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

Catalog Number MS-05040

Device Problem Gel Leak (1267)

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

Event Date 10/30/2018

Event Type  malfunction  

Manufacturer Narrative

This mdr report is based on the reclassification of a previously reviewed complaint.Returned product evaluation: evaluation of the device was not possible as it was not returned to illuminoss.Photographs of the device were made available to the firm, however they were inconclusive in terms of identifying the location or cause of the damage.Dhr review: the manufacturing records for the device were reviewed, and found that the device met specification at the time of manufacture and release.Followup information from the user: the user was performing a closed reduction of a fracture of the fifth metacarpal bone (left hand) on a 40 year-old male, using an illuminoss implant (ms-05040).The user reported that after the balloon was in place, they began injecting monomer.The user reported that the balloon ruptured proximally, and noted that monomer started exiting the balloon.The user stated that the implant may have been damaged during the preparation process while trying to remove residual air from inside the balloon.The user further reported that there was no harm to the patient.The firm concluded by confirming the user's assessment, that this device problem could have been caused by user handling which damaged the device during preparation, however that there was insufficient information to definitively identify root cause in this case.

Event Description

This mdr report is based on the reclassification of a previously reviewed complaint.On (b)(6) 2018 in a clinic in (b)(6), during a closed reduction of a fracture of the fifth metacarpal bone (left hand), an illuminoss implant (ms-05040) leaked during the procedure.It was reported by the user that after the balloon was in place, they began injecting monomer and noted that the balloon had proximal damage and monomer started exiting the balloon.The user stated that the implant may have been damaged during the preparation process while trying to remove residual air from inside the balloon.There was no harm was to the patient.

• 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: 16811643
• MDR Text Key: 314054673
• Report Number: 3006845464-2023-00009
• Device Sequence Number: 1
• Product Code: QAD
• Combination Product (y/n): N
• Reporter Country Code: WZ
• 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: 01/31/2022
• Device Catalogue Number: MS-05040
• Device Lot Number: 380868
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/11/2018
• Initial Date FDA Received: 04/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2018
• 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
• Patient Age: 40 YR
• Patient Sex: Male
• Patient Weight: 83 KG