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

Model Number USSL-2213220

Device Problem Loss of Osseointegration (2408)

Patient Problem Failure of Implant (1924)

Event Date 05/15/2017

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to illuminoss for evaluation.The final assessment of how the device fragmented was that it was due to excessive flexure and eventual fatigue failure as a result of a non-union of the bone where the implant was located, which was the expectation of the surgeon.Because of the non-union and the patient's physical therapy to relieve a frozen shoulder, the implant was subjected to stresses that may have contributed to the fragmentation of the implant.Please note this report is being resubmitted based upon correspondence with emdr staff.E\mdr was not able to be loaded of form was greater than 50 characters in length.

Event Description

A fragmented implant was reported to an illuminoss employee on (b)(6) 2018, the report was of an implant that was surgically implanted into the humerus (b)(6) 2016 as part of the (b)(6) clinical trial.An adverse event for non-union in this patient was reported through the ide.The clinical trial has since been closed.The physician indicated that the fragmented implant was first detected on (b)(6) 2017 although this was not reported to the manufacturer.The current report is being made due to a recent correspondence with the physician in which it was reported to the company of the device fracture.

• Brand Name: ILLUMINOSS PHOTODYNAMIC BONE STABILIZATION SYSTEM
• Type of Device: IN-VIVO CURED INTRAMEDULLARY FIXATION ROD
• Manufacturer (Section D): ILLUMINOSS MEDICAL INC; 993 waterman; east providenace RI 02914
• Manufacturer Contact: robert rabiner ; 993 waterman ave; east providence, RI 02914 ; 4017140008
• MDR Report Key: 8505453
• MDR Text Key: 145776041
• Report Number: 3006845464-2018-00004
• Device Sequence Number: 1
• Product Code: QAD
• UDI-Device Identifier: 161231360050D0
• UDI-Public: 01161231360050D0
• 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: health professional,study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2016
• Device Model Number: USSL-2213220
• Device Catalogue Number: USSL-2213220
• Device Lot Number: 360050
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/24/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/15/2016
• 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: 65 YR