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

Catalog Number USSL-1700260

Device Problem Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Type  malfunction  

Manufacturer Narrative

The original surgeon responsible for implanting the illuminoss device is no longer at the hospital where the procedure occurred.The surgeon who is now caring for the patient in question, had inquired about the illuminoss device and whether they could drill into the device and revise the fracture, as they were unfamiliar with the implant material.Very little information has been obtained regarding the patient's current condition and whether a revision was done.Additional information is being requested.

Event Description

A report was received on (b)(6) 2018 that an illuminoss implant had fractured post-operatively.It is unknown as to the cause or whether this issue was found during a routine follow-up.

• Brand Name: ILLUMINOSS PHOTODYNAMIC BONE STABILIZATION SYSTEM
• Type of Device: IN-VIVO INTRAMEDULLARY FIXATION ROD
• Manufacturer (Section D): ILLUMINOSS MEDICAL INC.; 993 watterman 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: 8254310
• MDR Text Key: 134585079
• Report Number: 3006845464-2019-00002
• 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: 06/30/2018
• Device Catalogue Number: USSL-1700260
• Device Lot Number: 380423
• Initial Date Manufacturer Received: 11/30/2018
• Initial Date FDA Received: 01/16/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/24/2018
• 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: 59 YR
• Patient Weight: 113