MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTALIF ANTERIOR SYSTEM; MECTALIF ANTERIOR STAND-ALONE TIPEEK CAGE 27X35X14 LORDOSIS 15°

Model Number	03.31.028
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
At about few days after primary, the patient came in reporting pain.From the tac it was visible that the screw implanted was near to s1 root.During the revision, because the head of the screw to be revised was stripped, all the implants had to be removed and a new cage, screws and plate put in.Surgery completed successfully.
Additional Manufacturer Narrative
Batch review performed on 16-apr-2025 (b)(4) items manufactured and released on 12-apr-2022.Expiration date: 17-mar-2027.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.Additional implants involved: mectalif anterior 03.30.202 mectalif anterior stand-alone plate flush h.14 mm (k124034) lot.2329503 batch review performed on 16-apr-2025 (b)(4) items manufactured and released on 23-jan-2024.Expiration date: 03-jan-2029.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.Mectalif anterior 03.30.133 mectalif anterior cage - enh screw diam.5x35 (2x) (k160605) lot.2228561 batch review performed on 16-apr-2025 (b)(4) items manufactured and released on 05-apr-2023.Expiration date: 13-mar-2028.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 department: a revision surgery was performed approximately 10 days after the primary alif (anterior lumbar interbody fusion) procedure.The patient reported pain, prompting a follow-up ct scan, which revealed that the lower screws securing the anterior plate were excessively long, breaching the sacral canal and impinging on the s1 nerve root.This complication may have been facilitated by suboptimal positioning of the interbody cage, which was not perfectly centered on the vertebral endplate.We do not have reasons to suspect a defective device.Root cause: based on the information available no definitive root cause can be established, although it is possible that the suboptimal positioning of the cage could have contributed to the event.There is no indication that any potential issue with the device may have caused or contributed to the event, and the device history record review does not indicate any potential manufacturing related issue.

• Brand Name: MECTALIF ANTERIOR SYSTEM
• Common Device Name: MECTALIF ANTERIOR STAND-ALONE TIPEEK CAGE 27X35X14 LORDOSIS 15°
• 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: 21968730
• Report Number: 3005180920-2025-00376
• Device Sequence Number: 8350855
• Product Code: OVD
• UDI-Device Identifier: 07630030834011
• UDI-Public: 07630030834011
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K160605
• 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): 05/05/2025

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: 03.31.028
• Device Lot Number: 2220166
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2025
• Initial Report FDA Received Date: 05/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/12/2022
• 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: 40 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White