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

Model Number USSL-2213260

Device Problem Gel Leak (1267)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/14/2022

Event Type  malfunction  

Event Description

This mdr report is based on the reclassification of a previously reviewed complaint.In a case to treat a traumatic humerus fracture for a 90 year old female, an illuminoss implant [size 22/13x260] was inserted, and during the monomer infusion process the syringe lost pressure.The implant was removed and had a visible tear in the balloon.The medullary canal was washed out and a second implant of the same size was inserted and implanted with no issues.There was no significant surgical delay due to the implant leaking and being replaced.The patient outcome was good.

Manufacturer Narrative

This mdr report is based on the reclassification of a previously reviewed complaint.Product evaluation: images of the device in question were provided to the firm of the balloon after its removed from the patient.The images show a large tear in the balloon starting at the proximal end of the balloon at the start of the spiral ink marking and extending down the balloon length for between 2-3 inches.The nature of the tear is consistent with a balloon being punctured by something sharp.The product itself was not returned for further device evaluation.Dhr review: the manufacturing records for the device were reviewed, and found the device was in specification at the time of manufacture and release.Followup information provided by the user: the implant was able to maintain a vacuum during the device preparation, which demonstrates the implant did not have a leak in the balloon prior to implantation into the medullary canal.The patient did not have any hardware in the anatomy being treated, and it was reported that the implant did not come into contact with any sharp instruments during prep or insertion.The user felt normal pressure during the balloon infusion process, until a specific moment in that process when a loss of syringe pressure was felt.The procedure was smooth until that point, with no observed deviations from the instructions for use.There may have been sharp bone at the fracture site that came into contact with the balloon.No x-rays were provided to the manufacturer to support this investigation.Conclusion existing evidence supports that the product did not have a tear prior to balloon insertion and infusion.The most likely cause of the observed balloon tear and leak in this case was due to the implant contacting a sharp bone fragment during infusion, although this cannot be definitely proven with the evidence available to the firm at this time.

• 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: 16811880
• MDR Text Key: 314273188
• Report Number: 3006845464-2023-00012
• Device Sequence Number: 1
• Product Code: QAD
• UDI-Device Identifier: M986USSL22132600
• UDI-Public: M986USSL22132600
• 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: 04/25/2023

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 Expiration Date: 05/31/2024
• Device Model Number: USSL-2213260
• Device Catalogue Number: USSL-2213260
• Device Lot Number: 410173
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/14/2022
• Initial Date FDA Received: 04/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2021
• 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: 90 YR
• Patient Sex: Female