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

Model Number USSL-2213260

Device Problem Gel Leak (1267)

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

Event Date 10/24/2022

Event Type  malfunction  

Manufacturer Narrative

The manufacturer is in process of investigating this event, and will submit a followup report with investigation findings and conclusions, and any updated information.

Event Description

A patient was being treated for a an impending pathologic fracture of the left distal femur.Two illuminoss implants (size 22/13 x 260mm) were inserted into the distal femur, one from the medial condyle one from the lateral condyle.There were no issues throughout the procedure until the surgeon was inflating the balloon.As the surgeon was injecting what should have been the final 10cc of monomer there was a noticeable decrease in the pressure needed to advance the monomer.When he drew back on the plunger blood and monomer filled the syringe.Realizing there was a leak he removed all the monomer, irrigated the wound, and suctioned out any remaining monomer.A replacement balloon was then introduced and inflated with no issues, without significant delay.The patient outcome was good.On the back table it was determined and seen that there was a small hole about 15mm, from the end of the balloon.(the side closest to where the monomer was introduced).Although the investigation is still ongoing into the cause of the balloon leak, this may be the result of a device malfunction, and therefore this initial mdr is being submitted.

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 the investigation findings codes, investigation conclusion codes, and this manufacturer's narrative with the firm's root cause conclusions.The firm reviewed the manufacturing records for this device, and found that it was in specification at the time of manufacture and release.No evaluation of the device was possible as it was not able to be returned to illuminoss.Complaints in the previous 12 months (november 2021-october 2022) from the date the complaint was opened were reviewed for other instances of lot 400276 being involved in a complaint and none were identified in this time period.Follow-up information from the user and distributor: the user provided x-rays to the firm.The user also communicated additional information about the case, the device and patient preparation steps performed, and the additional instrumentation used.· to prepare the bone a small k-wire was inserted into the lateral condyle.· the canulated curved awl was inserted over the top of the k-wire.· the k-wire was removed and ball tip guidewire inserted.· the doctor then reamed over the guide wire starting with 6.5mm reamer and going up by 1mm until 8.5mm reamer was reached.· the illuminoss implants were prepped according to the surgical technique guide and the air was removed from them, the implants were able to draw a vacuum during device prep.· the implants were placed sequentially, the user tried to go laterally first but had difficulty, so they placed the medial side first, then went in through the lateral side second.· as the surgeon was infusion the final 10cc of monomer in the lateral balloon there was a noticeable decrease in the pressure needed to advance the monomer.When the surgeon drew back on the syringe plunger blood and monomer filled the syringe.· the surgeon realized there was a leak and removed all the monomer, irrigated the wound, and suctioned any remaining monomer.· a replacement illuminoss implant was then introduced with no issues.· on the back table the leaking implant was examined, and it was determined there was a small hole about 15mm from the proximal end of the balloon.· the patient had a total knee implant present prior to this procedure.There was no additional fixation used to treat this patient and the procedure was performed closed.Internal medical oversight review: additional review of the information about the case, medical records, and x-rays was performed with medical oversight to supplement the complaint investigation.Illuminoss clinical and medical affairs met with independent medical oversight and made the following observations: · nothing was observed about the patient anatomy which would be likely to damage a balloon intraoperatively.· there are no sharp fractures or bone fragments observed · the total knee implant does not appear in a position where it would have contacted the implants during inflation.· the canal was reamed using successively larger reamers, which would be likely to remove any debris in the intermedullary canal.· the conclusion from the medical oversight meeting is there is no observable evidence from the radiographs of something in the patient anatomy which may have damaged the implant, causing a leak.Review of ifu and potential user error there is no evidence that use error contributed to this event.· the distributor stated that the implants were prepped per the surgical technique guide · the distributor also reported that the user prepared the bone canal using a k-wire, curved awl, ball tipped guidewire, then a 6.5mm reamer up to an 8.5mm reamer in 1mm increments.There is no indication that the canal preparation technique contributed to this complaint.The surgeon in this situation followed similar steps as described in surgical technique guide 900611_b.In addition, there were no observed bone fragments within the canal in the pre-op radiographs furthermore, this was a procedure to treat pathologic lesions rather than a traumatic fracture.Therefore it is not probable that a bone fragment would be found in the intermedullary canal which might have punctured the balloon during inflation.· the distributor reported that the implant lost pressure during the infusion step when the final 10cc of monomer was being infused.Per the responses the firm received to followup questions, the user did not attempt to adjust or straighten the mostly filled implant while in the intermedullary canal or contact the balloon with an instrument, which is instructed against in the surgical technique guide 900611, "reduce the fracture prior to the placement of the implant; the inflation of the illuminoss implant will not reduce a fracture.Do not attempt to reduce a fracture or adjust the rotational alignment with an implant inflated and in contact with the cortical walls as this may cause a tear in the implant." "the illuminoss implant is constructed from a thin wall pet balloon.Do not bring instruments (k wires, screws, suture needles, clamps or other instruments) to come in contact with the implant prior to it being fully cured as it may damage or compromise the implant." · the firm notes that the treatment in this case is off-label use, but there is no evidence of a correlation between this off-label use and the product problem experienced.The user determined to treat a femur with only the illuminoss implants, rather than having the illuminoss implants provide supplemental fixation to an fda-cleared fracture fixation system in this anatomy.The user was notified of the approved indications for use and how this case deviated from them.There is no evidence that user error contributed to this complaint.Conclusion: the cause of the leak in the implant was due to a small hole about 15mm from the proximal end of the balloon.The cause of the hole in the balloon is unknown.The device was in specification at the time of manufacture and release, and the implant was able to draw a vacuum before implantation during device prep.Therefore, the hole in the balloon occurred sometime between device preparation and balloon infusion.There is no indication that something in the patient anatomy damaged the balloon, such as a bone fragment or sharp piece of hardware.There is no indication that user error damaged the balloon, such as attempting to adjust or straighten the balloon while infused or contacting the balloon with an instrument which could damage it.Therefore, the root cause of this complaint is unknown.

• Brand Name: PHOTODYNAMIC BONE STABILIZATION SYSTEM
• Type of Device: IN VIVO INTRAMEDUILLARY 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 provience, RI 02914 ; 4017140008
• MDR Report Key: 16023173
• MDR Text Key: 308449365
• Report Number: 3006845464-2022-00018
• 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,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/19/2022

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 Expiration Date: 03/31/2024
• Device Model Number: USSL-2213260
• Device Catalogue Number: USSL-2213260
• Device Lot Number: 400276
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/24/2022
• Initial Date FDA Received: 12/21/2022
• Supplement Dates Manufacturer Received: 10/24/2022
• Supplement Dates FDA Received: 12/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/22/2020
• 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 Age: 62 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White