MAUDE Adverse Event Report: ILLUMINOSS MEDICAL INC. ILLUMINOSS PHOTODYNAMIC BONE STABILIZATION SYSTEM; INVIVO INTRANEDULLARY FIXATION ROD

Catalog Number USSL-1700260

Device Problem Fracture (1260)

Patient Problem Fracture, Arm (2351)

Event Date 12/04/2019

Event Type  malfunction  

Manufacturer Narrative

Because it was felt that the light fiber may have been compromised due to the additional force applied to place it across the fracture, it was recommended that the implant be removed and replaced with a smaller diameter implant that would not require the same amount of force to place it into position.This ensured that the light fiber was not stressed and would transmit the expected light intensity necessary to cure the monomer material in the implant.This is the second attempt to submit this report.The initial submission made 01/03/2020, failed due to an unacceptable device problem code.

Event Description

During initial implant of a 17x260mm illuminoss implant in a (b)(6) female with a ewing's sarcoma tumor and tough irradiated bone, a 2nd year resident bent the catheter of the illuminoss implant while removing the sheath and attempting to get the implant in as far as possible.The implant was then evaluated through use of the illuminoss lightbox to determine whether the implant fiber was compromised.It was determined that the fiber was indeed compromised.The implant was then removed and replaced with a 17x220mm implant.The new implant was then inflated with monomer and cured.The patient was not affected.

• Brand Name: ILLUMINOSS PHOTODYNAMIC BONE STABILIZATION SYSTEM
• Type of Device: INVIVO INTRANEDULLARY 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: 9554034
• MDR Text Key: 196230238
• Report Number: 3006845464-2020-00001
• 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: 01/03/2020

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: Health Professional
• Device Expiration Date: 05/31/2023
• Device Catalogue Number: USSL-1700260
• Device Lot Number: 390282
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/05/2019
• Initial Date FDA Received: 01/06/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2019
• 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: 76 YR