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U.S. Department of Health and Human Services

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

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ILLUMINOSS MEDICAL INC. ILLUMINOSS PHOTODYNAMIC BONE STABILIZATION SYSTEM; INVIVO INTRAMEDULLARY FIXATION ROD Back to Search Results
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.
 
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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 Key9199585
MDR Text Key219554589
Report Number3006845464-2019-00006
Device Sequence Number1
Product Code QAD
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K181228
Number of Events Reported1
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 Date05/31/2023
Device Catalogue NumberUSSL-2213240
Device Lot Number390342
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 09/21/2019
Initial Date FDA Received10/16/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/02/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age66 YR
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