MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA M.U.S.T. MINI POLYAXIAL SCREW; CANNULATED POLYAXIAL SCREW 4.0 X 12 FULL THREAD + NUT

Model Number	03.75.201
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	07/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 29 july 2025: lot: 2459332: (b)(4) items manufactured and released on 01-jul-2024.Expiration date: 2029-04-06.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.Additional device involved, batch review performed on 29 july 2025: must mini 03.75.002 must mini poly.Screw-full thread-3.5x14+nut (ste) (k171369) lot: 2220379: (b)(4) items manufactured and released on 18-feb-2022.Expiration date: 2027-02-08.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
During surgery for metastatic spinal tumor, fixation was performed from c3 to c6 using lateral screws.C4-5 was skipped due to the presence of a tumor.A bony tunnel was created using the myspine guide, and after decompression, screws were inserted.At the stage of rod fixation, a fracture occurred at the base of the screw at c6 (l), prompting an extension of the fixation to bilateral c7.Although an attempt was made to insert a pedicle screw via the lateral mass at c7 (l), it interfered with the spinal canal and was subsequently removed.A pedicle screw was then inserted freehand along the ps trajectory, and the procedure was successfully completed.
Additional Manufacturer Narrative
Visual inspection performed by medacta spine r&d project manager: based the visual inspection on retrieved device, no anomalies were observed and detected that could lead to bone fracture.Bone fracture can be reported as a consequence of specific vertebra morphology, specific screw trajectory as well as the critical condition of bone like described in the case report.In conclusion, we can say that t is not uncommon that such a bone fracture occurs while attempting to insert pedicle screw in the cervical vertebrae.It is expected that the users are familiar with the implant devices as well as in determining the appropriate screws trajectory related to parient anatomy and bone condition.Note: the batch review of 2 screws was inserted in the initial report 3005180920-2025-00753 because they were the 2 screws at level c6, but it is unknown to us at now, which of the 2 screws was at the level of the bone fracture generated.Edited fields: h6 h11.

• Brand Name: M.U.S.T. MINI POLYAXIAL SCREW
• Common Device Name: CANNULATED POLYAXIAL SCREW 4.0 X 12 FULL THREAD + NUT
• 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: 22769926
• Report Number: 3005180920-2025-00753
• Device Sequence Number: 13096953
• Product Code: NKG
• UDI-Device Identifier: 07630030863790
• UDI-Public: 07630030863790
• 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): 10/01/2025

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: 03.75.201
• Device Lot Number: 2459332
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/11/2025
• Supplement Report FDA Received Date: 10/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2024
• 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 Age: 70 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian