MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA M.U.S.T. PEDICLE SCREW SYSTEM; FENESTRATED POLYAX. CANN. PED. SCR. 6X45,DUAL-DIAM

Model Number	03.61.324
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During a posterior spinal surgery, the first step reducer failed to properly attach to the screw head.Inspection revealed that a metal plate was missing from the distal part of the instrument.Intraoperative fluoroscopy confirmed that the piece was not retained inside the patient; it may have already been missing prior to surgery.On the right l5 screw, the second step reducer caused the set screw to repeatedly cross-thread, damaging the screw head threads.This reducer also lost the same small metal component.As a result, the surgeon replaced the right l5 screw and bent the rod into greater lordosis to place the set screw without a persuader, as no functioning reduction instrument was available.Surgery completed with 30/40 min delay (total time surgery 3 hours 10 minutes).No pieces left in the patient.
Additional Manufacturer Narrative
Batch review performed on 17 oct 2025.Pedicle screw 03.51.10.0581 1-step reducer enh.2019 lot 2161268: (b)(4) items manufactured and released on 22-jun-2022.No anomalies found related to the problem.To date, no similar events have been reported on the same lot during the period of review.Pedicle screw 03.51.10.0581 1-step reducer enh.2019 lot 2155227: (b)(4) items manufactured and released on 24-nov-2021 + (b)(4) items manufactured and released on 04-jan-2022.No anomalies found related to the problem.To date, 6 similar events have been reported on the same lot during the period of review.Pedicle screw 03.61.324 fenestrated polyax.Cann.Ped.Scr.6x45, dual-diam (k241034) lot 2464844: (b)(4) items manufactured and released on 10-dec-2024.Expiration date: 2029-nov-25.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 one of the plates of the tip that act as interface with the tulip is separated from the instrument due to damage of the welding.The screw presents damage to the thread of the tulip.This may have been caused by not optimal alignment between the instrument and the pedicle screw head, during reduction operation: if this happens, the retaining pins don't enter the respective socket in the head, leading to excessive load on the welding.Design modifications have been introduced to welding indications and inspection methods to improve the manufacturing process and potentially reduce damaging events.It is likely that the suboptimal alignment between the instrument and the pedicle screw head led the retaining pins to not engage in the respective sockets in the screw head, leading to excessive load on the welding of the plate, in combination with the inherent limitations of the design version involved.

• Brand Name: M.U.S.T. PEDICLE SCREW SYSTEM
• Common Device Name: FENESTRATED POLYAX. CANN. PED. SCR. 6X45,DUAL-DIAM
• 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: 23543692
• Report Number: 3005180920-2025-01083
• Device Sequence Number: 9458104
• Product Code: PML
• UDI-Device Identifier: 07630030862120
• UDI-Public: 07630030862120
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K241034
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/13/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 03.61.324
• Device Lot Number: 2464844
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2025
• Initial Report FDA Received Date: 11/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/10/2024
• 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 Sex: Unknown