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

Catalog Number USSL-1700280

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Date 10/21/2019

Event Type  Injury  

Manufacturer Narrative

Based on the patient's medical condition which was reported as multiple myeloma which is a disease that weakens bone, there appears to be a delayed union of the fracture.Because the bone was not healing, the implant was under continual stress for a period of three and a half months.This continual movement eventually weakened the implant at the fracture site which led to it breaking.As indicated in the risk section of the product's ifu (instructions for use), the following can occur: 'loosening, bending, cracking or fracture of the components or loss of fixation in bone attributable to delayed union, nonunion, insufficient quantity or quality of bone or markedly unstable comminuted fractures.'.

Event Description

(b)(6) 2019: oncology visit c/o arm pain no report of trauma cycle 4 day 1 velcade/dex, on aranesp (b)(6) 2019: ortho office visit delayed union at the fracture site which has created a fatigue fracture of the implant.Likely due to combination of local tumor and systemic therapy.Placed in humeral clamshell fracture brace.Re-evaluation in 2 months.Imaging: mri ((b)(6) 2019) extremely limited evaluation as outlined above with findings for fracture of the patient's intramedullary rod in its mid third where there is evidence of angulation of the humerus.Humerus 2 views ((b)(6) 2019) an underlying pathologic fracture, is present, involving the proximal aspect of the distal third of the right humerus, with anterolateral angulation.

• 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 ; 4017410008
• MDR Report Key: 9411108
• MDR Text Key: 169198177
• Report Number: 3006845464-2019-00007
• 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: 12/03/2019

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: No Information
• Device Expiration Date: 04/30/2021
• Device Catalogue Number: USSL-1700280
• Device Lot Number: 3804277R
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/12/2019
• Initial Date FDA Received: 12/04/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 61 YR