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

Catalog Number SL-2213240

Device Problems Fracture (1260); Material Twisted/Bent (2981)

Patient Problem Implant Pain (4561)

Event Date 09/26/2023

Event Type  Injury  

Manufacturer Narrative

At the time of this initial mdr report, the investigation into the cause of the event is still ongoing.Returned product evaluation: device evaluation in this case is not possible as it is believed that the device remains implanted.Dhr review: a review of the manufacturing records for this device found that the device met specifications at the time of manufacture and release.Review of ifu:.A review of the device labeling and indications for use found that the device was used to treat an anatomy (humerus) that is within its intended indications.Ifu 900365 rev.W was reviewed.The risk of possible implant fracture is included in the labeling.X-rays: the firm requested and received x-rays and ct scans from the user, and hosted an internal medical oversight review of the case information known, as well as these medical records, which will provide analysis for the firm's root cause investigation.Follow up with user the firm requested additional followup information from the user, about the patient's current condition, the user's conclusions about the condition of the illuminoss implant as it presented after the patient's 3 month followup, the user's conclusions about the cause of the implant bend or break, and the user's report of what actions were taken to treat the patient after the 3 month patient followup in which he reported pain.A follow-up mdr will be submitted when further information is known about this case.

Event Description

On (b)(6) 2023, doctors treated a patient's humerus shaft with an illuminoss implant at a hospital in germany.The procedure was reported to have gone smoothly.The day after the procedure, the user reported that the patient was doing very well.This patient came to the outpatient clinic after 3 months and complained of pain.At the time of this patient visit, the illuminoss implant was suspected to be broken or bent.At the time of the manufacturer submitting this initial medwatch report, the firm is awaiting followup information from the user about the user's final assessment of the condition of the illuminoss implant, what treatments were provided to the patient in response to the patient condition observed in the 3 month follow up visit described above, and the patient's current condition.

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 - a correction to the device lot number included in the initial mdr - an update to the health effect impact code - investigation findings codes - investigation conclusion codes - manufacturer's narrative with the firm's root cause conclusions.Returned product evaluation: device evaluation in this case is not possible as the user confirmed that the device remains implanted.The user reported that no further surgical treatment was provided or planned for the patient.The patient was provided with an upper arm brace as conservative therapy.Dhr review: a review of the manufacturing records for this device found that the device met specifications at the time of manufacture and release.X-rays: the firm requested and received x-rays and ct scans from the user.Follow up with user the firm requested additional followup information from the user, about the patient's condition, the user's conclusions about the condition of the illuminoss implant as it presented after the patient's 3 month followup, the user's conclusions about the cause of the implant bend or break, and the user's report of what actions were taken to treat the patient after the 3 month patient followup in which he reported pain the user provided infromation about the procedure, x-rays and ct scans, and reported that no further surgical treatment was provided or planned for the patient.The patient was provided with an upper arm brace as conservative therapy.Medical oversight review the firm and hosted an internal medical oversight review of the case information known, as well as the medical records received from the user.Based on review of the x-rays, ct scans, and other records provided, the medical oversight review determined: ·in the follow up x-rays, the implant appears bent, and it cannot be confirmed if the implant is broken or just bent.·there is a large segmental defect within this treated bone prior to implant placement, which was also the location of the implant bend.·the last spiral on the implant is smaller than the diameter of the canal, showing a lack of cortical wall contact in this area, which reduces the stable contact between the implant and the cortical wall.·in the post-op x-rays, the residual tumor can still be seen within the canal.Medical oversight requested followup to the user to identify if the canal had been reamed, and the user confirmed that it had been.·in the area of the lesion, the illuminoss implant is constricted, and the diameter of the implant is significantly less than 13mm (appears to be about 6-7mm in diameter).There was less space in the intermedullary canal for the implant to occupy due to lesion in this area.This is the area where the implant bent.Based on this evaluation of the evidence reviewed, the firm concluded that the implant bend/break was due to the device being used as a stand-alone implant to treat a bone with a large segmental defect, in addition to being used as a stand-alone implant to treat a humerus where the implant was significantly less than 13mm at the fracture site.The firm performed a review of the device labeling and instructions.·surgical technique guide for humerus instructs the user that if in the surgeon's judgment, large areas of bone are severely comminuted or missing (i.E., segmental defects) and stable contact between the cortical wall and the implant is not guaranteed, to consider the use of additional materials to achieve fracture stabilization.·surgical technique guide for humerus instructs the user that the canal must have a minimum diameter of 13mm to support the implant when used as a stand alone implant in the humerus.In cases which an implant diameter of at least 13mm at the fracture site cannot be reached, plates should be used in conjunction with the implant.·a review of the ifu found that the risk is included in the device labeling."risks, for all bones, as with any im fixation system or rod the following can occur: loosening, bending, cracking or fracture, or mechanical failure of the components or loss of or inadequate fixation in bone attributed to delayed union, nonunion, insufficient quantity or quality of bone or markedly unstable comminuted fractures, or insufficient initial fixation, loss of anatomic position with nonunion or malunion with rotation or angulation." conclusion: the implant failure was a result of use error causes, including: an implant diameter of less than 13mm used in the humerus without a plate, and treated a bone with a large segmental defect without additional supplemental fixation.

• Brand Name: PHOTODYNAMIC BONE STABILIZATION SYSTEM
• Type of Device: IN VIVO INTRAMEDULLARY FIXATION ROD
• Manufacturer (Section D): ILLUMINOSS MEDICAL, INC; 992 waterman ave; east providence RI 02914
• Manufacturer (Section G): ILLUMINOSS MEDICAL, INC; 993 waterman ave; east providencer RI 02914
• Manufacturer Contact: robert rabiner ; 993 waterman ave; east providence, RI 02914 ; 4017140008
• MDR Report Key: 18016904
• MDR Text Key: 326673982
• Report Number: 3006845464-2023-00044
• Device Sequence Number: 1
• Product Code: QAD
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 11/13/2023

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 Catalogue Number: SL-2213240
• Device Lot Number: 430193
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/26/2023
• Supplement Dates Manufacturer Received: 09/26/2023
• Supplement Dates FDA Received: 11/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2023
• 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: 70 YR
• Patient Sex: Male
• Patient Weight: 60 KG