MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTALIF OBLIQUE; MECTALIF OBLIQUE TIPEEK 12X32X12 L10°

Model Number	03.26.085
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Primary surgery performed on (b)(6) 2022.Single-segment spondylodesis l4-5 with myspine mc, must + mectalif oblique.First revision surgeryperformed on (b)(6) 2022 due to ventral cage migration.Second revision surgery performed on (b)(6) 2026 due tothe breakage of three screws ((b)(4)).Note: the complaint was not notified at the time the first revision surgery was performed.
Additional Manufacturer Narrative
Batch review performed on 06 febr 2026.Lot 2121367: (b)(4) items manufactured and released on 01-jul-2021.Expiration date: 2026-jun-10.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 clinical affairs dept.A revision surgery was performed a few days after l4-l5 fusion due to ventral migration of the interbody cage.The available x-ray image clearly confirms the occurrence of cage migration.This event is most likely related to insufficient primary stability, considering the very early occurrence.This could be associated with several factors, such as suboptimal positioning or sizing of the cage, endplate preparation, or inadequate posterior compression.Patient-specific factors may have also played a role.Based on the available information, it is not possible to draw definitive conclusions regarding the exact cause of the migration.Root cause: based on the information available, no definitive root cause can be established, while the device history record review does not indicate any potential manufacturing-related issue.Although it cannot be confirmed, the event is most likely related to insufficient primary stability, considering the very early occurrence.This could be associated with several factors, such as suboptimal cage positioning or sizing choise, combined with potential intraoperative variables, including endplate preparation or posterior compression.

• Brand Name: MECTALIF OBLIQUE
• Common Device Name: MECTALIF OBLIQUE TIPEEK 12X32X12 L10°
• 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: 24454889
• Report Number: 3005180920-2026-00138
• Device Sequence Number: 9968732
• Product Code: MAX
• UDI-Device Identifier: 07630030831034
• UDI-Public: 07630030831034
• Combination Product (Y/N): N
• PMA/510(K) Number: K133192
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 02/26/2026

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 Expiration Date: 06/10/2026
• Device Model Number: 03.26.085
• Device Lot Number: 2121367
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2026
• Initial Report FDA Received Date: 02/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2021
• 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: Unknown