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

Model Number USSL-2213160

Device Problem Fracture (1260)

Patient Problem Bone Fracture(s) (1870)

Event Date 04/17/2023

Event Type  Injury  

Manufacturer Narrative

Information provided by the user: additional information was collected from the distributor present at the case.The distributor stated that the patient had a humerus fracture 10 years ago which was treated with a plate in mexico.Then the patient fell and experienced the proximal humerus periprosthetic fracture.This fracture was treated with the illuminoss implant 2 months after the fracture was sustained, and 2 weeks post op the implant broke.The distributor also provided additional x-rays of the implant post break, showing the implant broke at the fracture site at the edge of the plate.The doctor reported that as the patient is very sick, and is still experiencing pain reduction post-illuminoss implantation despite the implant break, no further intervention is planned.Returned product evaluation no returned product evaluation was possible as the device remains in the patient.Dhr review: a review of the manufacturing records found that the device was in specification at the time of manufacture and release.Illuminoss medical oversight review: illuminoss performed a medical oversight review of this case, followup information received from the doctor, and radiographs provided.It was observed that the portion of the implant at the fracture site at the edge of the plate was very narrow and thin.When this patient fell and suffered the initial periprosthetic fracture, the plate acted as a stress riser resulting in the bone fracturing at the very edge of the plate.The plate then functioned in the same way as a stress riser with the narrowest part of the illuminoss implant at the edge of the plate.The combination of the forces on the illuminoss implant at the fracture site (the plate acting as a stress riser, the narrow implant, and the lack of support from bone at this location due to the fracture) contributed to implant breaking at this location.These forces created a significant lever on the implant at the fracture location, which resulted in the implant breaking here.The proximal fracture is oblique, and the user tried to impact that on the distal humerus shaft, which did not leave a lot of contact area for bone healing to occur in this area.The reduction is also off set, which is what caused the implant to be so narrow in the bone canal at the fracture site, because the diameter of the intermedullary canal in which the implant can fill is reduced when the reduction is off set.Narrowness of the implant at the fracture site due to offset in conjunction with the continued presence of the proximal end of the plate as a stress riser at the fracture site would contribute to device failure.2 months' time had elapsed between when the periprosthetic fracture was sustained and when the patient received treatment with the illuminoss.Medical oversight observed that the ideal time to treat a fracture is between 0-14 days post break, in order for bone healing to occur, as there is the potential for excess fibrous tissue to form over more time, and when the fracture is reduced, the fibrous tissue may get in the way and prevent healing.In this case 2 months passed between the fracture and the treatment occurring, and fibrous tissue may have formed and been in the way of the fracture reduction, reducing the ability of the fracture to heal and contributing to the stress upon the implant.Illuminoss medical oversight concluded the failure of the implant was likely caused by the offset reduction which led to a narrow portion of the illuminoss implant at the fracture site and the edge of the plate.This initial fixation resulted in a point of maximum stress at the implant's narrowest point.Additionally, the time elapsed between the break and the illuminoss implantation procedure reduced the changes of the fracture healing, which contributed to the stress on the implant.These combined stress factors caused the implant to break.Review of ifu: the instructions for use 900356_w includes the risk that "as with any im fixation system or rod the following can occur: loosening, bending, cracking, fracture, or mechanical failure of the component or loss of or inadequate fixation in bone attributable to delayed union, non union, insufficient quality or quality of bone, markedly unstable comminuted fractures, or insufficient initial fixation." conclusion the implant break was most likely caused by the insufficient initial fixation, due to the offset fracture reduction causing a narrow portion of the implant at the location of maximum stress due to it being at the edge of the plate, potentially contributed to by additional stress on the implant caused by reduced healing of the fracture.

Event Description

A very sick patient fell and experienced a periprosthetic proximal humerus fracture.The patient had experienced a fracture of the same humerus 10 years previously which had been treated with a plate.2 months after the periprosthetic fracture, the patient was treated with an illuminoss implant [size 22/13x160mm].Two weeks post implantation, the illuminoss implant broke through the fracture site at the edge of the humerus plate.

• 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: 16997022
• MDR Text Key: 315911300
• Report Number: 3006845464-2023-00033
• Device Sequence Number: 1
• Product Code: QAD
• UDI-Device Identifier: M986USSL22131600
• UDI-Public: M986USSL22131600
• 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: 05/24/2023

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: USSL-2213160
• Device Catalogue Number: USSL-2213160
• Device Lot Number: 390621
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/24/2023
• Initial Date FDA Received: 05/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2019
• 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 Outcome(s): Other
• Patient Age: 79 YR
• Patient Sex: Female