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

Model Number USSL-1700260

Device Problem Material Separation (1562)

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

Event Date 09/17/2019

Event Type  malfunction  

Event Description

This mdr report is based on the reclassification of a previously reviewed complaint.During preparation for a case in germany, a user found the light fiber of the illuminoss implant broken after taking it out of the package.The device was not used.Another illuminoss implant was used.There was no patient impact.

Manufacturer Narrative

This mdr report is based on the reclassification of a previously reviewed complaint.Followup information provided by the user: the user reported that the implant was broken in the package and was not at the table.They directly used a new implant.Records review: a review of manufacturing records was performed, and found that the device met speciations at the time of manufacture and release, including 100% inspection for light output of assembled light fibers.Returned product evaluation: the device was received on 18nov2019 for evaluation.Visual inspection was performed, as well as inspection under magnification.The product defect was verified.The light fiber was observed broken at the y-connector.The product evaluation was not able to identify the cause of the light fiber break.Conclusion: the firm was unable to determine the cause of this reported malfunction.

• 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: 16826289
• MDR Text Key: 314122735
• Report Number: 3006845464-2023-00029
• Device Sequence Number: 1
• Product Code: QAD
• UDI-Device Identifier: M986USSL17002600
• UDI-Public: M986USSL17002600
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K181228
• 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
• Report Date: 04/27/2023

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: 05/31/2023
• Device Model Number: USSL-1700260
• Device Catalogue Number: SL-1700260
• Device Lot Number: 381041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2019
• Initial Date Manufacturer Received: 10/21/2019
• Initial Date FDA Received: 04/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2018
• 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 Sex: Male