BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACDF MECTA-C SA - PLATE FLUSH LAG H7

    MDR report key: 19267221 · Received May 8, 2024

    Report

    Report Number
    3005180920-2024-00296
    Event Type
    Malfunction
    Date Received
    May 8, 2024
    Date of Event
    April 12, 2024
    Report Date
    June 14, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    OVE
    UDI-DI
    07630040725873
    PMA / PMN Number
    K192906
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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 · 0

    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.

    Description of Event or Problem · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    757806 ACDF MECTA-C SA - PLATE FLUSH LAG H7 SPINE PLATE OVE MEDACTA INTERNATIONAL SA 2023290 07630040725873

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other