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

Model Number	USSL-1700260
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2019
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 3006845464-2023-00029
• Device Sequence Number: 7014310
• Product Code: QAD
• UDI-Device Identifier: M986USSL17002600
• UDI-Public: M986USSL17002600
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K181228
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2019
• Initial Report FDA Received Date: 04/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/25/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male