MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTALIF 3D; MECTALIF POSTERIOR 3D 9X22X9 L5°

Model Number	03.41.057
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 04 may 2026 lot 2562442: 20 items manufactured and released on 03-sep-2025.Expiration date: 2030-07-24.No anomalies found related to the problem.To date, 14 items of the same lot have been sold with no similar reported events during the period of review.Clinical evaluation a few weeks after posterior l4-s1 fusion with plif cages, screws, and rods, revision surgery was performed due to cage backout.The available x-ray images clearly confirm that both l5-s1 cages migrated posteriorly.Early cage migration is typically associated with insufficient primary stability.This may be related to multiple factors including surgical variables (initial positioning, endplate preparation, posterior compression, etc), or patient-related factors (low bone quality, eccessive loading or movements, etc).Based on the available information, no definitive conclusion can be drawn regarding the root cause of this failure.However, there is currently no evidence suggesting a defective or malfunctioning device.
Event or Problem Description
Back-out of two mectalif posterior 3d cages implanted at l5/s via a unilateral approach was confirmed about 1 month after the primary surgery.Revision surgery performed using competitor`s cages.

• Brand Name: MECTALIF 3D
• Common Device Name: MECTALIF POSTERIOR 3D 9X22X9 L5°
• 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: 25253480
• Report Number: 3005180920-2026-00475
• Device Sequence Number: 21468953
• Product Code: MAX
• UDI-Device Identifier: 07630542731617
• UDI-Public: 07630542731617
• Combination Product (Y/N): N
• PMA/510(K) Number: K251016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2026

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: 03.41.057
• Device Lot Number: 2562442
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/22/2026
• Supplement Report FDA Received Date: 07/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/03/2025
• 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
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian