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

Catalog Number USML-09120

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bacterial Infection (1735)

Event Date 02/18/2023

Event Type  Injury  

Manufacturer Narrative

Returned product evaluation: no device was returned for evaluation as it remains implanted.Dhr review: a review of manufacturing records found that the devices were in specification at the time of manufacture and release.X-rays: radiographs of the treated anatomy were requested and received from the user.Followup information provided by the user additional information was provided by the user about the patient's medical history.The user clarified the patient had a total hip arthroplasty in 2022, and due to the traumatic fall in (b)(6) 2023, the hip implant was removed.The user stated to the best of their knowledge this patient does not have a history of prior infection, and prior to the traumatic fall and resulting fractures in (b)(6) 2023, the patient has had no previous fractures in the pelvis.The surgery to remove the hip arthroplasty was performed 1-2 days prior to the surgery to stabilize the fractures in which the illuminoss implant was used.The user stated he did not believe that this adverse event was related to the illuminoss device.He believed it was secondary to the concomitant implants that the patient had placed at the hip and the patient's overall health at the time the implant was placed.Medical oversight review.Illuminoss performed an internal medical oversight review of this case, information received from the doctor, and the radiographs provided.The patient's pre-existing medical conditions were also reviewed (including asthma, bradycardia, hyperlipidemia, edema, gastroesophageal reflux disease, hypertension, and prostate cancer).Medical oversight observed that given the patient's age (84 years), comorbidities, and extent of surgery required, he was more likely to develop a post-op infection.This patient having two surgeries in such a short amount of time (the hip arthroplasty implants were removed, and 1-2 days later the fracture stabilization procedure with the illuminoss was performed) increases the risk of infection to the patient.Medical oversight concluded that the illuminoss device performed as intended in this case, to provide fracture stabilization and support the acetabulum, and agreed with the treating physician's assessment that the post operative infection was most likely due to the multiple surgeries in succession, extent of the surgeries, and/or patient comorbidities.Review of ifu: the device labeling includes the risk of infection.900356_w states "risks: as with any im fixation system or rod the following can occur: infection, including wound complications." conclusion: the cause of the infection was not able to determined.The illuminoss device performed as intended in this case, to provide fracture stabilization and support the acetabulum.Both the treating physician as well as internal medical oversight concluded that the post operative infection was most likely due to the multiple surgeries in succession, extent of the surgeries, and/or patient comorbidities.

Event Description

An adverse event was entered into the illuminoss clinical study registry on (b)(6) 2023 for an event which occurred on (b)(6) 2023.An 84 year-old male patient had a total hip arthroplasty performed in 2022 and sustained a pelvis fracture due to a traumatic fall on (b)(6) 2023.Due to the injury in (b)(6) 2023, the hip implant was removed 1-2 days before the implantation of the illuminoss device to address the fractures.This patient underwent a pelvic reconstruction on (b)(6) 2023 in which 2 fractures were treated with illuminoss implants along with 1 plate with 6 screws, and 1 additional screw.Following the pelvic reconstruction, the patient developed an infection.The patient underwent 3 irrigation and debridement treatments in addition to antibiotics.The patient was discharged from the hospital on (b)(6) 2023 after his leukocytosis, and fever resolved.The patient will remain on lifetime suppressive antibiotics and the implants remain in place.The patient is no longer experiencing infection or pain, but now does have left leg edema.The treating physician does not believe this adverse event was related to the illuminoss device.He believes that the infection at the surgical site was secondary to the concomitant implants that patient had placed at the hip and the patient's overall physical health at the time the implant was placed.

• 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: 17415529
• MDR Text Key: 319962424
• Report Number: 3006845464-2023-00038
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/28/2023

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: 02/28/2024
• Device Catalogue Number: USML-09120
• Device Lot Number: 400978
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/28/2023
• Initial Date FDA Received: 07/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2020
• 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): Required Intervention
• Patient Age: 84 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White