MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTALIF POSTERIOR (TI PEEK) POSTERIOR INTERBODY FUSION DEVICE PEEK/TI; INTERBODY VERTEBRAL CAGE

Catalog Number	03.27.115
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	06/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 30 june 2021: lot 1922752: (b)(4) items manufactured and released on 06-dec-2019.Expiration date: 2024-11-12.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with 3 similar reported events.Note that two equal devices were reported in this case.
Event or Problem Description
The patient came in reporting pain and post-op x-rays indicated that the cages had ejected posteriorly.The patient will be revised and the date of the revision is unknown.No more information will be available.

• Brand Name: MECTALIF POSTERIOR (TI PEEK) POSTERIOR INTERBODY FUSION DEVICE PEEK/TI
• Common Device Name: INTERBODY VERTEBRAL CAGE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 12098252
• Report Number: 3005180920-2021-00537
• Device Sequence Number: 14517923
• Product Code: MAX
• UDI-Device Identifier: 07630040719452
• UDI-Public: 07630040719452
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K181970
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/01/2021

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: 11/12/2024
• Device Catalogue Number: 03.27.115
• Device Lot Number: 1922752
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2021
• Initial Report FDA Received Date: 07/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention