MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA ACDF MECTA-C SA - PLATE FLUSH LAG H7; SPINE PLATE

Catalog Number	03.18.217
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The anti-backout screw broke at the predetermined breaking point, but the thread of the anti-backout screw also broke off and got stuck in the plate flush lag.The surgeon decided to leave the cage in the patient without the antibackout screw.
Additional Manufacturer Narrative
Batch review performed on 19 april 2024 lot 2023290: (b)(4) items manufactured and released on 08-jun-2021.Expiration date: 2026-05-11.No anomalies found related to the problem.To date, 16 items of the same lot have been sold with no similar reported event during the period of review.Preliminary analysis performed by r&d project manager.The antibackout screw ((b)(4)) unexpectedly broke in the thread area.The device is designed to have a broken point between the screw head and the shaft used to handle the implant: during the insertion the surgeon keeps on screwing the implant and the shaft is detached from the screw.According to the pictures received the screw is correctly detached from the shaft but it is also broken under the screw head, in the thread area.From the information received it is not possible to clearly identify the root cause of this complaint.
Additional Manufacturer Narrative
Visual inspection performed by r&d project manager: the acdf antibackout screw is broken in two different points: one breakage point is correctly located in the shaft connection area while the second breakage point is where the thread begins, under the screw head.The antibackout screw is designed to have a desired breakage point where the shaft ends.The shaft should break when the screw is fully seated in the acdf lag plate and the screw should not break in the thread area.Considering the information available it is not possible to clearly identify the root cause of the complaint.Information reported in this follow up: piece returned on 16 may 2024.Visual inspection of the device.

• Brand Name: ACDF MECTA-C SA - PLATE FLUSH LAG H7
• Common Device Name: SPINE PLATE
• 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: 19267221
• Report Number: 3005180920-2024-00296
• Device Sequence Number: 6981112
• Product Code: OVE
• UDI-Device Identifier: 07630040725873
• UDI-Public: 07630040725873
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K192906
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/11/2026
• Device Catalogue Number: 03.18.217
• Device Lot Number: 2023290
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/08/2024
• Supplement Report FDA Received Date: 06/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/08/2021
• 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: Other
• Patient Sex: Male
• Patient Race: White