MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA M.U.S.T. SACRAL ILIAC SCREW AND PELVIC TRAUMA SYSTEM; MUST-SI TI-HA SCREW 8X50MM, FULL THREAD, STERILE

Model Number	03.65.506
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	11/12/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No batch review available since the lot is still unknown.Root cause: based on the information available no definitive root cause can be established, while there is no indication that any potential issue with the device may have caused or contributed to the event, and the device history record review does not indicate any potential manufacturing related issue.
Event or Problem Description
During a sacro-iliac joint fixation, approximately one month after the primary surgery, the patient returned reporting pain.X-rays showed a radiolucent shadow around the proximal must-si screw, leading the surgeon to suspect a possible infection.

• Brand Name: M.U.S.T. SACRAL ILIAC SCREW AND PELVIC TRAUMA SYSTEM
• Common Device Name: MUST-SI TI-HA SCREW 8X50MM, FULL THREAD, STERILE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro 6874 ; SZ 6874
• MDR Report Key: 23669498
• Report Number: 3005180920-2025-01201
• Device Sequence Number: 21257607
• Product Code: OUR
• UDI-Device Identifier: 07630030880865
• UDI-Public: 07630030880865
• Combination Product (Y/N): N
• PMA/510(K) Number: K171595
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/28/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 03.65.506
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2025
• Initial Report FDA Received Date: 11/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown