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

Catalog Number USMS-07070

Device Problem Gas/Air Leak (2946)

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

Event Date 07/27/2021

Event Type  malfunction  

Event Description

This mdr report is based on the reclassification of a previously reviewed complaint.During treatment for a metastatic 75 year old female, a user was not able to establish negative pressure during the illuminoss implant balloon preparation [size 7x70mm].The implant was not used nor implanted.Another illuminoss implant was used to successfully complete the procedure.

Manufacturer Narrative

This mdr report is based on the reclassification of a previously reviewed complaint.The complaint product was not returned for device evaluation, and no radiographs or photographs were provided to aid in the investigation.Without the ability to perform product evaluation, the firm could not verify the failure mode or identify the location of the potential damage/defect.Dhr review: a review of the manufacturing records for the device in question was performed and found that the device met its final release specifications at time of manufacture and release.Followup information provided by the user: the plan for this procedure was to use multiple illuminoss implants.This device malfunction was identified after successfully prep and placement of 3 previous implants.For this 4th device, the or tech was unable to completely withdraw all of the air from the balloon prior to priming it with monomer.The user tried a second syringe, but was only able to remove about 90% of the air.During additional attempts, the user reported that even less air could be withdrawn.There was no harm to the patient nor significant delay.The balloon never made it to the operative site.The user reported that they left the implant in the packaging during their attempt to prime the balloon, with the device's white protective tube left in place.The user reported they did not think any sharp instruments touched the balloon during prep.The surgeon performing this case had not previously utilized illuminoss implants, but the distributor present in this case was experienced and knowledgeable about the use of illuminoss products.The tech who was preparing the balloon which was unable to have the air evacuated had previously primed three balloons successfully, this balloon was her fourth, and the distributor reported that her technique seemed adequate.The firm determined that user error is unlikely to have caused or contributed to this event.The user reported the white protective tube was left on the implant during the preparation steps as instructed by the ifu, the device was not removed from the packaging during the priming attempt, there were no additional steps taken, and the implant did not contact any sharp instruments.This indicates it is unlikely the balloon sustained any damage which might have caused a leak, before being primed.Ifu review: instructions for use include the device preparation steps performed by this user in this case, to "evacuate all of the air out of the implant" prior to proceeding to priming the balloon with monomer.Conclusion: the investigation was not able to identify a cause for this malfunction.Therefore, the root cause is undetermined.

• 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: 16812186
• MDR Text Key: 313999072
• Report Number: 3006845464-2023-00015
• Device Sequence Number: 1
• Product Code: QAD
• 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 Catalogue Number: USMS-07070
• Device Lot Number: 390757R
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/02/2021
• Initial Date FDA Received: 04/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2021
• 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: 75 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White