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

Model Number USSL-1500260

Device Problem Lack of Effect (4065)

Patient Problem Non-union Bone Fracture (2369)

Event Date 11/21/2021

Event Type  malfunction  

Manufacturer Narrative

The manufacturer is in process of investigating this event, and will submit a followup report with investigation findings and conclusions, and any updated information.

Event Description

An adverse event was entered into the illuminoss clinical study registry on october 25, 2022 for an event which occurred on (b)(6) 2021.On (b)(6) 2021, an illuminoss implant (size 15mmx260mm) and also 4 screws were used to treat a patient with a metastatic fracture of the left humerus in a 63 year-old male patient.Significant bone loss was noted by the treating physician at the time of final reduction and implantation.The adverse event "loosening, bending, cracking, fracture or mechanical failure of components " was observed by the treating physician at a follow up visit on (b)(6) 2021.The user noted a large amount of callous formation.At that time the user also noted that the screws were stable, and that the fracture had no instability.The treating physician determined that no further treatment was necessary, and none was performed.Although the investigation is still ongoing into the cause of reported event, the "loosening, bending, cracking, fracture, or mechanical failure" reported by the registry participant may be the result of 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.The firm reviewed the manufacturing records for this device, and found that it was in specification at the time of manufacture and release.No evaluation of the device was possible as it remained within the patient.Information provided by the user: as an adverse event was entered into the illuminoss clinical study registry on october 25, 2022 for an event which occurred on november 19, 2021, information about the patient's pre-existing medical conditions as well as x-rays from before and after implantation, and also from follow up visits, was made available to the firm for this investigation.The treating physician noted that at the time of documenting the event of "loosening, bending, cracking or fracture of implant" at the 5 week follow-up on (b)(6) 2021, that the patient's fracture had no instability, and the screws were stable.The user also noted a large amount of callous formation observed at that time.The user determined that no further treatment was necessary, and none was performed.The treating institution further communicated that this patient was scheduled for a further 3 week follow up, but died of cancer before that appointment on (b)(6) 2021.This cause of death (cancer) was determined and documented by the treating institution, as not device or procedure related.The event of reported implant "loosening, bending, cracking, or fracture" was further investigated by the firm.A review of the instructions for use 900356_w identifies that the risks include "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 fracture, or insufficient initial fixation." internal medical oversight review: additional internal evaluation of the information about the case, medical records, and x-rays was performed with medical oversight, to supplement the complaint investigation.Illuminoss clinical and medical affairs met with independent medical oversight and made the following observations: in the preop and immediate post-op x-rays there is observable poor bone quality.Insufficient bone quality could compromise the implant's ability to provide the stability to the healing fracture.The initial reduction observed in the immediate post-op x-rays from on (b)(6) 2021 was not complete, and there is a slight bend in the implant at the onset.This is the shape that the implant was placed and cured in by the treating physician.This slight bend in the implant is again visible in the 5 week follow up x-rays, just in a different plane (the x-ray is from a different angle).The fracture reduction appears to be the same in the 5 week post op x-rays on (b)(6) 2022 as in the post op x-rays from on (b)(6) 2021.· there is bone callous observed in the x-rays from on (b)(6) 2021, indicating that there is some motion, and that healing is occurring.· be reviewing the x-rays from on (b)(6) 2022, the medical oversight team conclude that the implant is intact.It is neither broken nor in a different shape than it was upon initial implantation.· no device problem can be identified: it may have appeared to the user that the implant was bent in the 5 week follow up x-rays, however the fracture reduction angle at the 5 week follow up is the same as was present immediately post-up as seen in the initial x-rays.When viewed in a different plane, this may have led the user to conclude that there was a change in the shape of the implant, when there is not one.Conclusion: based on the follow up information from the user that the fracture had no instability and the screws were stable, that no further treatment was necessary and none was performed, combined with the internal medical oversight analysis that the fracture reduction and implant shape was the same in the immediate post op to the 5 week follow up, the firm concludes that there is no problem detected, either in the material integrity of the implant or in its efficacy in this case to support fracture stability to allow healing.

• 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: 15845382
• MDR Text Key: 307780655
• Report Number: 3006845464-2022-00017
• Device Sequence Number: 1
• Product Code: QAD
• UDI-Device Identifier: M986USSL15002600
• UDI-Public: M986USSL15002600
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/12/2022

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 Model Number: USSL-1500260
• Device Catalogue Number: USSL-1500260
• Device Lot Number: 400284
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/25/2022
• Initial Date FDA Received: 11/22/2022
• Supplement Dates Manufacturer Received: 10/25/2022
• Supplement Dates FDA Received: 12/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2020
• 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 Age: 63 YR
• Patient Sex: Male
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White