MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTALIF OBLIQUE (TI PEEK) OBLIQUE INTERBODY FUSION DEVICE PEEK/TI 12X28X8 L0°; INTERVERTEBRAL OBLIQUE CAGE

Model Number	03.26.035
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/05/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
At 3 months after primary surgery (l4/l5/s1), the surgeon noticed that 1 cage was migrated.The surgeon removed all the screws and the migrated cage, implanting a competitor cage with must pedicle screws.
Additional Manufacturer Narrative
Batch review performed on 08 november 2021: lot 1620019b: (b)(4) items manufactured and released on 06-july-2021.Expiration date: 2026-06-15.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Lot 1620019a: (b)(4) items manufactured and released on 14-may-2021.Expiration date: 2026-04-21.No anomalies found related to the problem.To date, the item has been sold.Lot 1620019: (b)(4) items manufactured and released on 25-may-2016.Expiration date: 2021-05-03.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.

• Brand Name: MECTALIF OBLIQUE (TI PEEK) OBLIQUE INTERBODY FUSION DEVICE PEEK/TI 12X28X8 L0°
• Common Device Name: INTERVERTEBRAL OBLIQUE CAGE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 12874438
• Report Number: 3005180920-2021-00930
• Device Sequence Number: 4353355
• Product Code: MAX
• UDI-Device Identifier: 07630030830556
• UDI-Public: 07630030830556
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133192
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• 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): 11/25/2021

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 Expiration Date: 06/15/2026
• Device Model Number: 03.26.035
• Device Catalogue Number: 03.26.035
• Device Lot Number: 1620019B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2021
• Initial Report FDA Received Date: 11/25/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/06/2021
• 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: 74 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian