MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTA C CERVICAL INTERBODY FUSION DEVICE TIPEEK "DOME SHAPED" 14X16X7 L5°; SPINE CERVICAL CAGE

Model Number	03.28.722
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	01/27/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 03 february 2022.Lot 1923200: (b)(4) items manufactured and released on 10-july-2020.Expiration date: 2025-june-29.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Clinical evaluation performed by medical affairs director.Cage revision on a (b)(6) old lady 7 days after the implantation.According to the report, patient reported cervicalgia and radiculopathy c6.On the basis of the single lateral radiografic projection provided, it cannot be stated the position of the cage nor if it has moved after the surgery.The reason of this event cannot be determined on the basis of the available information.There is no reason to suspect that a defect of the device generated this problem.
Event or Problem Description
He cage was revised 1 week after the primary following suspected cervicalgia and painful-sensory c6 radiculopathy left.

• Brand Name: MECTA C CERVICAL INTERBODY FUSION DEVICE TIPEEK "DOME SHAPED" 14X16X7 L5°
• Common Device Name: SPINE CERVICAL 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: 13558599
• Report Number: 3005180920-2022-00136
• Device Sequence Number: 3696253
• Product Code: ODP
• UDI-Device Identifier: 07630030833045
• UDI-Public: 07630030833045
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K142744
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 02/18/2022

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: 06/29/2025
• Device Model Number: 03.28.722
• Device Catalogue Number: 03.28.722
• Device Lot Number: 1923200
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2022
• Initial Report FDA Received Date: 02/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/10/2020
• 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: 76 YR
• Patient Sex: Female
• Patient Weight: 70 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White