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

Catalog Number SL-1700260

Device Problem Loss of Osseointegration (2408)

Patient Problem Failure of Implant (1924)

Event Date 10/24/2018

Event Type  Death  

Manufacturer Narrative

The device was not returned to illuminoss for evaluation.The final assessment of how the device was punctured based on the information received, was that it was due to the surgeon attempting to reduce the fracture with a bone span during the filling of the implant.The surgeon's guide for this product cautions the user that damage to the implant may occur if the implant or bone is moved while the implant is in place and inflated.In regards to the light box not being operational, it is specified in the pre-operational set-up section of the surgeons guide to turn on the light box before starting the procedure.This did not happen as the light box was turned on after the second implant was inserted and inflated.

Event Description

On (b)(6) 2018, during a repair of a fracture of the humerus, an illuminoss implant was damaged during an attempted reduction of the fracture using a bone span while the balloon was being filled.After it was determined that the implant was damaged, the damaged implant and monomer were removed from the canal.It should be noted that the surgeon's guide states that prior to attempting to move either the implant or bone after the implant is in place and inflated, the user is to deflate the implant or damage to the implant may occur.It was reported that during the filling of this first balloon, and prior to it being damaged, the patient experienced a minor cardiac event.The procedure continued once the patient was stabilized without any further complications.After the first implant and monomer were removed, a second implant was prepared, inserted and filled with monomer.Once the second balloon was filled, the lightbox was turned on.It should be noted that the light box had not been started to this point of the procedure.Upon turning the light box on, the "change bulb" indicator light came on that requires the bulb to be changed before it can be used.It was reported that the user facility did not have a spare bulb.Without an operational light box, the illuminoss system cannot be used.It should be noted that the surgeon's guide instructs the user to turn on the light box prior to the start of the procedure to ensure that it is operational.Once it was determined that the lightbox was not operational, the second implant was removed without incident.Subsequent to the removal of the second implant, the surgeon used a plate and screws to secure the fracture.Once this was completed, the patient began showing signs of difficulty coming out of anesthesia and was not able to be stabilized.They subsequently expired.

• Brand Name: ILLUMINOSS PHOTODYNAMIC BONE STABILIZATION SYSTEM
• Type of Device: IN-VIVO CURED INTRAMEDULLARY FIXATION ROD
• Manufacturer (Section D): ILLUMINOSS MEDICAL INC; 993 waterman avenue; east providence RI 02914
• Manufacturer (Section G): ILLUMINOSS MEDICAL INC; 993 waterman avenue; east providence RI 02914
• Manufacturer Contact: robert rabiner ; 993 waterman avenue; east providence, RI 02914 ; 4017140008
• MDR Report Key: 8095934
• MDR Text Key: 128097814
• Report Number: 3006845464-2018-00005
• 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: Physician
• Type of Report: Initial
• Report Date: 11/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: SL-1700260
• Device Lot Number: 380465
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/24/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ILLUMINOSS DEVICE, BONE SPAN, PLATES, SCREWS
• Patient Outcome(s): Death
• Patient Age: 73 YR