MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTALIF POSTERIOR CAGES; POSTERIOR INTERBODY FUSION DEVICE PEEK/TI 9X22X11 L5°

Model Number	03.27.114
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/10/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 14 july 2025.Lot 1822364e: (b)(4) items manufactured and released on 25-nov-2024.Expiration date: 2029-11-10.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events during the period of review (2 devices involved in this complaint).Clinical evaluation: a revision surgery was performed 9 days following an initial l3-l5 fusion surgery involving the use of plif cages at both levels.The reason for the revision was the complete migration of the right cage and slight posterior displacement of the left cage at the l4-l5 level.This cage migration is clearly confirmed by the available radiographic/ct images.The migration of the cage likely resulted from inadequate primary stability.This can be attributed to the initial positioning, but also to other potential surgical factors (related for example to preparation of the endpates, posterior compression, undersizing, etc).Additionally, at the superior level (l3-l4), the cages appear slightly posteriorly positioned.However, as these were not revised, this placement may reflect a deliberate surgical choice, although the exact reasoning cannot be confirmed based solely on the available information.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 issue reported may have resulted from application-specific factors, such as suboptimal cage positioning, in combination with potential intraoperative variables, including preparation of the endpates, posterior compression, undersizing.
Event or Problem Description
Revision surgery at 9 days after the primary at l3-l5 plif due to complete cage migration on the right side at l4-l5, and slight movement of the left-sided cage.Both cages at l4-l5 were replaced with competitor's cages.

• Brand Name: MECTALIF POSTERIOR CAGES
• Common Device Name: POSTERIOR INTERBODY FUSION DEVICE PEEK/TI 9X22X11 L5°
• 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: 22630979
• Report Number: 3005180920-2025-00703
• Device Sequence Number: 15765831
• Product Code: MAX
• UDI-Device Identifier: 07630040719445
• UDI-Public: 07630040719445
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K181970
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/28/2025

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: 03.27.114
• Device Lot Number: 1822364E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2025
• Initial Report FDA Received Date: 07/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/25/2024
• 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: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian