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

Model Number USSL-2213220

Device Problem Gel Leak (1267)

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

Event Date 07/20/2021

Event Type  malfunction  

Manufacturer Narrative

This mdr report is based on the reclassification of a previously reviewed complaint.Returned product evaluation: the product was disposed of at the hospital, so no product is available to be returned and evaluated.Dhr review: the firm reviewed the manufacturing records for this device, and found that the product met specifications at the time of manufacture and release.Followup information provided by the user: this patient experienced a distal femur fracture 1-2 years prior to this case, which was fixed with a blade plate and several screws, the patient also has a total knee replacement in the same leg as the distal femur fracture.There was a non-union of the fracture which was confirmed by ct.To correct the periprosthetic non-union this revision surgery was performed in which the illuminoss implant would be utilized for additional stabilization to the blade plate and screws.This event occurred during the revision surgery at the balloon infusion step, once the first illuminoss implant had been inserted into the intermedullary canal.In that revision surgery, the majority of the screws were removed and the non-union was taken down with reaming.The blade plate and at least one screw remained implanted in the patient.The illuminoss implant was prepped and primed with no issue, and the user was able to evacuate the air from the balloon and establish negative pressure.The illuminoss implant was inserted into the intermedullary canal and the user attempted to infuse the balloon with monomer.As the balloon reached maximum inflation a leak was suspected, and the implant was removed.A pinhole was noticed in the implant midway down the implant.A second balloon from the same lot was then prepped and primed and inserted into the intermedullary canal, infused with monomer, and successfully cured.New screws were implanted through the blade plate and into the illuminoss implant, and the procedure was completed as planned.This removal of the first balloon and prepping and insertion of the second created an 8 minute delay in the overall procedure.In response to the firm's questions, the user shared that there were no other provisional reduction instruments, or k-wires used, and that no instruments touched the balloon during preparation, implantation, or balloon filling.The user reported the fracture reduction was not adjusted or moved at all while the first balloon was inside the bone, and the fracture reduction was held in the same position as the first implant was removed and second implant inserted.The user also provided the firm with x-rays of the treated anatomy before, during and after this procedure.Medical oversight review the firm conducted an internal medical oversight review of the information and x-rays provided.Medical oversight identified via the x-ray review that the blade plate and at least one screw remained in the patient's femur during the illuminoss implantation, and observed in the x-ray imaging of the infused balloon which then leaked, that the sharp flanges of the blade plate appears to be touching the edge of the illuminoss implant.Medical oversight observed the sharp edge of the blade plate flange was in close proximity to the location on the condyle which the illuminoss balloon was implanted through, and that these sharp metal implant ends could have caused the hole in the balloon.Additionally, a screw through the distal portion of the blade plate was observed in the x-rays, which was present while the illuminoss was being implanted.The tip of the distal screw left in the bone could also have punctured the balloon during the implantation process.Review of ifu the ifu and surgical technique guides include instructions to the user not to bring the balloon into contact with hardware until after curing as it may damage or compromise the implant.Conclusion the device met its specification at the time of manufacturing, and the user reported being able to successfully draw a vacuum with this device during device prep.These investigation findings suggest that the damage was introduced after device preparation.Evidence reviewed identified that the damaged balloon likely came into contact with either the phlange of the blade plate at the implantation site, or the tip of the distal screw also present at the implantation site.Therefore the firm concluded that the most probable root cause of this event was allowing the balloon to come into contact with the sharp edges of the hardware that were present at the implantation site, which punctured the balloon during implantation.

Event Description

This mdr report is based on the reclassification of a previously reviewed complaint.During treatment of a traumatic distal femur fracture non-union for a 60 year old female who had been previously treated with a blade plate and screws, an illuminoss implant [size 22/13x220] was placed.Following insertion of implant, a hole was identified mid-balloon upon injection of monomer.The damaged baloon was removed, and a new balloon was used without issues.The surgical outcome was as planned, and there were no patient issues.

• 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 providence, RI 02914 ; 4017140008
• MDR Report Key: 16811693
• MDR Text Key: 314128385
• Report Number: 3006845464-2023-00010
• Device Sequence Number: 1
• Product Code: QAD
• UDI-Device Identifier: M986USSL22132200
• UDI-Public: M986USSL22132200
• 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: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/25/2023

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: 05/31/2023
• Device Model Number: USSL-2213220
• Device Catalogue Number: USSL-2213220
• Device Lot Number: 390380
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/21/2021
• Initial Date FDA Received: 04/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2019
• 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: 60 YR
• Patient Sex: Female
• Patient Ethnicity: Hispanic
• Patient Race: White