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

Catalog Number SL-1700260

Device Problem Deformation Due to Compressive Stress (2889)

Patient Problems Non-union Bone Fracture (2369); Implant Pain (4561)

Event Date 09/01/2019

Event Type  Injury  

Event Description

A serious adverse event was entered into the illuminoss clinical study registry on (b)(6) 2022 for a serious adverse event which occurred on (b)(6) 2019.A (b)(6) y/o male patient was treated on (b)(6) 2018 with illuminoss implant for an impending pathological fracture of the right humerus.The patient experienced loss of stabilization at the treated fracture site and a bent implant due to progressive bone loss and increased stress on the implant, and 153 days post implantation on (b)(6) 2019 the patient received surgical intervention to add additional fixation (plates and screws) to achieve stabilization of the original bone fracture.

Manufacturer Narrative

Root cause investigation.Information provided by the hospital/treating institution an adverse event was entered into the illuminoss clinical study registry on (b)(6) 2022 for an adverse event which occurred on (b)(6) 2019.The patient was treated for a pathologic humerus due to metastatic lung cancer with an illuminoss 17mmx260mm implant on (b)(6) 2018.Pre-operative x-rays from (b)(6) 2018 show a significant mid humeral bone defect and significant bone loss was noted at the time of final reduction during the procedure performed on (b)(6) 2018.Follow up x-rays were taken on (b)(6) 2018 which showed the illuminoss implant was intact, but the significant bone defect was still present.Additional follow up x-rays were taken on (b)(6) 2018 with a radiology report of "increased angulation of a pathologic mid right humeral shaft fracture" and patient pain reported as an 8/10.The illuminoss implant appears bent at the humeral fracture but still in one piece.Additional follow up x-rays were taken on (b)(6) 2018 with clinical details "he was found to have failure of the implant at the site of the fracture in association with local disease progression with progressive bone loss." the illuminoss implant is significantly bent at the fracture site.The treating institution concluded that the adverse event occurring on (b)(6) 2019 in which the implant failed (loss of stabilization at the treated fracture site and bent implant) was due to progressive bone loss and increased stress on the implant.The patient had revision surgery with stabilization with plate/screws at an outside hospital.No x-rays are available from the revision surgery.No returned product evaluation available as the implant remains in the patient.The manufacturing records for the device (17mmx260mm implant, lcn 380423) were reviewed and the device was found to be in specification at the time of manufacture and release.To aid in the root cause investigation the manufacturer conducted a medical oversight review of this event.The information provided by the treating institution and x-rays were reviewed.Comparing the date of implantation (performed on (b)(6) 2018) to the date of the adverse event onset of loss of stabilization ((b)(6) 2019) identified that ~5 months (or 153 days) had elapsed between the initial implantation and the implant failure.The progression of x-rays show that the patient had a non-union as the humerus bone defect did not heal and progressed onto a fracture with increasing angulation.The pre-op and initial follow up x-rays showed a significant mid shaft humeral bone defect prior to and after implantation, and the user noted there was significant bone loss present at the time of final reduction during the implantation procedure.It is noted by manufacturer's medical oversight review that in the (b)(6) 2018 follow up x-rays, there is now a fracture present in the humerus.The patient has also undergone radiation treatment of the humerus, which reduced the chance that the bone could heal.It was also noted that the distal portion of the implant which had sufficient cortical wall contact was quite short.The manufacturer's medical oversight review concluded that the cause of the loss and stabilization and implant bending was likely due to several factors including insufficient initial fixation due to quantity/quality of bone and the portion of the implant distal to the bone defect with cortical wall contact is short resulting in an implant stress riser, and extended implant stress due to nonunion, possibly attributable to the patient's metastatic cancer and radiation treatment which limited the ability of the fracture to heal.The patient had metastatic lung cancer with an impending pathologic mid shaft right humeral fracture, which was treated with radiation therapy and reduced the healing capacity of the humerus.The patient had an impending fracture on august 6, 2018, which became an actual fracture on or before (b)(6) 2018 and increased in angulation on november (b)(6) 2018 until the implant failed on (b)(6) 2019.The most likely cause of the implant failure was due to extended implant stress because of the nonunion of the humerus due to metastatic cancer and radiation treatment which limited the ability of the fracture to heal.Instructions for use were reviewed and found to contain the risk "as with any im fixation system or rod the following can occur: loosening, bending, cracking, fracture or mechanical failure of the components or loss of or inadequate fixation in bone attributable to delayed union, nonunion, insufficient quantity or quality of bone, markedly unstable comminuted fractures, or insufficient initial fixation." conclusion: the most likely cause of the implant failure (loss of stabilization, and bent implant) is due to extended implant stress due to nonunion, possibly attributable to the patient's metastatic cancer and radiation treatment which limited the ability of the fracture to heal.

• 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: 15567691
• MDR Text Key: 301476568
• Report Number: 3006845464-2022-00008
• 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: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: SL-1700260
• Device Lot Number: 380423
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/08/2022
• Initial Date FDA Received: 10/07/2022
• 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 Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 64 KG