MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA M.U.S.T. POLYAXIAL PEDICLE SCREW; ENH. CANN. PEDICLE SCREW 6X45MM + NUT (1X) STERILE

Model Number	03.52.324
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	02/02/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 06 febr 2026.Lot 2323172: (b)(4) items manufactured and released on 20-jun-2023.Expiration date: 2028-may-31.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 r&d project manager.The screw exhibits a fracture directly beneath the head, most likely resulting from fatigue failure due to cyclic loading.The failure is possibly associated with incomplete fusion, which may have created a stress concentration zone initiating crack propagation.Root cause: the most plausible contributing factor is the lack of solid osseous fusion postoperatively, which may have resulted in increased mechanical loading on the screw under physiological conditions, potentially leading to fatigue crack initiation and eventual breakage.While the exact root cause cannot be definitively confirmed, the investigation found no evidence of manufacturing defects or systemic issues related to the device.
Event or Problem Description
At 1 year and 2 months from primary, the patient came in presenting pain and the cause was determined to be a broken screw.The surgeon suspected loosening of the screws, but found one had completely broken at the l5 location.No indications of trauma were present.The surgeon revised the rods and all screws.The surgery was completed successfully.Bone quality reported to be normal.
Additional Manufacturer Narrative
Visual inspection performed by medacta spine r&d project manager: investigation performed in the intial mdr is confirmed.In the cross-sectional area at the fracture location, two distinct regions can be observed, which are typical of a fatigue fracture: the first one is smoother and relatively flat, while the second one is rougher and more irregular, corresponding to the final rapid fracture zone.Investigation reported in the intial mdr 2026-00123.Investigation performed by r&d project manager the screw exhibits a fracture directly beneath the head, most likely resulting from fatigue failure due to cyclic loading.The failure is possibly associated with incomplete fusion, which may have created a stress concentration zone initiating crack propagation.Root cause: the most plausible contributing factor is the lack of solid osseous fusion postoperatively, which may have resulted in increased mechanical loading on the screw under physiological conditions, potentially leading to fatigue crack initiation and eventual breakage.While the exact root cause cannot be definitively confirmed, the investigation found no evidence of manufacturing defects or systemic issues related to the device.

• Brand Name: M.U.S.T. POLYAXIAL PEDICLE SCREW
• Common Device Name: ENH. CANN. PEDICLE SCREW 6X45MM + NUT (1X) STERILE
• 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: 24481993
• Report Number: 3005180920-2026-00123
• Device Sequence Number: 21401943
• Product Code: NKB
• UDI-Device Identifier: 07630030857591
• UDI-Public: 07630030857591
• Combination Product (Y/N): N
• PMA/510(K) Number: K141988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2026
• 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): 03/24/2026

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: 03.52.324
• Device Lot Number: 2323172
• 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: 02/02/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/02/2026
• Supplement Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/20/2023
• 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 Sex: Female
• Patient Race: White