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

Model Number	03.27.045
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	01/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 03-jan-2020.Lot 1520401: (b)(4) items manufactured and released on 23-oct-2017.Expiration date: 03.10.2022.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Clinical evaluation: early back-out of a tlif cage at l4-l5 in a two-level lumbar fusion with additional pedicle screws.We cannot identify a clear cause for cage backout.This is a possible adverse event following lumbar stabilization surgery, described in literature, and causes remain often undetermined.There is no evidence of a product defect causing the adverse event.
Event or Problem Description
Tlif surgery was performed on december 4 at l4-s due to due to spinal canal stenosis.The surgeon discovered the back out of the cage at l4-l5 on (b)(6).Revision surgery will be performed on (b)(6) 2020.
Additional Manufacturer Narrative
Visual inspection performed by r&d project manager the cage 03.27.045 lot 1520401 doesn't present any cracks or damage neither on the body nor on the pyramids.The overall dimensions of the implants (length, height and width) are conformed and the height of the pyramids on both sides is at the minimum of the tolerance (0.40mm) but they are conformed.Some pyramids, on one side, are under tolerance (minimum height detected 0.315mm); this under tolerance is probably due to the usage of the implant.On the 2nd of april 2020 medacta has been informed that the implant has been used as a transforaminal-oblique cage instead of as a posterior cage (as it should be).The surgery, therefore, was performed not in accordance with the medacta mectalif posterior surgical technique.Considering what is stated above the route cause of the mobilization could be the non-correct usage (misuse) of the implant during the surgery.
Event or Problem Description
1 cage was inserted obliquely into the 1 vertebral space.The cage was a posterior cage, but it was used as an oblique cage.

• Brand Name: MECTALIF POSTERIOR (TI PEEK) POSTERIOR INTERBODY FUSION DEVICE PEEK/TI
• Common Device Name: POSTERIOR INTERBODY FUSION DEVICE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9621501
• Report Number: 3005180920-2019-01161
• Device Sequence Number: 585828
• Product Code: MAX
• UDI-Device Identifier: 07630030831874
• UDI-Public: 07630030831874
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2020

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: 10/03/2022
• Device Model Number: 03.27.045
• Device Catalogue Number: 03.27.045
• Device Lot Number: 1520401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/25/2019
• Supplement Date Received by Manufacturer: 12/25/2019
• Initial Report FDA Received Date: 01/23/2020
• Supplement Report FDA Received Date: 04/03/2020
• 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