MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA M.U.S.T. MINI POLYAXIAL SCREW; MUST MINI POLY.SCREW-FULL THREAD-3.5X14+NUT (STE)

Model Number	03.75.002
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	04/23/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 24 april 2025: lot 2460768: (b)(4) items manufactured and released on 05/07/2024.Expiration date: 11/06/2029.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.
Event or Problem Description
C2-c7 fixation surgery.Patient's pedicle bone cracked at c6 right side while inserting the 3.5x14 pedicle screw (2.7 diameter tapping performed).Strong bone.C6 level was skipped and the surgery was completed successfully.
Additional Manufacturer Narrative
Follow up 1: - device returned to manufactuer on 18-jun-2025 - visual inspection visual inspection: based on the event description, it was assumed that the patient bone condition was not optimal due to hard bone: basically, this condition could potentially introduce higher risk like bone or implant failure, in particular when screws are positioned under extreme trajectory and/or into reduced bone section.No defect can be found on the implant.The event was likely caused by factors that are independent from the screw.Conclusion: although no specific root cause can be confirmed, the issue experienced is likely related to the unique patient conditions and surgical application.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.

• Brand Name: M.U.S.T. MINI POLYAXIAL SCREW
• Common Device Name: MUST MINI POLY.SCREW-FULL THREAD-3.5X14+NUT (STE)
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 22025605
• Report Number: 3005180920-2025-00420
• Device Sequence Number: 9114690
• Product Code: KWP
• UDI-Device Identifier: 07630030863165
• UDI-Public: 07630030863165
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K171369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2025

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: 03.75.002
• Device Lot Number: 2460768
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/15/2025
• Supplement Report FDA Received Date: 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/05/2024
• 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: Other
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian