MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA ACDF 03.18.103 MECTA-C SA TIPEEK CAGE 15X13X7X7°; SPINE MECTA-C SA TIPEEK CAGE

Model Number	03.18.103
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 11 months from primary surgery the surgeon revised the acdf devices (c4-c5).The patient presented pseudoarthrosis, implant sublisdence, instability and metallosis was observed but for the surgeon it is unknown which is the principal revision reason.Revision was completed successfully implanting competitor devices.The primary surgery was performed as 2 level extension of an existent spinal implant (c5-c6-c7).
Additional Manufacturer Narrative
Batch review performed on 03 march 2023: lot 2020735: (b)(4) items manufactured and released on 03-july-2020.Expiration date: 2025-06-22.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event in the period of review.Clinical evaluation performed by medical affairs director: one year after anterior cervical stabilization c4-c5 with interbody cage and snap-on plate, fixed by lag screws, the patient develops pseudoarthrosis and other neurological symptoms.The patient is an elderly lady with former adjacent surgery.The images supplied show a very evident subsidence of the cage and radiolucent contour around the whole length of the screws.Fusion obviously did not take place at all.We cannot establish the root cause with the information at hand.We could not identify a product defect that may be traced back to have caused this adverse event.The report mentions some difficulties in retrieving the cage: this is a separate issue, at the moment we are verifying if the dedicated instruments were available or not, but the failure of the fusion therapy had taken place previously.The report does not mention concomitant metabolic disorders that may have hindered the patient's fusion process and osseointegration of the cage.No final conclusion can be reached at this stage.Visual inspection performed by r&d manager: a mecta-c stand alone implant was removed on the (b)(6) 2023 after it was implanted on the (b)(6) 2022.The reference no.And the lot no.Involved are the following: cage: ref 03.18.103, lot.2020735.Plate lag flush: ref 03.18.217; lot.2022955a.Drill screw lag: ref 03.18.633; lot.2122088.From the post-op x-rays of the first surgery ((b)(6) 2022) it is possible to see that the device was inserted in the level above a cervical plate previously implanted.The distance of the bone between the bottom of the cage and the screws of the cervical plate could be estimated from the picture in about 5mm.From the pre-op x-rays of the second surgery ((b)(6) 2023) it is possible to see that the thickness of the bone between the bottom of the cage and the screws of the cervical plate is close to 0 because of implant subsidence which can be caused by the non-union and continuous instability since the fusion did not take place as intended.Explanted implants returned to medacta do show some wear caused by the implant removal process most likely using and an aggressive forceps which is neither part of the standard instrumentation nor the surgical technique.The subsidence of the device could have caused some point of stress and as a consequence wear at the interface between screws and plates.Other devices involved: acdf 03.18.217 mecta-c sa - plate flush lag h7 (k192906) lot.2022955a: (b)(4) items manufactured and released on 03-mar-2021.Expiration date: 2026-02-16.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event in the period of review.No devices with lot 2022955 have been sold, they all have been transformed in 2022955a.Acdf 03.18.633 mecta-c sa drill screw lag ø3.8x16 (2x) (k192906) lot 2122088: (b)(4) items manufactured and released on 08-june-2021.Expiration date: 2026-05-19.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event in the period of review.

• Brand Name: ACDF 03.18.103 MECTA-C SA TIPEEK CAGE 15X13X7X7°
• 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: 16644026
• Report Number: 3005180920-2023-00177
• Device Sequence Number: 6157605
• Product Code: OVE
• UDI-Device Identifier: 07630040725576
• UDI-Public: 07630040725576
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K192906
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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
• Report Date (Section B): 03/30/2023

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: 06/22/2025
• Device Model Number: 03.18.103
• Device Catalogue Number: 03.18.103
• Device Lot Number: 2020735
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2023
• Initial Report FDA Received Date: 03/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/03/2020
• 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: 80 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White