MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTALIF TRANSFORAMINAL CAGES TIPEEK; MECTALIF TRANSFORAMINAL (TI PEEK) 03.23.151 TRANSFORAMINAL INTERBODY FUSION DEVI

Model Number	03.23.151
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 04 apr 2025.Lot 2463248: (b)(4) items manufactured and released on 16-dec-2024.Expiration date: 2029-11-28.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.Other device involved: mectalif transforaminal (ti peek) 03.23.151 transforaminal interbody fusion device tipeek 12x30x8 l5° (k200551) lot 2463925: (b)(4) items manufactured and released on 13-dec-2024.Expiration date: 2029-11-25.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.Visual inspection performed by r&d project manager two mectalif transforaminal tipeek cages, ref no.03.23.151, lot no.2463248, are damaged.In one of the cages, one of the endplates, in the area of connection with the inserter, is deformed: the endplate is bent, and the coating is cracked.In the other cage, the endplates are not deformed, but the coating is also cracked.The inserter used during the surgery was inspected, and it functions properly.Considering the description of the event and the damages to the cages, the root cause of the complaint could be that the implant was too large for the patient's anatomy.As a result, it was not possible to insert and pivot the device as prescribed in the surgical technique.An excessive force was then applied to the cage during hammering, leading to deformation of the implants.The surgeon revised liner height, which is a common practice to restore the joint stability.There is no indication that any potential issue with the device may have caused or contributed to the event.
Event or Problem Description
During surgery, the surgeon wanted a 7mm tlif cage, but the cages start from 8mm size.The surgeon tried to insert the cage 3 times, adjusting the cage position on the inserter each time (the cage was at 0° on the inserter).After three failed insertion attempts, the cage got damaged and the coating cracked.A new cage from a different lot also got damaged on the first attempt.The surgeon decided not to insert a cage.30 min of delay in the surgery due to this event (total time 2.5 hours).

• Brand Name: MECTALIF TRANSFORAMINAL CAGES TIPEEK
• Common Device Name: MECTALIF TRANSFORAMINAL (TI PEEK) 03.23.151 TRANSFORAMINAL INTERBODY FUSION DEVI
• 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: 21907228
• Report Number: 3005180920-2025-00323
• Device Sequence Number: 4085103
• Product Code: MAX
• UDI-Device Identifier: 07630030829284
• UDI-Public: 07630030829284
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K200551
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 04/25/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 03.23.151
• Device Lot Number: 2463248
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2025
• Initial Report FDA Received Date: 04/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2024
• 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: Other
• Patient Age: 47 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White