MAUDE Adverse Event Report: ILLUMINOSS MEDICAL INC ILLUMINOSS PHOTODYNAMIC BONE STABILIZATION SYSTEM; ILLUMINOSS SYSTEM

Model Number USSL-1700220

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/09/2018

Event Type  malfunction  

Manufacturer Narrative

Surgeon reported that the light fiber was plugged into machine at too acute of an angle and may have led to the failure.The light box was repositioned in a different location in operating room (or) in the second implant cured completely at 1200 seconds.Status of the patient is in good condition, went home post op (day of surgery).Please note this report is being resubmitted based upon correspondence with emdr staff.

Event Description

Case involving a (b)(6) male with left humerus, mid shaft fracture.The product was a 17 x 220 mm implant.The implant was place but then drained and removed in order to secure a biopsy.The implant was reinserted re-inflated and then cured.Approximately 2 minutes into curing some action by the medical staff caused the light fiber to break.An attempt to remove the original light fiber was made, towards inserting another fiber and continuing the curing cycle.Only a portion of the light fiber was able to be removed, which precluded the continuation of the curing cycle.An attempt to remove the monomer from the partially cured implant was made, by piercing the implant and aspirating some of the monomer.Some of the monomer was removed in this fashion, although not a significant amount.The original implant was attempted to be removed from the canal by pulling on the catheter, but was not able to be dislodged.A second implant 22/13 x 160 was delivered alongside the original implant.The second implant was infused with monomer.The expansion of the second implant caused the residual monomer in the first now pierced implant to be expelled through the pathway in the humeral head and removed.The second implant was cured for 1200 seconds.This represented an additional 400 seconds required for the second implant.The reason was to ensure curing of any residual monomer retained from the initial implant.There was no adverse event to the patient.However, the procedure was extended in time.

• Brand Name: ILLUMINOSS PHOTODYNAMIC BONE STABILIZATION SYSTEM
• Type of Device: ILLUMINOSS SYSTEM
• Manufacturer (Section D): 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: 7953117
• MDR Text Key: 124992846
• Report Number: 3006845464-2018-00002
• Device Sequence Number: 1
• Product Code: QAD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: DEN160062
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 09/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Model Number: USSL-1700220
• Device Catalogue Number: USSL-1700220
• Device Lot Number: 380231
• Was Device Available for Evaluation?: No
• Device Age: 2 YR
• Date Manufacturer Received: 08/09/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/29/2018
• 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: 68 YR