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

Model Number USSL-1700260

Device Problem Gel Leak (1267)

Patient Problem Fluid Discharge (2686)

Event Date 11/15/2022

Event Type  Injury  

Event Description

On (b)(6) 2022 a 69 year old female patient was being treated for a left pathologic humerus fracture.This patient has a long history of myeloma, and her status was post bone marrow transplant.She is currently in palliative care only, on hospice.A 17x260mm illuminoss implant was inserted and infused with monomer.After the implant was inflated, the user wanted to perform a minor re-reduction, so he aspirated some of the liquid monomer out, performed the minor re-reduction of the fracture using the c-arm imaging, and attempted to re-inflate the implant.The user noticed a tear in the implant and monomer leaked out of the balloon.The user removed the torn implant and performed rigorous irrigation and flushing of the canal with 2l normal saline and canal irrigator with suction.The user then inserted a new implant and successfully infused and cured it.About 2 weeks post operatively the patient was draining liquid from her elbow and had multifocal collections in upper arm at area of fracture.Cultures were taken of the fluid, and all were negative.The patient received dedicated wound care and packing to the area of drainage for 2 weeks, and her elbow wound healed.The patient did not require incision and drainage or return to the or.

Manufacturer Narrative

At the time of this initial mdr report, the investigation into the cause of the balloon leak, and into the potential for the device to have caused or contributed to the patient adverse event of wound drainage, is still ongoing.No evaluation of the device was possible as it was not able to be returned to illuminoss.A review of the manufacturing records for the device in question was performed and found that the device was in specification at the time of manufacture and release.A review of complaints found no other complaints for this lot number.A review of the manufacturer's instructions for use ifu 900356_w found that the ifu explains the risks specific to a photodynamic curing system can include "balloon leakage".The ifu also explains the risks for any im fixation system or rod can include "wound complications".Followup information from the user the firm has conducted follow-up interviews with the treating physician, and collected additional information about the initial implantation procedure, his observations about the patient condition at the time of the 2 week followup, and at the 4 week followup.The initial complaint report noted that this patient has a long history of myeloma, status post bone marrow transplant, and is currently in palliative care only, on hospice.Regarding the balloon leak, the user confirmed that the implant was able to be successfully infused with monomer initially, and that it was after the attempted re-reduction of the fracture that a tear in the balloon was observed.Regarding the patient presenting with draining liquid at the elbow 2 weeks post operatively, the user did not know if it was from the tumor or if it were perhaps monomer.Cultures were taken of the fluid, and all were negative.The user confirmed that during the implantation procedure when the balloon tore he performed rigorous irrigation and flushing of the canal with 2l normal saline and canal irrigator with suction.The user reported on (b)(6) 2022 that the patient's wound had healed.On (b)(6) 2023, the firm conducted an initial internal medical oversight review of the information provided from the user to support the investigation into the cause of the event.Follow-up requests were identified in this review, and the firm has reached back out to the user for some additional information at the time of this mdr report.A follow up mdr will be submitted when further information is known about this case.

Manufacturer Narrative

The firm's awareness date was incorrectly submitting on the medwatch report 3006845464-2023-00001 submitted 07jan2023.The firm's corrected awareness date for this event is 09 december 2022.

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 code.- investigation conclusion codes.- and this manufacturer's narrative with the firm's root cause conclusions.· no evaluation of the device was possible as it was not able to be returned to illuminoss · a review of the manufacturing records for the device in question was performed and found that the device was in specification at the time of manufacture and release.· a review of complaints found no other complaints for this lot number.· a review of the manufacturer's instructions for use ifu 900356_w explains the risks specific to a photodynamic curing system can include "balloon leakage".The ifu also explains the risks for any im fixation system or rod of "adverse tissue reaction" and "wound complications".The firm's investigation gathered followup information from the user about the initial implantation procedure, his observations about the patient condition at the time of the 2 week followup, and at the 4 week followup, and performed medical oversight review of the case to supplement the investigation.The initial complaint report noted that this patient has a long history of myeloma, status post bone marrow transplant, and is currently in palliative care only, on hospice.·regarding the balloon leak, the user confirmed that the implant was able to be successfully infused with monomer when first placed, and that it was after the attempted re-reduction of the fracture that a tear in the balloon ocurred.A 17x260mm illuminoss implant was inserted and infused with monomer.The user wanted to perform a minor re-reduction so he aspirated some of the liquid monomer out, performed the minor re-reduction using c-arm imaging, and attempted to re-inflate the implant.The user noticed a tear in the implant and monomer leaked out of the balloon.The distributor reported that a spike in the bone made a small hole in the implant and tore the balloon.The torn implant was removed and rigorous irrigation, flushing and suction of the canal was performed with 2l normal saline and canal irrigator with suction.The user then inserted a new implant and successfully infused and cured it.The cause of the implant leak is most likely due to balloon damage by a sharp bone fragment during the re-reduction.The initial monomer infusion of the balloon was achieved, indicating there was no tear in the balloon at that point in the procedure.The distributor reported that the balloon was torn by a bone spike that contacted the balloon during the fracture re-reduction, that was identified when monomer was re-infused into the balloon after the re-reduction was performed.·regarding the patient presenting with draining liquid at the elbow 2 weeks post operatively, the user's initial complaint report stated that the user did not know if it was from the tumor, or if it were perhaps a result of the liquid monomer from the initial implant leak.In response to the firm's follow-up requests, the user provided additional information.About 2 weeks post operatively the patient was draining liquid from her elbow and had multifocal collections in upper arm at area of fracture.The drainage was from distal to the elbow on the volar surface.The user reported that mri imaging showed fluid collections around fracture, and these were communicating with this distal site of drainage.The patient received dedicated wound care and packing to the area of drainage for 2 weeks, and her elbow wound healed in this time period.The user believes that whatever needed to express itself in her elbow did via high volume drainage at the elbow.The patient did not require incision and drainage or return to the or.The firm's medical oversight observed that the fluid drainage could be residual from the flushing and irrigation as 2l of normal saline was used.The user's actions to perform rigorous irrigation, flushing and suction of the canal with normal saline and canal irrigator with suction were the manufacturer's recommended instructions to remove any remaining liquid monomer, making it unlikely that the elbow wound was draining monomer.Medical oversight requested additional information from the user about if an evaluation of the drainage liquid was performed.The user reported back that cultures of the liquid were taken and were all negative.Additionally, the user reported that the wound had healed after dedicated wound care for 2 weeks.Medical oversight concluded that it was not an infection based on this information.The user reported that no further evaluation, such as histology, of the drainage liquid was performed.·the risk of adverse tissue reaction is captured in instructions for use, 900356_w as a risk that can occur as with any im fixation device.Skin sensitization in humans is characterized by pruritis (itchy skin), erythema (superficial reddening of the skin), and oedema (fluid retention).In this case, following the procedure the patient presented with drainage from the elbow and multifocal collections in the upper arm at the area of the fracture.One of the potential causes may be skin sensitization characterized by fluid retention.· skin sensitization is a t-cell mediated delayed-type hypersensitivity reaction induced by low molecular weight reactive chemicals (allergens) comprising two phases, induction and elicitation (ref: 1: iso 10993-1:2021).The sensitization tests on the implant portion of the illuminoss device in illuminoss biological safety testing report found the product to be non-sensitizing per iso 10993-10.Regarding the role that temporary contact with the liquid monomer that leaked through the tear in the first balloon might play, this report describes the potential risk of skin sensitization by the liquid monomer due to an ingredient in the monomer, 2-hydroxyethyle methacrylate.This was determined to be a weak skin sensitizer in the guinea pig maximization test, and based on ambiguous human patch test results, has sensitizing properties and potential cross-reactivity with other acrylates.In this report the margin of safety for 2-hydroxyethyle methacrylate was calculated and supports the conclusion that the risk of induced toxicity from this ingredient in the illuminoss photodynamic bone stabilization system is very small.However small, this risk is captured in the manufacturer's instructions for use 900356_w, that "the monomer in liquid form may cause sensitization by skin contact.In case of contact with skin, wash immediately with soap and water".There are also instructions for removing liquid monomer if a balloon leak occurs in surgical technique guide, which the user followed.· in this situation, liquid monomer leaked when the balloon tear occurred after re-reduction was performed.The treating physician followed the manufacturer's instructions and performed rigorous irrigation, flushing and suction of the canal with normal saline and canal irrigator with suction after the implant tear and removal, and before placing the 2nd implant.This reduces the likelihood that the presence of leaked monomer at the implantation site contributed to the skin sensitization reaction, however it does not eliminate it.As the treating physician was unable to determine the cause of the oedema, we cannot rule out a patient allergic reaction or a sensitization reaction to contact with the liquid monomer that was leaked when the first implant tore.Based on the information provided by the user, the firm's medical oversight review, and the firm's review of product validation testing, the firm concluded that the cause of the oedema and drainage from the patient's elbow could not be determined, and may have been attributed to 1) drainage from the tumor, 2) tissue reaction from contact with the liquid monomer, 3) tissue reaction from contact with other device material used at the time of the procedure, or 4) residual drainage from the rigorous flushing of the patient's canal to wash the liquid monomer out after the first implant tear after fracture re-reduction.Conclusion the cause of the implant leak is most likely due to balloon damage by a sharp bone fragment during the user's re-reduction of the fracture after successful initial monomer infusion.The cause of the drainage from the patient's elbow (and multifocal collections in upper arm at area of fracture) was undetermined, and could be attributed to 1) drainage from the tumor, 2) tissue reaction from contact with the liquid monomer, 3) tissue reaction from contact with other device material used at the time of the procedure, or 4) residual drainage from the rigorous flushing of the patient's canal to wash the liquid monomer out after the first implant tear after fracture re-reduction.

• 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: 16119298
• MDR Text Key: 306878942
• Report Number: 3006845464-2023-00001
• Device Sequence Number: 1
• Product Code: QAD
• UDI-Device Identifier: M986USSL17002600
• UDI-Public: M986USSL17002600
• 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,Followup,Followup
• Report Date: 02/14/2023

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 Model Number: USSL-1700260
• Device Catalogue Number: USSL-1700260
• Device Lot Number: 421128
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/14/2022
• Initial Date FDA Received: 01/08/2023
• Supplement Dates Manufacturer Received: 12/09/2022; 12/09/2022
• Supplement Dates FDA Received: 01/13/2023; 02/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2022
• 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 Outcome(s): Other
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White