MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA M.U.S.T. MIDLINE CORTICAL (MC) SCREW SYSTEM; MUST MC SCREW Ø7X40 CANNULATED

Model Number	03.58.264
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2025, the patient had primary spine surgery l3-l5.On (b)(6) 2025, the patient reported pain and during revision surgery, the surgeon discovered that vertebral fusion had failed and 3 screws were broken.The surgeon was able to remove all the broken screws and replace them.Also, construct was expanded with a screw in left s1.The surgery was completed successfully ((b)(4)).Presently, on (b)(6) 2025, the surgeon determined the s1 screw was implanted too low and needed re-adjustment.The surgery involved no new medacta implants, but did result in taking out the set screws, the rod and back out the left s1 screw to re-adjust its location and then re-implant the same rod and set screws.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 10-11-2025.Lot 2325869: (b)(4) items manufactured and released on 03-08-2023.Expiration date: 2028-07-12.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.Clinical evaluation performed by clincal department.A revision surgery was performed a few days after the initial procedure solely to adjust the position of the left s1 screw.This was a surgical decision related to screw placement and is not associated with any device defect or failure.Root cause: the revision surgery was performed according to the surgical decision to adjust the position of the left s1 screw.There is no indication that any potential issue with the device may have caused or contributed to the event, and the device history record review does not indicate any potential manufacturing related issue.

• Brand Name: M.U.S.T. MIDLINE CORTICAL (MC) SCREW SYSTEM
• Common Device Name: MUST MC SCREW Ø7X40 CANNULATED
• 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: 23669493
• Report Number: 3005180920-2025-01104
• Device Sequence Number: 13223271
• Product Code: NKB
• UDI-Device Identifier: 07630971293762
• UDI-Public: 07630971293762
• Combination Product (Y/N): N
• PMA/510(K) Number: K210427
• 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): 11/28/2025

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: 03.58.264
• Device Lot Number: 2325869
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2025
• Initial Report FDA Received Date: 11/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2023
• 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: Male