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

Catalog Number ML-08120

Device Problem Material Too Soft/Flexible (4007)

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

Event Date 02/14/2024

Event Type  malfunction  

Event Description

On (b)(6) 2024, during a procedure in germany to treat a traumatic fracture with an illuminoss implant (size 8x120mm), a curing failure was reported.The implant was inserted, infused the monomer, and cured for 300 seconds.After the curing process was completed, the user found that the implant was not cured.The user removed the implant and completed the procedure using a different device (not illuminoss), an osteosynthesis plate.It was reported that as of (b)(6) 2024, the patient is doing well.

Manufacturer Narrative

At the time of this initial mdr report, the investigation into the cause of the event is still ongoing.Returned product evaluation: the device is being returned for product evaluation, and was received at the firm's 3rd party decontamination provider on (b)(6) 2024.Device evaluation will be performed when the device is received at the firm's facility after decontamination is completed.Dhr review: a review of the manufacturing records for the device was performed, and found that the device met specifications at the time of manufacture and release, including the light output inspection performed for each device released with this lot.Follow up with user: the firm has reached out to the user for follow up information related to the case, and the patient outcome.The user reported that the patient outcome was good.A follow-up mdr will be submitted when the firm completes its product evaluation, and the investigation is complete.

Manufacturer Narrative

At the time of the initial mdr submission for this event, the investigation into the cause of this event was still underway.This followup mdr is submitted to submit new information, including - product evaluation results - investigation type codes, investigation findings codes, and investigation conclusion codes - and the manufacturer's narrative with the firm's root cause conclusions.Returned product evaluation: the implant device and the light box used in this case were returned to the manufacturer and tested.From the implant kit, the evaluation of the light fiber assembly found that this component was completely intact, and was not broken as initially reported.There was no visible damage to the light fiber assembly.Testing was performed on the actual complaint device, in which the returned implant light fiber was inserted into a new balloon, then infused with monomer and cured with the lightbox from this case, under worst-case conditions.This testing resulted in a fully cured implant.This product evaluation testing was repeated with a device of the same size from another lot, using the light box from this case, with the same results.Product evaluation was unable to replicate the reported product problem; the lightbox from this case successfully cured an implant sized 8x120 in 300 seconds, using the light fiber component of the returned complaint implant kit.Followup information: additional information was obtained from the reporter, that the product was not damaged at all prior to or during implantation.The device, including the light fiber assembly, was handled very carefully.And overall that everything worked very well, prior to discovering the under cured implant.In light of the returned product evaluation results, that the returned devices successfully cured balloons of the same size, other potential causes for the reported event were considered.There are potential use errors identified for this device that can lead to this failure mode, related to plugging components in to allow the light emitted from the light box to travel to the monomer within the balloon.Followup with the reporter related to these steps found that nothing out of the ordinary was observed or experienced with the illuminoss devices during these steps, and there was no report of any user errors.Therefore while potential use errors could theoretically have led to the event experienced, there is no evidence that they occurred in this case.Review of instructions for use: eu ifus for the implant and for the light box were reviewed, and found that they instruct the user of the risk of inability to properly deploy the device, and of the warning that a partially cured implant cannot be used to complete a procedure.Conclusion: the investigation included cure testing with the returned light box and implant light fiber, which successfully cured implants under worst-case conditions.The reported product problem could not be replicated.While there are potential use errors that can lead to this failure mode, followup with the reporter does not include any indication of use error contributing to the implant under curing.A root cause was not able to be determined.

• 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: 18858109
• MDR Text Key: 337865780
• Report Number: 3006845464-2024-00002
• 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: 04/04/2024

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: Health Professional
• Device Catalogue Number: ML-08120
• Device Lot Number: 431610
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2024
• Initial Date Manufacturer Received: 02/14/2024
• Initial Date FDA Received: 03/07/2024
• Supplement Dates Manufacturer Received: 02/14/2024
• Supplement Dates FDA Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/06/2023
• 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
• Treatment: SY-2000, ILLUMINOSS LIGHTBOX EU, UDI (B)(4).
• Patient Age: 81 YR
• Patient Sex: Male