was not successful and during the process of attempting to access the distal aspect of the implant, excess bone was removed which required repair with bone cement.Through the defect made, the surgeon was able to determine that the distal aspect of the implant was fully cured.Access to the fracture site was made and light fibers were placed into the uncured area of the implant (mid implant).They were successful in fully curing the implant with the additional light fibers and a 10-hole small fragment plate was placed to further secure the humerus.The additional incisions were closed, and the patient was removed from the or suite without further incident.The patient remained stable throughout the procedure which lasted approximately five hours and was resting comfortably after coming out of anesthesia.

• Brand Name: ILLUMINOSS PHOTODYNAMIC BONE STABILIZATION SYSTEM
• Type of Device: INVIVO 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: 9199585
• MDR Text Key: 219554589
• Report Number: 3006845464-2019-00006
• 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,health
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/16/2019

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
• Device Expiration Date: 05/31/2023
• Device Catalogue Number: USSL-2213240
• Device Lot Number: 390342
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/21/2019
• Initial Date FDA Received: 10/16/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2019
• 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): Required Intervention
• Patient Age: 66 YR