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 01/31/2019

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.Most probable root causes were discussed which included fracture misalignment during the implantation of the illuminoss device, added stress on the implant due to patient weight which was reported as (b)(6) 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.An illuminoss product specialist reported the following on 14feb2019 from dr.(b)(6): prof.Dr.(b)(6) informed the product specialist on 02-13-19 / 10.43 a.M., that an illuminoss implant had broken within a few weeks of implantation.The implantation date was (b)(6) 2019.The patient told the dr.That he had not sat up or fallen.As a result of the break, a revision was necessary and took place on (b)(6) 2019.Prof.(b)(6) removed a part of the illuminoss implant because he had to reposition the bone in a way that required its removal.After reducing the fracture, was treated with a plate and screws for additional stability.

• Brand Name: ILLUMINOSS PHOTODYNAMIC BONE STABILIZATION SYSTEM
• Type of Device: IN-VIVO 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: 8491703
• MDR Text Key: 141204302
• Report Number: 3006845464-2019-00005
• Device Sequence Number: 1
• Product Code: QAD
• UDI-Device Identifier: 22053138081M
• UDI-Public: 0122053138081M
• 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: Health Professional
• 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: 02/13/2019
• Initial Date FDA Received: 04/08/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/13/2018
• 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
• Treatment: ILLUMINOSS DEVICE
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Weight: 140