MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTALIF OBLIQUE (TI PEEK) OBLIQUE INTERBODY FUSION DEVICE PEEK/TI 12XX28X9 L5°; INTERVERTEBRAL CAGE

Catalog Number	03.26.044
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 20 november 2019: lot 1820087: 60 items manufactured and released on 21-jan-2019.Expiration date: 2024-01-07.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.
Event or Problem Description
The surgeon discovered the back out of the oblique interbody fusion device peek/ti at l5-s1.The patient had 2 surgeries before.This is the second experience of the back out for the same patient.The first surgery date is unknown.The second surgery was performed on august 23.No additional info is available at the moment.The surgeon successfully revised the implant.

• Brand Name: MECTALIF OBLIQUE (TI PEEK) OBLIQUE INTERBODY FUSION DEVICE PEEK/TI 12XX28X9 L5°
• Common Device Name: INTERVERTEBRAL CAGE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9408357
• Report Number: 3005180920-2019-01031
• Device Sequence Number: 16885678
• Product Code: MAX
• UDI-Device Identifier: 07630030830631
• UDI-Public: 07630030830631
• 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: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/04/2019

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: 01/07/2024
• Device Catalogue Number: 03.26.044
• Device Lot Number: 1820087
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2019
• Initial Report FDA Received Date: 12/04/2019
• 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
• Patient Age: 71 YR