MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA ACDF 03.18.118 MECTA-C SA TIPEEK CAGE 18X15X6X7°; SPINE MECTA-C SA TIPEEK CAGE

Model Number	03.18.118
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 25-apr-2023 lot 2127224: (b)(4) items manufactured and released on 22-mar-2022.Expiration date: 2027-03-06.No anomalies found related to the problem.To date, 7 items of the same lot have been sold with no similar reported case during the period of review.Clinical evaluation performed by medical affairs director: right after a single-level cervical stabilization surgery involving a interbody cage and an anterior plate mechanically connected to the cage, the xray image shows that the plate detached from the body of the cage.However, the screws appear to be well embedded in bone and probably the construct is stable, which is also confirmed by the clinical report.Therefore, no adverse consequence should be expected.Understandably, the surgeon decided to refrain from reintervention.A possible cause could be the plate was not fully engaged with the cage at the time of insertion, but of course we cannot state that this is the case.Other device involved: acdf 03.18.206 mecta-c sa - plate flush lock h6 (k192906) lot 2120801: (b)(4) items manufactured and released on 20-jul-2021.Expiration date: 2026-07-05.No anomalies found related to the problem.To date, 92 items of the same lot have been sold with no similar reported case during the period of review.
Event or Problem Description
During the follow up visit, the x-rays revealed a disconnection between the cage and the plate.Patient is stable and non symptomatic, the fusion of the vertebrae appears to be correct and no revision surgery has been planned.The surgeon reported that will maintain monitored the patient.

• Brand Name: ACDF 03.18.118 MECTA-C SA TIPEEK CAGE 18X15X6X7°
• Common Device Name: SPINE MECTA-C SA TIPEEK CAGE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 16917741
• Report Number: 3005180920-2023-00355
• Device Sequence Number: 17876265
• Product Code: OVE
• UDI-Device Identifier: 07630040725729
• UDI-Public: 07630040725729
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K192906
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/12/2023

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 Model Number: 03.18.118
• Device Catalogue Number: 03.18.118
• Device Lot Number: 2127224
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2023
• Initial Report FDA Received Date: 05/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/22/2022
• 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: Required Intervention
• Patient Age: 47 YR
• Patient Sex: Male
• Patient Weight: 120 KG