MAUDE Adverse Event Report: ILLUMINOSS MEDICAL, INC. PHOTODYNAMIC BONE STABILIZATION SYSTEM; INTRAMEDULLARY FIXATION ROD, PRODUCT CODE QAD

Catalog Number SY-2000-01

Device Problem Optical Problem (3001)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/15/2024

Event Type  malfunction  

Manufacturer Narrative

At the time of this initial mdr report, the investigation into the cause of the event is still ongoing.The firm has conducted a review of the manufacturing records for the device, and found that the device met specifications at the time of manufacture and release.On april 1, 2024 the firm received the returned device from the sales rep.The firm is performing device evaluation in order to complete the complaint investigation.A follow up mdr will be submitted when further information is known about this case.

Event Description

During routine check of equipment prior to any case, an illuminoss sales rep noticed that a light box appeared too dim.He returned the lightbox to illuminoss and did not use it in a case.This potential device defect was identified without user or patient involvement.

Manufacturer Narrative

At the time of this update report , the investigation into the cause of the event is still ongoing.The firm has conducted a review of the manufacturing records for the device and found that the device met specifications at the time of manufacturing and release.On april 1, 2024 the firm received the returned device from the sales rep.The firm is performing device evaluation in order to complete the complaint investigation and this effort is still ongoing.

Event Description

During routine check of equipment prior to any case, an illuminoss sales rep noticed that a light box appeared too dim.He returned the lightbox to illuminoss and did not use it in a case.This potential device defect was identified with user or patient involvement.

Manufacturer Narrative

At the time of this update report , the investigation into the cause of the event is still ongoing.The firm has conducted a review of the manufacturing records for the device and found that the device met specifications at the time of manufacturing and release.On april 1, 2024 the firm received the returned device from the sales rep.The firm is performing device evaluation in order to complete the complaint investigation and this effort is still ongoing.The light bulb was exchanged for a new bulb and light output measured on (b)(6) 2024.The light box output was 19.1w/cm2 and the light guide output was 342mw/cm2, both of which are in specification.The old bulb was then put back into the light box.This indicates that the light bulb is the cause of the low light output of the light box.The light box and light guide were then sent to the supplier for further evaluation.

Event Description

During routine check of equipment prior to any case, an illuminoss sales rep noticed that a light box appeared too dim.He returned the lightbox to illuminoss and did not use it in a case.This potential device defect was identified with user or patient involvement.

• Brand Name: PHOTODYNAMIC BONE STABILIZATION SYSTEM
• Type of Device: INTRAMEDULLARY FIXATION ROD, PRODUCT CODE QAD
• Manufacturer (Section D): ILLUMINOSS MEDICAL, INC.; 993 waterman ave; providence RI 02914
• Manufacturer (Section G): ILUMINOSS MEDICAL INC.; 993 waterman ave; providence RI 02914
• Manufacturer Contact: robert rabier ; 993 waterman ave; east providence, RI 02914 ; 4017140008
• MDR Report Key: 19098442
• MDR Text Key: 340804570
• Report Number: 3006845464-2024-00005
• 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,Followup
• Report Date: 05/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: SY-2000-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2024
• Initial Date Manufacturer Received: 03/15/2024
• Initial Date FDA Received: 04/12/2024
• Supplement Dates Manufacturer Received: 03/15/2024
• Supplement Dates FDA Received: 05/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/17/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1