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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	06/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Few days after the primary lumbar fusion with posterior supplementation performed on (b)(6) 2026, the patient developed an infection.The patient received two other surgeries for surgical cleaning, on (b)(6) 2026.No devices revised.
Additional Manufacturer Narrative
Batch review performed on 07 july 2026 03.52.323 enh.Cann.Pedicle screw 6x40mm + nut (1x) sterile (k141988) lot 2566405: (b)(4) items manufactured and released on 09-dec-2025.Expiration date: 09-nov-2030.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.03.52.322 enh.Cann.Pedicle screw 6x35mm + nut (1x) sterile (k141988) lot 1923102c: (b)(4) item manufactured and released on 29-aug-2025.Expiration date: 28-jul-2030.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.03.52.322 enh.Cann.Pedicle screw 6x35mm + nut (1x) sterile (k141988) lot 2020513a: (b)(4) items manufactured and released on 29-aug-2025.Expiration date: 27-jul-2030.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.03.52.426 enh.Bent rod ti r200 5.5x50mm - sterile (k141988) lot 2561862: (b)(4) items manufactured and released on 28-jul-2025.Expiration date: 08-jul-2030.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.03.30.131 mectalif anterior cage - enh screw diam.5x25 (2x) (k160605) lot 2564903: (b)(4) items manufactured and released on 02-oct-2025.Expiration date: 21-sep-2030.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.03.30.132 mectalif anterior cage - enh screw diam.5x30 (2x) (k160605) lot 2559770: (b)(4) items manufactured and released on 09-apr-2025.Expiration date: 25-mar-2030.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.03.33.027 mectalif anterior flush mx tipeek 27x35x12 l15° (not registered in us) lot 2563914: (b)(4) items manufactured and released on 04-nov-2025.Expiration date: 05-oct-2030.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.Root cause: infection is a known possible complication of any surgery.Although no root cause can be established, there is no indication that any issue with the device may have caused or contributed to the event, and the document review does not indicate any potential manufacturing related cause.

• 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 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro 6874 ; SZ 6874
• MDR Report Key: 25854818
• Report Number: 3005180920-2026-00755
• Device Sequence Number: 5558284
• Product Code: NKB
• UDI-Device Identifier: 07630030857584
• UDI-Public: 07630030857584
• Combination Product (Y/N): N
• PMA/510(K) Number: K141988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/17/2026

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: 2566405
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2026
• Initial Report FDA Received Date: 07/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2025
• 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: Required Intervention
• Patient Sex: Female