MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA M.U.S.T. MINI POLYAXIAL SCREW; MUST MINI POLY.SCREW-FULL THREAD-3.5X12+NUT (STE)

Model Number	03.75.001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	03/12/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 30 march 2026.Lot: 2564334: (b)(4) items manufactured and released 09-oct-2025.Expiration date: 2030-sep-28.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 root cause: 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.
Event or Problem Description
Bone fracture during c2d t3 fixation at the base of the right c4/c6 screws.Pedicle preparation was carried out using the myspine guide, followed by decompression and screw insertion.After the insertion of the rod into the pedicle screw tulip, a fracture occurred and the screws were removed.Fixation at the affected level was skipped, and the procedure was concluded.No critical delay.
Additional Manufacturer Narrative
(b)(4) d9: pieces returned on 21 april 2026.R&d analysis.Based on the event description it was assumed that the bone condition and or the particular anatomy of the patient were not optimal to house the screw in a safe side in spine surgery, it is not uncommon that such a issue happen during the position of screw, causing the removal of screw from the fractured bone.In conclusion, we can assess that this accident is categories as individual patient anatomy related issue.The screw implant design is safe and effective.

• Brand Name: M.U.S.T. MINI POLYAXIAL SCREW
• Common Device Name: MUST MINI POLY.SCREW-FULL THREAD-3.5X12+NUT (STE)
• 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: 24762670
• Report Number: 3005180920-2026-00299
• Device Sequence Number: 10276534
• Product Code: NKG
• UDI-Device Identifier: 07630030863158
• UDI-Public: 07630030863158
• Combination Product (Y/N): N
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2026

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: 03.75.001
• Device Lot Number: 2564334
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/02/2026
• Supplement Report FDA Received Date: 05/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/09/2025
• 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 Age: 70 YR
• Patient Sex: Male
• Patient Race: Asian