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

Model Number	03.27.033
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/31/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 09 september 2020: lot 1921458: (b)(4) items manufactured and released on 08-oct-2019.Expiration date: 2024-09-16.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.Clinical evaluation: a plif lumbar cage backs out few days after stabilization surgery and is replaced, along with the second cage at the same level, with a thicker one.Such problems are normally originated by excessive or asymmetrical distraction or excessive movements of the patient's spine.No reason to think that a defect of the product caused it.
Event or Problem Description
Plif surgery was performed with the mectalif posterior cage and competitor's pedicle screws at l4-l5 on (b)(6) 2020.All pedicle screws size were ø7mm-40mm.The back out of the right side of the cage was discovered at x ray after the primary surgery.Revision surgery was performed on (b)(6).All pedicle screws were replaced the size ø7mm with the size ø7.5mm.The surgeon replaced the 2 mectalif posterior cage 11x22x8 l5° with 2 mectalif posterior cage 11x22x10 l5°.

• 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: 10586670
• Report Number: 3005180920-2020-00647
• Device Sequence Number: 1257682
• Product Code: MAX
• UDI-Device Identifier: 07630030831751
• UDI-Public: 07630030831751
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K133192
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/16/2024
• Device Model Number: 03.27.033
• Device Catalogue Number: 03.27.033
• Device Lot Number: 1921458
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2020
• Initial Report FDA Received Date: 09/25/2020
• 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
• Patient Age: 80 YR