MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTA C CERVICAL INTERBODY FUSION DEVICE TIPEEK "DOME SHAPED" 14X16X4; SPINAL CERVICAL CAGE

Catalog Number	03.28.719
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 19-jul-2023.Lot 1923055: (b)(4), manufactured and released on 16-mar-2020.Expiration date: 2025-02-24.No anomalies found related to the problem.To date, (b)(4), of the same lot have been sold without any similar reported event during the period of review.
Event or Problem Description
Revision surgery performed due to infection that caused caudal and cranial vertebral fracture about 2 months after the primary surgery.The cage was replaced.
Additional Manufacturer Narrative
Visual inspection performed by r&d manager: the mecta-c cage ref.03.28.719, lot no.1923055, appears damaged.Both the cranial and caudal endplates are damaged and it can be related both to the mobilization of the implant because of the non-fusion that occurred and to the attempt to remove the device during the revision surgery.

• Brand Name: MECTA C CERVICAL INTERBODY FUSION DEVICE TIPEEK "DOME SHAPED" 14X16X4
• Common Device Name: SPINAL CERVICAL 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: 17387948
• Report Number: 3005180920-2023-00605
• Device Sequence Number: 6083732
• Product Code: ODP
• UDI-Device Identifier: 07630030833014
• UDI-Public: 07630030833014
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K142744
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2023

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 Expiration Date: 02/24/2025
• Device Catalogue Number: 03.28.719
• Device Lot Number: 1923055
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2023
• Supplement Date Received by Manufacturer: 07/07/2023
• Initial Report FDA Received Date: 07/25/2023
• Supplement Report FDA Received Date: 09/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/16/2020
• 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: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male