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

Catalog Number SL-2213220

Device Problem Fracture (1260)

Patient Problem Non-union Bone Fracture (2369)

Event Date 02/02/2021

Event Type  malfunction  

Manufacturer Narrative

The following information was collected and reviewed by the investigation team: information received from the treating physician radiographs , ifu review: 900535 rev b, manufacturing dhrs of the product in question, validation testing of the product in question.White paper: orthopedics research and traumatology, volume 1 : issue 1, article ref.#: 1000ortoj1102, entitled "a biomechanical comparison of a novel expandable photodynamic intramedullary system to a metal plate and screw system in humerus and femur osteotomy models returned product evaluation: evaluation of the complaint device was not possible, as it remained implanted in the patient.Review of manufacturing records: a review of manufacturing records found that the device met specification at the time of manufacture and release.Follow up information from the doctor: the doctor initially reported that although seriously ill (cancer), the patient is still very active.She is in no pain and the doctor doesn't want to do anything else at first because the patient has a very bad prognosis (in the end stage of cancer disease).Despite the broken implant, she is completely painless and the doctor wants to see how she goes along.If an operation is necessary, he will perform an additional plate fixation.The extent of the patient's pre-existing medical conditions included metastatic bone disease, breast cancer, and that the humerus had been irradiated before the surgery.The doctor originally reported that the patient presumably heavily supported herself with the arm and the implant broke as a result (the patient was quite active).Later follow up on the patient condition identified that the patient did not want another surgery.In a third followup requesting information on the patient condition, the doctor identified that no revision surgery was performed, and additionally that he had some suspicion that this patient may have suffered a physical collision at the time of the implant break.Medical oversight review: illuminoss performed a medical oversight review of the case, the information provided by the doctor, and the radiographs provided.It was observed during review of the radiograph images received that the patient appeared to have a metastatic lesion on the right side of the humeral fracture site.This potential lesion could prevent the balloon from making full contact with the cortical wall.It was also observed by the investigation team that the balloon was not making full contact with the cortical wall along other portions of the bone canal.Failure to make contact along the entire length of the canal will not provide the necessary stability to hold the fractured bone in place in order to heal.Without the full contact of the cortical wall it may be able to move and may lead to eventual fatigue failure.The extent of the patient's pre-existing medical conditions was identified via follow up with the treating physician, and included metastatic bone disease, breast cancer, and that the humerus had been irradiated before the surgery.Because of these patient conditions at the time of the implantation, a longer healing period would be anticipated.The investigation team learned through follow up with the treating physician that the reported implant break was reported 48 days after implantation.With delayed healing, the implant must take on all of the load as opposed to sharing it with the healing bone.Root cause analysis tool: using the information, the analysis tool used to summarize this investigation was the 5-whys: q1 - what is most likely contributing cause of the implant break? a1 - it appears the implant was not in full contact with the cortical wall.Q2 - what contributes to the balloon not being in contact with the cortical wall? a2 - if the user does not completely fill the balloon upon implant placement, it willl not inflate to conform to the intramedullary canal thereby allowing for movement of the fractured bone q3 - what happens when the fractured bone is allowed to continually move? a3 - movement of the fractured bone may contribute to a non-union q4 - what are the consequences of a non-union? a4 - a non-union will allow continual flexure of the illuminoss implant which will eventually lead to a fatigue failure of the implant.Q5 - does current labeling provided by illuminoss warn that contact with the cortical wall is necessary to ensure fracture stabilization? a5 - the surgical technique guide includes the warning that fracture stabilization cannot be assured when the illuminoss implant is not in contact with the cortical wall or if the implant is moving within the intramedullary canal.Conclusion: given the information presented above, it is suspected that due to the combination of the patient's anticipated longer healing time due to their metastatic cancer, the underfilled balloon which allowed for movement of the balloon in the canal, and the potential for a metastatic lesion at the break site, it appears that the break was the result of fatigue failure, caused by insufficient contact with the cortical wall.

Event Description

This mdr report is based on the reclassification of a previously reviewed complaint.This cancer patient received implant on (b)(6) 2020 in her right humerus to treat a fracture.X-rays directly after surgery show that the implant is not broken.On (b)(6) 2021 the doctor reported that implant is broken as seen on x-ray taken (b)(6) 2021.No pain reported in patient.No further treatment was performed.

• 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: 15726335
• MDR Text Key: 307507055
• Report Number: 3006845464-2022-00011
• 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
• Report Date: 11/03/2022

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: 05/31/2024
• Device Catalogue Number: SL-2213220
• Device Lot Number: 400972
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/02/2021
• Initial Date FDA Received: 11/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2020
• 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 Outcome(s): Other
• Patient Age: 39 YR
• Patient Sex: Female
• Patient Weight: 50 KG
• Patient Ethnicity: Non Hispanic