MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTALIF POSTERIOR CAGES; MECTALIF POSTERIOR TIPEEK 9X22X12 L5°

Model Number	03.27.115
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery due toback-out of the cage (ref:03.27.115) at 6 months from the primary (cages were inserted between l5-s1).The cages were replaced with the other competitor&size39, s cages.The fixation range was extended from l4-s to l4-s2ai.Unilateralapproach was used for cage insertion, andthe patient’ s bone quality was reported to be coarse.
Additional Manufacturer Narrative
Batch review performed on 12 nov 2025.Lot 2459213: (b)(4) items manufactured and released on 19-jun-2024.Expiration date: 2029-jun-02.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.Root cause:.
Additional Manufacturer Narrative
Fu1: pieces returned on 19 january 2026.Visual inspection performed by r&d project manager: following a posterior surgery from l4 to s1, one cage at level l5-s1 backed out (ref.(b)(4) , lot no.1721102a).During the visual inspection, the part was examined and the height of the device was measured.The cage was found to be conforming; in particular, the device height complies with the specifications.Based on the information available, it is not possible to clearly identify the root cause of the complaint.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 combined with potential intraoperative variables.

• Brand Name: MECTALIF POSTERIOR CAGES
• Common Device Name: MECTALIF POSTERIOR TIPEEK 9X22X12 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: 23655153
• Report Number: 3005180920-2025-01156
• Device Sequence Number: 17349410
• Product Code: MAX
• UDI-Device Identifier: 07630040719452
• UDI-Public: 07630040719452
• Combination Product (Y/N): N
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2026

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: 03.27.115
• Device Lot Number: 2459213
• 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: 11/07/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 02/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/19/2024
• 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 Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian