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

Catalog Number USSL-2213220

Device Problem Device Damaged by Another Device (2915)

Patient Problem Failure of Implant (1924)

Event Date 10/15/2018

Event Type  malfunction  

Manufacturer Narrative

Implant date: (b)(6) 2018.It was reported that the case went well.After the monomer was cured, the operator drilled for and then inserted a zimmer 4.0mm cannulated screw.It was later learned that the screw was placed through the implant at the fracture site.Illuminoss trainers instruct users to place screws through the implant at least 3cms or more, away from the fracture line.

Event Description

Surgeon reported that a patient's implant had fractured.The patient had a fracture of the humerus with illuminoss implant and screw fixation.The surgeon also indicated that the fracture may have occurred within 6 weeks of the incident report date of (b)(4) 2018.It was noted by the surgeon that they had placed a 4.0mm cannulated screw through the implant directly at the fracture line.They believe the implant did not expand to its fullest diameter where the screw was placed which may have weakened the implant.However, a review of the x-ray showed the implant nearly fully expanded.The implant fracture occurred where the screw went through it.It was noted that the screw was not centered in the implant.The surgeon reported that the patient was doing fine and the fracture was healing as expected with the illuminoss product still in place.

• Brand Name: ILLUMINOSS PHOTODYNAMIC BONE STABILIZATION SYSTEM
• Type of Device: IN-VIVO CURED 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: 8254298
• MDR Text Key: 134883850
• Report Number: 3006845464-2019-00001
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: USSL-2213220
• Device Lot Number: 380340
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/31/2018
• Initial Date FDA Received: 01/16/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/02/2018
• 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
• Patient Age: 68 YR