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

Catalog Number USSL-1700220

Device Problem Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Date 12/29/2020

Event Type  Injury  

Manufacturer Narrative

Context: the device in question is an intramedullary balloon catheter (ibc) that is part of the illuminoss photodynamic bone stabilization system (pbss).It is a formed-in-place intramedullary implant used to stabilize bone fractures in much the same way as an intramedullary nail (imn) does.Details of the ibc are as follows: the ibc consists of a balloon attached to a catheter and y-body assembly that allows the user to infuse monomer material into the balloon to fill it once it is in the intramedullary canal and placed across the fracture site.The catheter and y-body also allow access for the light fiber into the balloon which provides the light necessary to harden the monomer into a polymer.The balloon, once hardened, is now able to stabilize the fracture during the healing process.Specific differences between the ibc and imn is that the ibc is a formed in place implant.The nail is not.The ibc, unlike the imn, must have cortical contact along its length.Because of this cortical contact, cross-locking screws are not required, which is also not the same as an imn as an imn requires these screws for stability.For humeral fracture treatments, it is recommended that the diameter of the created implant be a minimum of 13mm in order to provide optimal strength if used on its own.This is stated in the surgical technique guide (p/n 900510), it states that if the 13mm diameter is not achieved it is recommended to supplement the balloon implant with an fda cleared plate and screws.Investigation results: the root cause analysis tool used to determine potential root causes of this implant break was a rule in / rule out analysis which involved evaluation of available information (i.E.Complaint description, device history record reviews, ifu review, and review of x-rays).As each potential root cause for a failure of this type was identified, it was either ruled in or ruled out.At the completion of the analysis, all device related potential causes were considered ruled out based on the available information and physical evidence.Conclusion: after the analysis described above was completed, there were no device related potential causes identified based on the available information.

Event Description

Upon initial post-op visit, patient presented with a broken illuminoss implant at the initial site of fracture.Patient was put into a cast at office visit.The surgeon will re asses injury in a couple of weeks to determine any further treatment.

• Brand Name: 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: 11240379
• MDR Text Key: 229098813
• Report Number: 3006845464-2021-00001
• 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: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/27/2021

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: 05/31/2024
• Device Catalogue Number: USSL-1700220
• Device Lot Number: 400897
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/29/2020
• Initial Date FDA Received: 01/27/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2020
• 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 17MM X 220MM BALLOON CATHETER
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR