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

Catalog Number USSL-0900220

Device Problem No Apparent Adverse Event (3189)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/30/2018

Event Type  malfunction  

Event Description

Case involved a 20 y/o female with a left radus fracture due to a suspected pathology of fibrous dysplasia.Physician gained access to the intramedullary canal using technique described in product labeling which included insertion of a guidewire, sheath and dilator.The balloon implant was then prepped and the dilator and wire removed leaving the sheath in place.The balloon implant was a few mm long but decided ot go forth with the procedure.The balloon implant was inserted and inflated with the monomer.The rep reported that he observed the fluorography screen which demonstrated excellent inflation pattern.The resident attending the case stated that the balloon had reached a point where no more monomer was required.During the curing process it was noticed that the sheath had not been removed as per the device's instructions for use.This was noticed by the rep who informed the physician that removal of the sheath prior to inflation was required.Given the internal pressure of the inflated and cured implant it was difficult to remove the tear away sheath as part was contained between the balloon and the medullary canal.Only approximately 2/3 was removed leaving 1/3 in the patient pinned between the balloon and bone.The physician made no attempt to remove the piece of sheath remaining.The surgeon acknowledged the mistake and after the physician met with the family the rep spoke with the physician who reported that while not ideal, he did not appear overly concerned about the sheath and was hopeful to get rotational stability given the additional layer of material between the implant and bone.To be conservative, the physician decided to cast the patient and will be following-up the patient.The instructions for use clearly state to remove the tear away sheath from the canal, leaving the balloon in place, before filling the balloon with monomer.Follow-up report information: 1) physician stated that at two-week followup patient "was doing fine".2) sales rep.Discussed the procedure again with the physician and incident at length following the case.

Manufacturer Narrative

This report is being re-submitted retrospectively per fda request.From 10 oct 2018: instructions and surgical technique guide state to remove tear-away sheath prior to balloon inflation and curing of monomer.Physician did not follow the instructions for use or training on device which resulted in fragment of sheath remaining trapped between cured implant and bone.User error with no death or serious injury resulting.Please note this report was resubmitted on 10oct2018 based upon correspondence with emdr staff.Emdr was not able to be loaded as section d11 of form was greater than 50 characters in length.Emdr staff requested we truncate d11 and resubmit and add explanatory note in h10.

• 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: 7952916
• MDR Text Key: 317477308
• Report Number: 3006845464-2018-00001
• Device Sequence Number: 1
• Product Code: QAD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: DEN160062
• 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: 05/30/2023

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: 06/30/2019
• Device Catalogue Number: USSL-0900220
• Device Lot Number: 380176
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/30/2018
• Initial Date FDA Received: 10/10/2018
• Supplement Dates Manufacturer Received: 05/30/2018
• Supplement Dates FDA Received: 10/10/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2018
• 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
• Treatment: THE ILLUMINOSS SYSTEM INCLUDED ALL ACCESSORIES
• Patient Outcome(s): Other
• Patient Age: 20 YR
• Patient Sex: Female