MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA M.U.S.T. POLYAXIAL PEDICLE SCREW; ENH. CANN. PEDICLE SCREW 6X35MM + NUT (1X) STERILE

Model Number	03.52.322
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); Medical device site infection (4845)
Date of Event	10/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed by medacta medical affairs manager: the available images consist of only two ct scan slices, which makes it quite challenging to confirm the reported screw mobilization or to identify any signs of infection.However, delayed infection following spinal fusion surgery is a well-documented adverse event described in the literature.At present, there is no reason to suspect that the cause is related to the implanted devices.Batch reviews performed on 27 october 2025: pedicle screw 03.52.322 enh.Cann.Pedicle screw 6x35mm + nut (1x) sterile (k141988) lot 2324078: (b)(4) items manufactured and released on 21-jun-2023.Expiration date: 2028-jun-05.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.Pedicle screw 03.52.322 enh.Cann.Pedicle screw 6x35mm + nut (1x) sterile (k141988) lot 2323578: (b)(4) items manufactured and released on 14-jun-2023.Expiration date: 2028-may-21.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.Pedicle screw 03.52.324 enh.Cann.Pedicle screw 6x45mm + nut (1x) sterile (k141988) lot 2321377: (b)(4) items manufactured and released on 03-may-2023.Expiration date: 2028-apr-04.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.Pedicle screw 03.52.324 enh.Cann.Pedicle screw 6x45mm + nut (1x) sterile (k141988) lot 2325799: (b)(4) items manufactured and released on 21-sep-2023.Expiration date: 2028-aug-30.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.Pedicle screw 03.50.450 bent rod ti 5.5 x 35mm - sterile (k121115) lot 2126659: (b)(4) items manufactured and released on 12-jan-2022.Expiration date: 2026-dec-21.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.Pedicle screw 03.50.451 bent rod ti 5.5 x 40mm - sterile (k121115) lot 2323419: (b)(4) items manufactured and released on 07-jun-2023.Expiration date: 2028-may-15.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.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.
Event or Problem Description
The patient had an infection and the pathogen is unknown.At about 5 months post primary the surgeon observed that the screws were loose due to the infection.The surgeon revised the screws and the rods.The surgery was completed successfully.

• Brand Name: M.U.S.T. POLYAXIAL PEDICLE SCREW
• Common Device Name: ENH. CANN. PEDICLE SCREW 6X35MM + 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: 23510664
• Report Number: 3005180920-2025-01088
• Device Sequence Number: 10097831
• Product Code: NKB
• UDI-Device Identifier: 07630030857577
• UDI-Public: 07630030857577
• Combination Product (Y/N): N
• PMA/510(K) Number: K141988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/10/2025

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: 03.52.322
• Device Lot Number: 2323578
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2025
• Initial Report FDA Received Date: 11/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2023
• 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 Age: 75 YR
• Patient Sex: Female