MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA ACDF STAND ALONE CERVICAL; MECTA-C SA DRILL SCREW LOCK Ø3.8X14 (2X)

Model Number	03.18.622
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery 9 months after the primary due to mecta c sa plate fixation screw loosening.
Additional Manufacturer Narrative
Batch review performed on 12 december 2025.Acdf 03.18.622 mecta-c sa drill screw lock ø3.8x14 (2x) lot.2328162 (k192906) lot 2328162: (b)(4) items manufactured and released on 11-nov-2023.Expiration date: 2028-10-31.No anomalies found related to the problem.To date, 71 items of the same lot have been sold with no similar reported events during the period of review.Root cause: it is possible that variables unique to the specific surgical application involved may have resulted in the issue, however no confirmation can be made based on the evaluation.The device history record review does not indicate any potentially related manufacturing issue.

• Brand Name: ACDF STAND ALONE CERVICAL
• Common Device Name: MECTA-C SA DRILL SCREW LOCK Ø3.8X14 (2X)
• 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: 23864344
• Report Number: 3005180920-2025-01301
• Device Sequence Number: 10006282
• Product Code: OVE
• UDI-Device Identifier: 07630040726603
• UDI-Public: 07630040726603
• Combination Product (Y/N): N
• PMA/510(K) Number: K192906
• 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): 12/22/2025

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: 03.18.622
• Device Lot Number: 2328162
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2025
• Initial Report FDA Received Date: 12/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2023
• 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: 56 YR
• Patient Sex: Female