MAUDE Adverse Event Report: Advanced Research Medical Trident; Sacroiliac Joint Fixation

Catalog Number	03-03
Medical Device Problem Codes	Mechanical Problem (1384); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	06/02/2026
Type of Reportable Event	Malfunction

• Brand Name: Trident
• Common Device Name: Sacroiliac Joint Fixation
• Manufacturer (Section D): Advanced Research Medical; 1515 highway 13 east; burnsville MN 55337
• Manufacturer (Section G): Advanced Research Medical; 1515 highway 13 east; burnsville MN 55337
• MDR Report Key: 50778688
• Report Number: 3016002322-2026-00002
• Device Sequence Number: 10754818
• Product Code: OUR
• UDI-Device Identifier: 00840239800244
• UDI-Public: 00840239800244
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K203373
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/15/2026

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 Catalogue Number: 03-03
• Device Lot Number: TG127AA
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 06/02/2026
• Initial Report FDA Received Date: 09/15/2026
• Is the Device Labeled for Single Use? (Y/N): No
• 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: Unknown