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

Catalog Number USSL2213260

Device Problem Fracture (1260)

Patient Problem Fracture, Arm (2351)

Event Date 11/15/2019

Event Type  Injury  

Manufacturer Narrative

Based on the review of the implant's dhrs which indicated no abnormalities with the manufacture of the balloon or catheter, and the review of the complaint description, it appears that the use of the rod pusher / high hat device as a means to move the balloon implant further down into the canal, may have contributed to the creation of a hole in the balloon.It is unclear how the pusher rod was used but any contact with the balloon could either damage it directly or force the balloon into the area of the fracture and against sharp bone fragments, causing a tear.Return of the device is expected.An investigation to confirm the above currently identified cause.This is the second attempt to submit this report.The initial attempt made on dec 6, 2019, failed due to the use of an incorrect device problem code.

Event Description

On (b)(6) 2019, a procedure involving the fixation of the right humerus with the illuminoss implant was completed on a (b)(6) male patient.He was in stable condition throughout the procedure.In an effort to drive the implant more medial, the surgeon directed the fellow to use the rod pusher/high hat as a tool for such.Once they were more satisfied with the placement of the balloon, they began inflating.The inflation proceeded as expected.As the fellow approached the maximum inflation, it was noted that there it suddenly seemed to yield a bit.At this time, it was evident that monomer was oozing out of the insertion site.The fellow attempted to deflate the balloon.After filling one syringe and attempting to fill a second, due to an apparent hole in the implant, air was entering the syringe despite the implant not being fully deflated.At this time the implant was removed.A new implant was prepped, inserted, inflated, and cured without further issue.The incision was closed, and the patient was removed from the or suite without incident.The patient remained stable throughout the procedure which lasted approximately one hour and was resting comfortably after coming out of anesthesia.

• Brand Name: ILLUMINOSS PHOTODYNAMIC BONE STABILIZATION SYSTEM
• Type of Device: INVIVO 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: 9554265
• MDR Text Key: 175182883
• Report Number: 3006845464-2019-00008
• 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: 12/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 05/31/2023
• Device Catalogue Number: USSL2213260
• Device Lot Number: 390368
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/29/2019
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR