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

Model Number USSL-1700280

Device Problems Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017); Device Damaged by Another Device (2915)

Patient Problem Failure of Implant (1924)

Event Date 09/13/2018

Event Type  malfunction  

Manufacturer Narrative

Surgeon was trained the day prior to the procedure being performed.Surgical technique guide instructs users of the device that if adjustments of the balloon position or bone is required depressurize balloon by opening stopcock and aspirating monomer out of the implant.Attempts at repositioning a fully filled balloon may cause damage to the balloon.Physician attempted to adjust the bone position with the bone clamp during the cure cycle with fully inflated balloon.Physician acknowledged that they erred in attempting to readjust the bone.

Event Description

This incident occurred during an off label use procedure.The user attempted to implant the device into the patient's femur.The intended use of this product is in the humerus/radius/ulner.The area above the femur was opened.The patient's hip prosthesis and plate were removed.The canal was reamed to 16-17mm.A 17x280mm implant was prepped and implanted into the femoral canal from the medial condyle.The implant was positioned across the fracture and filled with monomer.A bone clamp was used to hold the fracture together.The curing process was initiated and about 100 sec into the curing process the surgeon attempted to reposition the bone clamp and at that point the surgeon stated the bone clamp had perforated the balloon.The light box was turned off and monomer was suctioned from the balloon at the perforation site.The implant was removed from the canal easily.The site and canal were cleaned using suction/irrigation.A new 17x260 balloon catheter was prepped and implanted.The surgeon applied pressure to the fracture using a mallet to maintain reduction and the implant was successfully cured.As of september 19th, it was reported that the patient was doing ok and in recovery at the hospital.In addition to the balloon implant procedure which was 30-40 min in duration, there were additional procedures performed to remove a hip prosthesis and plate which took 2 1/2 hrs.Patient's hospital stay was due to these additional procedures.

• Brand Name: ILLUMINOSS PHOTODYNAMIC BONE STABILIZATION SYSTEM
• Type of Device: IN-VIVO CURED INTRAMEDULLARY FIXATION ROD
• 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: 7958334
• MDR Text Key: 123956702
• Report Number: 3006845464-2018-00003
• 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
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 10/11/2018

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: 06/30/2019
• Device Model Number: USSL-1700280
• Device Catalogue Number: USSL-1700280
• Device Lot Number: 380427
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/13/2018
• Initial Date FDA Received: 10/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2018
• 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 Age: 65 YR