MAUDE Adverse Event Report: Medacta International SA M.U.S.T. Polyaxial Pedicle Screw; M.U.S.T. cannulated polyaxial pedicle screw 6x40mm

Model Number	03.52.323
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	08/26/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
During revision surgery for an unknown cause, the screw fractured during extraction at the junction between the shaft and the screw head.
Additional Manufacturer Narrative
Batch review performed on 11 september 2026 03.52.323 m.U.S.T.Cannulated polyaxial pedicle screw 6x40mm (k141988) lot.2125453: 80 items manufactured and released on 04 november 2021.Expiration date: 18 october 2026.No anomalies found related to the problem.To date, 78 items of the same lot have been sold with no similar reported event during the period of review.R&d analysis the screw fracture occurred just below the spherical head.Two distinct areas can be observed on the fracture surface, which may be indicative of a progressive failure mechanism.No detailed information regarding the indication for the revision surgery is currently available, and no x-rays were provided for evaluation.Based on the available information, it cannot be excluded that the screw was exposed to repeated cyclic loading over time, potentially in association with an incomplete fusion condition.This hypothesis cannot be confirmed in the absence of radiographic and additional clinical information.Nevertheless, the observed fracture appearance is compatible with a possible fatigue-related failure mechanism, where repeated cyclic loading may have progressively propagated a crack until final breakage occurred.Conclusion: the screw breakage is compatible with a fatigue-related fracture due to repeated cyclical loading over time, and this may have involved a lack of fusion, however the specific factors involved cannot be confirmed and the reason for revision surgery was reported as unknown with no clinical data provided.Although a specific root cause cannot be determined, the investigation does not indicate any potential manufacturing related issue or systemic deficiency.

• Brand Name: M.U.S.T. Polyaxial Pedicle Screw
• Common Device Name: M.U.S.T. cannulated polyaxial pedicle screw 6x40mm
• 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: 50946479
• Report Number: 3005180920-2026-00967
• Device Sequence Number: 9499621
• Product Code: KWQ
• UDI-Device Identifier: 07630030857584
• UDI-Public: 07630030857584
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K141988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2026

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: 03.52.323
• Device Lot Number: 2125453
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/21/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/30/2026
• Supplement Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/04/2021
• 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: Required Intervention
• Patient Age: 82 YR
• Patient Sex: Male