MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTALIF; MECTALIF OBLIQUE TIPEEK 10X24X10 L5°

Model Number	03.26.256
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Osseointegration Problem (3003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	07/30/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 06 aug 2025.Lot 2126732: (b)(4) items manufactured and released on 09-mar-2022.Expiration date: 2027-02-23.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.Lot 2224681: (b)(4) items manufactured and released on 02-sept-2022.Expiration date: 2027-08-17.No anomalies found related to the problem.Clinical evaluation performed by medical affair department a few weeks after an l2-l5 fusion surgery, the oblique cage placed at the l4-l5 level migrated posteriorly.The patient did not report any discomfort, and the migration was identified during a routine follow-up visit.The available x-ray images clearly confirm the occurrence.Given the short interval since surgery, the migration is most likely related to insufficient primary stability.This may be attributable to the initial positioning of the cage, but other surgical factors could also have contributed[?]for example, endplate preparation, posterior compression, or cage undersizing.Based on the current information, however, there is not enough evidence to draw a definitive conclusion.A revision surgery was not planned due to the patient's refusal; however, we cannot guarantee that leaving the cage in this position is without consequences.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.Note.One of the two cages was involved, and batches from both lots above have been reported.
Event or Problem Description
At 1 month and a half from primary spine surgery, during a post-op visit, the surgeon observed that the 10x24x10 l5° oblique cage had migrated out of the l4-l5 disc space.The patient's bone quality shows signs of osteopenia.A unilateral approach was used, compression was applied after cage insertion, shavers were used, not trials.The patient is not reporting pain and has refused a revision surgery at this time.

• Brand Name: MECTALIF
• Common Device Name: MECTALIF OBLIQUE TIPEEK 10X24X10 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: 22920622
• Report Number: 3005180920-2025-00792
• Device Sequence Number: 9235759
• Product Code: MAX
• UDI-Device Identifier: 07630971290587
• UDI-Public: 07630971290587
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K212831
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 08/29/2025

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: 03.26.256
• Device Lot Number: 2126732
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2025
• Initial Report FDA Received Date: 08/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/09/2022
• 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: 72 YR
• Patient Sex: Female