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

Catalog Number SL-1700260

Device Problem Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Date 02/20/2019

Event Type  Injury  

Manufacturer Narrative

A review of the information detailing this incident as well as the radiographs of the implant, found no conclusive evidence of root cause.Probable root causes were discussed which included poor bone quality (osteoporotic bone-very thin), what appears to be a potential failure of a competitor's plate and screws used to secure the fracture, and the potential of not inflating the implant to the minimum diameter of 13mm at the fracture site to ensure effective load bearing strength.A review of the manufacturing records specific to the delivery kit and balloon assembly found no anomalies in the manufacturing process.Additionally, a review of the device history record of the timer key that was placed in this delivery kit that is used to control the amount of light needed to fully cure the infused monomer within the implant, was per specification.

Event Description

It was reported that a patient's illuminoss implant had fractured approximately 2 weeks after implantation.Report received on 22feb2019 that on (b)(6), dr (b)(6) needed to revise a fracture of the left humerus as a result of a small plate partially detached from the bone and a fractured illuminoss implant.The illuminoss device had been implanted along with a plate on (b)(6) 2019.The dr found that the illuminoss implant had fractured and the distal end of the small plate had detached from the patient's bone (screws pulled out of the bone).Dr (b)(6) proceeded to revise the fracture by leaving the broken illuminoss inside but removed the small plate.A larger angle-stable plate (humerus plate) was inserted and attached to the humerus.It was reported that dr (b)(6) had fixed the problem and the humerus was stable.Dr (b)(6) also indicated that the patient had very poor bone quality.The dr added that the patient had an infection prior to using the illuminoss implant.Prior to using the illuminoss implant, another company's metal nail had been used as the intramedullary support.After implanting the nail, the patient developed an infection.The nail was removed and replaced with the illuminoss device and small plate.It was reported that after the illuminoss product was implanted the infection cleared up.The dr also noted that the patient preferred sleeping on their side (also with the illuminoss implant).

• Brand Name: ILLUMINOSS PHOTODYNAMIC BONE STABILIZATION SYSTEM
• Type of Device: IN-VIVO INTRAMEDULLARY FIXATION ROD
• Manufacturer (Section D): ILLUMINOSS MEDICAL INC.; 993 waterman ave; eats 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: 8484552
• MDR Text Key: 140962432
• Report Number: 3006845464-2019-00004
• Device Sequence Number: 1
• Product Code: QAD
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 04/04/2019

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: No Information
• Device Expiration Date: 05/31/2022
• Device Catalogue Number: SL-1700260
• Device Lot Number: 380817
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/22/2019
• Initial Date FDA Received: 04/04/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/13/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ILLUMINOSS DEVICE & COMPETITOR'S SCREWS/PLATES
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR
• Patient Weight: 80