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

Catalog Number SL-1700280

Device Problem Fracture (1260)

Patient Problem Bone Fracture(s) (1870)

Event Date 10/06/2023

Event Type  Injury  

Event Description

In the eu, an 87 year old male patient underwent implantation of an illuminoss device to treat a large segmental defect in a metastatic humerus with a plate and screws.8 weeks after implantation, the humerus and illuminoss implant broke at the proximal end of the plate as the tumor had continued to grow.The patient is currently receiving a 3rd cycle of chemotherapy.

Manufacturer Narrative

At the time of this initial mdr report, the investigation into the cause of the event is still ongoing.Returned product evaluation: device evaluation in this case is not possible as the device remains implanted.X-rays: radiographs of the treated anatomy have been received from the user.Follow up with user the user has provided additional details surrounding the case, describing the treatment performed, and the role that disease progression (humeral tumor) had in causing the re-fracture.Review of ifu: ifu 900535 rev.D was reviewed.The risk of possible implant fracture is included in the labeling, "risks for all bones as with any im fixation system or rod the following can occur: loosening, bending, cracking or fracture, or mechanical failure of the components or loss of or inadequate fixation in bone attributable to delayed union, nonunion, insufficient quantity or quality of bone or markedly unstable comminuted fractures, or insufficient initial fixation, loss of anatomic position with nonunion or malunion with rotation or angulation." the firm will perform a medical oversight review of this case in order to complete its investigation.A follow-up mdr will be submitted when the firm's investigation is complete.

Manufacturer Narrative

At the time of the initial mdr submission for this event, the investigation into the cause was still underway.This followup mdr is submitted to submit new information, including health effect impact codes, investigation findings codes, and investigation conclusion codes.And the manufacturer's narrative with the firm's root cause conclusions.The firm performed an internal medical oversight review of this case, and agreed with the user's assessment of the main cause of the fracture of the illuminoss implant being the progression of the patient's tumor in the treated arm.The rapid growth of the tumor that continued after the initial implantation surgery, and the diminishing quantity of cortical bone within the treated anatomy as a result of the fast growing tumor, led to increased strain on the illuminoss implant, and its eventual break.

• 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: 18279372
• MDR Text Key: 329888427
• Report Number: 3006845464-2023-00045
• Device Sequence Number: 1
• Product Code: QAD
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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,Followup
• Report Date: 01/05/2024

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: SL-1700280
• Device Lot Number: 400163
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/06/2023
• Initial Date FDA Received: 12/06/2023
• Supplement Dates Manufacturer Received: 11/06/2023
• Supplement Dates FDA Received: 01/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2020
• 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
• Patient Outcome(s): Other
• Patient Age: 87 YR
• Patient Sex: Male