MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA M.U.S.T. MINI POLYAXIAL SCREW; CANN.POLY.SCREW-FULL THR-4.0X14+NUT(STE)

Model Number	03.75.202
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	12/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation performed by spine r&d project manager.I checked the myspine case code m_mot_ops_yu_17061943 and the planning information provided.In the complaint is mentioned that the right side of c04 was fractured.The fracture most likely occurred during the probing/tapping since in the pre-op scan there is no sign of fractures.Batch review performed on 18 november 2025: lot 2124396: (b)(4) items manufactured and released on 30-sep-2021.Expiration date: 2026-sep-09.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.Patient match planning review performed by spine mysolution project manager: our analysis of the myspine process of this case found no deviations from the standard procedures.Each step has been performed correctly.Root cause:the c4 pedicle fracture was most likely caused by intraoperative mechanical stress during probing, tapping, or screw insertion, potentially due to minor alignment variations between the actual surgical trajectory and the prepared pedicle anatomy.These biomechanical stresses, although within normal surgical technique parameters, may have exceeded the structural tolerance of the pedicle, resulting in the fracture.There is no indication that any potential issue with the device may have caused or contributed to the event, and the investigation does not indicate any potential manufacturing-related issue.
Event or Problem Description
Spinal fixation was performed at c3-c5 with myspine cervical guide.Patient's bone quality is normal.The pedicle bone was fractured while attempting to insert a pedicle screw into the right side of c4, finally, the screws in c4 were not implanted.Screw hole preparation: 12mm stopper drill through myspine guide, 20mm stopper probe, 3.5mm tapping, pedicle screw insertion through guidewire.
Additional Manufacturer Narrative
Follow up reason: due to human error, incorrect ref and lot was reported in the complaint form.Discrepancy confirmed on (b)(6) 2025 at device receipt.Batch review performed on 18 november 2025: lot 2124296: (b)(4) items manufactured and released on 13-sep-2021.Expiration date: 2026-aug-23.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.Investigation performed by (b)(4) project manager.After reviewing the myspine case and the available planning information, the fracture on the right side of c04 most likely occurred during the probing/tapping phase, as no evidence of a fracture is visible on the pre-operative scan.Conclusion: the c4 pedicle fracture was most likely caused by intraoperative mechanical stress on the bone during probing, tapping, or screw insertion.These biomechanical stresses, although within normal surgical technique parameters, may have exceeded the structural tolerance of the pedicle, resulting in the fracture.There is no indication that any potential issue with the device may have caused or contributed to the event, and the investigation does not indicate any potential manufacturing-related issue.

• Brand Name: M.U.S.T. MINI POLYAXIAL SCREW
• Common Device Name: CANN.POLY.SCREW-FULL THR-4.0X14+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: 23669499
• Report Number: 3005180920-2025-01178
• Device Sequence Number: 18566820
• Product Code: NKG
• UDI-Device Identifier: 07630030863806
• UDI-Public: 07630030863806
• 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): 12/22/2025

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 Expiration Date: 08/23/2026
• Device Model Number: 03.75.202
• Device Lot Number: 2124296
• 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: 11/11/2025
• Supplement Date Received by Manufacturer: 12/09/2025
• Initial Report FDA Received Date: 11/28/2025
• Supplement Report FDA Received Date: 12/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/13/2021
• 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: 76 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian