MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA M.U.S.T. MIDLINE CORTICAL (MC) SCREW SYSTEM; PEDICLE SCREW 03.58.234 MUST MC SCREW Ø5.5X40 CANNULATED

Model Number	03.58.234
Medical Device Problem Codes	Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Plif surgery was performed at l3-l5 with the myspine mc guide on (b)(6) 2025.The day after the surgery, ct scan was taken and it appeared that the entire guide had been placed tilted to the left (meaning that the trajectory of the screws are very different from the planning).No fitting issue with the guides was experienced during surgery.The patient is currently asymptomatic, and the surgeon is currently waiting for the bone fusion.Weak bone quality.
Additional Manufacturer Narrative
Batch review performed on 30 june 2025.Lot 2463010: (b)(4) items manufactured and released on 15/10/2024.Expiration date: 25/09/2029.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.Other device involved: myspine 7.0723 myspine-mc drill guide l03 (k173472) lot 17218s: (b)(4) items manufactured and released on 02/052025.Expiration date: 2025/10/24.No anomalies found related to the problem.Patient match planning review: our analysis of the myspine process of this case found no deviations from the standard procedures.Each step has been performed correctly.We have reproduced all guides with their bone model, in order to check the fitting again.We can confirm the stability and conformity of the guides.Clinical evaluation: a plif surgery at levels l3-l5 was performed utilizing patient-matched guides for screw positioning.According to the surgical report, the guide at the l3 level was positioned carefully.However, the postoperative ct revealed incorrect placement of both the left and right screws, which resulted out of the bone.Currently, the patient remains asymptomatic, and no decision regarding revision surgery has been made at this time.The analysis conducted by the patient-matched guide department revealed no procedural errors during the manufacturing or planning phases.Thus, it is reasonable to conclude that the event may be attributable to factors related to the intraoperative positioning of the guide, incomplete preparation of the bone for guide positioning, or anatomical changes in the bone structure that occurred in the interval between the preoperative ct scan and the actual surgery.While a definitive root cause could not be established, the investigation did not identify any deviations or anomalies in the device used, the planning protocol, or the manufacturing of the patient-specific guides.The incident is potentially attributable to intraoperative variables, such as suboptimal guide placement or bone preparation, or anatomical variations of the bone structure that may have arisen between the preoperative ct acquisition and the surgical procedure.

• Brand Name: M.U.S.T. MIDLINE CORTICAL (MC) SCREW SYSTEM
• Common Device Name: PEDICLE SCREW 03.58.234 MUST MC SCREW Ø5.5X40 CANNULATED
• 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: 22520976
• Report Number: 3005180920-2025-00656
• Device Sequence Number: 8633290
• Product Code: NKB
• UDI-Device Identifier: 07630971293465
• UDI-Public: 07630971293465
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K210427
• 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): 07/16/2025

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: 03.58.234
• Device Lot Number: 2463010
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2025
• Initial Report FDA Received Date: 07/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/15/2024
• 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 Age: 78 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian