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

Model Number	03.27.046
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
L1 / l2 / l3 / l4 / l5 fixation surgery was performed on (b)(6) 2021.The surgeon noticed the cage back out by x-ray images on (b)(6) 2022.There was no problem with the x-ray image immediately after the surgery.The patient is currently asymptomatic.Two cages were reported, it is unknown which one has backed out.
Additional Manufacturer Narrative
Batch review performed on 26 january 2022.Lot 1920666: (b)(4).Expiration date: 2025-jul-21.No anomalies found related to the problem.(b)(4).In this case, two devices with the same lot numbers were reported, however, only one mobilized (unknown which one).Clinical evaluation performed by medical affairs director.Few weeks after multi-level lumbar stabilization surgery with pedicle screws and posterior cages, one of the cages at lower level backs out.It may require revision at later stage.Spontaneous cage back out is a possible adverse event following lumbar stabilization, vastly described in literature; the cause is often linked to insufficient compression or loss of compression bewtween vertebrae.No reason to suspect a faulty device at the origin of this complaint.

• Brand Name: MECTALIF POSTERIOR (TI PEEK) POSTERIOR INTERBODY FUSION DEVICE PEEK/TI
• Common Device Name: SPINE POSTERIOR 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: 13513696
• Report Number: 3005180920-2022-00087
• Device Sequence Number: 4207674
• Product Code: MAX
• UDI-Device Identifier: 07630030831881
• UDI-Public: 07630030831881
• 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
• 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): 02/11/2022

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: 07/21/2025
• Device Model Number: 03.27.046
• Device Catalogue Number: 03.27.046
• Device Lot Number: 1920666
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2022
• Initial Report FDA Received Date: 02/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/11/2020
• 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: Other
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian