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

Model Number USSL-2213240

Device Problem Fracture (1260)

Patient Problem Bone Fracture(s) (1870)

Event Date 11/22/2022

Event Type  malfunction  

Manufacturer Narrative

At the time of this initial mdr report, the investigation into the cause of the event is still ongoing.Follow up with user: we have reached out to the user multiple times with followup questions, to supplement this investigation, including to determine what if any treatment was provided to this patient as a result of the adverse event reported.The firm will continue to follow up in order to learn this information.Returned product evaluation: device evaluation in this case is not possible as it is believed that the device remains implanted, although this information is still being verified by the manufacturer.Review of ifu: ifu 900365 rev.W was reviewed.The risk of possible implant break is invluded in the labeling, "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".X-rays: radiographs of the treated anatomy were requested and received from the user.Medical oversight review: additional review of the information about the case, product images, and x-rays was performed with internal medical oversight, to supplement the complaint investigation.Illuminoss clinical and medical affairs met with independent medical oversight and identified additional information to request from the user to support the investigation.Medical oversight is still investigating this incident, including contacting the user for additional followup requests.A follow-up mdr will be submitted when further information is known about this case.

Event Description

On (b)(6) 2022, a 77 year old male was treated for an impending pathologic fracture and lesions in the humerus with an illuminoss implant [size ussl-2213240].On (b)(6) 2022, the bone and implant fractured at the distal third.Although the investigation is still ongoing into the cause of the implant break, and whether or not the patient suffered a serious injury, this incident may qualify as a device malfunction, and therefore this initial mdr is being submitted.

Manufacturer Narrative

At the time of the initial mdr submission for this event, the investigation into the cause of this event was still underway.This followup mdr is submitted to submit new information, including - the investigation findings codes - investigation conclusion codes - and this manufacturer's narrative with the firm's root cause conclusions.Follow up with user the firm has reached out to the user multiple times with followup questions, to supplement this investigation, including to determine what if any treatment was provided to this patient as a result of the adverse event reported.The firm has not received any additional information in response to the requests for information about whether or not additional treatment was performed for this patient, and what the current patient condition is.The patient had a pending pathologic fracture lesion which was treated on october 21st with an illuminoss 22/13x240mm implant as a stand alone fixation method.The patient's bone had been irradiated prior to implantation.On november 22nd the implant fractured at the distal third at the distal pathologic lesion.Returned product evaluation: no returned product evaluation was possible.The firm has been unable to verify whether the device remains implanted, or whether any further revision surgery was performed, which may have involved implant removal.Dhr review a review of manufacturing records for the device was performed, and found that the device was in specification at the time of manufacture and release.Medical oversight review.Additional review of the information about the case, product images, and x-rays was performed with internal medical oversight, to supplement the complaint investigation.Illuminoss clinical and medical affairs met with independent medical oversight and was able to come to the following conclusions after review of the information available: · review of the x-rays provided indicates that the implant is broken.The implant's radiopaque market shows an interruption in the spiral marking, and there is a sharp angulation of the implant at the break point observed.· the bone had been irradiated, which can lessen the bone's ability to heal, and contribute to an implant fatigue fracture.· a hypertrophic fracture callus can be observed forming, most likely from motion, but also potentially because the bone was trying to heal, however it was not able to heal fast enough before the implant failed.· the distal canal of the humerus appears small, and the implant diameter at the portion of the canal where the lesion being treated was located appears to be less than 13mm in diameter.It appears to be approximately 9mm in diameter at that point.The small diameter of the implant in the distal canal creates a "lever" action in the humerus because the proximal canal is larger allowing for a greater diameter implant at that point.· no other fixation devices (e.G.Plates) were used in conjuction with the illuminoss implant to treat this injury review of ifu ifu 900365 rev.W was reviewed.The risk of possible implant break is included in the labeling, "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." the surgical technique guide for humerus, radius & ulna (900510_d) states "note: a minimum canal diameter of 13mm is required for the stand-alone use of the implant in load bearing indications.Utilize fda cleared plates in conjunction with the implant in those cases where the implant will not achieve 13mm in diameter in the area of the fracture." the distal portion of the humerus canal including the distal edge of the lesion is less than 13mm in diameter, resulting in an implant diameter of less than 13mm in diameter.Therefore, the use of the illuminoss as a standalone implant in this situation is not per the instructions for use, and this user error contributed to the device failure.Conclusion the distal humeral intermedullary canal diameter, including the distal edge of the lesion, is less than 13mm in diameter, which resulted in the illuminoss implant being less than 13mm in diameter in the distal portion of the humerus.The use of the illuminoss implant in this case (humeral canal smaller than 13mm at the fracture site) as a standalone implant is not per the manufacturer's instructions, and this unintended user error contributed to the implant break.

• 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: 16029039
• MDR Text Key: 308174887
• Report Number: 3006845464-2022-00025
• 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
• Type of Report: Initial,Followup
• Report Date: 01/20/2023

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 Model Number: USSL-2213240
• Device Catalogue Number: USSL-2213240
• Device Lot Number: 400877
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/22/2022
• Initial Date FDA Received: 12/21/2022
• Supplement Dates Manufacturer Received: 11/22/2022
• Supplement Dates FDA Received: 01/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2022
• 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: 77 YR
• Patient Sex: Male